RESEARCH STRATEGY · PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Myers, Ronald E. PCORI Research...

PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Myers, Ronald E.

PCORI Research Plan – PFAs 1-4

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PCORI RESEARCH PLAN Applicants are encouraged to refer to the contents of the PCORI Methodology Report in developing their Research Plan.

RESEARCH STRATEGY

(Use continuation pages as needed to provide the required information in the format shown below. Limit 15 pages for this section. Refer to the PCORI

Application Guidelines and the PFA to which you are applying, found on the PCORI Funding Center, for additional guidance. )

RESPONSE TO REVIEWERS

Project Summary.

Comment 1: Provide more details about colorectal cancer (CRC) screening innovativeness.

Response: CRC screening is widely accepted in preventive health care. Therefore, CRC screening is not novel. The proposed study will test the impact of an innovative decision support and navigation intervention (DSNI) on CRC screening adherence. The innovative nature of the multi-level DSNI as an intervention strategy is described in Sections 3.1.1 and 3.1.2. It is also novel that the DSNI will be tested among Hispanic primary care patients for the first time.

Comment 2: Explain how patient experiences related to CRC screening will be improved.

Response: Section 3.3.4 describes steps that will be taken in the DSNI Group to improve patient knowledge about CRC screening, access to a preferred screening test, development of a patient-centered screening plan, navigation through the process of implementing the personalized screening plan, and communication with primary care providers.

Criterion 1. Demonstrate that the condition imposes a significant burden on the health of individuals and populations

Comment 1: Explain why increasing CRC screening is particularly important for Hispanics (R1).

Response: CRC screening rates among Hispanics are significantly lower than screening rates among non-Hispanic whites. This disparity contributes to the detection of more late-stage disease at time of diagnosis among Hispanics, which leads to higher mortality and lower survival. Reducing the persistent disparity in screening will help to mitigate related disparities in mortality and survival among Hispanics.1,2

Comment 2: Explain how the issue of undocumented workers will be addressed (R2).

Response: The research team is sensitive to the possible reluctance of undocumented immigrants to participate in a publically-funded study. In describing the study to prospective participants, we will explain that information related to their participation will be known only by members of the research team, and information related to screening will be shared only by with their health care provider.

Criterion 2. Explain how the results of the study would likely improve health care and outcomes

Comment 1: Provide evidence that patients or clinician groups have identified this type of research as a priority (R1).

Response: Hispanic primary care patients and primary care provider stakeholders in the Lehigh Valley Health Network (LVHN) who participated in focus groups described in Section 4.1 of the application expressed concerns about CRC and support for efforts aimed at increasing knowledge about CRC, improving communication with primary care providers about CRC and screening, raising CRC

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screening rates in the Hispanic community, and reducing the disparity between Hispanics and nonHispanic whites in CRC screening. These reports are consistent with findings reported in various research studies referenced in the application and in the Latino Cancer Report.3

Comment 2: Explain why a marginal change in screening is an important improvement (R1).

Response: We estimate that the DSNI will generate a CRC screening adherence rate that is at least 15 percentage-points higher than the mailed standard intervention (SI), or 45% versus 30% screening rates, respectively. This level of impact is a conservative estimate of the proposed DSNI effect, and represents a 50% increase over the SI. This level of improvement, along with increased complete follow-up of participants who have an abnormal screening test result can substantially increase the likelihood of finding colorectal adenomas and early CRC, attenuate the screening disparity between Hispanics and nonHispanic whites, and reduce disparities in CRC mortality and survival.

Comment 3: Explain the added value of decision support over and above navigation (R1)

Response: An important aspect of the proposed DSNI is that bilingual Hispanic patient navigators (promotoras) will be trained to support both study participants and primary care providers. In terms of decision support for participants, the navigator will clarify each participant’s preferred screening test; elicit personal, culturally-relevant barriers to and facilitators of performance of screening; develop a person-centered screening plan; and, send a copy of the plan to the participant. In terms of primary care provider support, the navigator will inform the provider of the participant’s screening plan; will contact the practice office manager to ensure provider support for the screening plan; and, will act as an agent for the provider to facilitate screening plan implementation, including obtaining needed referrals and appointment-scheduling.

Comment 4: Explain how research findings will translate to other locations (R2).

Response: Study findings will be immediately relevant, not only to LVHN primary care practices, but also to primary care practices and health care systems that serve Hispanic patients. Intervention materials and methods will be available in English and Spanish. In addition, the research team will make the training manual developed in the project available for use in the LVHN and other health care systems. Effective intervention materials and methods will also be made available through an online National Institutes of Health-supported intervention dissemination website, known as Cancer Control Planet, which dedicated to disseminating “Research Tested Intervention Programs.”

Comment 5: Clarify the role of patient navigator – and justify 100% FTE (R2).

Response: In the proposed study, the navigator will be a bilingual health educator with a bachelor’s degree (or equivalent experience) in a healthcare related field. Initially the navigator will obtain certification for human subject protection and participate in training on study design and intervention implementation procedures. Once intervention delivery begins, the navigator will contact each participant randomized to the DSNI Group to establish the patient’s decision regarding screening, and establish the participant’s preferred method of screening. For those who prefer to complete a stool blood test (SBT), the navigator will assure that the participant has the appropriate screening kit and instructions for collecting and returning the specimen. For those who prefer colonoscopy, the navigator will obtain the needed specialist referral, schedule the screening appointment, explain procedure preparatory steps, arrange transportation where necessary, and make follow-up contact to assure completion of the procedure. The navigator will assure that all patients in the study who have a positive SBT test, whether intervention or control, will be scheduled for and complete a diagnostic colonoscopy. The navigator will also record and manage research data related to the position, and prepare reports for the patient and stakeholder advisory committee and the research team. Furthermore, the navigator will contact the office manager of each participating practice in order to ensure receipt of the screening plan developed for each DSNI Group participant and the screening record. We believe it is reasonable



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to expect that the navigator will devote 100% effort in Years 1 and 2, when patient and provider contacts are the most intensive, and will devote 50% effort in Year 3, when patient and provider contacts are less frequent.

Comment 6: Indicate if the healthcare system has implemented prior findings from the research team (R1, R2).

Response: The study team previously conducted CRC screening research sponsored by the Agency for Healthcare Research and Quality.4 Findings from that earlier project have influenced the LVHN clinic system to make CRC screening more readily accessible to primary care patients. Specifically, the Community Health and Wellness Center (a community-focused outreach office that supports LVHN clinics) has initiated a centralized registry service for identifying and recruiting patients to participate in the current screening programs. The Center for Health and Wellness also added stool blood test kits to the choices made available for patients.

Comment 7: Evaluate costs of intervention implementation (R1).

Response: PCORI explicitly excludes cost analyses from being part of research studies it supports. The planned multi-level evaluation included in the proposed study will provide insights into barriers to and facilitators of screening intervention implementation, and resources needed for implementation.

Criterion 3: Demonstrate the technical merit of the application (Previously Criterion 5: Rigorous research methods, Criterion 6: Inclusiveness of different populations and Criterion 7: Research team and environment)

Comment 1: Explain why navigation wasn’t chosen as the comparator, rather than mailed intervention (R1).

Response: The use of mailed contacts to encourage screening has been shown to be effective in numerous published studies, and is endorsed by the Guide to Community Preventive Services.5 According to reviews by Robinson-White et al. 6 and Robie et al.,7 few reports on patient navigation related to CRC screening among Hispanics have been reported in the literature; and those that have been reported enrolled patients at the time of a scheduled office visit. The few CRC screening navigation studies that have focused on Hispanics have offered stool blood testing as a screening test, and these studies have reported mixed results. Furthermore, no studies have reported on the impact of combined decision support and navigation versus a mailed standard intervention (SI) on CRC screening with stool blood testing and colonoscopy. Therefore, we believe that it is appropriate to compare the DSNI to the SI.

Comment 2: Explain why the generalizability of findings will not be decreased by the use of charity care or other mechanisms to pay for screening (R1).

Response: In the context of healthcare reform, Medicare, Medicaid, and private insurers will be required to cover “A” and “B” level screening recommendations from the United States Preventive Services Task Force (USPSTF). Importantly, USPSTF guidelines give CRC screening the highest level (“A”) recommendation. Also, healthcare organizations that aspire to become accountable care organizations will be required to promote population and community health, making programs like “Reduced Cost Care” in the Lehigh Valley Health Network more common in the United States.

Comment 3: Provide more details on the data analysis plan (R2).

Response: More details about the data analysis plan are provided in Section 3.4 of the application.

Comment 4: Explain how patients will be selected for follow-up focus groups, and how balance will be achieved in gender, age, etc. (R2).



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Response: Participants who reflect the demographic (gender and age) composition of the study population will be invited to be in the focus groups.

Comment 5: Describe who the navigators will be: lay vs. professional, ages or gender matched (R2).

Response: The navigator(s) will be trained bilingual health educators whose language fluency and culture sensitivity are appropriate for the study population. A recent review of patient navigation in breast cancer screening7 did not find evidence to support age- or gender-matching of navigators to patients. However, the study did conclude that it is important to ensure that navigators are adequately trained and supervised, and that they have good communication skills. As described in Section 3.3.2, the research team will hire, train, and supervise health educators from the Hispanic community in the Lehigh Valley to provide patient decision counseling and navigation services related to CRC screening. Furthermore, we will also assess the fidelity of intervention delivery throughout the study.

Comment 6: Consider collecting information on income, insurance coverage, employment and assessing patient desires, approaches to decision making, health beliefs, etc. (R1)

Response: The research team will add items to assess income level, employment status, level of acculturation, and preferred language on a planned 6-month survey. (See appendix) Data on insurance coverage will be obtained from medical records. We will also gather data on perceptions related to CRC screening on the 6-month survey. Information on patient decision factors and likelihood of screening will be collected as part of the decision counseling session described in Section 3.3.4. These data will be used in data analyses described in Section 3.4.

Comment 7: Determine the cultural make-up of the Hispanic population of the Lehigh Valley to identify unique cultural beliefs (R2).

