Shared Medical Appointment for diabetes (SMART) in China: design of an optimization trial

Background and purpose Diabetes is a highly prevalent non-communicable disease with severe clinical consequences. China has 140.9 million diabetes patients aged 20–79 years, with a prevalence of 10% in 2021. The Shared Medical Appointment (SMA) is a group-based Chronic Care Model that has improved patient health outcomes and integration of treatment and health management in high-income countries or areas. Still, little is known about selecting active components and their levels (e.g., different health service forms, intensity, or frequency) to select effective components to set an optimal SMA configuration for its implementation when human and financial resources are limited in resource-limited communities. This study aims to identify the optimal SMA configuration in resource-limited communities in China to improve type 2 diabetes treatment and health management. Methods/design Two factorial trials will be conducted in the preparation and optimization phases. In two factorial design trials, we used a Multiphase Optimization Strategy (MOST) to guide the trial's conduct in Zunyi and Tongren, China. We will test the factorial trial implementation procedures in 12 primary healthcare facilities in the pilot trial. After the pilot trial, we can identify stakeholders' preferred candidate SMA components and prioritize barriers to develop optimal criteria based on the EASE (Effectiveness, Affordability, Scalability, Efficiency) principle. In the full optimization trial, a complete or fractional factorial randomized design trial will be conducted in the rest of all Bozhou and Bijiang districts' facilities. Proctor's implementation outcome framework and RE-AIM will guide outcomes assessment in the two trials. The Multilevel linear mixed modeling (MLM) will test the Effectiveness of outcomes and Efficiency of the components in the SMA configuration. The stakeholders' preferences, resource constraints, and expert consensus will be used to select the affordable and Scalable SMA configuration. All EASE-based criteria will be balanced. A cost-effective analysis (CEA) will also be conducted. The study will use multiple imputation methods to address missing data. Intention-to-treat analysis will be used. SMA configuration maintenance will be followed up six months after each phase. Discussion If an optimal SMA configuration is identified, it should effectively improve the patient-oriented primary outcome and balance cost, staff or patients' time, human resources, and other valuable resources, and there is no need to modify it in a wide-range implementation. The research findings have the potential to be integrated into the frontline routines to improve diabetes treatment and health management in resource-limited communities in China. Trial registration The Shared Medical Appointment for diabetes (SMART) in China: an optimization trial, ChiCTR2300069904. Registered 29 March 2023-Retrospectively registered, https://www.chictr.org.cn/showproj.html?proj=189298 URL of trial registry record