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

Fen Dong, Kaiyuan Zhen, Zhu Zhang, Chaozeng Si, Jiefeng Xia, Tieshan Zhang, Lei Xia, Wei Wang, Cunbo Jia, Guangliang Shan, Zhenguo Zhai, Chen Wang, Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group, Fen Dong, Kaiyuan Zhen, Zhu Zhang, Chaozeng Si, Jiefeng Xia, Tieshan Zhang, Lei Xia, Wei Wang, Cunbo Jia, Guangliang Shan, Zhenguo Zhai, Chen Wang, Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group

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.

Copyright © 2020 Elsevier Inc. All rights reserved.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Process for thromboprophylaxis in hospital.
Figure 3
Figure 3
Principles of VTE prophylaxis based on VTE and bleeding risk. * Basic prophylaxis includes patient education, early mobilization, functional exercise, and avoiding dehydration or unnecessary immobilization.

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