Response: While census data does not clearly delineate the percentages of people within each subculture of the Hispanic population of the Lehigh Valley, it is known that there are Puerto Rican, Dominican, Cuban, Mexican, and other Central or South American communities are represented in the Lehigh Valley. We will collect information on participant perceptions about CRC and screening on the 6-month survey. These data will be reviewed to identify participant psychosocial and cultural beliefs about CRC screening and to assess intervention impact on those beliefs. Inspection of these data will also provide insights into differences in subgroup perceptions about CRC screening.8

Comment 8: Include patients other than focus groups in preparation of the proposal and include healthcare stakeholders in the research project (R1)

Response: Section 4.3 explains that we have constituted a patient and stakeholder advisory committee (PASAC) that includes Hispanic patients and primary care providers. The committee and the research team have been engaged in planning the proposed study, will continue to work closely together during study implementation, and will collaborate on developing plans for intervention dissemination. We will also track these activities in planned committee meetings during the course of the study. Comment 9. Include letters of support from local organizations (R2).

Response: Letters of support are provided in the appendix of the application.

Criterion 4. Demonstrate the patient centeredness of the application

Comment 1: Explain if Hispanics see the CRC screening disparity as a priority (R1)

Response: See response to Criterion 2, Comment 1.



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Comment 2: Explain what happens to patients who are contacted by a DSNI Group navigator and decline or refuse CRC screening, and how the intervention will move patients along the continuum of readiness for change (R1 and R2).

Response: Past research shows that when presented with an opportunity to screen with either SBT or colonoscopy, most individuals indicate a preference for one test over the other. Very few (~1%) indicate that they have decided against doing both tests. For participants in the former category, the DSNI Group navigator will generate a personalized screening plan for each participant that is keyed to the preferred test. For participants who decide against screening with either test at the time of navigator contact, the navigator will ascertain factors influencing the decision. This information will be noted in the participant’s screening plan, along with a recommendation for follow-up contact within six months to assess screening decision stage and encourage screening adherence.

Comment 3: Explain how the intervention will address outcomes other than screening (R2).

Response: Aim 2 of the proposed study is to assess the impact of DSNI versus SI on change in participant CRC screening decision stage. Aim 3 of the study is to determine DSNI versus SI effects relative to participant test-specific screening adherence. Aim 4 is to find out if the DSNI and SI differ in terms of their impact on participant knowledge and psychosocial perceptions related to CRC screening.

Comment 4: Provide more details about the PAPM (R3).

Response: The Precaution Adoption Process Model (PAPM) specifies seven distinct stages in the journey from lack of awareness to adoption and/or maintenance of a behavior. In the first stage of the

PAPM, an individual may be completely unaware of a risk (e.g. risk for CRC). The person may subsequently become aware of the issue but remain unengaged by it (Stage 2). Next, the person faces

a decision about acting (Stage 3); may decide not to act (Stage 4), or may decide to act (Stage 5). The stages of action (Stage 6) and maintenance (Stage 7) follow. In the proposed study, we will use PAPM

decision staging to identify CRC screening test-specific decision stage and overall CRC screening decision stage. Following methods used previously by the research team (see Sections 3.2.2 and

3.2.3), we will elicit each participant’s decision stage for colonoscopy and for stool blood test screening. By comparing participant responses, we will determine the participant’s preferred screening test and

overall screening decision stage.

Criterion 5. Demonstrate the commitment to patient and stakeholder engagement

Comment - This criterion did not exist when the initial application was reviewed.

Response: See Section 5 of the application for details.

Protection of Human Subjects

Comment 1: Explain how patients who have an adverse reaction to screening will be managed.

Response: See the Protections against Risk subsection of this part of application for details.



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1. Demonstrate that the condition imposes a significant burden on the health of individuals and/or

populations (Criterion 1)

In 2013, there will be an estimated 50,830 deaths from colorectal cancer (CRC) in the United States.9 Many of these deaths will be due to missed opportunities to identify colorectal adenomas and early-stage CRC. It is well-known that CRC screening can find colorectal adenomas, which can be removed before they progress to CRC, and can detect early-stage CRC, when the disease can be cured. Guidelines of the United States Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), and other organizations recommend CRC screening for persons who are 50 to 75 years of age and are at average risk for CRC.10 Having a colonoscopy every 10 years or annual stool blood testing (SBT) are the CRC screening tests most frequently by primary care physicians.11

CRC screening rates are rising in the general population, but are low among Hispanics. Unfortunately, Hispanics have a significantly lower CRC screening rate than non-Hispanic whites and African Americans, and, as a consequence, are more likely to be diagnosed with late-stage CRC. Lower CRC screening rates among Hispanics translate into to relatively high mortality and low survival from CRC among Hispanics compared to nonHispanic whites and African Americans. In fact, CRC is the second leading cause of cancer deaths among Hispanics in this country. The disparities in CRC screening and mortality between Hispanics and non-Hispanic whites persist, even when adjusting for education, income, and insurance status.12,13 The potential gains associated with CRC screening can only be realized among Hispanics if screening rates rise in this segment of the population.

2. Explain how results of the study would likely improve health care and outcomes (Criterion 2)

The Institute of Medicine (IOM) has encouraged research that addresses racial and ethnic disparities in health care.14 The IOM’s highest priority recommendations for areas of research include studies that focus on the comparative effectiveness of interventions (e.g., multi-level interventions versus single level methods of health education) to reduce disparities in major chronic diseases, including cancer. The IOM also has highlighted the need to compare the effectiveness of patient decision support tools, and to compare the effectiveness of different strategies to engage and retain patients in care and to delineate barriers to care, especially for members of populations that experience health disparities. In 2011, the Agency for Health Research and Quality (AHRQ) also called for research on the implementation of interventions that aim to reduce health disparities in priority populations, including racial and ethnic populations.15 The proposed study is responsive to these IOM and AHRQ priorities in the context of primary care. Achieving high CRC screening rates in primary care can have a substantial, positive impact on CRC-related mortality and survival, along with related disparities, and can reduce economic costs associated with the disease.16 In a recent analysis, Zauber et al.17 estimated that by increasing CRC screening rates to 70% we could achieve a 53% reduction in CRC mortality. In economic terms, Bradley et al.18 have projected that increased CRC screening could result in almost $15 billion in savings between 2005 and 2020.

Raising CRC screening rates among Hispanics will have substantial benefits for this segment of the population and will contribute to societal gains related to CRC prevention and control. Effective, patient-centered interventions are needed, however, to increase screening19 and reduce the unequal burden of the disease experienced by Hispanics.3,8 According to reviews by Robie et al.6 and Gonzalez et al.,20 however, few randomized, controlled trials of different interventions intended to increase CRC screening among Hispanics have been reported in the literature. Gonzalez found only four such studies in the literature, and most of those studies focused only on SBT screening, included Hispanic patients who presented for a primary care clinic office visit, and used mailed contacts and/or telephone reminders to boost screening rates. Few studies have intervened with Hispanic patients outside the context of an office visit and none have assessed the impact of decision support and navigation on SBT and colonoscopy screening rates. The proposed study will reach Hispanic patients outside the context of an office visit who are not up-to-date with CRC screening, are unlikely to have been informed about screening, and are unlikely to have received a physician referral for screening. In addition, we will test the impact of an integrated decision support and patient navigation intervention on CRC



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screening adherence. This strategy is intended to engage Hispanic primary care patients and their primary care providers in the screening process. Decision support, which has been shown to facilitate patient informed decision making in cancer prevention and control,21-23 and can be readily incorporated into patient navigation.

In the proposed study, a bilingual health educator (promotora) trained in patient decision support and navigation will contact participants by telephone, provide information about SBT and colonoscopy screening, and identify the participant’s preferred test. Following Motivational Interviewing (MI) principles,24 the navigator then will elicit factors that are likely to influence performance of the preferred test (“pro” and “con” factors), the importance each decision factor, and the likelihood of screening adherence. The navigator then will engage the participant in developing a personal screening plan, and will help to implement the individualized plan. For participants who prefer colonoscopy screening, the navigator will help the participant obtain a screening referral and screening appointment; and for patients who prefer SBT screening, the navigator will provide step-by-step instructions in test performance. Furthermore, the navigator will track participants through the screening process, inform their provider of progress, and encourage provider follow-up of non-adherers and those who have an abnormal screening test result. Consequently, we expect that increased screening adherence and complete follow-up will occur. The research team will also conduct a multi-level evaluation to identify patient, provider, and health system barriers to dissemination and implementation of the decision support and navigation intervention. To our knowledge, this multi-level evaluation will be the first that focuses on Hispanic patients in a set of primary care practices affiliated with a large, urban health care system. Findings from this aspect of the study will help to inform the development and implementation of preventive health care interventions in the context of patient-centered medical homes (PCMHs) and accountable care organizations (ACOs).

3. Demonstrate the technical merit of the application (Criterion 3)

3.1. Background and Significance. The literature on methods for increasing CRC screening adherence is growing. Much of this research has focused on single-level patient or provider contacts; and findings suggest that multi-level interventions which engage both patients and providers are likely to be more effective in raising screening rates than single-level interventions. Few studies have reported on the use of multi-level methods, however, and little is known about the impact of such strategies in Hispanic patient populations.

3.1.1. Mailed Contacts, Message Tailoring, and Preference. Recent reviews have found that generic patient contacts (e.g., print materials, mailed SBTs, reminder mailings) have produced a modest, positive impact on CRC screening, especially SBT screening.25-28 Rawl et al.28 also reported that mailed patient-oriented, personalized print education materials may have a positive impact on CRC screening, especially in minority populations. However, Gonzalez et al.20 found mailed patient materials had a modest positive impact on SBT screening among Hispanic primary care patients. Research on message tailoring in CRC screening in the general population is limited, and is almost nonexistent in Hispanic populations.

Message tailoring refers to the delivery of educational messages that address personal barriers (i.e., cognitive needs and psychosocial concerns related to specific behaviors) and serves to minimize or remove psychosocial obstacles to action.29-32 Educational message tailoring has been used successfully to promote smoking cessation, reduce dietary fat intake, increase cholesterol testing, physical activity, and mammography use19-31. To reduce disparities, Kreuter et al.33,34 and Powe 35,36 have encouraged the delivery of tailored messages that address barriers relevant to population subgroups. Only a few research studies have reported on the use of message tailoring to address psychosocial barriers to CRC screening.37-39 To date, these efforts have generated only modest effects at best. The use of message tailoring based on personal preference for different CRC screening tests may be more successful. However, no studies have been reported on the use of such methods among Hispanics.

