Implementation of a comprehensive intervention for patients at high risk of cardiovascular disease in rural China: A pragmatic cluster randomized controlled trial.

Xiaolin Wei,John D Walley,James N Newell,Guanyang Zou,Anthony D Harries,Min Yu,Joseph P Hicks,Simin Deng,Weiwei Gong,Zhitong Zhang,Marc K C Chong,Jieming Zhong

doi:10.1371/journal.pone.0183169

Abstract

ObjectiveThis study aims to assess whether a standard intervention package of cardiovascular disease (CVD) care was being delivered effectively, and if it was associated with improved lifestyle and biomedical indicators.MethodsIn rural China, we implemented a pragmatic cluster randomized controlled trial for 12 months, randomized at the township hospital level, and compared with usual care. Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1) prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2) advice about specific lifestyle interventions; and 3) advice about medication adherence. Participants were 50–74 years old, had hypertension and CVD risk scores >20% or diabetes, but were excluded if a history of severe CVD events. We also randomly selected 100 participants from six selected clusters per arm as a panel to collect intermediate biomedical indicators over time.ResultsA total of 28,130 participants, in 33 intervention and 34 control township hospitals, were recruited. Compared with the control arm, participants in the intervention arm had substantially improved prescribing rates of anti-hypertensives, statins and aspirin (P<0.001), and had higher medication taking rates of aspirin and statins (P<0.001). Mean systolic and diastolic blood pressures were similar across both arms (0.15 mmHg, P = 0.79, and 0.52 mmHg, P = 0.05, respectively). In the panel, (950) rates of smoking (OR = 0.23, P = 0.02) and salt intake (OR = 2.85, P = 0.03) were significantly reduced in the intervention versus control arms, but there were no statistically significant improvement over the 12 month follow-up period in biomedical indicators (P>0.05).ConclusionImplementation of the package by family doctors was feasible and improved prescribing and some lifestyle changes. Additional measures such as reducing medication costs and patient education are required.Trial registrationCurrent Controlled Trials ISRCTN58988083

Highlights

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide
Intervention case management guideline, training and performance monitoring meeting and patient support activities were designed to fit within the job description of family doctors in the township hospitals and comprised: 1) prescription of a standardised package of medicines targeted at those with hypertension or diabetes; 2) advice about specific lifestyle interventions; and 3) advice about medication adherence
The global burden of diabetes is no less challenging with over 400 million people estimated to have the disease, half of whom are undiagnosed, with complications being a major cause of disability and reduced quality of life [3]

Summary

Introduction

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. The global burden of diabetes is no less challenging with over 400 million people estimated to have the disease, half of whom are undiagnosed, with complications being a major cause of disability and reduced quality of life [3]. Every year over nine million people die from hypertensionrelated disease and nearly five million die from diabetes, with most of this mortality being premature [4]. Despite this huge disease burden, access to prevention and treatment remains out of reach for most people in low- and middle-income countries [5]

Methods

Results

Discussion

Conclusion