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

Not Applicable

Recruiting

• Conditions: Venous Thromboembolism; Venous Thromboembolic Disease; Deep Venous Thrombosis; Quality Improvement; Pulmonary Embolism
• Interventions: Other: Routine VTE prophylaxis; Other: The multifaceted interventions

• Registration Number: NCT04211181
• Lead Sponsor: China-Japan Friendship Hospital

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.

Study Timeline

• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-26
• Study Start: 2022-01-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20
• Primary Completion: 2023-10-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5800

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine VTE prophylaxis in local clinical practice	Routine VTE prophylaxis	Patients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices.
The multifaceted QI interventions	The multifaceted interventions	Hospitals randomized into experimental group will implement follow interventions including：the distribution of the guideline and pathway, a computer alert(computer-based clinical decision support system and computerized reminders),audit and feedback.

Primary Outcome Measures

Name	Time	Method
The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE)	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	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 Outcome Measures

Name	Time	Method
Proportion of complications related to the intervention	90 days after hospital admission	complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention
All-cause mortality	90 days after hospital admission	Proportion of participants who was dead(all-cause mortality)

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China