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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06353373
Other study ID # HZKY-PJ-2024-7
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2024
Est. completion date February 28, 2025

Study information

Verified date March 2024
Source Navy General Hospital, Beijing
Contact ZHI-GENG JIN, Doctor
Phone 8615801402223
Email lwgjzg@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Venous thromboembolism (VTE) is the third leading cause of cardiovascular disease deaths globally, and its incidence is increasing over the years. Hospital-acquired VTE accounts for approximately 75% of all deaths attributed to VTE. However, only half of patients with indications for VTE prophylaxis take preventive measures, and high rates of inappropriate VTE prophylaxis prescribing contribute to the gap between VTE prophylaxis and guidelines. To further minimize the gap between clinical practice and guidelines, a range of strategies have been employed across various fields of VTE prophylaxis. One of the most effective measures is the utilization of a Clinical Decision Support System (CDSS). Smart technology-based CDSS facilitates automated evaluation of VTE risk and detection, addressing issues at both the beginning and end of the in-hospital VTE prevention process. but there is still a lack of research on how to effectively implement evidence-based VTE prophylaxis in the middle of the process. In our hospital, routine use of DeVTEcare system (a CDSS for VTE risk assessment and integrated care) for in-hospital management of VTE has been launched since 2021. This study aims to investigate the effect of integrating bundled guideline-based VTE prevention strategies into the DeVTEcare system on in-hospital VTE prophylaxis.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15626
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Discharged patients who were =18 years of age at admission were included in the observation cohort. If a patient had multiple hospitalizations, information on only the longest hospitalization was included in the study. Exclusion Criteria: - Lack of diagnostic information; - Length of hospitalization = 24 hours; - Patients on anticoagulation therapy at the time of admission: e.g., those with established VTE, atrial fibrillation, acute myocardial infarction, ischemic stroke, those on continuous renal replacement therapy, extracorporeal membrane pulmonary oxygenation, hemodialysis, and mechanical valve implantation status.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Application of the modified DeVTEcare system
The modified DeVTEcare system, which incorporates bundled guideline-based VTE prevention measures, will be utilized to assist healthcare providers in VTE prophylaxis after September 2024.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Navy General Hospital, Beijing

References & Publications (3)

Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism: effect on physician behavior. JAMA. 2000 Jun 7;283(21):2816-21. doi: 10.1001/jama.283.21.2816. — View Citation

Henke PK, Kahn SR, Pannucci CJ, Secemksy EA, Evans NS, Khorana AA, Creager MA, Pradhan AD; American Heart Association Advocacy Coordinating Committee. Call to Action to Prevent Venous Thromboembolism in Hospitalized Patients: A Policy Statement From the American Heart Association. Circulation. 2020 Jun 16;141(24):e914-e931. doi: 10.1161/CIR.0000000000000769. Epub 2020 May 7. Erratum In: Circulation. 2020 Jun 16;141(24):e932. Circulation. 2021 Feb 16;143(7):e249. — View Citation

Jin ZG, Zhang H, Tai MH, Yang Y, Yao Y, Guo YT. Natural Language Processing in a Clinical Decision Support System for the Identification of Venous Thromboembolism: Algorithm Development and Validation. J Med Internet Res. 2023 Apr 24;25:e43153. doi: 10.2196/43153. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital VTE In-hospital VTE refers to the occurrence of a VTE in a patient who did not have a VTE on admission but developed one during the course of their hospital stay. During the hospitalization (assessed up to 30 days)
Secondary Guideline-compliant prescription of VTE prophylaxis Guideline-compliant prescription of VTE prophylaxis refers to the adoption of risk stratification to guide clinicians' decisions to prescribe guideline recommended thromboprophylaxis. During the hospitalization (assessed up to 30 days)
Secondary Preventable VTE Preventable VTE is defined as occurring in a high-risk patient not prescribed adequate VTE prophylaxis. During the hospitalization (assessed up to 30 days)
Secondary Hospital-related VTE death Hospital-related VTE death is defined as patient who died during the present hospitalization while having an in-hospital VTE event. During the hospitalization (assessed up to 30 days)
Secondary Major bleeding The major bleeding events are defined by the International Society on Thrombosis and Hemostasis (ISTH) and are further categorized into VTE prophylaxis-related major bleeding and VTE treatment-related major bleeding. During the hospitalization (assessed up to 30 days)
Secondary Non-major bleeding The non-major bleeding events are defined by the International Society on Thrombosis and Hemostasis (ISTH) and are further categorized into VTE prophylaxis-related non-major bleeding and VTE treatment-related non-major bleeding. During the hospitalization (assessed up to 30 days)
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