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.

Abstract

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.