Annual Meeting

Therapeutic Frontiers Award Lecture—Therapeutic Frontiers In Health Services Research: Methods and Intervention Models Activity No. 0217-0000-11-065-L04-P (Knowledge-Based Activity) Sunday, October 16 10:30 a.m.–11:30 a.m. Convention Center: Spirit of Pittsburgh Ballroom A Moderator: William A. Kehoe, Pharm.D., FCCP, BCPS ACCP President, Professor of Clinical Pharmacy and Psychology; Chair, Department of Pharmacy Practice, University of the Pacific Stockton, California Speaker: Barry L. Carter, Pharm.D., FCCP, BCPS Professor, College of Pharmacy, University of Iowa, Iowa City, Iowa Faculty Conflict of Interest Disclosures Barry L. Carter: no conflicts to disclose. Learning Objectives

1. Briefly review rigorously designed controlled clinical trials on team-based care for the

management of hypertension. 2. Discuss various methodologies for conducting prospective interventional studies. 3. Describe new methodologies to evaluate technology, implementation, dissemination and/or

sustainability.

Self-Assessment Questions Self-assessment questions are available online at www.accp.com/am

Therapeutic Frontiers In Health Services Therapeutic Frontiers In Health Services Research: Methods and Intervention Research: Methods and Intervention

Therapeutic Frontiers In Health Services Therapeutic Frontiers In Health Services Research: Methods and Intervention Research: Methods and Intervention

ModelsModelsModelsModels

Barry L. Carter, Pharm.D., FCCP, FAHA, FASHDepartment of Pharmacy Practice and Science

Patrick E. Keefe Professor in PharmacyCollege of Pharmacy and

Professor and Associate Head for ResearchDepartment of Family Medicine

Roy J. and Lucille A. Carver College of MedicineRoy J. and Lucille A. Carver College of MedicineUniversity of Iowa

Our Research TeamOur Research Team

Thanks to my family…..Thanks to my family…..

Thank you to the ACCP Research Thank you to the ACCP Research InstituteInstitute

1.1. 1990 ACCP1990 ACCP--Mead Johnson Family Medicine Mead Johnson Family Medicine

InstituteInstitute

yyClinical Pharmacy Research Award. Clinical Pharmacy Research Award.

2. 19972. 1997--1998 ACCP 1998 ACCP -- Merck Merck PharmacoeconomicsPharmacoeconomicsll h ( hll h ( h llll ))Fellowship (Sarah Fellowship (Sarah BillupsBillups).).

3. 19993. 1999--2000 ACCP 2000 ACCP -- Merck Merck PharmacoeconomicsPharmacoeconomicsFellowship (Sam Ellis)Fellowship (Sam Ellis)Fellowship (Sam Ellis).Fellowship (Sam Ellis).

All investigators who have yet to beAll investigators who have yet to beAll investigators who have yet to be All investigators who have yet to be federally funded should definitely federally funded should definitely consider applying for the ACCP FITconsider applying for the ACCP FITconsider applying for the ACCP FIT consider applying for the ACCP FIT program!!!program!!!

ObjectivesObjectives

1. Briefly review rigorously designed, y g y g ,controlled clinical trials on team-based care for the management of hypertension.

i i h d l i f2. Discuss various methodologies for conducting prospective interventional studiesstudies.

3. Describe new methodologies to evaluate technology, implementation,technology, implementation, dissemination and/or sustainability.

Important Concepts that Determine Important Concepts that Determine Various Study MethodologiesVarious Study MethodologiesVarious Study MethodologiesVarious Study Methodologies

Diff i th i t t d l d dDiffusion: the passive, untargeted, unplanned and uncontrolled spread of new interventions. See later CAPTION study example…..later CAPTION study example…..

Implementation: is the process of putting to use p p p gor integrating evidence-based interventions within a specific setting. See later CAPTION study…..

Rabin BA et al. A glossary for dissemination and implementation Rabin BA et al. A glossary for dissemination and implementation research in health. J Public Health Management Practice research in health. J Public Health Management Practice 2008;14:1172008;14:117--123.123.

Important Concepts that Determine Important Concepts that Determine Various Study MethodologiesVarious Study Methodologies

Sustainability: describes to what extent an id b d i i d li ievidence-based intervention can deliver its

intended benefits over an extended period of time after external support from the donor agency isafter external support from the donor agency is terminated. See two later examples….

