Health Services and Outcomes Research
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Health Services and Outcomes Research Randomized Trial of the Effect of Pharmacist Prescribing on Improving Blood Pressure in the Community The Alberta Clinical Trial in Optimizing Hypertension (RxACTION) Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc; Sherilyn K.D. Houle, BSP, PhD; Theresa L. Charrois, BSc(Pharm), PhD; Michael R. Kolber, MD, MSc; Meagen M. Rosenthal, MA, PhD; Richard Lewanczuk, MD, PhD; Norm R.C. Campbell, MD; Dale Cooney, BScPharm; Finlay A. McAlister, MD, MSc; for the RxACTION Investigators* Background—Hypertension control rates remain suboptimal. Pharmacists’ scope of practice is evolving, and their position in the community may be ideal for improving hypertension care. We aimed to study the impact of pharmacist prescribing on blood pressure (BP) control in community-dwelling patients. Methods and Results—We designed a patient-level, randomized, controlled trial, enrolling adults with above-target BP (as defined by Canadian guidelines) through community pharmacies, hospitals, or primary care teams in 23 communities in Alberta. Intervention group patients received an assessment of BP and cardiovascular risk, education on hypertension, prescribing of antihypertensive medications, laboratory monitoring, and monthly follow-up visits for 6 months (all by their pharmacist). Control group patients received a wallet card for BP recording, written hypertension information, and usual care from their pharmacist and physician. Primary outcome was the change in systolic BP at 6 months. A total of 248 patients (mean age, 64 years; 49% male) were enrolled. Baseline mean±SD systolic/diastolic BP was 150±14/84±11 mm Hg. The intervention group had a mean±SE reduction in systolic BP at 6 months of 18.3±1.2 compared with 11.8±1.9 mm Hg in the control group, an adjusted difference of 6.6±1.9 mm Hg (P=0.0006). The adjusted odds of patients achieving BP targets was 2.32 (95% confidence interval, 1.17–4.15 in favor of the intervention). Conclusions—Pharmacist prescribing for patients with hypertension resulted in a clinically important and statistically significant reduction in BP. Policy makers should consider an expanded role for pharmacists, including prescribing, to address the burden of hypertension. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT00878566. (Circulation. 2015;132:93-100. DOI: 10.1161/CIRCULATIONAHA.115.015464.) Key Words: delivery of health care ◼ hypertension ◼ outcome assessment (health care) ◼ pharmacists ypertension is a key risk factor for cardiovascular dis- Editorial see p 75 Hease and premature mortality worldwide, affecting 1 Clinical Perspective on p 100 in 5 North American adults and with 35% to 50% remain- ing uncontrolled.1,2 Because the prevalence of hypertension Given the increasing workloads placed on primary care increases with age,2,3 it is expected that an aging population physicians, pharmacists are well positioned to take on a will lead to an even higher prevalence of hypertension and greater role in the management of chronic disease. Indeed, a greater burden on existing healthcare resources to man- research has demonstrated the effectiveness of pharmacist- age elevated blood pressure (BP) and its sequelae in the provided disease management activities, including for hyper- coming years. tension.4–10 Specific to hypertension, a recent systematic Received January 18, 2015; accepted May 6, 2015. From EPICORE Centre/COMPRIS, Faculty of Medicine and Dentistry (R.T.T., S.K.D.H., T.L.C., M.R.K., M.M.R., F.A.M.), Department of Medicine, Faculty of Medicine and Dentistry (R.T.T., S.K.D.H., M.M.R., R.L., F.A.M.), Mazankowski Alberta Heart Institute (R.T.T., S.K.D.H., R.L., F.A.M.), Faculty of Pharmacy and Pharmaceutical Sciences (T.L.C.), and Department of Family Medicine, Faculty of Medicine and Dentistry (M.R.K.), University of Alberta, Edmonton, Canada; School of Pharmacy, University of Waterloo, Kitchener, ON, Canada (R.T.T., S.K.D.H.); Department of Medicine, Faculty of Medicine, University of Calgary, AB, Canada (N.R.C.C.); and Alberta College of Pharmacists, Edmonton, Canada (D.C.). *A complete list of the RxACTION Investigators can be found in the online-only Data Supplement. The online-only Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIRCULATIONAHA. 