CME Author: Zeena Nackerdien
Study Authors: Ronald Victor (deceased), Ciantel Blyler, et al.
Target Audience and Goal Statement: Cardiologists, primary care physicians, emergency physicians, and pharmacists
- Would the reduction in systolic blood pressure (BP) achieved after 6 months in the initial phase of a cluster-randomized trial of non-Hispanic African-American men with uncontrolled hypertension (HTN) who received pharmacist-led interventions via barbershops be sustained at 12 months?
Synopsis and Perspective
According to the 2017 national guideline of the American College of Cardiology (ACC), the American Heart Association (AHA), and other professional organizations for the prevention, detection, evaluation, and management of high blood pressure in adults, the standards for accurate BP measurement include stratifying the levels as follows:
- Normal BP (<120/<80 mm Hg)
- Increased BP (120-129/<80 mm Hg)
- HTN stage 1 (130-139 or 80-89 mm Hg)
- HTN stage 2 (≥140 or ≥90 mm Hg)
African-Americans in the U.S. have among the highest rates of HTN in the world, with >40% of non-Hispanic African-American men and women known to have high BP. Obesity, diabetes, and a gene that makes African-Americans more salt-sensitive than the general population are among the factors thought to play a role. Furthermore, the age-adjusted HTN-related death rate is 3.3-times higher among black men than white men.
Ciantel A. Blyler, PharmD, of Cedars Sinai Smidt Heart Institute in Los Angeles, and colleagues, analyzed data from a 6-month extension of their Los Angeles Blood Pressure Study, which was designed to compare two types of barbershop-based, patient-centered BP programs to see which was more effective in reducing uncontrolled HTN in non-Hispanic African-American men. One intervention focused on BP medication and the other emphasized lifestyle modification.
The investigators explained that they assumed that, as pharmacists are more accessible than primary care physicians, these allied healthcare professionals would be amenable to receiving training on patient education and would then be able to impart additional information about medications.
“Black men have less physician interaction than black women do and thus lower rates of treatment and control of HTN. Health outreach in barbershops is well established throughout the United States,” the study’s first author, Ronald G. Victor, MD, who died shortly before the updated paper was submitted, told MedPage Today when the 6-month data were presented at the American College of Cardiology 2018 scientific sessions and simultaneously published in theNew England Journal of Medicine.
During the initial 6 months of the trial, a cohort of 319 black male patrons (ages 35-79) with a systolic BP of 140 mm Hg or more from 52 black-owned barbershops participated in a cluster-randomized trial. Men randomized to the active arm saw pharmacists certified by the American Society of Hypertension, who under an agreement with participants’ primary care physicians, monitored the participants’ BP, along with their plasma electrolytes and creatinine, and provided lifestyle recommendations.
The pharmacists also prescribed a combination antihypertensive drug regimen following a generally fixed set of medication adjustments. In the control group, barbers promoted follow-up with primary care providers and lifestyle modification. Barbers were trained to encourage participants in each group accordingly.
The prespecified BP target goal of <130/80 (which Blyler et al. noted was influenced by the Systolic Blood Pressure Intervention Trial [SPRINT])is less than the <140/90 goal that many community physicians would have used based on the 2017 ACC/AHA guideline. SPRINT investigators stated that "among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause."
Compared with the rate of 11.7% of participants in the control group, a BP-level of <130/80 mm Hg was achieved among 63.6% of the participants in the intervention group. At 6 months, there was a three times larger effect compared with other pharmacist-led HTN intervention trials with baseline systolic BP levels of about 150 mm Hg.
The same randomization and intervention protocols were kept for the 6-month extension of the study (125 participants in 28 intervention shops completed the year-long study vs 163 participants in 24 control shops; cohort retention =90%). That the intervention provided BP management to patrons in their barbershops was not only more convenient, but also helped address the known distrust and avoidance of the medical profession among many black men by using trusted barbers whom the participants had visited on average every 2 weeks for at least a decade.
