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This webinar discusses evidence-based strategies for implementing team-based care for the management of hypertension and explores the components and results of the CAPTION Trial. Limitations of past studies evaluating team-based care are also discussed.
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Team-Based Care for Hypertension in the Age of Healthcare Reform Barry L. Carter Pharm.D., FCCP, FAHA, FASH, FAPHA The Patrick E. Keefe Professor in Pharmacy University of Iowa November 10th, 2015 Moderated By: J. Nwando Olayiwola, MD, MPH, FAAFP Tem Woldeyesus, BS Kira Levy, MS Center for Excellence in Primary Care Webinar sponsored by: The Center for Excellence in Primary Care and the Center for Care Innovations
Team-based Care for Hypertension in the Age of Healthcare Reform 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
Grant Support: NIH, AHRQ, VA HSR&D. • Member of the JNC 5, 6, 7 and 8 committees • I have had NONE of the following in the past 18 years: Consultant, Speakers Bureau, Major Stock Shareholder, or Other Support from Industry. Disclosure of Relationships
Objectives • To discuss evidence-based strategies for implementing team-based care for the management of hypertension. • To describe components and results of the CAPTION Trial.
Limitations with many studies evaluating team-based care • Small sample sizes (low power or limited generalizability) • Single site and single intervention pharmacist or nurse • Bias in BP measurement • Lack of control groups (pre- post- design only) • No evaluation of key covariates • Few were intention-to-treat analyses Carter BL, Bosworth HB, Green BB. State of the Art Review: The Hypertension Team: The role of the pharmacist, nurse and teamwork in hypertension therapy. J Clin Hypertens 2012;14:51-65
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
Physician/Pharmacist Collaborative Management
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. • Research 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
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
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.
Baseline Demographics * p < 0.001
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.
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.
“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
Guideline 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.
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).
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).
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.
*- statistically 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: 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.
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.
CollaborationAmongPharmacists and Physicians ToImproveOutcomesNow(CAPTION) Funded by NHLBI/NIH, R01 HL091841 Carter et al. A Cluster-randomized Trial of a Physician/Pharmacist Collaborative Model to Improve Blood Pressure Control. Circulation: Cardiovascular Quality and Outcomes. 2015; 8:235-43. . 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
CAPTION Study Outcomes Primary outcome = BP control @ 9 months BP control defined as: < 140/90 for patients with uncomplicated hypertension < 130/80 for patients with diabetes or chronic kidney disease** Secondary endpoints: Mean BP @ 12, 18, 24 months
CAPTION • Offices Stratified on: • 1. Pharmacy Structure Score (high vs. low) • 2. Percent minorities (<44% vs. >44%) • 32 offices 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? • Does the intervention benefit patients from minority groups?
Demographics * lower treatment goal (<130/80) making it more difficult to achieve control Carter et al. Circulation: Cardiovascular Quality and Outcomes. 2015; 8:235-43.
Primary Outcome 9-Month BP Control * Defined as <140/90 for uncomplicated BP, <130/80 for diabetes or CKD Carter et al. Circulation: Cardiovascular Quality and Outcomes. 2015; 8:235-43.
9 – month BP- All subjects Carter et al. Circulation: Cardiovascular Quality and Outcomes. 2015; 8:235-43.
2014 Evidence-Based Guideline for the Management of High Blood Pressure in AdultsReport from the Panel Members Appointed to the Eighth Joint National Committee (JNC 8) James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, Lefevre ML, Mackenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E James PA, Oparil S, Carter BL et al. JAMA. 2014; 311 (February 5):507-520.
Sensitivity Analysis Using JNC-8 • If we exclude 138 subjects who would not have qualified because their BP would have been considered controlled by JNC-8, 9-month BP Control: Carter et al. Circulation: Cardiovascular Quality and Outcomes. 2015; 8:235-43.
Economics of Team Care: Community Preventive Services Task Force: 2012 • 31 studies total • Intervention for BP cost $198 per person per year. • $87 per mm reduction in SBP. • 20 year cost per QALY: • $24,042 for Nurse • $10,244 for Pharmacist and other Jacob V et al. Am J Prev Med 2015;49:772-83.
CAPTION Cost and RVU Analyses • Included Brian Isetts, Ph.D. and Dan Buffington, Pharm.D. as consultants to perform RVU analysis. • Linnea Polgreen, Ph.D. conducting cost-effectiveness analysis. Manuscript in review
CAPTION Cost and RVU Analyses (N=390) first 9 months • Pharmacists made 1,169 recommendations to: • start a new drug (443) • discontinue a drug (283) • increase dose (329) • decrease dose (94) • change regimen-same dose (20) • Physicians accepted 1,153 (98.6%)
CAPTION Cost and RVU Analyses • Drs. Isetts and Buffington consult directly with CMS and AMA on CPT coding. • These data will be used to better establish relative value units (RVUs) for pharmacist intervention and re-imbursement mechanisms.
Cost-Effectiveness Analysis • The additional cost of the intervention was $203 or $33 for each mm Hg reduction in SBP or $23 for each percentage point increase in BP control over 9 months. • Polgreen LA, Han J, Carter BL et al. Hypertension 2015 (in press)
Cost-Effectiveness Analysis * - Mean (SD) U.S. dollars
CAPTION Conclusions • Clinic-based pharmacists in primary care enhance effectiveness for BP control. • 53% were minorities (2/3 AA, 1/3 Hispanic). • Many of the subjects in CAPTION had not had controlled BP for years. • > 25% - Medicaid/ self-pay, about 50% had incomes <$25,000/yr, 50% had DM or CKD. • Cost compared to usual care - $203 ($33/mm Hg reduction in SBP), $23 for each percentage point increase in BP control.
Recommendations of the Community Preventive Services Task Force • Include team-based care to improve BP. • More research needed on the type of provider-patient interaction needed. • More research needed in disadvantaged populations. • Need more information on strategies to develop teams, resources infrastructure and costs. Am J Prev Med 2014;47:100-102
Recommendations • Team-based care should be a critical component of primary care to improve BP control in African Americans (SBP reductions of 5-14 mm Hg). • A pharmacist and nurse should be integrated into practices to improve BP control. • Several studies have found that the most potent strategy appears to be medication intensification. • The team member (pharmacist or nurse) should independently implement the intervention as this is the most effective strategy for rapid implementation.