Jan D Hirsch1, Neil Steers2, David S Adler3, Grace M Kuo4, Candis M Morello3, Megan Lang5, Renu F Singh3, Yelena Wood6, Robert M Kaplan7, Carol M Mangione8. 1. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California-San Diego (UCSD), La Jolla, California. Electronic address: janhirsch@ucsd.edu. 2. Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles (UCLA), Los Angeles, California. 3. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California-San Diego (UCSD), La Jolla, California. 4. Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California-San Diego (UCSD), La Jolla, California; Department of Family and Preventive Medicine, School of Medicine, UCSD, La Jolla, California. 5. Medical Center, Department of Pharmacy, UCSD, La Jolla, California. 6. Department of Medicine, UCSD, La Jolla, California. 7. Department of Health Policy and Management, Fielding School of Public Health, UCLA, Los Angeles, California. 8. Department of Medicine, David Geffen School of Medicine, University of California-Los Angeles (UCLA), Los Angeles, California; Department of Health Policy and Management, Fielding School of Public Health, UCLA, Los Angeles, California.
Abstract
PURPOSE: A collaborative pharmacist-primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensive patients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic. METHODS: This randomized, pragmatic clinical trial was conducted in hypertensive patients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥ 18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥ 140/≥ 90 mm Hg (≥ 130/≥ 80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol. FINDINGS: A total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (-7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (-5.2 [16.9] vs -1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001). IMPLICATIONS: A PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556. Published by Elsevier Inc.
RCT Entities:
PURPOSE: A collaborative pharmacist-primary care provider (PharmD-PCP) team approach to medication-therapy management (MTM), with pharmacists initiating and changing medications at separate office visits, holds promise for the cost-effective management of hypertension, but has not been evaluated in many systematic trials. The primary objective of this study was to examine blood pressure (BP) control in hypertensivepatients managed by a newly formed PharmD-PCP MTM team versus usual care in a university-based primary care clinic. METHODS: This randomized, pragmatic clinical trial was conducted in hypertensivepatients randomly selected for PharmD-PCP MTM or usual care. In the PharmD-PCP MTM group, pharmacists managed drug-therapy initiation and monitoring, medication adjustments, biometric assessments, laboratory tests, and patient education. In the usual-care group, patients continued to see their PCPs. Participants were aged ≥ 18 years, were diagnosed with hypertension, had a most recent BP measurement of ≥ 140/≥ 90 mm Hg (≥ 130/≥ 80 mm Hg if codiagnosed with diabetes mellitus), were on at least 1 antihypertensive medication, and were English speaking. The primary outcome was the difference in the mean change from baseline in systolic BP at 6 months. Secondary outcomes included the percentage achieving therapeutic BP goal and the mean changes from baseline in diastolic BP and low- and high-density lipoprotein cholesterol. FINDINGS: A total of 166 patients were enrolled (69 men; mean age, 67.7 years; PharmD-PCP MTM group, n = 75; usual-care group, n = 91). Mean reduction in SBP was significantly greater in the PharmD-PCP MTM group at 6 months (-7.1 [19.4] vs +1.6 [21.0] mm Hg; P = 0.008), but the difference was no longer statistically significant at 9 months (-5.2 [16.9] vs -1.7 [17.7] mm Hg; P = 0.22), based on an intent-to-treat analysis. In the intervention group, greater percentages of patients who continued to see the MTM pharmacist versus those who returned to their PCP were at goal at 6 months (81% vs 44%) and at 9 months (70% vs 52%). No significant between-group differences in changes in cholesterol were detected at 6 and 9 months; however, the mean baseline values were near recommended levels. The PharmD-PCP MTM group had significantly fewer PCP visits compared with the usual-care group (1.8 [1.5] vs 4.2 [1.0]; P < 0.001). IMPLICATIONS: A PharmD-PCP collaborative MTM service was more effective in lowering BP than was usual care at 6 months in all patients and at 9 months in patients who continued to see the pharmacist. Incorporating pharmacists into the primary care team may be a successful strategy for managing medication therapy, improving patient outcomes and possibly extending the capacity of primary care. ClinicalTrials.gov identifier: NCT01973556. Published by Elsevier Inc.
Authors: Marie A Chisholm-Burns; Jeannie Kim Lee; Christina A Spivey; Marion Slack; Richard N Herrier; Elizabeth Hall-Lipsy; Joshua Graff Zivin; Ivo Abraham; John Palmer; Jennifer R Martin; Sandra S Kramer; Timothy Wunz Journal: Med Care Date: 2010-10 Impact factor: 2.983
Authors: Stephen M Petterson; Winston R Liaw; Robert L Phillips; David L Rabin; David S Meyers; Andrew W Bazemore Journal: Ann Fam Med Date: 2012 Nov-Dec Impact factor: 5.166
Authors: Barry L Carter; Gail Ardery; Jeffrey D Dawson; Paul A James; George R Bergus; William R Doucette; Elizabeth A Chrischilles; Carrie L Franciscus; Yinghui Xu Journal: Arch Intern Med Date: 2009-11-23
Authors: Beverly B Green; Andrea J Cook; James D Ralston; Paul A Fishman; Sheryl L Catz; James Carlson; David Carrell; Lynda Tyll; Eric B Larson; Robert S Thompson Journal: JAMA Date: 2008-06-25 Impact factor: 56.272
Authors: Barry L Carter; George R Bergus; Jeffrey D Dawson; Karen B Farris; William R Doucette; Elizabeth A Chrischilles; Arthur J Hartz Journal: J Clin Hypertens (Greenwich) Date: 2008-04 Impact factor: 3.738
Authors: Katherine J Overwyk; Steven P Dehmer; Kakoli Roy; Michael V Maciosek; Yuling Hong; Madeleine M Baker-Goering; Fleetwood Loustalot; Christa-Marie Singleton; Matthew D Ritchey Journal: Med Care Date: 2019-11 Impact factor: 2.983
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: J Am Coll Cardiol Date: 2019-03-17 Impact factor: 24.094
Authors: Donna K Arnett; Roger S Blumenthal; Michelle A Albert; Andrew B Buroker; Zachary D Goldberger; Ellen J Hahn; Cheryl Dennison Himmelfarb; Amit Khera; Donald Lloyd-Jones; J William McEvoy; Erin D Michos; Michael D Miedema; Daniel Muñoz; Sidney C Smith; Salim S Virani; Kim A Williams; Joseph Yeboah; Boback Ziaeian Journal: Circulation Date: 2019-03-17 Impact factor: 29.690