Wolf et al. elicited CRC screening test preferences among minority patients attending an urban health care clinic, and found that survey respondents commonly reported a preference for SBT screening.40 Hawley et al.41 reported that race was associated with differences in screening test preference among patients who visited a primary care practice. The literature also suggests that personal preference not only influences health



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behavior, but may also be related to observed disparities in preventive health behavior.42-48 Shokar et al. 49 found that whites and African Americans tended to differ in terms of how they valued the attributes of different CRC screening tests. Recently, Inadomi et al.50 reported that among patients in an urban health care clinic who were offered SBT and colonoscopy screening, adherence varied by race and ethnicity. Members of the research team have reported on the use of decision staging, based on the Precaution Adoption Process Model (PAPM), to identify an individual’s preferred CRC screening test.51,52 Findings from a recently-reported study conducted by the group showed that aligning patient preference for a given CRC screening test with access to that test boosted screening adherence in a diverse primary care clinic patient population.53

3.1.2. Decision Support and Navigation for Patients and Providers. Patient navigation is recognized as a promising way to increase adherence to recommended health behaviors. Traditionally, patient navigators have been nurses who are assigned to help patients diagnosed with cancer to find their way through the complex and confusing diagnostic and treatment process.54-59 Trained health educators and lay health advocates have also acted as patient navigators to effectively facilitate preventive health behaviors.60 In terms of cancer screening, most navigation studies have addressed breast and cervical cancer screening, and a small number of studies were focused on CRC screening.61 A few CRC screening studies have involved contacting the general primary care patient population residing in the community. In those studies, a patient navigator called patients by telephone and encouraged them to arrange colonoscopy screening. This strategy generated screening rates ranging from 27% to 41%.37.51,62 In other CRC screening studies, primary care providers issued a colonoscopy screening referral for patients at the time of an office visit, and then “handed off” the patients to a navigator authorized to arrange a screening appointment. This approach produced screening rates ranging from 54% to 66%.63-65 This interpretation is consistent with other reports suggesting that patient navigation has a greater impact on colonoscopy screening when the navigator is recognized as an agent of the primary care provider, and when the navigator assumes responsibility for appointment scheduling.66-68 This type of CRC screening support is often not provided in primary care practices, however.

Lebwohl et al. reported that the volume of screening colonoscopies among urban clinic patients at large urban hospital increased coincident with the initiation of a patient navigator program69. In a small, randomized pilot study, Christie, et al. 62 showed that among low-income minorities, patients who received navigation were more likely to have CRC screening than controls (54% and 13%, respectively). Chen, et al. 63 reported that a cohort of patients using a patient navigator, including a subset of Hispanic patients, increased adherence. In a randomized trial using a single clinic, Percac-Lima et al.37 found that those assigned to receive a patient navigator intervention were more likely to undergo CRC screening than control patients (27% vs. 12%). In a recent randomized trial that involved Hispanic patients who visited a university-based primary care clinic,70 researchers found that adding targeted messages that were culturally-specific and sensitive to navigation contacts did not increase colonoscopy performance as compared to navigation alone. Findings from that study suggest that there is a need to identify a more effective, personalized way to enhance the impact of patient navigation among Hispanics. Recent reviews suggest that decision support interventions (DSIs) used in the context of patient navigation may offer a novel patient-centered strategy that can substantially improve CRC screening adherence, especially in minority populations.20,71,72 To date, however, little research has been reported on the use of preference-based DSIs to increase CRC screening.73,74

3.2. Preliminary Studies. The proposed study builds on and extends findings reported in the literature and those obtained from prior studies carried out by members of the research team.

3.2.1. A Low-Intensity Intervention Study in the Lehigh Valley Health Network (LVHN). In 2007, Thomas Jefferson University, Lehigh Valley Health Network, and CNA (a non-profit research and analysis company), formed the CNA Health ACTION Partnership. These partners worked together on a demonstration project intended to design an intervention that could be used to increase CRC screening and follow-up in primary care practices in the LVHN of Eastern Pennsylvania. The project was funded by the Centers for Disease Control and Prevention (HHSA290200600014-290-06-0014-1) between October 2007 and July 2010. The final report is available online at http://www.ahrq.gov/research/crcscreeningrpt/. Key features of the intervention included educational outreach to primary care providers; use of an electronic medical records system to identify primary care practice patients eligible for CRC screening; delivery of a mailed immunochemical SBT kit to patients on

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request; tracking the performance of screening; and providing performance feedback on screening and follow-up rates to LVHN primary care providers. The study was conducted over the course of one year in 15 Intervention Group practices, beginning in 2009. CRC screening rates were monitored over the same time period in five additional matched Control Group practices. (None of these practices will be included in the proposed study). Twenty-eight percent of patients in Intervention Group practices requested an SBT kit. At endpoint, patients in Intervention Group practices had significantly higher CRC screening rates than patients in the Control Group practices, but rates were low (9% versus 4%). These findings suggested the need for a more intensive intervention approach. It should also be noted that data on patient race/ethnicity were not collected as part of the study. Therefore, intervention impact among Hispanic patients was not assessed.

3.2.2. A Randomized Trial of Mailed and Navigation Contacts in the General Patient Population. The research team recently completed an NCI-funded randomized, controlled trial titled, Tailored Navigation in CRC Screening (CA116576).52 This trial involved primary care practices in Delaware and patients who were 50 to 74 years of age, were not previously diagnosed with CRC, and were not up to date with CRC screening. We enrolled 945 consenting participants, who were randomized to one of three study groups: a Control Group (n=317), Standard Intervention (SI) Group (n=316), and Tailored Navigation Intervention (TNI) Group (n=312).

The Control Group received usual care. The SI Group received a mailed informational booklet on CRC screening; a personalized letter that included a nurse contact telephone number to call in order to arrange a colonoscopy, an SBT kit, and a mailed reminder at 30 days. Participants who called the nurse contact number were given the telephone number of a colonoscopy provider approved by their primary care practice, and were encouraged to schedule the procedure. The nurse was not authorized to schedule a colonoscopy appointment however all TNI Group participants initially were sent the CRC screening booklet and a personalized letter keyed to CRC screening test preference (i.e., preferred colonoscopy, equal preference for colonoscopy and SBT, or preferred SBT) assessed on the baseline survey. Those who preferred colonoscopy screening received a letter that included a navigator contact telephone number to call and discuss colonoscopy. Again, the navigator was authorized only to give the participant the telephone number of a gastroenterology practice affiliated with the participant’s primary care practice. Those with an equal preference for colonoscopy and SBT screening received a letter, the navigator contact number, and an SBT kit. Persons preferring SBT screening received a letter and an SBT kit. After this initial mailing, a trained navigator called each participant; verified test preference; and encouraged test performance. Participants then received a reminder letter. Finally, a 6-month survey and 12-month medical records review were completed for all study groups.

According to study protocol, all SI Group participants received both mailed colonoscopy instructions and an SBT kit. TNI Group participants who preferred SBT screening received only a mailed SBT kit, and those who preferred colonoscopy screening received only mailed colonoscopy instructions. TNI Group participants who preferred colonoscopy and SBT screening equally received both a mailed SBT kit and colonoscopy instructions. Furthermore, although navigators encouraged participants to complete their preferred test, but did not offer decision support, did not develop a screening plan, and did not engage the participant’s primary care provider in screening plan implementation or follow-up. Overall 12-month screening rates were: Control Group (18%), SI Group (36%), and TNI Group (43%). Thus, both interventions increased CRC screening rates significantly over usual care (p<0.001), and telephone navigation had a stronger but nonsignificant effect than the mailed intervention (p=0.118). In secondary analyses, we have projected that if colonoscopy instructions and SBT kits had been sent to all TNI Group participants, the overall screening rate in that group would have been substantially higher. We believe that colonoscopy rates would also have been higher if navigators had been authorized to schedule colonoscopy appointments for participants who preferred that test. It is important to mention that there were very few Hispanic participants in this study. Thus, we could not determine intervention impact in this segment of the population. Furthermore, neither patients nor physicians were provided decision support.

3.2.3. Mailed and Navigation Contacts among African American Primary Care Patients. Members of the research team recently concluded an American Cancer Society-funded Research Scholar Award (RSGT-08-017-01-CPPB) to determine the impact of a preference-based navigation intervention on CRC screening among African American patients in primary care practices. The study included African American patients who



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were 50-74 years of age, had not been diagnosed with CRC, received medical care in a primary care practice setting (Jefferson Family Medicine Associates (JFMA) practice or Einstein Healthcare Network (AEHN) –affiliated practices), and were eligible for CRC screening.

In this study, 764 participants completed a baseline telephone survey and were randomly assigned either to a Standard Intervention (SI) Group (n=380) or a Tailored Navigation Intervention (TNI) Group (n=384). The SI Group received a mailed informational booklet on CRC screening; a personalized letter that included a colonoscopy contact telephone number, an SBT kit, and a mailed reminder at 30 days. TNI Group participants received preference-based contacts according to a protocol similar to the one described in Section 3.2.2. The primary outcome of the study was adherence to CRC screening within 12 months after randomization.

Participant background characteristics were as follows: male (36%), 60 years of age or older (33%), married (29%), and at least a high school education (40%). Final data analyses were

completed in February 2013. Table 1 shows that adherence to screening was significantly higher among participants in the TNI Group than in the SI Group (43% and 32%, respectively, p=0.002). Thus, preference-based navigation had a significantly greater positive impact on screening adherence than a standard mailed intervention among African Americans. As this study included only African American patients, we do not know the potential effect of tailored navigation on CRC screening adherence among Hispanic patients. Finally, neither patients nor physicians were provided decision support. The proposed study will provide needed information related to these matters.

3.3. Study Design. The proposed study will compare the effectiveness of a multi-level decision support and navigation intervention (DSNI) to a single-level mailed standard intervention (SI) in a randomized, controlled trial that involves Hispanic patients who are served by primary care practices in the Lehigh Valley Health Network (LVHN).

3.3.1. Research Setting and Patient Population. The LVHN is a multi-center, non-profit healthcare delivery system with a National Community Cancer Center Program in Eastern Pennsylvania. LVHN’s primary services areas include Lehigh and Northampton counties, which include over 645,000 residents, of whom 96,967 are Hispanic or Latino. The city of Allentown in Lehigh County is home to over 105,000 residents, 40% of which are Hispanic or Latino. Twenty-two percent of the population of Allentown lives below the poverty line, and 36% of people living in Allentown speak a language other than English at home.75 The majority speak Spanish. The sampling frame for this proposed study will be patients from four (4) LVHN primary care clinic practices serving center city Allentown and a large LVHN community practice. The research team will engage patients and primary care providers in those practices, along with gastroenterology and colorectal specialists who perform screening colonoscopy in the LVHN system. Inspection of medical records shows that <35% of patients in the general patient population of LVHN practices are up-to-date with CRC screening guidelines. The CRC screening rate among potentially-eligible Hispanic patients in participating LVHN practices is <30%.

