Elsevier

The Lancet

Volume 401, Issue 10380, 18–24 March 2023, Pages 928-938
The Lancet

Articles
Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention versus usual care on cardiovascular disease (CRHCP): an open-label, blinded-endpoint, cluster-randomised trial

https://doi.org/10.1016/S0140-6736(22)02603-4Get rights and content

Summary

Background

Effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention on cardiovascular disease has not been established. We aimed to test the effectiveness of such an intervention compared with usual care on risk of cardiovascular disease and all-cause death among individuals with hypertension.

Methods

In this open-label, blinded-endpoint, cluster-randomised trial, we recruited individuals aged at least 40 years with an untreated systolic blood pressure of at least 140 mm Hg or a diastolic blood pressure of at least 90 mm Hg (≥130 mm Hg and ≥80 mm Hg for those at high risk for cardiovascular disease or if currently taking antihypertensive medication). We randomly assigned (1:1) 326 villages to a non-physician community health-care provider-led intervention or usual care, stratified by provinces, counties, and townships. In the intervention group, trained non-physician community health-care providers initiated and titrated antihypertensive medications according to a simple stepped-care protocol to achieve a systolic blood pressure goal of less than 130 mm Hg and diastolic blood pressure goal of less than 80 mm Hg with supervision from primary care physicians. They also delivered discounted or free antihypertensive medications and health coaching for patients. The primary effectiveness outcome was a composite outcome of myocardial infarction, stroke, heart failure requiring hospitalisation, and cardiovascular disease death during the 36-month follow-up in the study participants. Safety was assessed every 6 months. This trial is registered with ClinicalTrials.gov, NCT03527719.

Findings

Between May 8 and Nov 28, 2018, we enrolled 163 villages per group with 33 995 participants. Over 36 months, the net group difference in systolic blood pressure reduction was –23·1 mm Hg (95% CI –24·4 to –21·9; p<0·0001) and in diastolic blood pressure reduction, it was –9·9 mm Hg (–10·6 to –9·3; p<0·0001). Fewer patients in the intervention group than the usual care group had a primary outcome (1·62% vs 2·40% per year; hazard ratio [HR] 0·67, 95% CI 0·61–0·73; p<0·0001). Secondary outcomes were also reduced in the intervention group: myocardial infarction (HR 0·77, 95% CI 0·60–0·98; p=0·037), stroke (0·66, 0·60–0·73; p<0·0001), heart failure (0·58, 0·42–0·81; p=0·0016), cardiovascular disease death (0·70, 0·58–0·83; p<0·0001), and all-cause death (0·85, 0·76–0·95; p=0·0037). The risk reduction of the primary outcome was consistent across subgroups of age, sex, education, antihypertensive medication use, and baseline cardiovascular disease risk. Hypotension was higher in the intervention than in the usual care group (1·75% vs 0·89%; p<0·0001).

Interpretation

The non-physician community health-care provider-led intensive blood pressure intervention is effective in reducing cardiovascular disease and death.

Funding

The Ministry of Science and Technology of China and the Science and Technology Program of Liaoning Province, China.

Introduction

Hypertension is the leading global modifiable risk factor for cardiovascular disease and all-cause death, especially in low-income and middle-income countries (LMICs).1, 2 Approximately 75% of individuals with hypertension live in LMICs, and only 7·7% have their blood pressure controlled.3 Randomised controlled trials have documented that antihypertensive treatment reduces the risk of cardiovascular disease and all-cause death among patients with hypertension.4, 5 However, this evidence-based intervention is not being fully implemented in low-resource settings. Multiple barriers to hypertension control among health-care systems, health-care providers, patients, and communities could contribute to this knowledge–implementation gap. For example, poor access to high-quality health care, antihypertensive medication costs and availability, low health literacy, and poor awareness of hypertension status are major barriers to hypertension control in low-income populations.6, 7, 8 Previous studies have shown that non-physician health-care provider-led interventions were effective in overcoming these barriers and improving hypertension control in low-resource settings.9, 10, 11 However, the effectiveness of a non-physician health-care provider-led blood pressure intervention on cardiovascular disease among patients with hypertension has not been studied.

