Team-based Care to Improve Blood Team-based Care to Improve Blood Pressure Control: The CAPTION TrialPressure Control: The CAPTION TrialTeam-based Care to Improve Blood Team-based Care to Improve Blood Pressure Control: The CAPTION TrialPressure Control: The CAPTION Trial

Barry L. Carter, Pharm.D., FCCP, FAHA, FASH, FAPHAThe Patrick E. Keefe Professor in Pharmacy

Department of Pharmacy Practice and ScienceCollege of Pharmacy and

ProfessorDepartment of Family Medicine

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

See Agenda

ObjectivesObjectives

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

A Cluster Randomized Trial to Evaluate Physician/Pharmacist Collaboration toImprove Blood Pressure Control

Barry 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 HL69801

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

Cluster, Randomized Efficacy Trial

Collaborative Management of Collaborative Management of Hypertension StudyHypertension Study: Efficacy : Efficacy

TrialTrial• Only faculty / private physicians involved in the study.• 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.

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

Journal of Clinical Hypertension Journal of Clinical Hypertension 2008;10:260-2712008;10:260-271

Physician/PharmacistPhysician/PharmacistCollaborative ManagementCollaborative Management

InterventionIntervention

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

• Pharmacist made recommendations to MD and 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 9 months.

NHLBI: RO1 HL69801

Data AnalysisData Analysis

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

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

Baseline Demographics

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

Age 61.0 + 11.3 59.6 + 13.7*

BP meds 1.4 + 1.0 1.5 + 1.0

Baseline med adherence

88.6% 71.1%*

# co-existing DX 0.46 + 0.78 0.47 + 0.81

Diabetes 24.4% 24.8%

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

* - p < 0.001* - p < 0.001

Results

* p<0.05, ** p<0.01, *** * p<0.05, ** p<0.01, *** p<0.001, p<0.001,

******

******

** ****

****

Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260-271.Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260-271.Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228-235.Carter BL, Doucette WR. Franciscus CL, et al. Pharmacotherapy 2010;30:228-235.

Sustainability

Results: BP Control RatesResults: BP Control Rates

Control Interven-tion

Adjusted OR

CI; p value

All patients

52.9% 89.1% 8.9 3.8-20.7P<0.00

1

Diabetes

23.5% 81.8% 40.1 4.1-394.7

P=0.002

- Carter BL, Bergus GR, Dawson et al. Journal of - Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260-271.Clinical Hypertension 2008;10:260-271.

- Von Muenster SJ, et al. Pharmacy World & - Von Muenster SJ, et al. Pharmacy World & Science 2008:30:128-135.Science 2008:30:128-135.

Main Finding: The major reason for the high control was due to intensification of medications.

Physicians accepted 95.8% of 267 pharmacist recommendations

Recommendation Frequency by Visit

 0

MoOpt

2 Mo

4 Mo

6 Mo

8 Mo

9 Mo

Added Thiazide n=45 40 2 3 0 0 0 NA

Added Other Drug n=79

30 13 18 9 6 3 NA

Increased Dose n=89 28 21 14 9 9 8 NA

Changed Dose Frequency n=7

2 0 1 3 1 0 NA

Switch Within Class n=15 6 3 1 3 2 0 NA

Decreased Dose n=14 3 3 3 2 3 0 NA

Drug Discontinued n=18 2 4 8 3 1 0 NA

Total n=267

111 46 48 29 22 11 NA

BP Control Rate n=101 0 - 52% 67% 73% 84% 89%• Von Muenster SJ, Carter BL, Weber CA et al. Description of Description of

pharmacist interventions during physician-pharmacist co-pharmacist interventions during physician-pharmacist co-management of hypertension. Pharmacy World & Science management of hypertension. Pharmacy World & Science 2008:30:128-135.2008:30:128-135.

ORIGINAL INVESTIGATIONORIGINAL INVESTIGATION

Physician and Pharmacist Collaboration to Improve Blood Pressure Control

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

HEALTH CARE REFORMHEALTH CARE REFORM

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

Arch Intern Med. 2009;169(21):1996-2002Arch Intern Med. 2009;169(21):1996-2002

““Mixed” Efficacy-Effectiveness Mixed” Efficacy-Effectiveness trialtrial

Adherence Study: Adherence Study: Combination of Efficacy and Combination of Efficacy and

EffectivenessEffectiveness

Adherence Study: Adherence Study: Combination of Efficacy and Combination of Efficacy and

EffectivenessEffectiveness• Prospective, 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 baseline and 6 months.

