Clinical & Translational Science Institute (CTSI): Recruitment and Retention Resources

SCORE – October 8, 2015

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Accessing Available Resources and Services

Carrie Dykes, PhD Research Engagement Specialist

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Peer Institutions •UNYTE •CTSAs

Government Agencies Contract Research Organizations Others Identified to meet needs

Research Help

Center for Community Health Center for Human Experimental

Therapeutics (CHET) Clinical Research Center

Center for Research Implementation and Translation

ClinicalTrials.gov Registration Customized Action Plan Education and Training eRecord for Research

FDA Regulatory Compliance Mentoring

Research Ethics Research Subject Advocacy

Funding sources

Biostatistics Biomedical Informatics Comparative Effectiveness

Epidemiology Human Behavior Assessment Physical Exercise Activity

Kinesiology (PEAK) Lab URMC Labs

Shared Resource Laboratories

Consultations

Research Services and Resources Connect. Learn. Get Help.

Support Provided Through the CTSI:

CTSI-Associated Centers:

UR Resources:

External Resources:

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• Bioinformatics

• Clinical Research Center

• ClinicalTrials.gov Registration and Reporting

• Data Access and Management

• Developing an Informed Consent Process

• Data and Safety Monitoring Plan Development

• Clinical Material Services Unit (CMSU)

• Clinical Trials Coordination Center (CTCC)

• Investigational Drug Service (IDS)

CTSI Resources

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• eRecord for Researchers

• Guidance for FDA Regulatory Compliance

• Research Coordinators Group (SCORE)

• UR Connected

• Research Subject Advocacy

• URMC Labs

CTSI Resources - continued

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Recruitment and Retention

• Consultations

• Feasibility analysis

• Developing and writing recruitment plan

• Greater Rochester Practice-Based Research Network (Karen Vitale)

• Community Engagement (Gail Newton)

• Emergency Department Research

• ROC Health Website

• http://www.urmc.rochester.edu/health-research/

• ResearchMatch.org

• https://www.researchmatch.org/

• Marketing

• (flyers, brochures, TV, radio, web, social media)

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• Forteresearch.com • SCORE listserv • Commercial contact lists

• http://leads.infousa.com/UsConsumer/Selections

Recruitment and Retention

Examples of request for help

• “I am interested in learning more about how to market a research study to help with recruitment.”

• Carrie provided information from other investigators who have used radio and TV. IHeartRadio and TV producers Rose Films was provided. She is also meeting with Heather Doyle in graphics and will get internal film production contacts from her.

• “I wanted to inquire about commercial lists that could be purchased to send out letters to potential interested participants for research studies.”

• Carrie contacted investigators who have used this service and provided that info to requester

• “We need to enroll up to 20 typically developing children for a comparison group for a study we are conducting examining the socioemotional skills of children with fetal alcohol spectrum disorders. “

• Research connected requester with recruitment consultant, community engagement consultant, GR-PBRN, and participant registries

• “Do you know if anyone here at UR is doing social media advertising (e.g. Facebook, Twitter) for clinical research studies? I’d love to reach out to them to find out what specifically they are doing/have done and what steps they’ve taken with RSRB process. “

• Connected requester with group that uses social media

Research Help Desk

Submit questions and general requests: ResearchHelp@urmc.rochester.edu

(585) 275-2107 http://www.urmc.rochester.edu/ctsi/research-help

All requests will receive a response within 2 business days of submission

Connect. Learn. Get Help. Research teams work faster and better with the CTSI.

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How the CRC Assists in the Retention of Research Volunteers

Ann Miller, BSN, MS, CCRC Nurse Manager, Clinical Research Center (CRC)

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Administration

Giovanni Schifitto, MD, MS Medical Director

Kathleen Jensen, MHSA Executive Director of Finance for the Clinical

and Translational Science Institute Ann Miller, BSN, MS, CCRC Nurse Manager

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Sponsor

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The Clinical Research Center is a component of the NIH-Funded

Clinical & Translational Science Institute (CTSI)

What Do We Do?

• The CRC provides professional support for patient research

• We strive to create a

positive and consistent experience for all participants

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A Positive Experience = Subject Retention!

What Kind of Support?

• Dedicated inpatient & outpatient research unit • Professional clinical nurses • Bionutrition services • Specimen collection, processing, and storage • Coordination services • DEXA on-site

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Have a question – please call! Our nurses are happy to answer any clinical

research related question.

Nursing Personnel

Nursing experience: • Medical/Surgical & Pediatrics

Ann Miller, RN, BSN, MS Susan Haefner, RN, BSN Nancy Gillam, LPN Lisa Ryan, RN Maureen Costanza, RN, BSN Jacquelyn Felker, RN, BSN

Advocates for Good Clinical Practices (GCP) for all study volunteers

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Nurse Coordinator

Susanne Heininger, BS, RN, BSN

• Provides knowledge and support of the research process and planning

• Tailors coordination services based on project

needs, (temporary, short-term) • Fee-for-service

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Bionutrition

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250 Crittenden Blvd.