Research in context

Evidence before this study

We searched PubMed on Nov 26, 2022, using the search terms “nonphysician healthcare providers[Text Word]” OR “nurse[MeSH Terms]” OR “pharmacist[MeSH Terms]” OR “community health worker[MeSH Terms]” AND “antihypertensive treatment[MeSH Terms]” OR “blood pressure intervention[MeSH Terms]” AND “cardiovascular disease[MeSH Terms]” OR “myocardial infarction[MeSH Terms]” OR “stroke[MeSH Terms]” OR “heart failure[MeSH Terms]” AND “randomized controlled trial[Filter]”. We searched for randomised controlled trials on non-physician health-care provider-led blood pressure interventions on cardiovascular disease published between Jan 1, 1965 and Nov 26, 2022, with no language or date restrictions, and found no relevant publications. In addition, we searched for publications reporting results from randomised controlled trials on intensive blood pressure interventions (ie, systolic blood pressure target <130 mm Hg) on cardiovascular disease. The following search terms were used: “intensive blood pressure intervention[MeSH Terms]” OR “systolic blood pressure target <120 mm Hg[Text Word]” OR “systolic blood pressure target <130 mm Hg[Text Word]” AND “cardiovascular disease[MeSH Terms]” OR “myocardial infarction[MeSH Terms]” OR “stroke[MeSH Terms]” OR “heart failure[MeSH Terms]” AND “randomized controlled trial[Filter]”. We identified four randomised controlled trials that compared intensive blood pressure interventions with standard intervention. These trials were conducted in patients with lacunar stroke (the SPS3 trial) or type 2 diabetes (the ACCORD trial), those at high risk for cardiovascular disease (the SPRINT trial), or older patients aged 60–80 years (the STEP trial). Overall, among the four trials, there was a 20% reduction in the hazard of major cardiovascular disease (pooled hazard ratio [HR] 0·80; 95% CI 0·73–0·88; p<0·0001). There were no randomised controlled trials of intensive blood pressure interventions conducted in the general population with hypertension.

Added value of this study

To our knowledge, the China Rural Hypertension Control Project (CRHCP) is the first randomised controlled trial to test the effectiveness of a non-physician health-care provider-led hypertension control on cardiovascular disease outcomes. It is also the first randomised controlled trial to test the effect of an intensive blood pressure intervention on cardiovascular disease and mortality in the general population with hypertension. Non-physician health-care providers initiated and titrated antihypertensive medications based on a simple treatment protocol and were supervised by primary care physicians. They also delivered discounted and free medications to patients and conducted health coaching on lifestyle modification, home blood pressure measurement, and medicine adherence. In the intervention group, systolic blood pressure decreased from 157·0 mm Hg at baseline to 126·1 mm Hg at 36 months and diastolic blood pressure from 87·9 mm Hg to 73·1 mm Hg. The net group difference in blood pressure reduction was –23·1 mm Hg for systolic and –9·9 mm Hg for diastolic between two groups. The primary composite outcome of myocardial infarction, stroke, heart failure, or cardiovascular disease death was significantly reduced by 33% in the intervention group compared with the usual care group. The secondary outcomes also declined significantly in the intervention: there was a 23% reduction in myocardial infarction, 34% reduction in stroke, a 42% reduction in hospitalised heart failure, a 30% reduction in cardiovascular disease death, and a 15% reduction in all-cause death. The effect of blood pressure reduction on cardiovascular disease and all-cause mortality was consistent between older and middle-aged individuals, and between those at high risk and not at high risk for cardiovascular disease.