Rabin BA et al. A glossary for dissemination and implementation Rabin BA et al. A glossary for dissemination and implementation research in health. J Public Health Management Practice research in health. J Public Health Management Practice 2008;14:1172008;14:117--123.123.

Types of Designs:Types of Designs:

Efficacy trial: conducted under ideal circumstances with tight inclusion criteria Good internal validity butwith tight inclusion criteria. Good internal validity but low external validity (generalization). Example outcome measure: multiple BPs measured frequently ( thl ) b bli d d h(e.g. monthly) by a blinded research nurse.

Effectiveness trial: conducted under usual practiceEffectiveness trial: conducted under usual practice conditions and often using databases or retrospective designs. Prospective trials have few exclusions and less internal validity but high external validityless internal validity but high external validity. Example outcome measure: routine office-measured BPs measured whenever…..

Types of Designs Continued:Types of Designs Continued:

Combination trial: attempts to use features of both pefficacy and effectiveness trials. Example outcome measure: research measured BP but limit the frequency to reduce the effect on patient behaviorfrequency to reduce the effect on patient behavior.

T i l M th d f R d i tiT i l M th d f R d i tiTypical Method of Randomization:Typical Method of Randomization:

• By Patient: typical approach for randomized controlled drug trials but will inject g jcontamination for a behavioral intervention at MD level.

Gold Standard for HSR: Gold Standard for HSR: Cl R d i d D iCl R d i d D iCluster Randomized DesignsCluster Randomized Designs

• By Physician (MD clusters): reduces y ys c a ( c uste s) educescontamination since a given MD only has patients in one group. However, if MDs cover for one another or interact thencover for one another or interact, then contamination still occurs.

• By Clinic or Hospital (cluster randomized trial): The strongest design for behavioral interventions but requires many clinics or hospitals (usually no less than 10 for 2-arm study)study).

Limitations with many studies evaluating team based careevaluating team-based care

Small sample sizes (low power or limited generalizability)Small sample sizes (low power or limited generalizability)Single site and single intervention pharmacist or nurseBias in BP measurementL k f t l ( t d i l )Lack of control groups (pre- post- design only)No evaluation of key covariatesFew were intention-to-treat analysesFew were intention to treat analysesDid not adequately evaluate missing data (last value

carried forward versus more sophisticated modeling or l )sensitivity analysis).

Carter BL, Bosworth HB, Green BB. State of the Art Review: The Carter BL, Bosworth HB, Green BB. State of the Art Review: The Hypertension Team: The role of the pharmacist, nurse and Hypertension Team: The role of the pharmacist, nurse and teamwork in hypertension therapy. J Clin teamwork in hypertension therapy. J Clin HypertensHypertens (in press).(in press).

Examples of Clinical Trials with pDifferent Methodologies and

InterventionsInterventions

Contemporary and rigorously designed trialsdesigned trials

Efficacy study that evaluates sustainabilityEfficacy study that evaluates sustainability

Federal Study of Adherence to Medications in the ElderlyMedications in the Elderly

(FAME)Cli i l h i t l ti d d ti•Clinical pharmacist evaluation and education:

Medication names, indications, doses, frequency, side effects, and properfrequency, side effects, and proper medication-taking behavior

•Convenience aide:Custom blister packed medications

LLee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication ee JK, Grace KA, Taylor AJ. Effect of a pharmacy care program on medication dh d i t bl d d ldh d i t bl d d l d it li t id it li t i

Custom blister-packed medications

adherence and persistence, blood pressure, and lowadherence and persistence, blood pressure, and low--density lipoprotein density lipoprotein cholesterol: a randomized controlled trial. JAMAcholesterol: a randomized controlled trial. JAMA DeDec 6 2006;296(21):2563c 6 2006;296(21):2563--2571.2571.

FAME Study DesignFAME Study Design

Phase 1:Comprehensive Pharmacy Care

Phase 2: Continued

Run-in (Baseline)

Pharmacy Care Intervention (Adherence)

Pharmacy Care (Persistence)

( )

Usual Care (Persistence)

M th

0 1 8 10 12 142 4 6

MonthsRandomization

FAME Phase 1: Primary endpointFAME Phase 1: Primary endpoint Adherence:

• BaselineRun-in Phase 1: Pharmacy care

• 61.2 ± 13.5%

• End phase 1 96.9 ± 5.2%

16-fold in participants ≥ 80% adherent to all

P < .001adherent to all medications

LLee JK, Grace KA, Taylor AJ. JAMAee JK, Grace KA, Taylor AJ. JAMA DeDec 6 2006;296(21):2563c 6 2006;296(21):2563--2571.2571.

