CHIPs-VTE program to prevent hospital-acquired blood clots in hospitalized patients
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
This project tests whether a hospital-wide package of risk checks, computer alerts, staff education, and audits can increase appropriate clot-prevention for hospitalized patients in China.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5800 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04211181 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, cluster-randomized, open-label trial that randomizes hospitals within the CURES network to a multifaceted quality improvement intervention or to usual care. Hospitals in the intervention arm implement mandatory VTE risk assessment, a computer-based clinical decision support and reminder system, strengthened staff education, and ongoing audit and feedback. Patients aged 14 or older with an expected hospital stay of at least 72 hours are enrolled at the cluster level and followed for outcomes related to hospital-acquired venous thromboembolism. The control hospitals continue existing policies or recommended care while outcomes such as appropriate prophylaxis use and VTE events are compared between arms.
Who should consider this trial
Good fit: Ideal candidates are patients aged 14 or older admitted to a participating hospital with an expected stay of at least 72 hours who can give informed consent and be followed for three months.
Not a fit: Patients who already have a diagnosed VTE at or before enrollment, who require full-dose anticoagulation, have very short admissions, or cannot be followed for three months are unlikely to benefit from the intervention.
Why it matters
Potential benefit: If successful, the program could increase appropriate use of VTE prevention and reduce hospital-acquired blood clots among inpatients.
How similar studies have performed: Multifaceted quality-improvement programs in other countries have increased prophylaxis rates and reduced VTE in some settings, but no single protocol has been widely proven to drive breakthrough improvements across China.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Beijing, Beijing Municipality
- China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhenguo Zhai, Doctor — China-Japan Friendship Hospital
- Study coordinator: Zhenguo Zhai, Doctor
- Email: zhaizhenguo2011@126.com
- Phone: 86-10-84206265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.