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

January 19, 2023 updated by: Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Zhenguo Zhai, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
  1. An evidence-based clinical guideline and pathway in hospital.
  2. A series Written care protocols for the implementation of performance measures.
  3. 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.
  4. A full-time quality coordinator
  5. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after hospital admission
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)
90 days after hospital admission

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

December 8, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHIPs-VTE in inpatient

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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