A Primary-Care-Centered Integrated Care Intervention for Stratified Cardiovascular Risk Control in China: A Process Evaluation Protocol

Cardiovascular diseases (CVDs) represent a leading cause of mortality worldwide, with a particularly high burden in low- and middle-income countries (LMICs). The lack of well-trained medical professionals in LMICs poses a fundamental challenge to the prevention of CVD. In response, a complex primary care-centered integrated care intervention (C-RISIMA) has been developed with a risk-stratified integrated care pathway and a team-based blended payment mechanism in primary care facilities in China. This paper presents a protocol for a mixed methods process evaluation of this complex intervention, conducted in a multi-center, two-arm, cluster randomized controlled trial. This process evaluation aims to explore how the C-RISIMA intervention is implemented within the context of China’s countywide health systems and incorporated into the existing practices, and how varied implementation shaped the outcome and sustainability of the intervention. The study incorporates quantitative data collection on intervention fidelity, dose, reach, and adaptation, as well as qualitative interviews and focus groups with involved stakeholders including healthcare professionals, patients, and administrators. The analysis will utilize a combination of realist evaluation and the Normalization Process Theory to distill insights about the intervention’s integration into routine clinical practice. The findings of this study will inform policymakers on the much-needed knowledge about implementing primary-care-centered integrated care interventions in similar settings, particularly in LMICs where the burden of CVDs is most acute.