Deep Venous Thrombosis, Pulmonary Embolism, Quality Improvement, Venous Thromboembolic Disease, Venous Thromboembolism
Conditions
Keywords
Quality improvement, Venous Thromboembolism, Hospital Associated-VTE
Brief 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.
Detailed 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.
Interventions
OTHERThe 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.
OTHERRoutine VTE prophylaxis
Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices
Sponsors
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of appropriate prophylaxis rate during hospitalization | 90 days after hospital admission | The proportion of appropriate prophylaxis is defined as the number of appropriate prophylaxis among the patients at risk of VTE and without corresponding contraindications. |
| The proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE) | 90 days after hospital admission | The incidence of HA-VTE is defined as the proportion of participants who developed the VTE(all, symptomatic, asymptomatic VTE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 90 days after hospital admission | Proportion of participants who was dead(all-cause mortality) |
| Proportion of complications related to the intervention | 90 days after hospital admission | complications(i.e. major bleeding,minor bleeding, thrombocytopenia) related to the intervention |
Countries
China
Contacts
Primary ContactZhenguo Zhai, Doctor
Outcome results
None listed