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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged ≥14 years 2. Have an expected hospital stay ≥72 hours for medical and/or surgical treatment 3. Written willing to sign a consent form Who Should NOT Join This Trial: 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 willing to sign a consent form 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

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 newly developed mobile application (mini-program) will be employed to facilitate venous thromboembolism (VTE) risk assessment and prophylaxis. Patients will scan a QR code to enroll in the program and be linked with their physician. Through the application, patients will complete standardized self-assessments of VTE risk, and physicians will receive periodic reminders indicating whether the assessment and prophylaxis orders have been completed.The application also provides educational modules and targeted messages for both patients and physicians, and enables interactive communication. 4. A quality-control team will receive weekly feedback reports to verify whether all enrolled patients underwent appropriate prophylaxis.

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

Locations (1)

China-Japan Friendship Hospital
Beijing, Beijing Municipality, China