'Bold' intervention trialed in developing countries
A tailored community-based intervention that leaned on the various skills of non-physician health workers (NPHWs) cut the risk of cardiovascular disease in patients with high blood pressure, results of the HOPE 4 trial showed.
Patients exposed to the intervention had an 11.17% reduction (-12.88 to -9.47) in Framingham Risk Score at 12 months versus a 6.40% reduction (95% CI -8.00 to -4.80) in the usual care group, reported Jon-David Schwalm, MD, MSc, of McMaster University and Hamilton Health Sciences in Hamilton, Ontario.
"A comprehensive model of care led by non-physician heath workers, involving primary care physicians and family, along with the provision of free antihypertensive medications and a statin, resulted in a greater than 40% reduction in cardiovascular risk and a doubling in the change in blood pressure control," he said during a press briefing here at the 2019 European Society of Cardiology congress.
HOPE 4 was a cluster randomized trial in Colombia and Malaysia that used NPHWs to screen and treat participants. The NPHWs used tablets with guideline-recommended treatment algorithms to determine appropriate therapy (after training they attained 93% concordance with physicians) -- patients received free antihypertensives and a statin. Family and community members served to support the study participants in terms of lifestyle changes and drug adherence.
In all, 69% of patients in the intervention group were able to get their blood pressure under control (systolic blood pressure [SBP] <140 mm Hg) compared with 30% in the usual care group (P<0.0001).
The intervention group's 4.78% absolute reduction (95% CI -7.11 to -2.44) in ten-year predicted cardiovascular disease risk -- the study's primary outcome -- was underpinned by greater reductions in SBP and LDL cholesterol (P<0.0001 for all):
- SBP: 11.45 mm Hg (95% CI -14.94 to -7.97)
- LDL: 0.41 mmol/L (95% CI -0.60 to -0.23)
No significant differences were seen for glucose concentrations or HDL. Results of the study were presented during a late-breaking trials session and published simultaneously in The Lancet.
The tailored aspect of the trial involved an initial systematic analysis of each country to identify patient-, provider-, and healthcare-system barriers to hypertension care. In Colombia for example, while blood pressure drugs may be subsidized for low-income individuals, long wait times often dissuade patients from bothering. In HOPE 4, locally available generic medications were made available free of charge for starters, and the NPHWs delivered them to patients' homes in some cases.
Jon-David Schwalm, MD, MSc, discussing the HOPE 4 results at ESC
These workers were already working in the communities and were "repurposed" for cardiovascular disease prevention. "It's a matter of shifting direction," Schwalm told MedPage Today.
Asked what lessons could be applied to North America, he said his group piloted the program in Canada, using firefighters as the NPHWs.
"In Canada, medication was not so much an issue," he said. "Finding what are the barriers in individual countries, I think that's where we are going to see the biggest benefit."
Researchers are ever seeking innovative ways to get antihypertensive treatments to patients. At last year's American College of Cardiology meeting, for example, a group from the University of California Los Angeles made a splash showing a 27 mm Hg drop in blood pressure when pharmacists at barbershops doled out antihypertensives (patients' primary care physicians had signed off).
In a linked comment in The Lancet, Tazeen H. Jafar, MD, MPH, of Duke-NUS Medical School in Singapore, and colleagues noted that the large effect size observed in the trial, compared with other pragmatic studies, can likely be explained by several key factors.
For starters, patients in HOPE 4 were high risk at baseline (mean Framingham Risk Score >30%). Second, the study relied on NPHWs who possess a "higher mix of skills and competencies," which is not always the case in such trials. Third, the trial opted for a free statin plus single-pill blood-pressure medication. Lastly, the use of patient support led to excellent adherence to the protocol (64% vs 40% in the usual care group).
"However, these same study design attributes might also limit sustainability and scalability. Of paramount importance is the concept of integration within the existing health-care system," Jafar's group wrote. "NPHWs in HOPE 4 were private contractors and hired exclusively for the trial. If staff were employees in existing health systems, rather than private contractors, competing tasks might compromise the acceptability, fidelity, effectiveness, and sustainability of the HOPE 4 intervention strategies when scaled up in the real world."
They called for a comprehensive analysis to determine the cost-effectiveness of such an approach; Schwalm said his group is in the process of working on such an analysis.
"HOPE 4 and similar highly important studies should prompt the scientific and legislative communities to rethink the scale-up of large, evidence-based approaches to dramatically reduce the burden of uncontrolled hypertension and lower cardiovascular risk," Jafar and coauthors wrote. "Such bold strategies cannot be ignored."
From 2014 to 2017, the study enrolled 1,371 hypertensive patients age 50 and older who were screened from 30 communities in Colombia and Malaysia. Door-to-door hypertension screening was performed in Colombia while individuals in Malaysia were screened mostly at community gatherings. In all, 14 of these communities were randomized to the intervention while 16 received usual care.
HOPE 4 was funded by the Canadian Institutes of Health Research, Grand Challenges Canada, the Ontario SPOR Support Unit, the Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, the World Health Organization, and the Population Health Research Institute.
Schwalm and co-authors disclosed institutional relationships with the study backers.
Jafar and co-authors declared no conflicts of interests.
Source Reference: Schwalm JD, et al "A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): A cluster-randomised controlled trial" Lancet 2019; DOI: 10.1016/S0140-6736(19)31949-X.
Source Reference: Jafar TH, et al "Parallel community solutions for cardiovascular risk reduction" Lancet 2019; DOI: 10.1016/S0140-6736(19)31995-6.
Read the original article on Medpage Today: Community Health Workers Slinging Free Heart Drugs Cut CV Risks