In the proposed study, we will randomize equal numbers of Hispanic patients to one of two intervention arms, an SI Group (n=200) or a DSNI Group (n=200). The SI Group will receive a mailed CRC screening kit (colonoscopy instructions and a SBT kit) and a reminder. The DSNI Group will also receive a mailed screening kit and a reminder. In addition, a trained navigator will engage participants and providers in the process of performing the CRC screening test preferred by the participant. The relative effectiveness of these intervention strategies will be measured in terms of CRC screening adherence within 12 months. Choice of these two comparators has been informed by results from preliminary studies conducted by the research team and the screening literature which suggest that DSNI may be more effective than SI in boosting CRC screening minority populations. We have chosen not to include a usual care control group in the study design, because

Table 1. CRC Screening Among African Americans by Intervention Group

Screening Status SI Group (n=380) TNI Group (n=384)

Screened, n (%)

122 (32)

137 (43)



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CRC screening is usually low in routine care, which is the case in LVHN practices. We believe that determining the impact of DSNI as compared to SI is more clinically meaningful than comparing DSNI or SI to usual care.

3.3.2. Navigator, Research Assistant, and Survey Interviewer Training/Supervision. Navigator and research assistant training will take advantage of an existing self-study manual developed in prior research. The manual, which will be adapted for use in this study, will include a copy of the study protocol, information on CRC screening and the diagnostic follow-up of patients with abnormal screening results; selected articles from the literature on patient navigation, message tailoring, preference clarification, and decision counseling. The Fox Chase Cancer Center Office of Health Communications & Health Disparities (OHCHD) will be responsible for translating all study print materials, text embedded in an online Decision Counseling Program© (see Section 3.3.4), and the navigation telephone script into Spanish.

Both bilingual project research assistants and patient navigators will complete the self-study manual. In addition, study navigators will complete a 2-day decision counseling and navigation training program. During this program, navigators will review the history and theory related to decision support and will receive instruction in decision counseling methods. In addition, the navigators will be provided current information on primary practices, providers and office managers; colonoscopy providers; and contacts and procedures for scheduling CRC screening. The navigators will conduct audio-recorded mock patient navigation calls with surrogate patients. During these calls, navigator adherence to study protocol will be evaluated by project staff. The study project manager and bilingual staff from OHCHD will review the audio recordings and complete a fidelity checklist that includes basic steps in the decision counseling and navigation process. Drs. Myers (Principal Investigator) and Sifri (Co-Investigator), along with the project manager will debrief the navigators and address any need for remediation. Specifically, barriers to effective interactions will be identified (e.g., inaccurate ascertainment of decision factors and related factor weights, incomplete development of an effective screening plan), and approaches for overcoming these barriers will be discussed and implemented. During the study, project leadership, the project manager, and OHCHD staff will listen to a sample of 10 navigation calls per year, assess intervention fidelity in an ongoing fashion, and provide remediation where necessary. Completeness of intervention delivery will also be documented in call contact logs.

A bilingual LVHN research assistant will contact potential participants to assess eligibility for the study, obtain verbal consent, and administer a baseline survey described below. In addition, bilingual survey interviewers from Survey Technologies Research (STR), a professional survey company, will administer a 6-month Survey. In preparation for making these patient contacts, the research assistant and STR interviewers will review the self-study manual, which will include the respective questionnaires and describe procedures for survey administration. The research assistant and the survey interviewers will also conduct audio-recorded survey calls with surrogate patients, and will be debriefed to maximize contact quality. During the study, Drs. Myers and Sifri, along with the project manager and OHCHD staff will listen to 5 calls per month for the research assistant and the survey interviewers. The project manager will also train and supervise the research assistant in accessing electronic medical records and recording appropriate data.

3.3.3. Participant Recruitment, Baseline Survey Administration, and Randomization. Initially, Hispanic patients who are 50 to 75 years of age, have not been diagnosed with CRC, and have not had a recent CRC screening test will be identified via LVHN electronic records. These individuals will be mailed a study invitation letter in English and Spanish. The letter will describe the proposed research and provide information about ways to opt out of or register to participate in the study (i.e., complete and return a study registration card in an addressed postage-paid return envelope, or call a toll-free telephone number.) The letter will also inform recipients that a research staff member will call non-respondents.

A trained bilingual research assistant will call patients within 15 days after the invitation letter mailing. The research assistant will conduct the call in the language preferred by the respondent. The research assistant will verify patient eligibility, describe the study, ascertain patient willingness to participate, obtain verbal consent, and administer a brief baseline survey to a total of 400 participants. As part of the survey, the research



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assistant will describe SBT and colonoscopy screening, and will ascertain the participant’s overall and test-specific screening decision stage. Following procedures used in prior research sudies,39,51,52 we will use the information to determine the participant’s overall CRC screening decision stage and preferred CRC screening test. Data on sociodemographic background will also be collected. At the end of the baseline survey, the interviewer will ask participants to indicate a day(s) of the week and time(s) of the day when research staff can most conveniently speak to the participant by telephone. The interviewer will also ask for a telephone number and email address for use in making contact. Finally, the research assistant will inform the participants that they will receive CRC screening materials in the mail, will determine whether the participant wants to receive study materials in English or Spanish, and will mention that the research team may contact them by telephone to discuss screening and will contact them to complete two follow-up surveys. As shown in Figure 1, research staff will randomly assign all consented participants either to a SI Group or a DSNI Group. Random assignment will be stratified by participant primary care practice.

Figure 1. Study Design

Baseline Survey

Randomization Intervention Delivery Records Review (6,12 month)

6-Month Survey

Standard Intervention (SI) (n = 200)

Mailed contacts* Complete (n = 190)

Complete (n = 160)

Complete

(N = 400)

Stratify random assignment by primary practice

Decision Support and Navigation Intervention (DSNI) (n = 200)

Mailed contacts, Support/Navigation contacts**

Complete (n = 190)

Complete (n =160)

* Mailed Contacts: Screening letter, informational booklet, colonoscopy instructions, SBT kit, and reminder letter.

**Mailed Contacts: Screening letter, informational booklet, colonoscopy instructions, SBT kit, and reminder letter; Support/Navigation contacts: navigator calls to provide decision counseling, develop screening plans, support plan implementation, and deliver screening plan and status reports.

3.3.4. Intervention Implementation. Following randomization, SI Group participants will be mailed a set of standard materials (see Appendix). The materials will include a letter from the participant’s primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT). Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided in the language the participant as preferred (English or Spanish) at the time of the baseline survey. At 45 days following random assignment, research staff will send participants a reminder letter from the participant’s primary care provider that endorses and encourages screening. Study participants assigned to the DSNI Group will also be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Again, print materials will be provided in the language specified by the participant at baseline. Within 7 days after this mailing, DSNI Group participants will also receive a telephone call from a trained bilingual study navigator. In the call, the navigator initially will review the CRC screening materials and verify the participant’s preferred CRC screening test. During this encounter, the navigator will



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also use an online Decision Counseling Program© (DCP) to identify barriers to and facilitators of preferred test performance, determine the likelihood of test performance, and develop a personal screening plan.

The online DCP includes a script that guides the navigator and participant through a structured telephone encounter with participants. Following the script, the navigator will elicit major factors that would influence the participant to or not to (pros and cons) screen, determine the level of importance the patient assigns to each factor (not important to overwhelmingly important), enter the reported factors and factor weights into the DCP, and compute a screening likelihood score (low to high). The navigator will then review the result with the patient, and will use a Motivational Interviewing approach to develop a plan to reinforce facilitators and overcome barriers to performing the individual’s preferred test. For participants who prefer colonoscopy screening, the navigator will be authorized to obtain appropriate referral approvals, and will help to schedule a colonoscopy appointment at the time of the navigation call. For those who prefer SBT screening, the navigator will explain steps for performing the test, and offer to be available to answer questions that arise about SBT completion. For colonoscopy and SBT screening, the navigator will follow up with the participant to address emergent questions or concerns.

The navigator will enter a description of each participant’s screening plan into the DCP, will print out a 1-page summary of the decision counseling session and screening plan, and will send to a copy this form to the participant. Importantly, primary care practices included in this study share an electronic medical record (Centricity) that includes a “progress note” feature, to which the navigator will have access. The navigator will use this feature to enter the participant’s CRC screening plan directly into the electronic medical record, along with information on scheduled appointments and test performance. When the plan is entered, it will be routed to both the patient's primary physician and the practice office manager to authorize any necessary insurance referral(s), and send the referral(s) directly to the navigator and participant. The navigator will contact the office manager to verify provider receipt of the screening plan and obtain any needed referrals. At 45 days after random assignment, research staff will send participants a reminder that includes a provider endorsement and encouragement of screening. Note: the grant will cover the cost of the mailed SBT kit and, LVHN will help participants with limited or no insurance coverage by providing colonoscopy and follow-up, including treatment, at little or no cost via Medical Assistance applications and an established Charity Care program.

At 6 months after randomization, the navigator will use the same progress note feature in Centricity to provide the provider and office manager of the participant’s primary care practice a participant CRC screening status report. This report will be based on screening data obtained by project staff from the 6-month survey and medical records review described below. The report will indicate whether the participant adhered to screening, and if the participant is in need of diagnostic follow-up for an abnormal SBT result. For those participants who are nonadherent to CRC screening, the report will advise providers and the office manager to contact the participant and encourage screening. For those screenees who require follow-up of an abnormal SBT result, the report will also encourage providers to arrange a diagnostic colonoscopy. For patients who had a normal SBT result, the report will encourage providers to contact patients in a year to offer screening. Finally, 30 days after the screening status report is mailed, the navigator will contact the office manager to verify provider receipt of the screening status report and to record follow-up action(s) taken.

3.3.5. Six-Month Survey and Medical Records Review. Six months after randomization, a survey interviewer from Survey Technology and Research (STR), a professional survey company, will contact each participant by telephone and administer a 6-month Survey (see Appendix). The survey will include items that assess participant sociodemographic characteristics (e.g., age, gender, education, income, employment status, knowledge about CRC screening, and health literacy;76,77 and operationalize constructs reflected in the Model of Decision Support and Navigation shown in Figure 2. This model, which informs the DSNI and survey data collection, is based constructs drawn from the Preventive Health Model (PHM) and the Precaution Adoption Process Model (PAPM). Specific PHM and PAPM constructs include perceived CRC susceptibility, and salience and coherence, worries and concerns, response efficacy, fatalism, acculturation, and social support for screening.