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Parking

Reserved parking First come basis

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Location

Room # G-5035

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Main Entrance

Waiting Room

Resources

• Inpatient & Outpatient Rooms

• 4 unit wireless telemetry monitoring

• Dedicated room for muscle testing

• Proper equipment for accurate collection of research data

• Skilled research staff collect, process, and document data

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Inpatient Rooms

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• 4 private inpatient rooms • Cable television • Wireless internet

Outpatient Rooms

• 3 rooms with

stretcher or bed • 5 exam rooms

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Rooms have the flexibility for short or long study visits.

One exam room is pediatric themed.

Specimen Processing Room

• Serial and non-serial specimen collection

and processing • Short-term refrigeration

and freezer storage

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Investigator-Coordinator Office

Dedicated Space

Computers, Copier & Fax

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Dual-energy X-ray absorptiometry (DEXA)

• Infant through adult

DEXA scans and analysis collaborative arrangement with Imaging Services

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Patient Satisfaction Survey Results

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Would you volunteer for another research study that utilized the Clinical Research Center?

Yes 39 100% No 0 0% Totals 39 100%

2015 Spring results

Patient Satisfaction Survey Results

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What can we do to improve the experience of research volunteers?

• Everyone is very helpful, always on track! Everyone was so nice and helpful. It made the time here so nice.

• Everything was good. I cannot think of any improvements that would be required.

• I can't imagine working with a nicer group of people! The staff here is wonderful. Thank you to all of them. It was all great!!

• Made my stay pleasant and would not hesitate to come again. Good professional people.

• More CRC specific parking, especially in bad weather. The employees at the CRC are always helpful and caring. They go above and beyond to accommodate any needs I might have. They deserve a lot of credit for making research patients feel comfortable at all times. Personally I have seen the great strides made in research over the last 25 years. I would like to thank everyone who is working so hard to make a difference for those who have FSH muscular dystrophy.

• Very nice staff. The only thing that is needed is a little stronger Internet at times would be helpful. Thank you.

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Patient Satisfaction Survey Results – continued

Application Process

• Consult with the CRC team during the study feasibility process to discuss and identify project requirements and CRC-related costs for budget completion

• Obtain IRB approval o Investigator-initiated studies, submit your RSRB online application

via (ROSS System). o Industry sponsored or previously approved RSRB studies now

utilizing the CRC, submit CRC application found on the CRC web page:

• Obtain CRC Team approval

Forms/Application: https://www.urmc.rochester.edu/crc/forms.cfm

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Clinical Research Center

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We welcome your feedback.

Ann Miller, BSN, MS, CCRC Nurse Manager 585-275-2907 Ann_Miller@urmc.rochester.edu https://www.urmc.rochester.edu/crc/

Bionutrition Department Clinical Research Center

Nellie Wixom, RD

Mission

To contribute to the field of nutrition by assisting investigators in planning, developing, implementing, analyzing and evaluating the nutrition aspects of their clinical research protocols to produce quality grant applications and publications.

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Staff

The Bionutrition Department is managed by a PhD- level dietitian, and staffed by a full-time lead diet technician with over 25 years of research experience and a part time research dietitian.

• Patricia Stewart, PhD, RD • Robin Peck, DTR • Nellie Wixom, RD

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Specialized Nutrition Services

Nutrient Analysis/Assessment of Food Intake • Identification and review of selected nutrition tools

for interventions • Dietary data collection using 24 hour recalls, 3 day

food records, and food frequency questions • Data input and nutrient analysis using NDS-R, a

comprehensive nutrition research software • Customized nutrition assessments using a

specialized nutrient analysis tool called SNAC that can be used for individualized counseling

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SNAC: Simple NDSR Analysis Comparison Tool

Visual display that provides a nutrient/energy intake summary

Allows for individual comparison to the DRIs in a visually appealing format including the Upper Limit (UL)

Estimates energy expenditure Calculates BMI Nutrition assessment easily translated to study

subjects Lists the top nutrient contributors

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Specialized Nutrition Services

Consultation services regarding: • Protocol design • Budgets • Data analysis and interpretation • Grant and manuscript preparation

Nutrition Interventions: • Study specific- development and implementation of

nutrition interventions for individuals or groups including staff support

• Curriculum/educational material development • Nutrition lifestyle counseling for individuals or groups

based on customized dietary assessments • Development of manual of operations for nutrition

interventions

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Standardized Diets

Metabolic Kitchen: design, produce and deliver diets for controlled feeding studies

• Constant diet • Controlled nutrient diet • Control of timing for meal service • Estimated diet • Formula diet • Metabolic balance diet • Micro and macro nutrient control • Observed monitoring of intake

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Recruitment and Retention Services

• Nutrition assessment: SNAC Tool • Nutrition counseling • Standardized meal quality

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Summary

Whether nutrition is a small component or a major component of your study, the Bionutrition Department provides trained professionals who deliver specialized nutrition services in addition to providing quality foods with a high level of customer service which can be significant in recruitment and retention.

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For more CTSI information…

www.urmc.rochester.edu/ctsi

http://urctsi.wordpress.com/

http://www.linkedin.com/groups/University-Rochester-CTSI-4334207?trk=myg_ugrp_ovr

http://www.youtube.com/user/URCTSI/featured

https://twitter.com/#!/ur_ctsi

http://www.flickr.com/people/urctsi

Web

http://us6.campaign-archive1.com/home/?u=85ca914d3653b31ff7ca776b9&id=65bec3c724

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