InterventionIntervention

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

• Pharmacist made recommendations to MD and 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 3 months with a goal to achieve BP control by 6 months (but they could see patients more often).

Research BP MeasurementResearch BP Measurement

• Automated Omron Device

• Measure 1 BP, record but do not use for research value

• Measure 2 BP values and average them if less than 4 mm Hg apart.

• If more than 4 mm different, measure a 4th BP and average the 2 closest BP values (from the 2nd to 4th BP measurements).

Systolic Blood Pressure

•- p<0.001; **- p=0.0015; *** - p=0.0023- p<0.001; **- p=0.0015; *** - p=0.0023Arch Intern Med. 2009;169(21):1996-2002Arch Intern Med. 2009;169(21):1996-2002Journal of Clinical Hypertension 2011;13:431-437.Journal of Clinical Hypertension 2011;13:431-437.

Retrospective evaluation of sustainability…

17

Meta-analysis of Potency of individual components of team-based 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]

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

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

Collaboration Among Pharmacists

and Physicians To Improve

Outcomes Now

(CAPTION)

Collaboration Among Pharmacists

and Physicians To Improve

Outcomes Now

(CAPTION)

Barry L. Carter, Pharm.D.Barry L. Carter, Pharm.D.Principal Investigator, CCCPrincipal Investigator, CCCDepartment of Pharmacy Practice and Department of Pharmacy Practice and Science, College of Pharmacy andScience, College of Pharmacy andProfessor Professor Department of Family MedicineDepartment of Family Medicine Roy J. and Lucille A. Carver College of Roy J. and Lucille A. Carver College of MedicineMedicine

Christopher Coffey, Ph.D.Christopher Coffey, Ph.D.Principal Investigator, DCCPrincipal Investigator, DCCProfessor and Director, Clinical Trials DataProfessor and Director, Clinical Trials Data Management CenterManagement Center

College of Public HealthCollege of Public Health

* The study is being funded by

NHLBI/NIH, R01 HL091841-01A1.

Important Concepts that Important Concepts that Determine Various Study Determine Various Study

MethodologiesMethodologies

Implementation: is the process of putting to use or integrating evidence-based interventions within a specific setting. Sustainability: describes to what extent an evidence-based intervention can deliver its intended benefits over an extended period of time after external support from the donor agency is terminated.

Rabin BA et al. A glossary for dissemination Rabin BA et al. A glossary for dissemination and implementation research in health. J and implementation research in health. J Public Health Management Practice Public Health Management Practice 2008;14:117-1232008;14:117-123..

CAPTION Study Outcomes

Primary outcome = BP control @ 9 months (determined via research

measurement)

BP control defined as:• < 140/90 for patients with

uncomplicated hypertension

• < 130/80 for patients with diabetes or chronic kidney disease**

Outcomes (cont.)

Secondary endpoints include:• Mean BP @ 12, 18, 24 months

CAPTIONCAPTIONCAPTIONCAPTION32 offices stratified by degree of pharmacy

services and racial minorities:Then randomized to:

1. Usual care group2. 9-month pharmacist intervention3. 24-month pharmacist intervention.

Subjects followed for 24 months to determine:1. What happens when the intervention is

stopped?2. Can the intervention be sustained for 2 years?3. Does the intervention benefit patients from

minority groups?

Participating Locations

DemographicsDemographicsDemographicsDemographics

Variable 9 Month (N=194)N (%)

24 Month (N=207)

N (%)

Control (N=224)N (%)

Total (N=625)N (%)

p-value

Female 119 (61.3) 125 (60.4) 133 (59.4) 377 (60.3) 0.938

Age (SD) 60.6 (12.4) 56.7 (11.8) 60.5 (13.8) 59.3 (12.8) 0.055BMI (SD) 33.8 (8.5) 35.2 (9.0) 32.9 (7.7) 33.9 (8.5) 0.090DM or CKD *

102 (52.6%)

109 (52.7%)

103 (46.0%)

314(50.2%)

0.599

5SBP (SD)

147.6 (13.7)

149.8 (15.6)

149.6 (15.3)

149.1 (15.0)

0.458

* - Required a lower treatment goal (<130/80) * - Required a lower treatment goal (<130/80) making it more difficult to achieve controlmaking it more difficult to achieve control

Pharmacist InterventionsPharmacist InterventionsPharmacist InterventionsPharmacist Interventions

GroupFirst 9 Months (rate/month)

9-24 Months(rate/month)