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Figure 2. Model of Decision Support and Navigation

- Perceived Susceptibility

- Salience and Coherence

- Worries and Concerns

- Response Efficacy

- Social Support

- Decision Stage

Preference

Clarification

Likelihood

Assessment

Planning

Decision Performance

Experience

Vernon, Myers, and Tilley78 have reported on the development and validation of PHM survey items. Tiro et al.79 have confirmed the invariance of PHM psychological and social influence factors across gender and racial subgroups in the United States; and Ritvo et al.80 and Flight et al.81 have established the validity of PHM factors in diverse populations internationally. In addition, items will be included on the survey to assess CRC screening decision stage and screening test preference, which are based on the PAPM.78,79 Here, the PAPM will be applied to CRC screening in order to identify the following decision stages: decided against screening, never heard of screening, not considering screening, undecided about screening, and decided to do screening. In terms of actual screening adherence, survey respondents will also be asked to report any CRC screening tests performed during the 6 months. For all reported tests, participants will be asked to provide a date of testing. Following prior studies, we will allow for 20% missing survey data.

A 6-month medical records review for DSNI Group participants will be completed by a study research assistant. Screening adherence data collected on the 6-month survey and 6-month medical records review will be used to prepare the DSNI Group screening status report described earlier, and to assess the CRC screening outcome. Participant insurance status will also be ascertained on medical records review. Following methods used elsewhere,39,51,52 CRC screening adherence will reflect performance of any ACS or USPSTF guidelines-recommended CRC screening test recorded in the chart or self-reported on the survey, if the survey report is accompanied by a procedure date that falls within the 6-month study period following randomization.

3.3.6. Twelve-Month Medical Records Review. At 12 months after randomization, an endpoint medical records review will be performed on all study participants to assess CRC screening adherence. The medical records review will be conducted by a study research assistant who will be blinded to each participant’s study group assignment. Any ACS or USPSTF guidelines-recommended CRC screening test will be accepted. Following prior studies, we will allow for 5% missing endpoint medical records data. As part of the records review, we will review electronic medical records for all participants in the last year of the study to characterize patterns of screening use among participants after the study observation period. This information will be combined with self-reported CRC screening from the 6-month survey and 6-month medical records review to determine the main study outcome in the analyses.

3.3.7. Data Management. The research team will collect patient information related to recruitment, consent, telephone survey administration, and random assignment for all participants. Navigator call information will be obtained from data entered into the online decision counseling program and navigator call logs. We will collect baseline and 6-month telephone survey data for study participants, along with participant 6- and 12-month medical records review data. (see Data Inventory in the Appendix for details).

3.4. Analytic Methods. The main study outcome will be overall CRC screening adherence. Overall CRC screening adherence will be defined as any guidelines-recommended CRC screening test, if performed within 12 months from study enrollment. Tests that are identified during the 12-month Medical Records Review and those that are reported by study participants on the Endpoint Survey will both be counted. The use of the Endpoint Survey will allow us to capture screening tests (particularly colonoscopies) that may be performed outside the LVHN system. Test-specific screening adherence (SBT or colonoscopy) will be an additional outcome. We will also elicit CRC screening decision stage separately for stool blood test and colonoscopy (decided against, not considering, undecided, decided to do), and compute an overall CRC screening decision stage as the higher of the two test-specific decision stages. We will elicit decision stage both at the baseline survey and at the 6-month survey. The change in overall CRC screening decision stage from baseline to the 6-



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month survey will be another study outcome. CRC screening adherence and decision stage will allow for the assessment of the intervention effectiveness in terms of outcomes that are relevant to patients. We will also assess intervention effectiveness in terms of knowledge and perceptions related to CRC screening, which will provide a more detailed assessment of patient-centered dimensions of this preventive health behavior. Finally, we will seek to address intervention effects at multiple levels of the LVHN system (see Section 5.3). The data for each study group will be described using both graphical methods and summary statistics. Analyses related to the assessment of intervention effects will follow the intent-to-treat principle and will control for practice.

3.4.1. Study Aims and Hypotheses. The study will rely on a randomized design to assess the two interventions. Because of this design, we expect the two intervention groups to be comparable with respect to all participant and practice characteristics. However, if there is substantial imbalance in any of the baseline variables, the analyses will control for them. Some of the planned analyses will rely solely on endpoint survey data (Aims 2 and 4) and survey non-response might negatively impact study group comparability. In our prior research, we have found that overall non-response rates and the characteristics of non-respondents (i.e., non-response patterns) do not differ substantially across different types of CRC screening interventions, suggesting little missing data bias. Nevertheless, we plan to control for all baseline characteristics to account for any differential missing data patterns. In addition, we will also explore multiple imputation analyses, particularly if the endpoint survey non-response is higher than expected. Research data will be described for each study group using both graphical methods (boxplots for continuous variables, and bar graphs for categorical variables) and summary statistics (mean and standard deviation for continuous variables, frequency counts and percentages for categorical variables). Main analyses will follow the intent-to-treat principle and will control for practice (stratification variable at randomization).

3.4.1.1. Aim 1 (DSNI versus SI on overall CRC screening adherence). The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening status will be determined using both the 6-month survey and 12-month medical records review data. We hypothesize that DSNI Group participants will have higher overall screening than SI Group participants. We will analyze screening (yes vs. no) via logistic regression, using study group (DSNI versus SI) as the main predictor. As mentioned above, we expect the two study groups to be comparable at baseline due to randomization. So, the model will control only for practice and participant gender and age (the latter two variables will be included to allow addition of interaction between study group and gender or age in secondary analyses). If, however, substantial baseline imbalances occur, the model will include for those additional variables.

3.4.1.2. Aim 2 (DSNI versus SI on change in CRC screening decision stage). CRC screening decision stage will be assessed in both the baseline and 6-month surveys. Forward change (between baseline and endpoint) will encompass any movement from a lower to a higher decision stage. We hypothesize that DSNI Group participants will have greater forward movement in screening decision stage than SI Group participants. We will analyze forward change in screening decision stage (yes vs. no) via logistic regression. These analyses will be based on 6-month survey data. Prior research suggests that survey response will be comparable in both study groups. The model will include practice and participant baseline characteristics.

3.4.1.3. Aim 3 (DSNI versus SI on test-specific CRC screening adherence). The two study groups will be compared in terms of the fraction of participants who undergo a SBT or a colonoscopy within 12 months. Due to current screening practices in primary care, we expect very few, if any, instances of screening via other modalities. We hypothesize that DSNI Group participants will have higher SBT and colonoscopy screening than SI Group participants. The main analysis of test-specific screening (no screening, SBT screening, colonoscopy screening) will be based on polytomous (multinomial) logistic regression. The analysis strategy will be similar to that for Aim 1 (i.e., control for practice, as well as participant gender and age).

3.4.1.4. Aim 4 (DSNI versus SI on CRC and screening knowledge and perceptions). Knowledge and perceptions (PHM scales) about CRC and screening will be assessed at the 6-month survey. We hypothesize that DSNI Group participants will have higher knowledge and more favorable perceptions than SI Group



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participants. The analyses of knowledge and perception scales will be based on linear regression. However, if some of the scales are skewed, some transformation will be needed prior to the analyses (e.g., log). Alternatively, some of the outcomes might be used as dichotomous or categorical, in which case the analyses will rely on logistic regression. The analysis strategy will be similar to that for Aim 2 (i.e., control for practice, as well as all participant baseline characteristics).

3.4.1.5. Additional Analyses. Data on tailored navigation and support delivery (e.g., number and timing of navigator call attempts, time from randomization to initiation and completion of contact, validation of test preference, assessment of screening likelihood, reasons for incomplete delivery of the navigation call, and mailing of the screening plan and screening status report) will also be collected and summarized. We will also assess the potential interaction between study group and sex and age, by the addition of corresponding interaction terms to the main logistic regression model of Aim 1. Using electronic medical records data for SBT screenees, we will also describe patterns of screening beyond the initial 12-month observation period for SBT-negative patients and patterns of diagnostic follow-up for SBT-positive patients.

3.4.2. Sample Size and Power. As shown in Figure 1 above, we will randomize 400 LVHN Hispanic patients (200 per study group). We expect to have CRC screening data for at least 95% of the participants, given access to patient electronic medical records, and direct reports from a centralized SBT laboratory (N~380). Given our prior experience in similar research studies, we also expect an 80% completion rate for the endpoint survey (N~320).

3.4.2.1. Power for Aim 1. Based on our previous research and given the planned enhancements in the decision support and navigation intervention, we expect overall CRC screening rates to be about 30% in the SI Group and at least 45% in the DSNI Group (odds ratio, OR = 1.9). Given a projected total sample size of 380 and a two-sided alpha of 0.05. the study has 85% power for Aim 1.

3.4.2.2. Power for Aim 2. We expect a similar magnitude of difference between the two study groups on forward change in CRC decision stage (e.g., 35% in SI vs. 51% in DSNI, OR = 1.9). Thus, the study has 82% power (projected N~320, two-sided alpha = 0.05).

3.4.2.3. Power for Aim 3. Finally, with respect to test-specific CRC screening, we expect SBT screening rates to be 20% in the SI Group versus 30% in the DSNI Group, and colonoscopy rates to be 10% versus 15% for the two groups, respectively. Thus, the study has 78% power (projected N~380, two-sided alpha = 0.05).

As described in Section 3.3.2., we will also monitor the intervention fidelity. Given our prior research, we expect more than 95% of the mailed materials to be received by study participants. Furthermore, we expect that navigation will be actually delivered to about 85% of the DSNI Group participants. However, if the intervention completion rate turns out to be lower, we will carry out additional analyses to explore the differences between DSNI Group participants who received versus those who did not receive navigation.

4. Demonstrate the patient-centeredness of the application (Criterion 4)

4.1. Patient Involvement in Developing the Study. As mentioned earlier, the sampling frame for this study will include Hispanic patients from four LVHN primary care clinic practices serving center city Allentown, and from the Neighborhood Health Center of the Lehigh Valley (NHCLV), a community health center that is finalizing its status as a Federally-Qualified Health Center. In 2012 and 2013, the research team conducted 4 focus groups with LVHN Hispanic patients and members of Hispanic community and support groups. The groups were conducted in Spanish and English. Participants were presented with a description of the proposed study, and reviewed a draft copy of the study informational booklet on CRC screening and draft study letters written in English and Spanish. The moderators then asked participants to share their personal views about CRC screening, existing barriers to screening, and the study. Focus group participants were surprised to learn of the CRC screening disparity between Hispanics and nonHispanic whites, stressed the importance of this issue in their community, and supported the use of interventions intended to reduce the disparity. Participants



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recommended that the research team work should seek to increase community awareness of the proposed study among eligible primary care patients. Regarding potential barriers to CRC screening, focus group participants highlighted the lack of knowledge in the Hispanic community about CRC screening tests, limited communication between population members and primary care providers about CRC screening and other preventive health behaviors, a sense of fatalism about the effectiveness of early detection, limited financial means of the potential participants, and the lack of a trusted intermediary to engage patients in screening.3 Participants noted that the planned preference-based screening approach is likely to improve screening rates among Hispanic patients.