FAME Phase 1: Secondary endpointFAME Phase 1: Secondary endpoint

A i t dAssociated changes in BP and LDL-C among gpatients with drug-treated HTN or HLDHLD

N Baseline End phase 1 P

Systolic BP (mm Hg) 142 133 2 ± 14 9 129 9 ± 16 0 02Systolic BP (mm Hg) 142 133.2 ± 14.9 129.9 ± 16.0 .02

Diastolic BP (mm Hg) 142 70.5 ± 9.2 69.7 ± 10.5 .30

LDL‐C (mg/dL) 122 91.7 ± 26.1 86.8 ± 23.4 .001

FAME Phase 2: BP and LDLFAME Phase 2: BP and LDL--CCPre-specified analyses

Systolic BP Change SBP 95% CI P (within group)

P (between group)group) group)

Usual care -1.0 mm Hg -5.9 to 3.9 .69 .04

Pharmacy care -6.9 mm Hg -10.7 to -3.1 .001

Cluster, Randomized Efficacy Trial

O r i g i n a l P a p e r

A Cluster Randomized Trial to EvaluateA Cluster Randomized Trial to Evaluate Physician/Pharmacist Collaboration toI Bl d P C t lImprove Blood Pressure ControlBarry L. Carter, PharmD; George R. Bergus, MD; Jeffrey D. Dawson, ScD;

Karen B. Farris, PhD; William R. Doucette, PhD; Elizabeth A. , ; , ;Chrischilles, PhD; Arthur J. Hartz, MD, PhD

Funded by NHLBI: RO1 HL69801Funded by NHLBI: RO1 HL69801Journal of Clinical Hypertension 2008;10:260Journal of Clinical Hypertension 2008;10:260--271271

Collaborative Management of Collaborative Management of H t iH t i St dSt d Effi T i lEffi T i lHypertension Hypertension StudyStudy: Efficacy Trial: Efficacy Trial

• Only faculty / private physicians involved in the study.P ti t 21 85 ith di i f h t i• Patients 21-85 years with diagnosis of hypertension.

• Baseline BP: 145-179 SBP or 95-109 DBP for uncomplicated.• 135-179 SBP or 85-109 DBP for diabetes.135 179 SBP or 85 109 DBP for diabetes.

• Clinic BP at 0, 2, 4, 6, 8, 9 months• 24-hour BP at baseline and 9 months

Journal of Clinical Hypertension 2008;10:260Journal of Clinical Hypertension 2008;10:260--271271

Physician/PharmacistPhysician/PharmacistCollaborative ManagementCollaborative ManagementCollaborative ManagementCollaborative Management

InterventionIntervention

• Pharmacist conducted interview and assessed patient for strategies to improve BP controlpatient for strategies to improve BP control.

• Pharmacist made recommendations to MD and patient to improve BP control.patient to improve BP control.

• Pharmacists and physicians worked to overcome/prevent sub-optimal treatment, clinical inertia, poor adherence, adverse reactions, drug interactions

• Pharmacists saw patients at least every 2 months x• Pharmacists saw patients at least every 2 months x 9 months.

NHLBI: RO1 HL69801

Data AnalysisData Analysis

• Continuous variables – likelihood-based mixed models with random patient effects fit to SAS pProc Mixed in an intention-to-treat analysis.

• Models adjusted for baseline BP, age, gender, race, education, insurance status, household income marital status smoking status alcoholincome, marital status, smoking status, alcohol intake, BMI, number of co-existing conditions, baseline medication adherence and total number of visits during the study.

Dealing with Missing DataDealing with Missing Data

• Common methods are to use the baseline BP or the last value carried forward, these are now ,considered inferior approaches.

