Protocol for the ACTIVE trial: a multicentre, open-label, cluster-randomized controlled trial of a quality improvement programme for older adults with hip fracture in resource-limited hospitals in China

Aims: The primary aim of the Action on Hip Fracture Management Quality Improvement (ACTIVE) trial is to evaluate whether a context-tailored quality improvement programme improves health-related quality of life at 120 days after hospital admission, among adults aged 65 years or older with a hip fracture, in less-resourced hospitals in China. Secondary aims are to compare health-related quality of life at 30 days, complication and morbidity at 30 and 120 days, proportion of patients receiving surgery, proportion of patients on full weightbearing at one week after surgery, time from admission to surgery, length of hospital stay, 120-day mortality, and inpatient costs between the two groups, and to evaluate the implementation and cost-effectiveness of the intervention. Methods: This is a multicentre, open-label, pragmatic, parallel-group, cluster-randomized controlled trial conducted in 80 less-resourced county- or district-level public general hospitals across ten provinces in China (all hospitals are graded 3B or below; 3A is considered the most high-ranking or well-resourced hospital). Hospitals are randomized 1:1 within each province to either intervention or the control group. Eligible participants are adults aged 65 years or older with acute unilateral hip fracture confirmed by radiography or CT. The intervention consists of optimization of in-hospital management processes, empowerment of surgeons and physicians, and health education for patients and their family members. Hospitals allocated to the control group continue usual orthopaedic-led care. Participants are followed up at 30 and 120 days after admission. The primary outcome is health-related quality of life at 120 days after admission. A total of 8,800 participants will be recruited. Conclusion: The results of the ACTIVE trial will inform whether a context-tailored quality improvement programme, consisting of interventions on health administrators, health providers, and patients, can improve outcomes for older adults with hip fracture in less-resourced hospitals in China, and many countries beyond with emerging burden of ageing population.