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 randomized controlled trial

Background: 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 utilization of evidence-based clinical practice guidelines is inadequate.This study aims to evaluate the effectiveness of three popular frameworks (Consolidated Framework for Implementation Research, Theoretical Domains Framework, and Normalization Process Theory) in improving implementation outcomes for the integrated TCM and western medicine clinical practice guideline for stroke management. Methods: The study will employ a hybrid type III design, utilizing a factorial randomized controlled approach. Implementation facilitators will be trained and randomly assigned to participating organizations. Forty-five TCM hospitals will be randomly assigned to one of eight experiment conditions, allowing for the evaluation of each framework's main effect, two-way interactions, and three-way interaction. The outcomes will be assessed using the RE-AIM framework, including reach, effectiveness, adoption, implementation, and maintenance. Hierarchical logistic regression models will be used to test the hypotheses. Qualitative methods, such as interviews and focus groups, will provide contextual information, and a Cost-effectiveness analysis (CEA) will be conducted. Discussion: This proposed hybrid type III study will integrate implementation science(frameworks), epidemiology (factorial design), and health economic approaches (CEA) to advance our empirical understanding of the strengths and weaknesses of implementation frameworks, implementing the TCM guideline promotion practices in hospitals and its health economic evaluation. The study answers the question that which framework combination works well in facilitating the implementation of clinical intervention. The results of the trial will offer valuable insights into how best to implement evidence-based practices (TCM guidelines) in hospitals under the consideration of economic evaluation.