• We used statistical modeling for missing data.• We then performed as sensitivity analysis

under worst-case scenario to demonstrate the effect was robust:effect was robust:– Missing data for subjects in the control group all

assumed to have controlled BP– Missing data for subjects in the intervention groups

assumed to have uncontrolled BP

Baseline Demographics

Control (n=78) Intervention (n 101)(n=101)

Age 61.0 + 11.3 59.6 + 13.7*

BP meds 1 4 + 1 0 1 5 + 1 0BP meds 1.4 + 1.0 1.5 + 1.0

Baseline med adherence

88.6% 71.1%*adherence# co-existing DX 0.46 + 0.78 0.47 + 0.81Diabetes 24.4% 24.8%

BMI (kg/m2) 31.8 (+14.7) 32.3 (+7.7)

* * -- p < 0.001p < 0.001

Evaluating Clustering EffectsEvaluating Clustering Effects

When adjusting for the intervention effect the• When adjusting for the intervention effect, the within-clinic Intercluster Correlation Coefficient (ICC) is needed to determine the variability(ICC) is needed to determine the variability within office or within physician cluster.

• Measuring patient level data without accounting for clustering will potentially bias g g p ythe results.

Results of Clustering AnalysesResults of Clustering Analyses

• ICC for SBP at 9 months was 0.0084 (<1%). Th ithi li i i 139 dThe within clinic variance was 139 and between clinic variance of 1.2 (NS). When adjusting for all relevant baseline covariatesadjusting for all relevant baseline covariates, ICC dropped to 0.0010.

• Within-physician ICC was 0.0097 (NS), within-physician variance was 138.4, between-physician variance was 138.4, betweenphysician variance was 1.4. When adjusting for covariates, ICC dropped to 0.0005.

ResultsResults• Mean difference (control group minus the

intervention group) in SBP was -8.7 (95% g p) (CI: -4.4, -12.9) mm Hg

• Mean difference in DBP was -5.4 (CI: -2.8, 8 0) mm Hg-8.0) mm Hg.

• 24-hour BP levels mean difference in SBP of -8.8 (CI: -5.0, -12.6) mm Hg -4.6(CI: -2.4, -6.8) mm Hg for DBP.

ResultsS li BP Ti

Intervention - CMH (n=101)

C t l CMH ( 78)

155

160Systolic BP vs. Time Control - CMH (n=78)

Intervention - post-study (n=64)

Control - post-study (n=39)

140

145

150

Hg

)

Sustainability

** ** **125

130

135

SB

P m

m H

*** *******

**********

** **

115

120

125

**************

1100 2 4 6 8 10 12 14 16 18 20 22 24 26

Time in Months

* p<0.05, ** p<0.01, *** p<0.001, * p<0.05, ** p<0.01, *** p<0.001, Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260--271.271.Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228--235.235.

Results: BP Control RatesResults: BP Control RatesMain Finding: The major reason for the high control was due to intensification of medications.

Control Interven-tion

Adjusted OR

CI; p valuep

All patients

52.9% 89.1% 8.9 3.8-20.7P<0 001patients P<0.001

Diabetes 23.5% 81.8% 40.1 4.1-394.7P=0.002

-- Carter BL, Bergus GR, Dawson et al. Journal of Clinical Carter BL, Bergus GR, Dawson et al. Journal of Clinical H t i 2008 10 260H t i 2008 10 260 271271Hypertension 2008;10:260Hypertension 2008;10:260--271.271.

-- Von Muenster SJ, et al. Pharmacy World & Science Von Muenster SJ, et al. Pharmacy World & Science 2008:30:1282008:30:128--135.135.

“Mixed” Efficacy“Mixed” Efficacy--Effectiveness trialEffectiveness trialORIGINAL INVESTIGATIONORIGINAL INVESTIGATION

HEALTH CARE REFORMHEALTH CARE REFORM

Physician and Pharmacist Collaboration to Improve Blood Pressure Controlto Improve Blood Pressure Control

Barry L. Carter, PharmD; Gail Ardery, PhD; Jeffrey D. Dawson, ScD; Paul A. y y yJames, MD; George R. Bergus, MD; William R. Doucette, PhD; Elizabeth A. Chrischilles, PhD; Carrie L. Franciscus, MA; Yinghui Xu, MS

Trial Registration: clinicaltrials.gov Identifier:Trial Registration: clinicaltrials.gov Identifier:NCT00201019NCT00201019

Arch Intern Med. 2009;169(21):1996Arch Intern Med. 2009;169(21):1996--20022002

Adherence Study: Combination of Adherence Study: Combination of Efficacy and EffectivenessEfficacy and Effectiveness

Adherence Study: Combination of Adherence Study: Combination of Efficacy and EffectivenessEfficacy and EffectivenessEfficacy and EffectivenessEfficacy and EffectivenessEfficacy and EffectivenessEfficacy and Effectiveness

• Prospective, cluster-randomized controlled trial inProspective, cluster randomized controlled trial in 6 community-based family medicine residency clinics all with clinical pharmacist faculty in the medical office.

