NCT04211181

CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,800 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China. A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.

Detailed description

Hospitals nationwide which have willingness to participate this study in CURES group will be selected. Each selected hospital will be regarded as a cluster and randomized into interventional or control group. During the study period, eligible patients enrolled in hospitals assigned to interventional group will receive a variety of the multifaceted quality improvement(QI) interventions, including mandatory risk assessment, a computer alert(computer-based clinical decision support system and computerized reminders), strengthened education, and audit. Patients in hospitals assigned to control group will receive common recommended care only, or an existing policy.

Conditions

• Venous Thromboembolic Disease
• Pulmonary Embolism
• Venous Thromboembolism
• Deep Venous Thrombosis
• Quality Improvement

Interventions

Type	Name	Description
OTHER	The multifaceted interventions	1. An evidence-based clinical guideline and pathway in hospital. 2. A series Written care protocols for the implementation of performance measures. 3. A newly developed mobile application (mini-program) will be employed to facilitate venous thromboembolism (VTE) risk assessment and prophylaxis. Patients will scan a QR code to enroll in the program and be linked with their physician. Through the application, patients will complete standardized self-assessments of VTE risk, and physicians will receive periodic reminders indicating whether the assessment and prophylaxis orders have been completed.The application also provides educational modules and targeted messages for both patients and physicians, and enables interactive communication. 4. A quality-control team will receive weekly feedback reports to verify whether all enrolled patients underwent appropriate prophylaxis.
OTHER	Routine VTE prophylaxis	Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-31
• Completion: 2026-12-31
• First posted: 2019-12-26
• Last updated: 2025-09-17

Locations

1 site across 1 country: China