Comparing primary-tertiary multidisciplinary collaborative care with usual care in community patients with atrial fibrillation: The protocol for a cluster randomized controlled trial.

BACKGROUND

The community health service centers (CHCs) are becoming the major undertakers in China in the prevention and treatment of chronic cardiovascular and cerebrovascular diseases such as atrial fibrillation (AF). The objective of this study was to evaluate the effect of a standardized model of primary-tertiary multidisciplinary collaborative care (PTCC) compared to usual care on AF patients in the community settings.

METHODS

This study is a two-arm, prospective, multicenter, cluster randomized controlled, non-inferiority trial. A total of 220 AF patients aged 65 years or more will be recruited from 16 CHCs in the Yuexiu District of Guangzhou, China. The 16 CHCs will be randomly assigned to the PTCC intervention group and usual care control groups (1:1). The interventions will last for two years, and the survey will be conducted at baseline, 3-month, 6-month, 12-month, and 24-month. The baseline information from AF patients will be collected through face-to-face interviews with a standardized questionnaire or retrieval of health records and medical treatment records, and the following-up data will be collected by regular telephone calls or outpatient face-to-face interviews at each follow-up. The primary endpoint is the anticoagulation rate and the secondary outcomes include AF-related adverse events (cardiovascular mortality, cardiovascular and non-cardiovascular hospitalizations, major adverse cardiovascular events, stroke, major bleeding, clinically relevant non-major bleeding), health-related quality of life, and cost-effectiveness.

DISCUSSION

The implementation of the PTCC program in AF patients may provide evidence for the management of AF patients and promote their prognosis in community.

TRIAL REGISTRATION NUMBER

This study is registered at the Chinese Clinical Trial Registry (ChiCTR2200057242).