Venous ThromboembolismSmaVTE-BESTNCT06353373
Smart Technology Facilitated Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies
An observational study of Venous Thromboembolism and Clinical Decision Support Systems, run by Navy General Hospital, Beijing.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Clinical Decision Support Systems, Digital Health
- What is being tested?
- Application of the modified DeVTEcare system
- How many people
- 15,626 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- Application of the modified DeVTEcare system
- Keywords
- Venous Thromboembolism, Clinical Decision Support Systems, Prophylaxis
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the modified DeVTEcare systemOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Application of the modified DeVTEcare system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the hospitalization (assessed up to 30 days)
Secondary outcomes (5)
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.
Measured: During the hospitalization (assessed up to 30 days)
Preventable VTE
Preventable VTE is defined as occurring in a high-risk patient not prescribed adequate VTE prophylaxis.
Measured: During the hospitalization (assessed up to 30 days)
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.
Measured: During the hospitalization (assessed up to 30 days)
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.
Measured: During the hospitalization (assessed up to 30 days)
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.
Measured: During the hospitalization (assessed up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Sep 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,626 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ZHI-GENG JIN, Doctor, Study chair, Sixth Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353373
- Sponsor's protocol ID
- HZKY-PJ-2024-7
- Acronym
- SmaVTE-BEST
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32375490Jin 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.
PubMed 37093636Durieux 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.
PubMed 10838650
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Technology Facilitated In-hospital Venous Thromboembolism Prophylaxis Based on Bundled Evidence-based Prevention Strategies: the SmaVTE-BEST Study
- ClinicalTrials.gov ID
- NCT06353373
- Acronym / sponsor ID
- SmaVTE-BEST / HZKY-PJ-2024-7
- Keywords
- Venous Thromboembolism, Clinical Decision Support Systems, Prophylaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,626 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Application of the modified DeVTEcare systemThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the modified DeVTEcare systemThe modified DeVTEcare system, which incorporates bundled guideline-based VTE prevention measures, will be utilized to assist healthcare providers in VTE prophylaxis after September 2024. | Other | Post-Modified DeVTEcare Group |
Primary outcome
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.
5 secondary outcomes
Guideline-compliant prescription of VTE prophylaxis
Time frame: During the hospitalization (assessed up to 30 days)
Preventable VTE
Time frame: During the hospitalization (assessed up to 30 days)
Hospital-related VTE death
Time frame: During the hospitalization (assessed up to 30 days)
Major bleeding
Time frame: During the hospitalization (assessed up to 30 days)
Non-major bleeding
Time frame: During the hospitalization (assessed up to 30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Background: PubMed 32375490Henke 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.
- Background: PubMed 37093636Jin 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.
- Background: PubMed 10838650Durieux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZHI-GENG JIN, Doctor study chair
Sixth Medical Center of Chinese PLA General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Clinical Decision Support Systems, run by Navy General Hospital, Beijing.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ZHI-GENG JIN, Doctor (8615801402223, lwgjzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital VTE (time frame: During the hospitalization (assessed up to 30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06353373, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.