A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

Ronald G. Victor, M.D., Kathleen Lynch, Pharm.D., Ning Li, Ph.D., Ciantel Blyler, Pharm.D., Eric Muhammad, B.A., Joel Handler, M.D., Jeffrey Brettler, M.D., Mohamad Rashid, M.B., Ch.B., Brent Hsu, B.S., Davontae Foxx-Drew, B.A., Norma Moy, B.A., Anthony E. Reid, M.D., and Robert M. Elashoff, Ph.D. April 5, 2018 N Engl J Med 2018; 378:1291-1301 DOI: 10.1056/NEJMoa1717250 Abstract Background Uncontrolled hypertension is a major problem among non-Hispanic black men, who are underrepresented in pharmacist intervention trials in traditional health care settings. Methods We enrolled a cohort of 319 black male patrons with systolic blood pressure of 140 mm Hg or more from 52 black-owned barbershops (nontraditional health care setting) in a cluster-randomized trial in which barbershops were assigned to a pharmacist-led intervention (in which barbers encouraged meetings in barbershops with specialty-trained pharmacists who prescribed drug therapy under a collaborative practice agreement with the participants’ doctors) or to an active control approach (in which barbers encouraged lifestyle modification and doctor appointments). The primary outcome was reduction in systolic blood pressure at 6 months. Results At baseline, the mean systolic blood pressure was 152.8 mm Hg in the intervention group and 154.6 mm Hg in the control group. At 6 months, the mean systolic blood pressure fell by 27.0 mm Hg (to 125.8 mm Hg) in the intervention group and by 9.3 mm Hg (to 145.4 mm Hg) in the control group; the mean reduction was 21.6 mm Hg greater with the intervention (95% confidence interval, 14.7 to 28.4; P<0.001). A blood-pressure level of less than 130/80 mm Hg was achieved among 63.6% of the participants in the intervention group versus 11.7% of the participants in the control group (P<0.001). In the intervention group, the rate of cohort retention was 95%, and there were few adverse events (three cases of acute kidney injury). Conclusions Among black male barbershop patrons with uncontrolled hypertension, health promotion by barbers resulted in larger blood-pressure reduction when coupled with medication management in barbershops by specialty-trained pharmacists. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT02321618.) Supported by the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (R01HL117983), the NIH National Center for Advancing Translational Sciences UCLA Clinical and Translational Science Institute (UL1TR001881), the California Endowment (grant numbers 20131872 and 20162257), the Lincy Foundation, the Harriet and Steven Nichols Foundation, the Burns and Allen Chair in Cardiology Research at the Smidt Heart Institute, and the Division of Community Relations and Development at Cedars–Sinai Medical Center. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. This article was published on March 12, 2018, at NEJM.org. We dedicate this article to Anthony E. Reid, M.D., the invaluable community cardiologist for the trial, who died shortly before the trial was completed. Author Affiliations From the Smidt Heart Institute at Cedars–Sinai Medical Center (R.G.V., K.L., C.B., E.M., M.R., B.H., D.F.-D., N.M., A.E.R.), the Department of Biomathematics, David Geffen School of Medicine, University of California, Los Angeles (N.L., R.M.E.), and Kaiser Permanente (J.H., J.B.) — all in Los Angeles. Address reprint requests to Dr. Victor at ronald.victor@cshs.org. Anthony E. Reid, M.D., is deceased.