Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies

NCT06353373 | Not Yet Recruiting DMC

• 1 other identifier: HZKY-PJ-2024-7
• Study Type: observational
• Target: 15,626
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Venous Thromboembolism; Clinical Decision Support Systems; Digital Health

Keywords

Venous Thromboembolism; Clinical Decision Support Systems; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Guideline-compliant prescription of VTE prophylaxis

  During the hospitalization (assessed up to 30 days)

• Preventable VTE

  During the hospitalization (assessed up to 30 days)

• Hospital-related VTE death

  During the hospitalization (assessed up to 30 days)

• Major bleeding

  During the hospitalization (assessed up to 30 days)

• Non-major bleeding

  During the hospitalization (assessed up to 30 days)

Study Arms (2)

Pre-Modified DeVTEcare Group

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. By retrospectively collecting information on discharged patients, all patients discharged from our hospital between April 2023 and April 2024 will be included in the pre-modified DeVTEcare group.

Post-Modified DeVTEcare Group

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. By retrospectively collecting information on discharged patients, all patients discharged from our hospital between September 2024 and February 2025 will be included in the post-modified DeVTEcare group.

Other: Application of the modified DeVTEcare system

Interventions

Application of the modified DeVTEcare system OTHER

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.

Post-Modified DeVTEcare Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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. By retrospectively collecting information on discharged patients, all patients discharged from our hospital between April 2023 and April 2024 will be included in the pre-modified DeVTEcare group. 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. By retrospectively collecting information on discharged patients, all patients discharged from our hospital between September 2024 and February 2025 will be included in the post-modified DeVTEcare group.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navy General Hospital, Beijing: lead

Related Publications (3)

• 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.

  PMID: 32375490 BACKGROUND

• 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.

  PMID: 37093636 BACKGROUND

• 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.

  PMID: 10838650 BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ZHI-GENG JIN, Doctor

  Sixth Medical Center of Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

ZHI-GENG JIN, Doctor

CONTACT

8615801402223; lwgjzg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 9, 2024
• Study Start: September 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share