• Research nurse in each clinic measured BP at baseline, 3 and 6 months and 24-hour BP at b li d 6 hbaseline and 6 months.

InterventionIntervention

• Pharmacist conducted interview and assessed patient for strategies to improve BP controlpatient for strategies to improve BP control.

• Pharmacist made recommendations to MD and patient to improve BP control.patient to improve BP control.

• Pharmacists and physicians worked to overcome/prevent sub-optimal treatment, clinical inertia, poor adherence

• Pharmacists only encouraged to see patients at baseline and 1 month with a telephone call at 3baseline and 1 month with a telephone call at 3 months with a goal to achieve BP control by 6 months (but they could see patients more often).( y p )

Danger of Cluster Randomized Designs With Small Number of ClinicsNumber of Clinics

Control(n=210)

Intervention (n=192)

P-value(n=210) (n=192)

Caucasian 163 (77.6%) 165 (85.9%) 0.039Married 91 (43.3%) 130 (67.7%) <0.001( ) ( )Income <$25,000

109 (51.9%) 41 (21.4%) <0.001

BMI 34.2 (+8.7) 32.1 (+6.8) 0.010DM 80 (38.1%) 38 (19.8%) <0.001C 3 6 ( 2 2) 2 8 ( 8) 0 00Co-existing DX 3.6 (+2.2) 2.8 (+1.8) <0.001BP medications

1.9 (+1.0) 1.3 (+1.2) <0.001medications

Carter et al. Archives of Internal Medicine 2009; 169:1996Carter et al. Archives of Internal Medicine 2009; 169:1996--2002.2002.

Systolic Blood Pressure160

*

150

mH

g) *

130

140

Pre

ssu

re (

mm

**

120

130

stol

ic B

lood

P

Prospective study ended Retrospective evaluation of sustainability

110

Sys p y

Intervention stoppedRetrospective evaluation of sustainability…

1000 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24Time (months)

••-- p<0 001; **p<0 001; **-- p=0 0015; ***p=0 0015; *** -- p=0 0023p=0 0023•• p<0.001; p<0.001; p=0.0015; p=0.0015; p=0.0023p=0.0023Arch Intern Med. 2009;169(21):1996Arch Intern Med. 2009;169(21):1996--20022002Journal of Clinical Hypertension 2011;13:431Journal of Clinical Hypertension 2011;13:431--437.437.

Implementation Trial (can theImplementation Trial (can the model work in typical busy yp y

practices?):Ad tiAdoptionDiffusionDiffusion

Sustainability

C A PC A PCollaboration Among Pharmacists and

Physicians To Improve Outcomes Now

Collaboration Among Pharmacists and

Physicians To Improve Outcomes NowPhysicians To Improve Outcomes Now

(CAPTION)

Physicians To Improve Outcomes Now

(CAPTION)

Barry L. Carter, Barry L. Carter, Pharm.DPharm.D..Principal Investigator, CCCPrincipal Investigator, CCC

Christopher Coffey, Ph.D.Christopher Coffey, Ph.D.Principal Investigator, DCCPrincipal Investigator, DCCPrincipal Investigator, CCCPrincipal Investigator, CCC

Department of Pharmacy Practice and Science, Department of Pharmacy Practice and Science, College of Pharmacy andCollege of Pharmacy and

Professor and Associate Head for ResearchProfessor and Associate Head for ResearchDepartment of Family MedicineDepartment of Family Medicine

Principal Investigator, DCCPrincipal Investigator, DCCProfessor and Director, Clinical Trials DataProfessor and Director, Clinical Trials Data

Management CenterManagement Center

College of Public HealthCollege of Public HealthDepartment of Family MedicineDepartment of Family MedicineRoy J. and Lucille A. Carver College of Roy J. and Lucille A. Carver College of MedicineMedicine

* The study is being funded y gby NHLBI/NIH, R01 HL091841-01A1.

Participating Locationsp g

CAPTION Study Design:CAPTION Study Design: Cluster Randomized Trial

1.1. One goal is to determine if the intervention One goal is to determine if the intervention is effective in minorities so goal is to enrollis effective in minorities so goal is to enrollis effective in minorities so goal is to enroll is effective in minorities so goal is to enroll 40% minorities.40% minorities.

