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

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04211181

Collaborator

(none)

5,800

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolic Disease Pulmonary Embolism Venous Thromboembolism Deep Venous Thrombosis Quality Improvement	Other: The multifaceted interventions Other: Routine VTE prophylaxis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

5800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The multifaceted QI 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.	Other: The multifaceted interventions An evidence-based clinical guideline and pathway in hospital. A series Written care protocols for the implementation of performance measures. A computer-based clinical decision support system(CDSSs) and a computerized reminder, which was referred to as a key element to enhance VTE assessment and prophylaxis. A well-designed computer program will be integrated into the Electronic Medical Record(EMR) of intervention group and By processing, analyzing, summarizing and representing crucial information, physicians can be altered. A full-time quality coordinator A trained physician or nurse in each intervention cluster will be acted as a quality coordinator. The responsibility of the quality coordinator includes:
Active Comparator: Routine VTE prophylaxis in local clinical practice Patients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices.	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

Arm

Intervention/Treatment

Experimental: The multifaceted QI 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.

Other: The multifaceted interventions

An evidence-based clinical guideline and pathway in hospital. A series Written care protocols for the implementation of performance measures. A computer-based clinical decision support system(CDSSs) and a computerized reminder, which was referred to as a key element to enhance VTE assessment and prophylaxis. A well-designed computer program will be integrated into the Electronic Medical Record(EMR) of intervention group and By processing, analyzing, summarizing and representing crucial information, physicians can be altered. A full-time quality coordinator A trained physician or nurse in each intervention cluster will be acted as a quality coordinator. The responsibility of the quality coordinator includes:

Active Comparator: Routine VTE prophylaxis in local clinical practice

Patients in the routine VTE prophylaxis(control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices.

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

Outcome Measures

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).