Focus group participants strongly supported the elements of individualized education, preference assessment, and tailored navigation, particularly if provided by a navigator who was culturally appropriate for the patient base. Participants were in strong favor of the support of the patient navigator and commented that s/he should be not only bi-lingual, but also have experience in community work. Overall, the tailored navigation was thought to be a high-value aspect of the intervention. Patients were excited to learn of the research teams efforts and several participants volunteered to sit on the Patient and Stakeholder Advisory Committee. Participants were particularly enthusiastic about the fact that navigator would help facilitate communication between patients and their primary care physicians related to implementation of the screening plan. Finally, participants pointed out that formation of an advisory committee that includes Hispanic representatives, along with LVHN primary care providers would help to ensure that the voice of the patients in the community is represented along with LVHN clinicians involved in the project. To this end, we have established a patient and stakeholder advisory committee (PASAC) to guide study development, implementation, and evaluation (see Section 4.2).

4.2. Patient and Stakeholder Involvement in Implementing and Evaluating the Study. The PASAC, which is conceived of as an essential part of the research team, includes 5 patient stakeholders and 7 LVHN and community stakeholders. Patient membership includes: Mr. Fior Dali Diaz, Ms. Valeria Negron, Ms. Awilda Martinez, Ms. Maria Ayala and Mr. Victor Laboy. The PASAC currently includes Dr. Myra Piña from the Latino Leadership Alliance of the Lehigh Valley; Claudia Santiago, LVHN Operations Coordinator; Community Health and Wellness Center; Ada Rivera, Director, Department of Medicine, John and Dorothy Morgan Cancer Center; Timothy Friel, MD, Vice-Chair Internal Medicine Research, Clinical Medical Director; Alicia Rivera, LVHN Community Liaison; Orlando Penaloza, MD, clinic physician; and Annette Sanchez, Office Manager, Neighborhood Healthcare Center of the Lehigh Valley. Acting as co-chairs of the committee, Brian Stello, MD (site Principal Investigator) and an Hispanic primary care patient, Ms. Awilda Martinez, will convene meetings three times a year. Minutes from each prior meeting will be reviewed at the beginning of each meeting, and the planned meeting will follow an agenda developed by the co-chairs. PASAC members will receive $50 for attendance at each meeting to defray costs associated with participation. Meetings will be conducted in both English and Spanish, as determined by the members, with assistance provided by bilingual facilitators from the Fox Chase Cancer Center OHCHD.

At the initial meeting of the study period, members of the PASAC will be provided with a copy of the study protocol and documents that will be used for patient recruitment to the study and data collection. In addition, intervention materials and methods will be shared with participants. All participants will be encouraged to share their perceptions of the research proposal, their roles in the process, expectations, recommendations on methods for foster trust and open communication with other members of the research team. At subsequent PASAC meetings, project staff will present the PASAC with regular study progress reports. These meetings will focus on generating feedback from patients and stakeholders that can facilitate study culturally-sensitive, effective and efficient recruitment intervention implementation, and evaluation.

The initial meeting and all subsequent meetings of the PASAC will be audio recorded. OHCHD staff will transcribe and analyze the audio recordings to create an objective record of PASAC meeting discussions, recommendations made by participants, and research team responses to those recommendations. This level of reporting is likely to improve balanced participation, ensure that the patient voice is represented in study



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operations, and contribute to the patient-centeredness of the study.82,83 Harper and Salina84 and White et al.85 have observed that patients and stakeholders who have been engaged in project planning and proposal preparation also benefit from obtaining increased knowledge about and understanding of research activities.

During the study, the PASAC will work with other members of the research team to (1) plan study development and implementation; (2) review study implementation progress; (3) provide guidance on developments in the community and in the health system that could affect intervention implementation and/or dissemination, (4) review study progress reports, and (5) contribute to manuscript development and preparation.

5. Demonstrate the commitment to patient and stakeholder engagement (Criterion 5).

5.1. Patient Engagement. During the first six months of the proposed study, we will work with the Fox Chase Cancer Center OHCHD to develop study materials and conduct two focus groups with Hispanic patients from LVHN primary care practices. The OHCHD has 30 years of experience communicating and disseminating current, evidence-based, culturally-appropriate cancer information. OHCHD staff members have expertise in health communications and cancer control, and bi-lingual, bi-cultural staff members have extensive experience in developing programs for racial and ethnic minorities and in conducting focus groups in Spanish.

In the study, the OHCHD will translate printed English language materials used in prior research into Spanish, and ensure that informational content and visual presentation is culturally-sensitive and is clear and literacy-appropriate. We will also translate the script that will be used in telephone navigation contacts. Study materials and methods will be reviewed in two new focus groups with Hispanic patients (n=10 in each group). The focus groups will be conducted in Spanish or English, as determined by attendees at the time of the group session. Both focus groups will be audio recorded and will be transcribed prior to initiating the coding process. Fox Chase Cancer Center OHCHD staff will develop a coding scheme using MaxQDA professional text analysis and content analysis software; and will review data output to identify the most common themes and responses voiced by participants. Basic descriptive statistics (frequencies) will reveal key themes, which will be presented in a formal report.

In the last year of the study, the research team will also work with the OHCHD to conduct two focus groups with DSNI Group participants. The two focus groups will include screenees (n=10) and nonscreeners (n=10). We will develop discussion guides for use in eliciting participant perceptions about intervention contacts, and barriers to and facilitators of screening. Focus groups will be conducted in Spanish or English, as needed, and will be audio recorded. As in Year 1, the focus group audio recordings will be transcribed and prior to initiating the coding process, a coding scheme will be developed using MaxQDA professional text analysis and content analysis software. Output will be reviewed to identify the most common themes and responses. Basic descriptive statistics (frequencies) will be used to identify key themes, which will be presented in a final report. The PASAC and the rest of the research team will review focus group results, and will make recommendations to advance intervention implementation and dissemination in LVHN and other health care systems.

5.2. Provider Engagement. The research team held several meetings with network senior leadership, clinic physicians, administrators from the LVHN Cancer Center, GI clinic, the Community Health and Wellness Center, leaders of the Latino Leadership Alliance, and the Wellness Director at the local YM/WCA to discuss community needs related to CRC and screening, and LVHN commitment to address the CRC screening disparity. Echoing patients and community members, meeting participants felt strongly that a need exists to identify interventions that can be used to overcome barriers and access to screening among Hispanic patients. Several participants offered feedback on the patient navigator role in the proposed study, indicating that the navigator should not only be bi-lingual but also “bi-cultural”, understanding the local Latino community, having prior experience in the community outreach. It was also suggested that the navigator role should include evening hours to accommodate working patients. Participating primary care clinicians expressed the need for frequent follow-up communication between the navigator and the primary care practice, with the navigator acting as an extension of the practice. In addition, participants expressed their interest in helping to convene focus groups in the study and work with the research team to facilitate participant recruitment. They also



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expressed willingness to become involved in the PASAC. Feedback from leadership of the LVHN Network Office of Research and Innovation conveyed substantial support and encouragement for advancing this initiative. LVNH leadership assured the research team that health system has the capacity to handle the proposed increased demands related to CRC screening, diagnostic follow-up, and treatment that this study may generate. It is understood that the research grant will cover the cost of the mailed SBT kit, and LVHN will help participants with limited or no insurance coverage by providing colonoscopy and follow-up, including treatment, at little or no cost via Medical Assistance applications and an established Charity Care program. In addition, the study team met with Gregory Harper, MD, PhD (LVHN Director of the John & Dorothy Morgan Cancer Center), leadership of the LVHN primary care clinics, and key LVHN administrative leaders. These meetings were convened to strategize about how to integrate with the Cancer Center and the LVHN Community Health and Wellness Center, as well as to engage providers in the study. Input from these provider leaders and representatives endorsed the plan to authorize patient navigators schedule colonoscopy screening and deliver patient-specific screening reports to primary care providers. Follow-up discussions with providers resulted in letters of support for the proposed study.

5.3. Multi-Level Evaluation. The research team will apply the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework,86,87 the Organization Transformation Model or OTM,88 and the PRECEDE-PROCEED Model to evaluate the intervention process.89 The RE-AIM framework was developed to generate information that could be used to guide health care program planning, implementation, and evaluation, with the goal of translating research findings into practice. The OTM is intended to gain insights into a wide range of factors that influence organization and leadership readiness to adopt change. Furthermore, the PRECEDE/PROCEDE Model provides a conceptual framework for classifying organizational factors into categories (i.e., predisposing, reinforcing, and enabling factors) that can guide the development of strategies for translating research into practice.

As described by Bakken and Ruland,90 the “Reach” dimension is conceived of as an individual level measure of the number and percentage of targeted individuals (patients and/or health care providers) who actually receive the program or intervention. The “Efficacy/Effectiveness” dimension refers to measurement of the number and percentage of individuals (patients and/or providers) who exhibit intended and unintended outcomes as a result of exposure to the program or intervention. “Adoption” is defined as the number and percentage of participating agents or settings (providers and practices) that play important roles in delivering the program or intervention components. ”Implementation” refers to the number and percentage of agents or settings that actually deliver the program or intervention strategy to the target population. Finally, “Maintenance” is defined as the degree to which a program or intervention become routine and part of the everyday culture of an organization.

