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Clinical Trials/NCT04211181
NCT04211181
Recruiting
Not Applicable

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

China-Japan Friendship Hospital1 site in 1 country5,800 target enrollmentAugust 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality Improvement
Sponsor
China-Japan Friendship Hospital
Enrollment
5800
Locations
1
Primary Endpoint
The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)
Status
Recruiting
Last Updated
7 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 1, 2025
End Date
December 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
China-Japan Friendship Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zhenguo Zhai,MD,PhD

Principal investigator

China-Japan Friendship Hospital

Eligibility Criteria

Inclusion Criteria

  • Aged ≥14 years
  • Have an expected hospital stay ≥72 hours for medical and/or surgical treatment
  • Written informed consent

Exclusion Criteria

  • Inability to be followed-up at until 3 months after randomization
  • Have participated in similar trials or are undergoing other clinical trials
  • Refuse or are unable to give informed consent
  • VTE identified on CTPA or lower extremity vein ultrasound at or any time before enrollment
  • Requiring a full dose of anticoagulant treatment (e.g., recent VTE, atrial fibrillation).

Outcomes

Primary Outcomes

The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)

Time Frame: 90 days after hospital admission

The incidence of HA-VTE is defined as the proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)

Proportion of appropriate prophylaxis rate during hospitalization

Time Frame: 90 days after hospital admission

The proportion of appropriate prophylaxis is defined as the number of appropriate prophylaxis among the patients at risk of VTE and without corresponding contraindications.

Secondary Outcomes

  • Proportion of complications related to the intervention(90 days after hospital admission)
  • All-cause mortality(90 days after hospital admission)

Study Sites (1)

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