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 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.