Process Evaluation of a Clustered Randomized Control Trial of a Comprehensive Intervention to Reduce the Risk of Cardiovascular Events in Primary Health Care in Rural China.

Abstract

Background: Cardiovascular disease (CVD) is a major public health challenge in China. This study aims to understand the processes of implementing a comprehensive intervention to reduce CVD events in areas of drug therapy, lifestyle changes, and adherence support in a clustered randomized controlled trial (cRCT). This trial consisted of 67 clusters spanning over 3 years in Zhejiang Province, China. Method: A qualitative process evaluation was nested within the cRCT conducted in 9 township hospitals with 27 healthcare providers, 18 semi-structured interviews, and 23 observational studies of clinical practices within the intervention arm. Results: Effective and repeated trainings using an interactive approach were crucial to improve the prescribing behaviour of family doctors and their patient communication skills. However, the awareness of patients remained limited, thus compromising their use of CVD preventive drugs and adoption of healthy lifestyles. Health system factors further constrained providers’ and patients’ responses to the intervention. Financial barrier was a major concern because of the low coverage of health insurance. Other barriers included limited doctor–patient trust and suboptimal staff motivation. Conclusion: Our study suggests the feasibility of implementing a comprehensive CVD risk reduction strategy in China’s rural primary care facilities. However, health system barriers need to be addressed to ensure the success and sustainability of the intervention.