In the final year of the study, we will complete an assessment of RE-AIM dimensions at different levels of the LVHN. Specifically, we will assess intervention reach at the patient level in terms of the number/percentage of study participants who receive planned intervention contacts as compared to those who are eligible to receive such contacts. We will also determine the number/percentage of providers who receive participant screening plans and reports. In addition, navigators will be asked about their experiences in delivering intervention contacts to participants and providers. Mail and telephone records, along with navigator logs, will be used to obtain data to measure this dimension. We will measure intervention efficacy/effectiveness at the patient level in terms of impact on defined primary outcomes (i.e., screening adherence, screening decision stage, and test-specific adherence). Here, we will use data from the 6-month survey, 6-month medical records review, and 12-month medical records review to evaluate this dimension. In terms of intervention adoption, we will determine the number and percentage of providers and office managers who acknowledge receipt of screening plans and reports by study navigators and provide feedback on provider review of this documentation. We will assess intervention implementation by determining the number and timing of attempted and completed navigator calls, time from call initiation to call completion, length of calls, and reasons for incomplete calls. We will also track navigator contacts with provider practices in a similar manner. In addition, qualitative data will be collected from the navigators about their experience implementing the intervention: what worked well and what



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didn’t, whether patients utilized their assistance, and what were the key services that they offered that they believe contributed to completion of screening. We will also interview selected lead physicians and office managers from participating practices in order to obtain information on their experience receiving and acting on intervention-related contacts, including feedback from patients, study navigator contacts, and their receipt of participant screening plans and reports. These interviews will be conducted by Drs. Myers (Principal Investigator) and Sifri (Co-Investigator).

Given the 3-year duration of the study, we will not be able to measure long-term intervention maintenance in LVHN practices. However, we will be able to assess the potential for maintenance by conducting interviews with members of the PASAC, lead physicians from participating primary care practices, practice office managers, and LVHN administrative leaders. The research team will develop an interview guide to assess organizational factors that influenced the screening process (i.e., participant recruitment, contact, appointment scheduling, test performance, and results reporting). The guide will be used by Drs. Myers and Sifri to conduct interviews to obtain insights into LVHN response to study interventions, factors that may influence the dissemination of research findings, and future intervention implementation and maintenance (e.g., practice-based quality improvement initiatives, changes in primary care practice leadership and the organization of specialty care). Thus, we will determine system impetus for intervention maintenance, commitment to implementation and maintenance, alignment of the intervention and system goals, and agreement on steps for institutionalizing the intervention. Particular attention will be devoted to identifying opportunities and obstacles to the dissemination of findings from the study to the LVHN and other health systems in the region that serve Hispanic patients (e.g., Albert Einstein Health Network in Philadelphia and Christiana Care Health System in Delaware).91,92

The analysis of interviews with PASAC members, lead physicians, practice office managers, and administrators will be carried out by transcribing interview notes, reviewing these written transcripts, and by assigning codes to key themes. This review will be conducted by OHCHD staff. After initial review of interview transcripts with assignment of themes, OHCHD staff will compare observations and reach consensus about the most frequent and important observations. Where agreement is not achieved, members of PASAC and the research team will be asked to join the discussion to help arrive at consensus. After agreement is reached, the list of agreed upon themes will be categorized in terms of predisposing, reinforcing, and enabling constructs. Specification of these themes and categories will inform the development of recommendations for intervention dissemination and implementation.

6. Project Timeline

Activities 2014 2015 2016 J A J O J A J O J A J O

I Patient and Stakeholder Engagement

PASAC Meetings X X X X X X X X X X X X

Patient Focus Groups X --- --- --- --- --- --- --- --- --- X ---

II Implementation

Conduct baseline survey/randomize ......................... --- X X X X X --- --- --- --- --- ---

Deliver interventions .................................................. --- --- X X X X X X --- --- --- ---

Conduct 6-month survey ........................................... --- --- --- X X X X X X --- --- ---

Conduct 6-,12-month records review ........................ --- --- --- X X X X X X X --- ---

Conduct multi-level evaluation .................................... --- --- --- --- --- --- --- --- X X --- ---

III Data Management and Analysis X X X X X X X X X X --- ---

Complete outcomes data analyses ........................... --- --- --- X --- --- --- X --- --- X X

Complete multi-level evaluation analyses --- --- --- --- --- --- --- --- --- --- X X

Report progress and final results .............................. --- X --- X --- X --- X --- X --- X



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DISSEMINATION AND IMPLEMENTATION POTENTIAL (Use continuation pages as needed to provide the required information in the format shown below. Limit 2 pages for this section.

Mouse over each underlined subheading for a short description of each.

Refer to the PCORI Application Guidelines and the PFA to which you are applying, found on the PCORI Funding Center, for additional guidance.)

Please note, we are asking you to describe the potential for dissemination and implementation. PCORI does not expect you to undertake this

dissemination and implementation work at this juncture. For projects that produce important findings, PCORI will consider subsequent applications that

support dissemination and implementation efforts through separate funding announcements.

Describe the potential for disseminating and implementing the results of your work in other settings.

As described in Section 5.3 of the application, the research team will conduct a multi-level evaluation to identify patient, provider, and health system barriers to dissemination and implementation of the decision support and navigation intervention. This evaluation will be guided by the RE-AIM model and OTM, frameworks that have been developed to identifying factors that affect intervention dissemination and implementation in different organizational settings. In addition, we will interview PASAC members to identify their views related the development of a plan for dissemination and implementation throughout the LVHN and beyond. The research team will work with the PASAC to develop a plan for intervention dissemination and implementation in the LVHN. This plan will include in-person presentations by the research team to community groups and consortia, and the presentation of information about the study via print and radio as appropriate. We will also work with LVHN administration to disseminate information about the study to primary care physicians and specialists throughout the health system. In addition to dissemination within the LVHN, study team works closely with a number of additional health systems including Albert Einstein Health Network (AEHN) in urban Philadelphia and Christiana Care Health System (CCHS) in Delaware. Currently, the research team has a history of successful cancer screening research with primary care leadership in these health systems. These relationships will help to facilitate the dissemination research findings, and will open the door for dialogue related to intervention implementation for practices that service Hispanic patients. Since these systems have participated with us in previous studies, similar methods and communications have already been established. Furthermore, dissemination of findings to the larger community and academic audiences will take place through presentations at local/regional and national meetings (PCORI), and via publication in peer-reviewed journals.

Describe possible barriers to dissemination and implementation of your work in other settings.

In a recent review92, the authors identified major types of obstacles to dissemination and implementation as being structural-, organizational-, provider-, patient-, and innovation-level in nature. Structural-level factors include external policies, procedures, and economic development that affect the delivery of health care. Organizational-level factors include cultural climate related to innovation uptake and leadership effectiveness in promoting change. Provider-level factors may be viewed as the actions and attitudes of primary care providers and office staff, and by extension patient navigators, relative to interactions with study participants. Patient-level factors relate to participant sociodemographic background characteristics, beliefs and attitudes, and social influences that affect response to intervention contacts. Commonly reported obstacles, especially in minority and underserved populations include; lack of knowledge about research, limited awareness of research opportunities, mistrust of research and researchers, burdens of time and financial costs related to research participation, fear of experimentation, complexity of research study design, access to trial sites, past negative experiences with the health system, and lack of social support for participation in translational research.93 To identify and address these issues will involve Hispanic patients and community leaders along the continuum of research activities, from planning to implementation and through dissemination of research findings. In addition, we will engage LVHN stakeholders who serve Hispanic patients in developing plans for dissemination and implementation in LVHN and in other health care settings (see Section 5 for details).




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REPRODUCIBILITY AND TRANSPARENCY OF RESEARCH (Use continuation pages as needed to provide the required information in the format shown below. Limit 2 pages for this section.

Mouse over the underlined subheading for a short description. Refer to the PCORI Application Guidelines and the PFA to which you are applying, found

on the PCORI Funding Center, for additional guidance.)

Describe the ability to replicate potentially important findings from PCORI-funded studies in other data sets and populations. In accordance with our usual practices and PCORI regulations, we will register the proposed trial at www.clinicaltrials.gov . We will also create and maintain a Study Procedures Manual. The manual will be created in order to make available our final procedures and data management plan, and will consist of two sections; Planning and Implementation. The Planning portion will focus on staff training and data management. Data management includes the necessary procedures and permissions for accessing data from outside sites, steps that are necessary to document exclusions, and data transfer procedures. This section would allow for those replicating the study to learn any issues or requirements necessary to complete recruitment and eligibility screening. The more substantial Implementation section will focus on the detailed study protocol. This section will consist of approximately nine subheadings: Identification, Recruitment, Eligibility Screening and Consent, Survey and Enroll, Randomize, Intervention, Follow-up Data collection and Data Management. Within the Implementation section, we will outline procedures used to electronically identify potentially eligible patients from LVHN billing data. We will include programming code that can be used as a template for those attempting to replicate the program. We will also outline procedures for conducting an opt-out mailing, tracking responses, and managing potential participants. The Enrollment and Randomization subsections will discuss consenting and procedures. The Intervention subsection will cover both the SI and DSNI procedures. Also in the intervention section will be procedures regarding informational content, intervention mailings, and the timing of both the SI and DSNI contacts. Data collection instruments will be described and provided, along with coding schemes as well as instructions for administration and collection. Data collection instruments include baseline survey, navigation and decision counseling call log, 6-month survey, and 6- and 12-month chart reviews. A code book has already been created for these instruments and will be modified if necessary as the study progresses. In addition, this code book will be included as an appendix in the manual of procedures. In addition to data collection and coding, data management will also include database variables and set up necessary in order to run mailings and messaging efficiently. Additionally, the Manual will document a running list of issues, changes and solutions that occurred during implementation of the study in order to appropriately demonstrate to the reader changes that needed to be made in order to insure success. Following completion of the study, the research team will generate manuscripts for submission to peer-reviewed journals. In addition, we will summarize important results and make those reports available to the public on the Kimmel Cancer Center website (www. kimmelcancercenter.org). These manuscripts and reports will include describing the study population, testing secondary hypotheses and descriptions of data analysis and measures. In addition to manuscripts, a final protocol and the complete Procedures Manual will be delivered to PCORI within three months of the end of the funding period. Outside of our internal monitoring and recording of protocol and procedures, minutes and audio recordings from Patient and Stakeholder Advisory Committee (PASAC) meetings will collected and organized not only for continued use in our research, but also to provide information that will be useful in the dissemination of study findings and intervention implementation in the LVHN and other health systems.


http://www.clinicaltrials.gov/



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Reproduction of Research Findings (Data Sharing Plan) This criterion is not applicable, as this proposal is not requesting more than $500,000 in directs during any project year.



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PROTECTION OF HUMAN SUBJECTS

(Use continuation pages as needed to provide the required information. For detailed instruction, refer to the Supplemental Instructions for Preparing the

Protection of Human Subjects Section of the Research Plan in Part II of the Instructions for the PHS 398 Form, as found on the National Institutes of

Health (NIH) website. Do not exceed 5 pages.)

