1. Effect on Thromboprophylaxis among Hospitalized Patients Using a System-wide Multifaceted Quality Improvement Intervention: Rationale and Design for a Multicenter Cluster Randomized Clinical Trial in China☆
- Author
-
Tieshan Zhang, Chaozeng Si, Guangliang Shan, Zhu Zhang, Lei Xia, Cunbo Jia, Fen Dong, Jiefeng Xia, Zhenguo Zhai, Kaiyuan Zhen, Wei Wang, and Chen Wang
- Subjects
Adult ,medicine.medical_specialty ,China ,Hemorrhage ,030204 cardiovascular system & hematology ,Clinical decision support system ,Risk Assessment ,Article ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Patient Education as Topic ,law ,medicine ,Humans ,Single-Blind Method ,030212 general & internal medicine ,Intensive care medicine ,Adverse effect ,Proportional Hazards Models ,Intention-to-treat analysis ,business.industry ,Anticoagulants ,Guideline ,Venous Thromboembolism ,Decision Support Systems, Clinical ,Quality Improvement ,Hospitals ,Intention to Treat Analysis ,Clinical trial ,Practice Guidelines as Topic ,Guideline Adherence ,Cardiology and Cardiovascular Medicine ,Risk assessment ,business ,Patient education - Abstract
Background Venous thromboembolism (VTE) is a life-threatening disease that can affect each hospitalized patient. But the current in-hospital thromboprophylaxis remains suboptimal and there exists a large gap between clinical practice and guideline-recommended care in China. Methods To facilitate implementation of guideline recommendations, we conduct a multicenter, adjudicator-blinded, cluster-randomized clinical trial, aiming to assess the effectiveness of a system-wide multifaceted quality improvement (QI) strategy on VTE prophylaxis improvement and thromboembolism reduction in clinical setting. Hospitals are randomized into intervention or control group. In intervention group, hospitals receive the concept of appropriate in-hospital thromboprophylaxis plus a multifaceted QI which encompasses four components: (1) an electronic alert combining computer-based clinical decision support system and electronic reminders, (2) appropriate prophylaxis based on dynamic VTE and bleeding risk assessments, (3) periodical audit and interactive feedback on performance, (4) strengthened training and patient education. In control, hospitals receive the concept of recommended prophylaxis alone without QI. Thromboprophylaxis will be at the discretion of hospitals and conducted as usual. With a final sample size of 5760 hospitalized patients in 32 hospitals on mainland China, this trial will examine the effect of QI on improvement in thromboprophylaxis and patient-centered outcomes. This is an open-label trial that patients and healthcare professionals will know group allocation after enrollment, but endpoint adjudicators and statisticians will be blinded. RCT# NCT04211181 Conclusions The system-wide multifaceted QI intervention is expected to facilitate implementation of recommended VTE prophylaxis in hospital, thereafter reducing VTE incidence and relevant adverse events among hospitalized patients in China., Graphical abstract Unlabelled Image
- Published
- 2020