Long-Term Effectiveness of Intensive Blood Pressure Management Led by Nonphysician Community Healthcare Providers on Cardiovascular Events: 7-Year Follow-Up of a Cluster Randomized Trial.
BACKGROUND Hypertension is the leading risk factor for cardiovascular disease (CVD) worldwide. Implementation-based blood pressure (BP) control programs improve BP control and reduce CVD risk, but whether their benefits persist after withdrawal of trial-supported intervention components remains uncertain, especially when intensive BP control is targeted. In CRHCP (China Rural Hypertension Control Project), a nonphysician community healthcare provider (NPCHP)-led program with the intensive target of <130/80 mm Hg reduced CVD risk during the 4-year active intervention period. We extended follow-up for an additional 3 years to assess BP control and CVD outcomes over the 7-year overall period and during the 3-year posttrial period. METHODS CRHCP was a cluster-randomized controlled trial conducted in rural China. Eligible participants were ≥40 years of age with BP ≥140/90 mm Hg or ≥130/80 mm Hg if at high CVD risk or receiving antihypertensive treatment. We randomly assigned 326 villages 1:1 to NPCHP-led intensive BP control or usual care. During the 4-year intervention, trained NPCHPs initiated and titrated antihypertensive medications using a standardized protocol under primary care physician supervision and provided coaching on home BP monitoring, lifestyle modification, and medication adherence. The program also provided discounted or free antihypertensive medications, additional training, and performance incentives. Participants in the usual care group received local standard BP management throughout. During the 3-year posttrial period from years 4 to 7, intervention participants continued care with their original NPCHPs, with physician and hypertension specialist consultation available; discounted or free medications, additional training, and performance incentives were discontinued. The primary outcome was a composite of myocardial infarction, stroke, hospitalization for heart failure, and CVD death. Treatment effects were evaluated separately over the 7-year overall and 3-year posttrial periods with prespecified subgroup analyses. RESULTS Between May 8 and November 28, 2018, 33 995 participants were enrolled; 31 334 entered the posttrial follow-up. At the end of the 7-year overall period, BP was 138.8/80.7 mm Hg in the intervention group versus 152.3/86.1 mm Hg in the usual care group (between-group difference, -13.5/-5.4 mm Hg; P<0.0001 for both systolic and diastolic BPs); percentage of the participants with BP <130/80 mm Hg was 33.9% versus 10.5% (P<0.0001). During the 7-year overall period, the rate of composite CVD events was 2.4% versus 3.0% per person-year in the intervention and usual care groups, respectively (hazard ratio, 0.76 [95% CI, 0.72-0.81]; P<0.0001). During the 3-year posttrial period, the corresponding rates were 3.4% versus 4.2% per person-year (hazard ratio, 0.79 [95% CI, 0.73-0.85]; P<0.0001). Posttrial effects in CVD risk reduction were generally consistent across subgroups defined by baseline age, sex, education, and antihypertensive medication use. Over the 7-year overall period, the intervention group had higher risks of hypotension (risk ratio, 1.58 [95% CI, 1.39-1.79]) and mild hypokalemia (risk ratio, 1.38 [95% CI, 1.23-1.56]; P<0.001 for both). CONCLUSIONS Multicomponent BP management strategy with a BP target <130/80 mm Hg led by NPCHPs achieved sustained BP control and reduced CVD risk during both the 7-year overall and 3-year posttrial periods. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT03527719.