Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial
Introduction Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effec...
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BMJ Publishing Group
2025-01-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/1/e078103.full |
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| author | Zhuo Chen Yefeng Cai Wenjun He Yiyuan Cai Lingrui Liu Qing Zhao Sensen lv Dong (Roman) Xu Chun Hao Lanping Zhang Pengfei Guo Yuning Shi |
| author_facet | Zhuo Chen Yefeng Cai Wenjun He Yiyuan Cai Lingrui Liu Qing Zhao Sensen lv Dong (Roman) Xu Chun Hao Lanping Zhang Pengfei Guo Yuning Shi |
| author_sort | Zhuo Chen |
| collection | DOAJ |
| description | Introduction Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effectiveness of three popular frameworks—Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)—in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.Methods and analysis This study employs a hybrid type III design with a factorial randomised controlled trial, where 45 TCM hospitals will be randomly assigned to one of eight experimental conditions based on the use or non-use of each framework (CFIR, TDF, NPT). The factorial design allows for the evaluation of the main effects of each framework and their two-way and three-way interactions, offering insights into which combination of frameworks is most effective in enhancing implementation outcomes. The factorial design provides greater efficiency compared with traditional designs by enabling the simultaneous testing of multiple interventions and their combinations with the same sample size, which increases statistical power. Implementation facilitators will be trained to support the guideline adoption process, with interventions aligned to specific framework components (eg, CFIR for identifying barriers and facilitators, TDF for understanding behavioural influences and NPT for normalising practices within organisational routines). Outcomes will be evaluated using the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance). Hierarchical logistic regression models will test the study hypotheses, and qualitative methods, such as interviews and focus groups, will provide contextual understanding. Additionally, a cost-effectiveness analysis will be conducted to assess the economic feasibility of the implementation strategies.Ethics and dissemination This trial has been approved by the Institutional Review Board of Southern Medical University (approval number: #202261) and follows all relevant ethical guidelines for research involving human participants. On completion, the findings will be shared with patients, healthcare providers and stakeholders through various dissemination activities, including workshops and presentations within relevant TCM and stroke management networks. The results will be published in peer-reviewed academic journals and presented at national and international conferences to inform future practice and policy on the integration of TCM and Western medicine for stroke management.Trial registration details This study has been registered on the Open Science Framework with the DOI: 10.17605/OSF.IO/NJEVB. |
| format | Article |
| id | doaj-art-70da05aad3384cee82bf7d5efc1428b7 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-70da05aad3384cee82bf7d5efc1428b72025-01-30T10:55:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2023-078103Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trialZhuo Chen0Yefeng Cai1Wenjun He2Yiyuan Cai3Lingrui Liu4Qing Zhao5Sensen lv6Dong (Roman) Xu7Chun Hao8Lanping Zhang9Pengfei Guo10Yuning Shi115 Department of Health Policy and Management, The University of Georgia, Tbilisi, Georgia13 Department of Neurology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong, China1 Dermatology Hospital, Southern Medical University, Guangzhou, Guangdong, China2 Department of Epidemiology and Health Statistics, Guizhou Medical University, Guiyang, Guizhou, China12 Yale Center for Methods in Implementation and Prevention Science, New Haven, Connecticut, USA11 Department of Health Management, School of Health Management of Southern Medical University, Guangzhou, Guangdong, China9 The Third Hospital Of Xiamen, Xiamen, Fujian Province, China14 Southern Medical University Institute for Global Health, Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China3 Department of Medical Statistics, Sun Yat-Sen University, Guangzhou, Guangdong, China10 Department of the Third Pulmonary Disease, Shenzhen Third People’s Hospital, Shenzhen, Guangdong Province, China8 Department of Environmental Health Sciences, Yale University, New Haven, Connecticut, USA3 Department of Medical Statistics, Sun Yat-Sen University, Guangzhou, Guangdong, ChinaIntroduction Traditional Chinese medicine (TCM) is commonly used alongside Western medicine for stroke management in China. However, there is significant variation in TCM practice, and the utilisation of evidence-based clinical practice guidelines is inadequate. This study aims to evaluate the effectiveness of three popular frameworks—Consolidated Framework for Implementation Research (CFIR), Theoretical Domains Framework (TDF) and Normalization Process Theory (NPT)—in improving implementation outcomes for the integrated TCM and Western medicine clinical practice guideline for stroke management.Methods and analysis This study employs a hybrid type III design with a factorial randomised controlled trial, where 45 TCM hospitals will be randomly assigned to one of eight experimental conditions based on the use or non-use of each framework (CFIR, TDF, NPT). The factorial design allows for the evaluation of the main effects of each framework and their two-way and three-way interactions, offering insights into which combination of frameworks is most effective in enhancing implementation outcomes. The factorial design provides greater efficiency compared with traditional designs by enabling the simultaneous testing of multiple interventions and their combinations with the same sample size, which increases statistical power. Implementation facilitators will be trained to support the guideline adoption process, with interventions aligned to specific framework components (eg, CFIR for identifying barriers and facilitators, TDF for understanding behavioural influences and NPT for normalising practices within organisational routines). Outcomes will be evaluated using the RE-AIM framework (reach, effectiveness, adoption, implementation and maintenance). Hierarchical logistic regression models will test the study hypotheses, and qualitative methods, such as interviews and focus groups, will provide contextual understanding. Additionally, a cost-effectiveness analysis will be conducted to assess the economic feasibility of the implementation strategies.Ethics and dissemination This trial has been approved by the Institutional Review Board of Southern Medical University (approval number: #202261) and follows all relevant ethical guidelines for research involving human participants. On completion, the findings will be shared with patients, healthcare providers and stakeholders through various dissemination activities, including workshops and presentations within relevant TCM and stroke management networks. The results will be published in peer-reviewed academic journals and presented at national and international conferences to inform future practice and policy on the integration of TCM and Western medicine for stroke management.Trial registration details This study has been registered on the Open Science Framework with the DOI: 10.17605/OSF.IO/NJEVB.https://bmjopen.bmj.com/content/15/1/e078103.full |
| spellingShingle | Zhuo Chen Yefeng Cai Wenjun He Yiyuan Cai Lingrui Liu Qing Zhao Sensen lv Dong (Roman) Xu Chun Hao Lanping Zhang Pengfei Guo Yuning Shi Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial BMJ Open |
| title | Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial |
| title_full | Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial |
| title_fullStr | Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial |
| title_full_unstemmed | Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial |
| title_short | Effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional Chinese medicine hospitals in China: protocol for a factorial randomised controlled trial |
| title_sort | effectiveness of using implementation frameworks to facilitate the implementation of a stroke management guideline in the traditional chinese medicine hospitals in china protocol for a factorial randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/1/e078103.full |
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