Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies (SmaVTE-BEST)

April 7, 2024 updated by: Navy General Hospital, Beijing

Smart Technology Facilitated In-hospital Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies: the SmaVTE-BEST Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15626

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ZHI-GENG JIN, Doctor
  • Phone Number: 8615801402223
  • Email: lwgjzg@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital VTE
Time Frame: During the hospitalization (assessed up to 30 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline-compliant prescription of VTE prophylaxis
Time Frame: During the hospitalization (assessed up to 30 days)
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)
Preventable VTE
Time Frame: During the hospitalization (assessed up to 30 days)
Preventable VTE is defined as occurring in a high-risk patient not prescribed adequate VTE prophylaxis.
During the hospitalization (assessed up to 30 days)
Hospital-related VTE death
Time Frame: During the hospitalization (assessed up to 30 days)
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)
Major bleeding
Time Frame: During the hospitalization (assessed up to 30 days)
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)
Non-major bleeding
Time Frame: During the hospitalization (assessed up to 30 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Study Chair: ZHI-GENG JIN, Doctor, Sixth Medical Center of Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZKY-PJ-2024-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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