2.2. Clinics stratified based on the percent Clinics stratified based on the percent ppAfrican Americans or Hispanics (high or African Americans or Hispanics (high or low), and the score of a pharmacy services low), and the score of a pharmacy services provided by the clinical pharmacists (high or provided by the clinical pharmacists (high or low).low).

33 DCC then randomized the medical officesDCC then randomized the medical offices3.3. DCC then randomized the medical offices.DCC then randomized the medical offices.

Site Randomization to 3 ArmsSite Randomization to 3 Arms

Active Observation Group 1Active Observation Group 1 9 month BP intervention (n=24/site)

Active Observation Group 2 24 month BP intervention (n=24/site)

Usual Care/Practice Diversion Group Control arm for the hypertension study Control arm for the hypertension study

(n=24/site)

Diversion asthma interventionDiversion asthma intervention

Passive Observation Groups: ffDiffusion

Every site will also identify 18 patients withEvery site will also identify 18 patients with uncontrolled HTN who are not consented into the study (passive observation BPinto the study (passive observation BP group) who will undergo med record review to test whether the effect of thereview to test whether the effect of the intervention diffuses throughout the medical officemedical office.

32 clinics stratified

32 clinics randomized

BP 9 month Intervention

Group:

BP 24 month Intervention

BP Usual Care/ Asthma PPCM

(9 clinics)

BP Control Group: (n=216)

Group: (9 clinics, n=216)

Group: (9 clinics, n=216)

9-month asthma

intervention

BP Observational Cohort: 3 BP Arms (n=216)

9 month Intervention, then stopped

Intervention for 24

months

(n=100) (n=486)

Clinic BPs via

BP at baseline, 6, 9, 12, 18, 24

BP at baseline, 6, 9, 12, 18,

BP at baseline, 6, 9, 12, 18, 24

chart review for

Observational Cohort

24-month evaluation of BP and covariates (all HTN

9, 12, 18, 24 mos.

, , ,24 mos.

9, 12, 18, 24 mos.

patients)

The Electronic Communications and Home Blood Pressureand Home Blood Pressure

Monitoring Trial (e-BP)g ( )Comparison of 2 Interventions to Usual Care:• Home BP monitor and use of an existing patient g pWeb site

• This plus pharmacist care management (delivered via the patient Web site)

Green BB Cook AJ Ralston JD et al Effectiveness of home bloodGreen BB, Cook AJ, Ralston JD, et al. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. JAMA. Jun 25 2008;299(24):2857-28672008;299(24):2857 2867.

Funded by NHLBI: 5R01HL075263-04

BP control at 12 monthsControl BPM-Web

OnlyBPM-Web-Only Web

PharmAll 31% 36% 56%**

Systolic BP 20% 26% 54%**Systolic BP at baseline >160 mm

20% 26% 54%

**P < 0.001 compared to UC and BPM**P < 0.001 compared to UC and BPM--WebWeb

Conclusion: the addition of the pharmacist intervention to the web was necessary to achieve good BP control.

Green BB, et al. Green BB, et al. JAMA. JAMA. 2008;299(24):28572008;299(24):2857--2867.2867.

Numerous Meta-analyses of Team-Based Care in BPBased Care in BP

1. Walsh JM, et al. Med Care. Jul 2006;44(7):646-657.2 Carter BL et al Arch Intern Med 2009;169(19):17482. Carter BL, et al. Arch Intern Med. 2009;169(19):1748-

1755.3. Chisholm-Burns MA, et al. Med Care. 2010;48(10):923-

933.4. Machado M, et al. Ann Pharmacother. 2007;41(11):1770-

1781.5. Glynn LG, et al. Cochrane Database Syst Rev.

2010(3):CD005182.6 Fahey T et al Cochrane Database Syst Rev6. Fahey T, et al.. Cochrane Database Syst Rev.

2006(4):CD005182.7. Clark CE, et al.. BMJ. 2011;341:c3995.