Implications of all the available evidence

Previous randomised controlled trials have reported that non-physician health-care provider-led interventions were effective in reducing blood pressure and improving hypertension control in low-resource populations. This study has added new evidence that a non-physician community health-care provider-led blood pressure intervention reduced cardiovascular disease and all-cause death. Furthermore, this study has provided novel evidence that an intensive blood pressure intervention reduced cardiovascular disease and all-cause mortality in the general population with hypertension. Evidence from this trial and previous trials in high-risk and older populations support a lower blood pressure target (ie, systolic blood pressure <130 mm Hg and diastolic blood pressure <80 mm Hg) for all patients with hypertension to further reduce cardiovascular disease and all-cause mortality. Moreover, this non-physician community health-care provider-led strategy, which has proven to be feasible and effective, could be scaled up in rural China and other low-resource settings to reduce blood pressure-related cardiovascular disease and all-cause death.

Clinical trials have shown that more intensive blood pressure control further lowers risk of cardiovascular disease compared with conventional control.12, 13 In the Systolic Blood Pressure Intervention Trial (SPRINT), an intensive systolic blood pressure target of less than 120 mm Hg resulted in a 25% reduction in cardiovascular disease and a 27% reduction in all-cause death as compared with a standard target of less than 140 mm Hg among 9361 hypertensive patients at high risk for cardiovascular disease.12 In the Strategy of Blood Pressure Intervention in the Elderly Hypertensive Patients (STEP) trial, an intensive systolic blood pressure target of 110 to less than 130 mm Hg reduced cardiovascular disease by 26%, but not all-cause death, compared with a standard target of 130 to less than 150 mm Hg among 9624 hypertensive patients aged 60–80 years.13 The effect of intensive blood pressure control on cardiovascular disease and death has not been established in the general population with hypertension.

In the China Rural Hypertension Control Project (CRHCP) trial, an intensive blood pressure intervention was implemented by non-physician community health-care providers (ie, village doctors). These providers work on the frontline of basic primary care and public health service in rural China, and most of them have some medical training (ie, 3 years of vocational or junior medical education).14 We aimed to test the effectiveness of a non-physician community health-care provider-led intensive blood pressure intervention compared with usual care on risk of cardiovascular disease and all-cause death among patients with hypertension.

Section snippets

Study design and participants

We conducted an open-label, blinded-endpoint, cluster-randomised two-phase trial in 326 villages from three provinces (Liaoning, Shaanxi, and Hubei) in rural China. The primary outcome was blood pressure control at 18 months in phase 1 and cardiovascular disease events over 36 months in phase 2. The details of the study design and phase 1 results were published previously.7, 10 The trial was approved by the ethics committees of the First Hospital of China Medical University and all

Results

Between May 8 and Nov 28, 2018, a total of 33 995 participants were enrolled and randomised (table 1) and, of them, 32 387 (95·3%) were followed for clinical events over 36 months (appendix p 13). On average, study participants were aged 63·0 years, 20·9% (7090 of 33 995) had a self-reported history of cardiovascular disease, and 57·6% (19 564) were taking antihypertensive medications at baseline. All 201 trained non-physician community health-care providers and all 163 villages randomised to

Discussion

This study has shown that a non-physician health-care provider-led intensive blood pressure intervention significantly reduces risk of cardiovascular disease and all-cause deaths. The net group difference in systolic blood pressure reduction of –23 mm Hg and diastolic blood pressure reduction of –10 mm Hg was associated with a 33% (95% CI 27–39) reduction in the hazard of cardiovascular disease, a 34% (27–40) reduction in the hazard of stroke, and a 15% (5–24) reduction in the hazard of

Data sharing

Data from this study can be requested from Prof Yingxian Sun ([email protected]) and Prof Jiang He ([email protected]) after the publication of this study. Deidentified participant data, the data dictionary, and other specified data sets can be requested. The study protocol, statistical analysis plan, and informed consent form will also be made available upon request. Specific requests for data will require the submission of a proposal with a valuable research question as assessed by the study

Declaration of interests

We declare no competing interests.

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