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Open Access Study protocol

Population impact of a high cardiovascular risk management program delivered by village doctors in rural China: design and rationale of a large, cluster-randomized controlled trial

Lijing L Yan12, Weigang Fang3, Elizabeth Delong4, Bruce Neal5, Eric D Peterson6, Yining Huang7, Ningling Sun8, Chen Yao9, Xian Li1, Stephen MacMahon105 and Yangfeng Wu111129*

Author Affiliations

1 The George Institute for Global Health at Peking University Health Science Center, Beijing, China

2 Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

3 Division of General Internal Medicine, Department of Medicine, Peking Union Medical College Hospital, Beijing, China

4 Department of Biostatistics, Duke University, Durham, NC, USA

5 The George Institute for Global Health, University of Sydney, Sydney, Australia

6 Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA

7 Department of Neurology, Peking University First Hospital, Beijing, China

8 Department of Cardiology, Peking University People’s Hospital, Beijing, China

9 Peking University Clinical Research Institute, Beijing, China

10 The George Centre for Healthcare Innovation, University of Oxford, Oxford, UK

11 Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China

12 The George Institute for Global Health at Peking University Health Science Center, Level 18, Tower B, Horizon Tower, No.6 Zhichun Road, Beijing 100088, China

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BMC Public Health 2014, 14:345  doi:10.1186/1471-2458-14-345

Published: 11 April 2014

Abstract

Background

The high-risk strategy has been proven effective in preventing cardiovascular disease; however, the population benefits from these interventions remain unknown. This study aims to assess, at the population level, the effects of an evidence-based high cardiovascular risk management program delivered by village doctors in rural China.

Methods

The study will employ a cluster-randomized controlled trial in which a total of 120 villages in five northern provinces of China, will be assigned to either intervention (60 villages) or control (60 villages). Village doctors in intervention villages will be trained to implement a simple evidence-based management program designed to identify, treat and follow-up as many as possible individuals at high-risk of cardiovascular disease in the village. The intervention will also include performance feedback as well as a performance-based incentive payment scheme and will last for 2 years. We will draw two different (independent) random samples, before and after the intervention, 20 men aged ≥ 50 years and 20 women aged ≥60 years from each village in each sample and a total of 9,600 participants from 2 samples to measure the study outcomes at the population level. The primary outcome will be the pre-post difference in mean systolic blood pressure, analyzed with a generalized estimating equations extension of linear regression model to account for cluster effect. Secondary outcomes will include monthly clinic visits, provision of lifestyle advice, use of antihypertensive medications and use of aspirin. Process and economic evaluations will also be conducted.

Discussion

This trial will be the first implementation trial in the world to evaluate the population impact of the high-risk strategy in prevention and control of cardiovascular disease. The results are expected to provide important information (effectiveness, cost-effectiveness, feasibility and acceptability) to guide policy making for rural China as well as other resource-limited countries.

Trial registration

The trial is registered at ClinicalTrials.gov (NCT01259700). Date of initial registration is December 13, 2010.

Keywords:
Cardiovascular disease; Prevention; Primary care; Village doctor; Rural health; China; Cluster-randomized trial