Effectiveness of a Primary‐Care‐Centered Integrated Care Intervention for Stratified Cardiovascular Risk Control in China: Study Protocol for a Pragmatic Cluster Randomized Controlled Trial

Introduction Gaps in primary care (PC) restrict its potential as a core foundation of the health system in its response to the growing burden of cardiovascular disease (CVD). China has been promoting County‐wide Tight Medical Alliances to strengthen PC by integrating services from hospitals and PC providers. However, a practical model of care for effective CVD risk management is still lacking. We developed a multifaceted intervention, namely the Cardiovascular‐Risk‐Stratified Integrated Management model, to strengthen PC for CVD risk management by leveraging both PC providers and hospital‐based specialists in the County‐wide Tight Medical Alliances. The purpose of this study is to evaluate the effectiveness of the Cardiovascular‐Risk‐Stratified Integrated Management model. Methods This study is a multicenter, cluster‐randomized controlled trial conducted with a total of 2560 patients with diagnosed hypertension and/or diabetes, aged 41–70 years, served by 64 family doctor teams in three county‐wide tight medical alliances. The primary outcome is the change in 10‐year CVD risk score from baseline to 12 months after intervention, using the World Health Organization CVD risk laboratory‐based chart for East Asians. Secondary outcomes include 12‐month and 6‐month changes in CVD risk factors, and incidence rate of major adverse cardiovascular events, and so forth. All participants will receive outcome measurements at baseline, 6, and 12 months. Discussion This study pioneers a PC‐based integration of individualized CVD risk management with economic incentives, evaluating its effects on resource allocation and preventive outcomes to inform scalable models in low‐ and middle‐income countries. The study findings will be disseminated through multiple channels, including a final report, publications in peer‐reviewed journals, and evidence‐based recommendations tailored to healthcare providers, health service commissioners, and policymakers. Trial Registration Clinical Trials ID: NCT06302127. Date of registration: March 8, 2025. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06302127 .