At 12 months the benefits from the 6-month study were sustained — i.e., mean systolic BP fell by 28.6 mm Hg (from 152.4 to 123.8 mm Hg) in the intervention group and by 7.2 mm Hg (from 154.6 to 147.4 mm Hg) in the control group. Mean BP reduction was 20.8 mm Hg higher in the intervention group (95% CI, 13.9-27.7; P<0.0001).
The proportion of the intervention group who achieved a BP <130/80 mm Hg was 68% vs 11% in the control group. No treatment-related serious adverse events were observed in either group over the course of a year, the researchers reported.
Study limitations, Blyler and co-authors noted, included that the rate of participation was lower in the intervention group than in the control group, perhaps reflecting a lay bias regarding prescription drugs. And while the influence of financial incentives ($25 monthly haircut vouchers, and $25 in the intervention group to help offset the cost of generic drugs) on the outcome of the multifaceted intervention could not be discounted, the data suggest that this variable had only a small effect on medication adherence, the researchers stated.
Source Reference: Circulation, online Dec. 17, 2018; DOI: 10.1161/CIRCULATIONAHA.118.038165
Study Highlights: Explanation of Findings
The 12-month update of the study showed that health promotion by barbers resulted in a “large and sustained” BP reduction in a cohort of non-Hispanic African-American males with uncontrolled HTN when coupled with medication management delivered by American Society for Hypertension-certified pharmacists to these businesses.
Although the patrons interacted less with pharmacists during the extension phase of the trial (pharmacists in the second 6 months of the trial had 7±2 visits vs 4±2 in the first 6 month), mean reductions in systolic and diastolic BP observed at 12 months were indistinguishable from the results reported at the end of the first 6 months, Blyler and co-authors confirmed.
Several criteria suggest the sustainability of this HTN-treatment model, the team said: the 90% cohort retention; the improved patient satisfaction (self-rated health); and the fact that there were few treatment-related adverse events.
The researchers departed from usual care and guideline-recommended strategies on a couple of fronts: For example, they used an angiotensin-receptor blocker or an angiotensin-converting enzyme inhibitor plus amlodipine as a starting regimen, rather than thiazide-type diuretics and calcium-channel blockers. This treatment was effective and well-tolerated by the study participants (only half of the regimens needed three or more drugs), the researchers said, explaining that overall, the use of more combination regimens, more first-line BP drugs, and more long-acting drugs may explain the greater BP reduction observed in the intervention group vs standard treatment by community physicians.
Can the intervention potency demonstrated in this study be scaled and replicated elsewhere with different pharmacist-led teams? The answers may be attained through future appropriately designed studies, Blyler and co-authors said. As a first step, they suggested a focus on expanding collaborative practices between pharmacists and physicians. Also key, although admittedly time-consuming, the researchers noted, is establishing in-person trust through travel by pharmacists to and from barber shops. To improve operational efficiencies, the investigators suggested telemonitoring as a viable alternative.
“This is a home run,” said Eileen Handberg, PhD, ARNP, of the University of Florida in Gainesville, who discussed the 6-month results at an ACC press conference, but was not involved with the research. “This is something that clinical trialists dream of – to get this kind of impact in healthcare. This is taking care to where patients live. This is high-touch medicine,” she said.
Also enthusiastic was John Bisognano, MD, of the University of Rochester in New York, also not involved in the study: “The results were phenomenal, and likely represent one of the greatest innovations in healthcare delivery for hypertension in the past 30 years,” he told MedPage Today.
“So much of our hypertension management is focused on lifestyle modification and drug selection and follow-up,” Bisognano continued. “While this approach has been successful over the past half-century, treatment and control rates have largely stalled, and this approach has been particularly ineffective in non-Hispanic black men, who continue to have high rates of suboptimally treated HTN.”
Also offering an opinion and not involved in the trial was Khadijah Breathett, MD, of the University of Arizona College of Medicine in Tucson, who commented: “This landmark study heralds the need to engage community members where they live. Health equity will require moving beyond the confines of the ivory tower of medicine.”
Kate Kneisel wrote the original story for MedPage Today