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.
髋部骨折管理质量改进行动（ACTIVE）试验的主要目的是评估一项根据具体情境定制的质量改进方案能否改善中国资源较少医院中65岁及以上髋部骨折成人患者入院后120天的健康相关生活质量。次要目的包括比较两组患者入院后30天的健康相关生活质量、30天和120天的并发症和发病率、接受手术的患者比例、术后一周完全负重患者的比例、入院至手术时间、住院时长、120天死亡率及住院费用，并评估该干预措施的实施情况和成本效益。这是一项多中心、开放标签、实用性、平行组、整群随机对照试验，在中国十个省份的80家资源较少的县或区级公立综合医院开展（所有医院均为3B级或以下；3A级被视为最高等级或资源最充足的医院）。每家医院在各省内按1：1随机分配至干预组或对照组。符合条件的参与者为经X线摄影或CT确诊为急性单侧髋部骨折的65岁及以上成人。干预措施包括优化院内管理流程、赋权外科医生和内科医生，以及对患者及其家属进行健康教育。分配至对照组的医院继续接受常规的骨科主导诊疗。参与者在入院后30天和120天接受随访。主要结局为入院后120天的健康相关生活质量。共计划招募8，800名参与者。ACTIVE试验的结果将说明，一项由针对卫生管理者、卫生服务提供者和患者的干预措施组成的、根据具体情境定制的质量改进方案，能否改善中国资源较少医院中老年髋部骨折患者的结局，并对其他面临人口老龄化负担的新兴国家具有参考意义。
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. 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. 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.
Minghui Yang, Tingzhuo Liu, Gang Liu, Ning Tang, Xinyi Zhang, Rebecca Ivers, et al. 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.. Bone & joint open. 2026; doi:10.1302/2633-1462.78.BJO-2026-0136.R1.
Minghui Yang, Tingzhuo Liu, Gang Liu, Ning Tang, Xinyi Zhang, Rebecca Ivers, et al (2026). 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.. Bone & joint open. https://doi.org/10.1302/2633-1462.78.BJO-2026-0136.R1
Minghui Yang, Tingzhuo Liu, Gang Liu, Ning Tang, Xinyi Zhang, Rebecca Ivers, et al. 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.[J]. Bone & joint open, 2026 doi:10.1302/2633-1462.78.BJO-2026-0136.R1.
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