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

1. Team-based Care to Improve Blood Pressure Control: The CAPTION Trial Barry L. Carter, Pharm.D., FCCP, FAHA, FASH, FAPHA The Patrick E. Keefe Professor in Pharmacy Department of Pharmacy Practice and Science College of Pharmacy and Professor Department of Family Medicine Roy J. and Lucille A. Carver College of Medicine University of Iowa

2. Objectives See Agenda

3. Cluster, Randomized Efficacy Trial O r i g i n a l P a p e r A Cluster Randomized Trial to Evaluate Physician/Pharmacist Collaboration to Improve 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 HL69801 Journal of Clinical Hypertension 2008;10:260-271

4. Collaborative Management of Hypertension Study: Efficacy Trial • 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 2008;10:260-271

5. Physician/Pharmacist Collaborative Management

6. Intervention • 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

7. Data 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.

8. Baseline Demographics * - p < 0.001

9. Results Sustainability * * * * ** ** *** * p<0.05, ** p<0.01, *** p<0.001, 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.

10. Results: BP Control Rates Main Finding: The major reason for the high control was due to intensification of medications. - Carter BL, Bergus GR, Dawson et al. Journal of Clinical Hypertension 2008;10:260-271. - Von Muenster SJ, et al. Pharmacy World & Science 2008:30:128-135.

11. Von Muenster SJ, Carter BL, Weber CA et al. Description of pharmacist interventions during physician-pharmacist co-management of hypertension. Pharmacy World & Science 2008:30:128-135.

12. “Mixed” Efficacy-Effectiveness trial ORIGINAL INVESTIGATION HEALTH CARE REFORM 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; YinghuiXu, MS Trial Registration: clinicaltrials.gov Identifier: NCT00201019 Arch Intern Med. 2009;169(21):1996-2002

13. Adherence Study: Combination of Efficacy and Effectiveness • 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.

14. Intervention • 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).

15. Research 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).

16. Systolic Blood Pressure Retrospective evaluation of sustainability… • - p<0.001; **- p=0.0015; *** - p=0.0023 • Arch Intern Med. 2009;169(21):1996-2002 • Journal of Clinical Hypertension 2011;13:431-437.

17. Conclusion: All were effective but interventions by pharmacists appear to be more potent than by nurses. Carter BL, et al. Archives of Internal Medicine 2009; 169:1748-1755.

18. CollaborationAmongPharmacists and Physicians ToImproveOutcomesNow(CAPTION) * The study is being funded by NHLBI/NIH, R01 HL091841-01A1. Barry L. Carter, Pharm.D. Principal Investigator, CCC Department of Pharmacy Practice and Science, College of Pharmacy and Professor Department of Family Medicine Roy J. and Lucille A. Carver College of Medicine Christopher Coffey, Ph.D. Principal Investigator, DCC Professor and Director, Clinical Trials Data Management Center College of Public Health

19. Important Concepts that Determine Various Study Methodologies 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 and implementation research in health. J Public Health Management Practice 2008;14:117-123.

20. 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**

21. Outcomes (cont.) Secondary endpoints include: Mean BP @ 12, 18, 24 months

22. CAPTION • 32 offices stratified by degree of pharmacy services and racial minorities: • Then randomized to: • Usual care group • 9-month pharmacist intervention • 24-month pharmacist intervention. • Subjects followed for 24 months to determine: • What happens when the intervention is stopped? • Can the intervention be sustained for 2 years? • Does the intervention benefit patients from minority groups?

23. Participating Locations

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

25. Pharmacist Interventions

26. Primary Outcome 9-Month BP Control * - Defined as <140/90 for uncomplicated BP and <130/80 for diabetes or CKD

27. Provider Level Attitudes TBP = 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)

28. Primary Outcome 9-Month BP Control When Adjusted for Baseline Pharmacy Structure Score * - Defined as <140/90 for uncomplicated BP and <130/80 for diabetes or CKD

29. 9 – month BP- All subjects

30. Results – Minority subjects

31. Systolic BP Results

32. BP Control Rates Results

33. Summary: Comparison Of Other 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

34. Comments and Questions