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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
View:

• Aged ≥14 years

• Have an expected hospital stay ≥72 hours for medical and/or surgical treatment

• Written informed consent

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Zhenguo Zhai, Doctor
zhaizhenguo2011@126.com
86-10-84206265
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 5800
Treatments
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.
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.
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov

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