Actively Recruiting

Phase Not Applicable
Age: 14Years +
All Genders
ID04211181

Effect of a System-wide Multifaceted Quality Improvement Intervention on Thromboprophylaxis in Hospitalized Patients in China

Led by China-Japan Friendship Hospital · Updated on 2025-09-17

5800

Participants Needed

1

Research Sites

17 weeks

Total Duration

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AI-Summary

What this Trial Is About

The trial investigates hospital-acquired venous thromboembolism (VTE) prevention among hospitalized patients in China, focusing on improving the use of preventive methods that are currently underutilized despite being safe and effective. This cluster-randomized clinical trial aims to evaluate whether a multifaceted quality improvement (QI) intervention is feasible and applicable in real-world hospital settings across China. The study is conducted within the China Pulmonary Thromboembolism Registry Study (CURES) group and seeks to increase the rate of at-risk patients receiving appropriate prophylaxis and reduce the incidence of hospital-associated VTE within 90 days after admission. Participating hospitals are randomized into two groups: an interventional group receiving multifaceted QI interventions and a control group following routine VTE prophylaxis based on current guidelines. The QI interventions include mandatory risk assessments, a computer alert system with clinical decision support and reminders, education initiatives, audit and feedback, distribution of clinical guidelines and pathways, and a mobile application to facilitate VTE risk assessment and communication between patients and physicians. The control group receives standard care or existing policies without these additional supports. During the study, eligible hospitalized patients will be monitored for appropriate prophylaxis use and the occurrence of VTE events, both symptomatic and asymptomatic, up to 90 days after hospital admission. Researchers will collect data on prophylaxis rates, VTE incidence, all-cause mortality, and complications related to the interventions. Weekly feedback reports will be provided to quality-control teams to ensure adherence to protocols. The total participation period includes hospitalization and a follow-up of 90 days post-admission, with various assessments and educational activities throughout the study.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 14Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 14 years or older
  • Expected hospital stay of at least 72 hours for medical and/or surgical treatment
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unable to be followed up for 3 months after randomization
  • Participation in similar or other clinical trials
  • Refusal or inability to provide informed consent
  • Diagnosis of VTE at or before enrollment
  • Requiring full-dose anticoagulant treatment (e.g., recent VTE, atrial fibrillation)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of hospital stay, at least 72 hours

Participants receive either the multifaceted quality improvement interventions including risk assessment, computer alerts, education, and audit, or routine venous thromboembolism (VTE) prophylaxis according to current clinical guidelines during their hospital stay.

Hospitalization period visits as part of routine care

Follow-up

Duration - Up to 90 days after hospital admission

Participants are monitored for up to 90 days after hospital admission to assess prophylaxis effectiveness and any complications.

Follow-up visits or contacts as per study protocol

Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 100029

Actively Recruiting

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Research Team

Z

Zhenguo Zhai, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY): a pilot cluster randomized trial.

Menaka Pai, Nancy S Lloyd, Ji Cheng...

https://pubmed.ncbi.nlm.nih.gov/23279972

Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial.

Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet), Alexandre B Cavalcanti, Fernando Augusto Bozza...

https://pubmed.ncbi.nlm.nih.gov/27115264

A prospective, controlled trial of a pharmacy-driven alert system to increase thromboprophylaxis rates in medical inpatients.

David A Garcia, Jessica Highfill, Katie Finnerty...

https://pubmed.ncbi.nlm.nih.gov/19584716

Effectiveness of written guidelines on the appropriateness of thromboprophylaxis prescriptions for medical patients: a prospective randomized study.

A Fontaine, I Mahé, J F Bergmann...

https://pubmed.ncbi.nlm.nih.gov/16961674

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.

Fen Dong, Kaiyuan Zhen, Zhu Zhang...

https://pubmed.ncbi.nlm.nih.gov/32474204