115.015464/-/DC1. Correspondence to Ross T. Tsuyuki, BSc(Pharm), PharmD, MSc, EPICORE Centre/COMPRIS, 4-000 Research Transition Facility, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada T6G 2V2. E-mail [email protected] © 2015 American Heart Association, Inc. Circulation is available at http://circ.ahajournals.org DOI: 10.1161/CIRCULATIONAHA.115.015464 Downloaded from http://circ.ahajournals.org/93 by guest on July 13, 2015 94 Circulation July 14, 2015 review and meta-analysis assessing the effect of pharmacist to define uncontrolled BP, with the exact number depending on the intervention for outpatients with hypertension identified 39 level of BP). Overall, this meant a BP >140/90 mm Hg for most and randomized, controlled trials comprising >14 000 patients.11 >130/80 mm Hg for those with diabetes mellitus. Because the CHEP guidelines specify a number of diagnostic scenarios with different BP Compared with usual care, interventions including pharma- cutoffs and the number of readings required, readers are referred to cists resulted in improvements in both systolic (−7.6 mm Hg; the guidelines for the clinical definitions of uncontrolled BP for the 95 % confidence interval, −9.0 to −6.3) and diastolic BP (−3.9 purpose of this study.15,17–20 Patients meeting any of the criteria for mm Hg; 95 % confidence interval, −5.1 to −2.8). Of note, diagnosis or, if already diagnosed, remaining above the specified tar- a greater effect size was observed among the 23 studies in get given their age and comorbidities could be included. Any changes to these guideline definitions over the course of the study were con- which the pharmacist led the intervention, resulting in mean currently applied to the inclusion criteria for the study. systolic and diastolic BP differences of −8.5 and −4.6 mm Hg, Exclusion criteria included hypertensive urgency or emergency respectively, compared with usual care. However, the pharma- (defined as systolic BP≥ 200 or diastolic BP ≥130 mm Hg with/with- cist interventions provided largely involved patient education, out symptoms), pregnancy, or unwillingness or inability to provide medication management activities (defined as monitoring consent to participate. The study received ethics approval from the University of Alberta Health Research Ethics Board, and written activities with medication adjustment), and recommendations informed consent was obtained from all participants. to physicians. Therefore, the effectiveness of these interven- All BP measurements performed by the pharmacist were made tions largely remains dependent on physician follow-through with the automated BpTRU (BpTRU Medical Devices, Coquitlam, on drug therapy recommendations made by the pharmacists, a BC, Canada), which takes 6 readings, discarding the first and taking type of “ceiling effect.” the average of the remainder. Home measurements were performed with the LifeSource UA-787 home BP monitor. Both devices are It is postulated that allowing pharmacists to indepen- validated or approved by CHEP, and pharmacists were to ensure that dently prescribe drug therapy may result in even better patient proper cuff sizes were used for all measurements.21,22 Home measure- outcomes than interventions based solely on providing rec- ment was used for those patients requiring >2 office screening visits, ommendations. Since 2007, the Health Professions Act of as defined by the CHEP guidelines,15,17–20 as a guideline-concordant Alberta, Canada has allowed pharmacists to apply for autho- option for obtaining these additional BP readings. All patients using rization to prescribe.12 To receive this authorization, pharma- home measurement were provided verbal and written instruction on proper measurement technique by the pharmacist and were provided cists must have a minimum of 1 year of practice experience a cuff of proper size to ensure accuracy. and must successfully complete an application process, Randomization was conducted at the level of the patient and was including the submission of patient care cases documenting performed via a centralized secure Web site at the Epidemiology their clinical involvement to demonstrate skills in patient Coordinating and Research (EPICORE) Center (http://www.epicore. assessment, judgment, care planning, and follow-up.13 To ualberta.ca) to ensure randomization concealment. Patients were ran- domized in a 2:1 ratio to either intervention or usual care. Because of ensure continuity of care, pharmacists must communicate all the nature of the intervention, blinding was not possible. prescribing decisions to the patient’s primary care physician The intervention group received enhanced pharmacist care, which and are responsible for conducting follow-up on their pre- was guided by the CHEP guidelines and consisted of pharmacist scribing decisions. Additionally, all Alberta pharmacists are assessment of and counseling about cardiovascular risk and BP con- able to order laboratory studies for patients under their care trol, review of antihypertensive medications, and prescribing/titrating of drug therapy if deemed necessary, in addition to a wallet card for as required. Pharmacists are required to maintain professional recording BP measurements, lifestyle advice, and written information liability insurance. on hypertension developed by CHEP. The patient’s primary care phy- The present study was designed to test the hypothesis sician was notified of all assessment results and drug therapy changes that pharmacist prescribing for community-dwelling patients in person or by fax. Intervention group patients were followed up at with uncontrolled hypertension would result in improved BP monthly intervals until their BP was at target for 2 consecutive visits and thereafter at 3-month intervals for the duration of the study period reduction over usual care. as per CHEP recommendations.