Meta-Analysis: Potency of individual components of team-based care

Median reduction in SBP(mm Hg)

Pharmacist recommended medication to physician -9.3*

Education on BP medications -8.75*

Pharmacist did the intervention -8 44Pharmacist did the intervention -8.44

Assessed medication compliance -7.9

Counseling on lifestyle modification -7.59Counseling on lifestyle modification 7.59

Nurse did the intervention -4.8*

**-- statistically significantstatistically significant

Carter BL, Rogers M, Daly J, Zheng S, James JA. Quality Improvement Strategies for Hypertension: The Potency of Team-based Care Interventions. Archives of Internal Medicine 2009; 169:1748-1755. Adapted from the methods of:W l h J t l H t i C Cl i th Q lit G A iti l l i f lit

statistically significantstatistically significant

46

Walsh J et al. Hypertension Care. Closing the Quality Gap: A critical analysis of quality improvement strategies. (Prepared by Stanford -UCSF Evidence-based Practice Center, Contract No. 290-02-0017). AHRQ publication No. 04-0051-3, Rockville, MD. January 2005.

Meta-analysis of Potency of individual components of team-based carebased care

Odds that BP was controlled (95% confidence Interval)

Studies involving nurses 1.69 (1.48-1.93)

[69% increased chance]

Studies involving pharmacists within physician offices or clinics

2.48 (2.05-2.99)

[148% increased chance]

Studies done in community pharmacies

2.89 (1.83-4.55)

[189% increased chance]

Conclusion: All were effective but interventions by pharmacists appear to be more potent than by nurses

47Carter BL, et al. Archives of Internal Medicine 2009; 169:1748-1755.

nurses.

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:Health Services Research: Health Services Research:

QuestionsQuestionsHealth Services Research: Health Services Research:

QuestionsQuestionsb d h l lb d h l l1.1. TeamTeam--based care interventions have clearly based care interventions have clearly

been shown to be effective for a variety of been shown to be effective for a variety of chronic conditions but many questions remainchronic conditions but many questions remainchronic conditions but many questions remain chronic conditions but many questions remain and and NIH will fund such studiesNIH will fund such studies::a.a. Can the models be scaled up andCan the models be scaled up anda.a. Can the models be scaled up and Can the models be scaled up and

implemented in large numbers of diverse implemented in large numbers of diverse and very busy practices?and very busy practices?

b.b. Can the effect be sustained in the longCan the effect be sustained in the long--term? Are “booster” interventions needed?term? Are “booster” interventions needed?

cc Is there a viable business model for currentIs there a viable business model for currentc.c. Is there a viable business model for current Is there a viable business model for current and future payment structures?and future payment structures?

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:Health Services Research: Health Services Research:

Summary of Key PointsSummary of Key PointsHealth Services Research: Health Services Research:

Summary of Key PointsSummary of Key Points1. Health-care reform, the patient-centered

medical home and technology will require much more health services research studies in team-based care.

2. Studies must be rigorously designed, tested and analyzed which will likely require federallyand analyzed which will likely require federally funded grants.

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:

The Therapeutic Frontiers in The Therapeutic Frontiers in Health Services Research:Health Services Research:Health Services Research: Health Services Research:

Summary of Key PointsSummary of Key PointsHealth Services Research: Health Services Research:

Summary of Key PointsSummary of Key Points

3. Clinical pharmacy scientists must have strong training in grant writing Should attend astraining in grant writing. Should attend as many grant writing workshops as possible.

4. You must consider the ACCP FIT program if you are a clinical pharmacy researcher desiring federal funding.

Comments and QuestionsComments and QuestionsComments and QuestionsComments and QuestionsComments and QuestionsComments and QuestionsComments and QuestionsComments and Questions

Suggested readings:

1. Okonofua EC, Simpson KN, Jesri A, Rehman SU, Durkalski VL, Egan BM. Therapeutic inertia is an impediment to achieving the Healthy People 2010 blood pressure control goals. Hypertension. Mar 2006;47(3):345-351.

2. Walsh JM, McDonald KM, Shojania KG, et al. Quality improvement strategies for hypertension management: a systematic review. Med Care. Jul 2006;44(7):646-657.

3. Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based care interventions for hypertension: a meta-analysis. Arch Intern Med. Oct 26 2009;169(19):1748-1755.

4. Chisholm-Burns MA, Kim Lee J, Spivey CA, et al. US pharmacists' effect as team members on patient care: systematic review and meta-analyses. Med Care. Oct 2010;48(10):923-933.

5. McKenney JM, Slining JM, Henderson HR, Devins D, Barr M. The effect of clinical pharmacy services on patients with essential hypertension. Circulation. Nov 1973;48(5):1104-1111.

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