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

China-Japan Friendship Hospital

Status: Enrolling

Conditions: Quality Improvement; Venous Thromboembolism; Pulmonary Embolism; Deep Venous Thrombosis; Venous Thromboembolic Disease

Treatments: Other: Routine VTE prophylaxis; Other: The multifaceted interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT04211181

CHIPs-VTE in inpatient

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,800 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

5,800 participants in 2 patient groups

The multifaceted QI interventions

Experimental group

Description:

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.

Treatment:

Other: The multifaceted interventions

Routine VTE prophylaxis in local clinical practice

Active Comparator group

Description:

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

Treatment:

Other: Routine VTE prophylaxis