9 –Month Group 0.576 0.074

24 – Month Group 0.503 0.261

Primary Outcome 9-Month BP Primary Outcome 9-Month BP ControlControl

Primary Outcome 9-Month BP Primary Outcome 9-Month BP ControlControl

Variable

Intervention Groups

(N = 401)(N=226

minorities)

Control Group

(N = 224) (N=111

minorities)

Model-Adjusted Difference –

Intervention vs. Control(95% CI)

p-value

BP Control All subjects

43% 34% 1.57 ( 0.99 , 2.50 )

0.052

BP Control Minorities

37% 28% 1.54 ( 0.84 , 2.81 ) 0.16

* - Defined as <140/90 for uncomplicated BP and * - Defined as <140/90 for uncomplicated BP and <130/80 for diabetes or CKD<130/80 for diabetes or CKD

Provider Level AttitudesProvider Level AttitudesProvider Level AttitudesProvider Level Attitudes

Variable 9 Month (N=11)

24 Month (N=9)

Control (N=12)

p-value

Pharmacy Structure Score *** Low High

3 (27%)8 (73%)

3 (33%)6 (67%)

4 (33%)8 (67%)

1.00

Pharmacist TPBMean (SD) 21.0 (2.18) 21.8 (1.42) 21.2 (3.89) 0.76Physician TPBMean (SD 19.8 (2.39) 20.2 (1.56) 17.4 (2.85) 0.02TBP = Theory of Planned BehaviorTBP = Theory of Planned Behavior

*** - There was a significant relationship between offices with higher PSC and better BP control, adjusted odds ratio and CI = 1.75 ( 1.23 , 2.49 ), p = 0.002*** - Subjects from sites with higher PSC had a mean lower SBP of 4 mm Hg (p=0.007) and 2 mm DBP (P=0.009)

Primary Outcome 9-Month BP Control Primary Outcome 9-Month BP Control When Adjusted for Baseline Pharmacy When Adjusted for Baseline Pharmacy

Structure ScoreStructure Score

Primary Outcome 9-Month BP Control Primary Outcome 9-Month BP Control When Adjusted for Baseline Pharmacy When Adjusted for Baseline Pharmacy

Structure ScoreStructure Score

Variable

Intervention Groups

(N = 401)(N=226

minorities)

Control Group

(N = 224) (N=111

minorities)

Model-Adjusted Difference –

Intervention vs. Control(95% CI)

p-value

BP Control All subjects

43% 34% 1.52 ( 1.02 , 2.29 )

0.042

BP Minority Subjects

37% 28% 1.54 ( 0.84 , 2.81 )

0.016

* - Defined as <140/90 for uncomplicated BP and * - Defined as <140/90 for uncomplicated BP and <130/80 for diabetes or CKD<130/80 for diabetes or CKD

9 – month BP- All subjects9 – month BP- All subjects9 – month BP- All subjects9 – month BP- All subjects

VariableIntervention

Groups(N = 401)

Control Group

(N = 224)

Model-Adjusted

Difference – Intervention vs. Control

(95% CI)

p-value

SBP Mean (SD)

131.6 (15.8)

138.2 (19.7)

-6.07( -9.64, -2.50 )

0.001

DBP Mean (SD)

76.3 (11.1)

78.0 (14.5)

-2.89( -4.80, -0.99 )

0.003

Results – Minority subjectsResults – Minority subjectsResults – Minority subjectsResults – Minority subjects

VariableIntervention

Groups(N = 226)

Control Group

(N = 111)

Model Adjusted

Difference – Intervention vs. Control

(95% CI)

p-value

SBP Mean (SD)

133.0 (16.3)

140.3 (21.4)

-6.42( -10.97, -1.87 ) 0.006

DBP Mean (SD)

77.9 (10.7)

78.8 (15.9)

-2.98( -5.76, -0.20 ) 0.036

Systolic BP ResultsSystolic BP Results

BP Control Rates ResultsBP Control Rates Results

Summary: Comparison Of Summary: Comparison Of Other Studies With CAPTIONOther Studies With CAPTION

• Mean difference (control group minus the intervention group) in SBP was -8 to -10 mm Hg in other studies and -6.1 mm Hg in CAPTION

• Mean difference in DBP was -3 to -6 mm Hg in other studies and -2.9 mm Hg in CAPTION

• While the effect was slightly less in CAPTION, the results were expected and very similar to other studies

Comments and QuestionsComments and QuestionsComments and QuestionsComments and Questions