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.
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Yang Minghui, Liu Tingzhuo, Liu Gang, Tang Ning, Zhang Xinyi, Ivers Rebecca, Wang Yongchen, Tian Maoyi, ACTIVE trial Investigators, Sun Zhenghua, Shen Jiarong, Nan Boya, Tian Wei, Li Qiang, Si Lei, Wong Ronald Man Yeung, Zhang Jing, Xiong Shangzhi, Ye Pengpeng, Yang Lei, Li Liming, Costa Matthew, Liu Jianyu, Hao Chenguang, Zhou Tingting, Xing Baorui, Luo Wenming, Sun Xuecheng, Sun Haibin, Wang Shuyuan, Wu Xuefei, Dong Honghua, Cheng Fuhong, Wu Dongsheng, Song Bihui, Shou Kangquan, Li Yang, Liu Zhengqiang, Li Jun, Chen Shangmin, Zhong Zhigang, Zhu Zhichao, Yang Wenbo, Yan Jianbang, Shi Chunlei, Xi Zhuhui, Wen Baozhu, Guo Jinbao, Feng Chengyu, Wu Desheng, Guo Sheng, Zhang Xiaowei, Chi Xingke, Peng Yongli, Li Tianliang, Fan Qingzheng, An Zhiwen, Guan Yue, Lv Zhichang, Wang Jianbing, Yuan Yanguang, Cheng Xuehao, Liu Haipeng, Du Fei, Tan Ruiyong, Ji Liangquan, Liu Zhaoyong, Dou Fengquan, Guo Yuzhu, Liu Qifu, Wang Shuwei, Zhao Fuwei, Sun Hongchao, Wang Xingyan, Cao Yu, Zhang Yuhu, Wang Hao, An Dongfeng, Jia Wenfeng, Yang Heng, Ni Xiaohui, Wang Shunbing, Chen Xiang, Li Cheng, Zhu Yuehua, Zhu Haitao, Zhao Fuwen, Ni Tongwei, Guo Xia, Lu Wanqing, Shan Junping, Jia Wenpeng, Bai Yongle, Wang Xiqing, Jiao Pingzhou, Chen Guoliang, Sun Kai, Zhao Junfeng, Xie Yupeng, Tan Minzhi, Liu Shaoping, Lu Wei, Zhou Jianbo, Huang Quanchuan, Tu Jing, Long Xingchun, Liu Yuanchun, Chen Yonghua, Tan Demeng, Peng Qiqi, Zhang Xiaolin, Mou Yiguang, Peng Lunhua, Tang Yinzhi, Hou Yanyang, Wang Zilong, Zhao Han, Wei Gang, Xu Zhen, Feng Senping, Ouyang Ping, Xiao Jie, Zhang Jianhua, Wu Feng, Wu Fengcai, Xiao Yuandong, Xing Hongji, Wu Zhanpeng, Lin Liehao, Lin Jie, Xu Jianbiao, Lin Chubiao, Zhao Zijian, Wu Zhaoxiong, Lin Ruizhong
Аннотация
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.