Protection of Human Subjects

All study participants will be drawn from the patient populations served by the Lehigh Valley Health Network (LVHN) in the Lehigh Valley of Pennsylvania. The LVHN is a multi-center, non-profit healthcare delivery system with a National Community Cancer Center Program in Eastern Pennsylvania. LVHN’s primary services areas include Lehigh and Northampton counties, which include over 645,000 residents, of whom 96,967 are Hispanic or Latino. The city of Allentown in Lehigh County is home to over 105,000 residents, 40% of which are Hispanic or Latino. Twenty-two percent of the population of Allentown lives below the poverty line. Data from the American Community Survey indicates that 36% of people living in Allentown speak a language other than English at home, the majority of whom speak Spanish.

Sampling Frame. The primary sampling frame for this proposed study will be patients from six primary care clinic practices serving center city Allentown, supplemented by LVHN community practices. Among patients receiving care from LVHN clinics, fewer than 35% of eligible patients have been diagnosed with or screened for colorectal cancer. The research team for the proposed study will engage the patient populations of participating primary care practices, primary care providers in those practices, and gastroenterology and colorectal specialists who perform screening colonoscopy in the LVHN system. To be eligible, patients must be 50 to 75 years of age and have complete address and telephone number information. As age 50 is the standard age at which CRC screening is initiated in average risk populations, no persons younger than 50 will be enrolled. Patients will be ineligible if they have had a recent CRC screening examination, are up to date with CRC screening according to United States Preventive Service Task Force (USPSTF) guidelines, have been diagnosed with colorectal neoplasia (cancer or polyps) or inflammatory bowel disease, or have a family history of CRC diagnosed before the age of 60 years. We will include only Hispanic patients in the proposed study.

Data Collection. The Baseline Survey instrument will include decision stage for SBT and colonoscopy screening and sociodemographic questions. Screening knowledge and PHM measures will be measured on a 6--month survey. Data on screening test performance and screening test results will be collected on a 6-month medical records review and on a 12-month medical records review.

http://www.grants.nih.gov/grants/funding/phs398/phs398.doc

http://www.grants.nih.gov/grants/funding/phs398/phs398.doc



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Data Type Data Elements Data Source

Demographic data

Name, telephone number(s), mailing address, insurance status

LVHN IDX administrative database

Age, ethnicity, race, education, income and marital status. E-mail address and cell telephone number. Language preference.

Baseline survey

Existing data Colorectal cancer related screening and diagnostic history

LVHN IDX administrative database

Data collected for the study

Decision stage related to screening SBT and colonoscopy Decision factors, factor weights, screening likelihood score

Baseline & 6-month survey Decision counseling session (DSNI Group only)

Factors that influence screening, barriers to screen and steps in the screening plan.

Navigation log

SBT (FIT or some other SBT) and colonoscopy screening use. Flexible sigmoidoscopy and barium enema x-ray use. Test-specific decision stage, acculturation, fatalism, and perceptions regarding CRC screening and CRC screening knowledge

6-month survey

SBT(FIT or some other SBT) and colonoscopy Screening use. Flexible sigmoidoscopy and barium enema x-ray use.

6- and 12-month medical records review/EMR

There are minimal risks to subjects related to their completion of survey questionnaires, reading educational materials, and contacts from patient navigator. There are minimal risks of emotional distress from discussing cancer screening. This is not a therapeutic treatment trial. In terms of study participation, the alternative is not to participate in the study.

Identifying and Enrolling Participants. Patients who are selected into the initial sample will be mailed a study invitation letter that describes the proposed research and information about ways to register for the study (i.e., complete and return a study registration card in a postage-paid envelop, call a toll-free telephone number, complete registration at the time of an office visit, or log onto a protected study website). Patients who initiate such contacts will have the opportunity to verify study eligibility and provide oral consent for study participation. Individuals who do not want to participate will be able to opt out of further contacts by using one of the contact methods above. The study will include 400 participants from the Hispanic patient population served by 5 LVHN centers. At 21 days after the initial mailing, a research assistant will place a telephone call to patients who have not opted out of the study. During this contact, the research assistant will verify eligibility, obtain consent for participation and administer a baseline survey to eligible, consenting respondents. The research assistant will



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administer a brief survey to collect background data and determine screening test preference. Calls will continue until 400 potentially eligible patients have been consented and enrolled. At six months following enrollment, participants will be called by Survey Technologies and Research (STR) in order to complete a follow-up telephone survey.

Randomization. Research staff will randomly assign all eligible patients who complete a baseline survey to either a Standard Intervention (SI) Group or a Decision Support and Navigation (DSNI) Group. An equal randomization scheme (1:1 for the two study groups) will be employed.

Protections against Risk. There are no known risks to participants from identification, recruitment and consent, randomization and exposure to the study interventions. In terms of confidentiality, a file linking participant names to numeric identifiers will be kept in a secure data file in the principal investigator’s office. When survey data are obtained from the study participants, only numeric identifiers will be attached to the records. Names and telephone numbers of consented participants will be shared with the professional survey company (STR) for administration of the baseline survey. All research staff with access to study data will be certified by the TJU Office of Human Research/ Division of Human Subjects Protection.

Potential Benefits of the Proposed Research to Human Subjects and Others. Potential benefits that might result from participation by age-eligible patients include increased knowledge about CRC screening and early diagnosis of CRC or adenomatous polyps. The potential benefits for the age-eligible population in general include the development of more effective methods for delivering information about CRC screening and promoting the completion of SBT and screening colonoscopy examination. The potential benefits to individual participants and for the target population in general are significantly greater than the possible minimal risks.

Importance of the Knowledge to be Gained. The proposed project is a comparative effectiveness study of intervention methods designed to increase colorectal cancer (CRC) screening among patients of a large multi-facility, multi-organizational, non-profit healthcare delivery system in Pennsylvania. Results from the study will not only be implemented by the LVHN, but also will be disseminated for use by other healthcare delivery systems. Colorectal cancer screening programs in various populations have demonstrated a positive impact on colon cancer morbidity and mortality. Widespread implementation of effective screening programs has a great potential benefit to individual patients as well as the medical care system.

Data Safety Monitoring Plan. In the proposed study, we will employ a Data Safety and Monitoring Committee (DSMC), whose members will be otherwise unaffiliated with the project. Members of the DSMC include: Drs. Terry Hyslop, PhD., Associate Professor, Pharmacology and Experimental Therapeutics, Thomas Jefferson University; Nancy Brisbon, Assistant Professor, Family and Community Medicine, Thomas Jefferson University; and Andrea Barsevick, PhD, Associate Professor, Department of Medical Oncology, Division of Population Science, Thomas Jefferson University. The DSMC will meet formally at least annually after the start of enrollment, and will review the progress of the study, as well as any implementation problems, human subjects issues, and adverse events. Committee recommendations will be submitted to Ronald E. Myers, PhD, the study Principal Investigator, who is responsible for making decisions regarding possible modifications to the study or any needed measures to safeguard the subjects’ health and well-being. The DSMC will keep official minutes of its meetings and recommendations.



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REFERENCES CITED

(Use continuation pages as needed to provide the required information. Do not exceed 10 pages.)

Provide a list of references cited in the Research Plan. Each reference must include names of all authors (in the same sequence in which they appear in

the publication); the article title; and journal or book title, volume number, page numbers, and year of publication. Include only bibliographic citations.

Follow scholarly practices in providing citations for source materials relied on in preparing any section of the application. Refer to the PCORI Application

Guidelines and the PFA to which you are applying, found on the PCORI Funding Center, for additional guidance.

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CONSORTIUM/CONTRACTUAL ARRANGEMENTS (Use continuation pages as needed to provide the required information. Do not exceed 5 pages.)

Use this section to further describe the research projects of the subcontracts and explain the strengths that the partners bring to the overall project.

The proposed study involves Thomas Jefferson University (TJU) as the lead organization and Lehigh Valley Health Network (LVHN) as a subcontractor organization. This contractual arrangement is reasonable, given that TJU faculty and staff are members of the research team responsible for providing overall scientific leadership, and for training, data management, data analysis, reporting in the project; while LVHN clinical and administrative personnel will provide operational leadership for the project. Through its subcontract, LVHN study personnel will work closely with affiliated primary care practices identify and recruit patients to the study to deliver study interventions to participants. In addition, the subcontract will support LVHN chart audit data collection. Furthermore, LVHN personnel will assemble and manage a Patient and Stakeholder Advisory Committee (PASAC), an important group that will play a key role in guiding the project. Finally, LVHN represents the setting in which study intervention dissemination and implementation will take place. In addition, TJU will be entering into a consortium agreement with Fox Chase Cancer Center (Fox Chase) to undertake the research project described in this proposal. The Office of Health Communications and Health Disparities (OHCHD) at Fox Chase, under the direction of site Principal Investigator Evelyn Gonzalez, MA, has extensive experience both conducting focus groups and working with the Latino/Hispanic population in Pennsylvania. Their Office actually developed Spanish-language health education materials subsequently adapted by the state for use in a state-wide cancer education program. In addition, bilingual program staff has developed strong working partnerships with a variety of Hispanic/Latino groups throughout the region. The OHCHD has also done substantial work regarding CRC screening. Working with Penn State Hershey, they have actively participated in research to better understand what contact methods increase the percentage of patients completing FIT screening in Appalachia. They have also conducted focus groups on many cancer-related topics including bio-specimens collection, clinical trials and others and are experienced at creating focus group guides and analyzing group results. The OHCHD will bring necessary experience and abilities to the successful completion of the proposed project.



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APPENDIX

(Use continuation pages as needed to provide the required information. Note that the Appendix is optional.)

Table of Contents

Description

Data Collection Materials

Eligibility Screener

Baseline Survey

6-month Survey

6- and 12-Month Medical Records Review

Data Inventory

Intervention Materials

Screening Invitation Letter (English and Spanish)

Informational Booklet (English and Spanish)

Screening Plan (English; to be translated)

Reminder Letter (English; to be translated)

Navigation and Support Training

Training Manual Outline

Subcontract Documentation

Lehigh Valley Health Network

Letter of Intent to Form a Consortium

Scope of Work

Brian Stello, MD Letter of Support

Fox Chase Cancer Center

Letter of Intent to Form a Consortium

Scope of Work

Evelyn Gonzalez, MA, Letter of Support

RESEARCH STRATEGY · PRINCIPAL INVESTIGATOR (LAST, FIRST, MIDDLE): Myers, Ronald E. PCORI Research...

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