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Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT) (DC-eALERT)

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ClinicalTrials.gov Identifier: NCT03728166
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
Portola Pharmaceuticals
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Brief Summary:

Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death compared with short-duration enoxaparin. Obstacles to integration of these data in the hospitalized Medical Service patient population, including failure to identify at-risk patients, educational gaps in strategies for VTE prevention after discharge, and medication nonadherence, can be overcome with alert-based computerized decision support. This study is a single-center, 400-patient, randomized controlled trial of an EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase prescription of extended-duration post-discharge thromboprophylaxis and decrease symptomatic VTE in high-risk patients hospitalized with medical illness.

Specific Aim #1: To determine the impact of electronic alert-based CDS (EPIC Best Practice Advisory [BPA]) on prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.

Specific Aim #2: To estimate the impact of electronic alert-based CDS (EPIC BPA) on the frequency of symptomatic VTE in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Behavioral: Electronic alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: U.S.-based, single-center, randomized controlled trial
Masking: Single (Participant)
Masking Description: Investigators will randomize patients by Attending Physician ID# to minimize the influence of an alert effect on the care of patients not randomized to the alert group but who have the same Attending Physician (thereby reducing what is called the "cluster-effect"). While investigators will randomize patients by Attending Physician of Record to minimize cluster-effect, the observational unit will be the patient.
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Computerized Decision Support for Prevention of Venous Thromboembolism in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : February 1, 2022

Arm Intervention/treatment
Experimental: Alert
On-screen electronic alert that notifies the provider about the increased risk for VTE after discharge and indication for thromboprophylaxis will be issued 48 hours after admission. This first on-screen electronic alert will provide the clinician with the opportunity to consider extended-duration, post-discharge thromboprophylaxis and start any required processes for prior authorization or medication coverage. The provider then will be given on-screen options to either order thromboprophylaxis (betrixaban or low-molecular weight heparin for 35 days) from a "Extended-Duration VTE Prevention" order template, follow a link to evidence-based practice guidelines, or defer prescribing extended-duration, post-discharge thromboprophylaxis.
Behavioral: Electronic alert
On-screen electronic alert that notifies the provider about the increased risk for VTE after discharge and indication for thromboprophylaxis will be issued 48 hours after admission. This first on-screen electronic alert will provide the clinician with the opportunity to consider extended-duration, post-discharge thromboprophylaxis and start any required processes for prior authorization or medication coverage. The provider then will be given on-screen options to either order thromboprophylaxis (betrixaban or low-molecular weight heparin for 35 days) from a "Extended-Duration VTE Prevention" order template, follow a link to evidence-based practice guidelines, or defer prescribing extended-duration, post-discharge thromboprophylaxis.

No Intervention: No Alert
No notification to the provider.



Primary Outcome Measures :
  1. Frequency of prescription of extended-duration post-discharge thromboprophylaxis. [ Time Frame: 90 days ]
    Investigators will review the order entry section of the Electronic Health Record (EPIC) to make this determination.


Secondary Outcome Measures :
  1. Frequency of symptomatic VTE at 90 days from randomization. [ Time Frame: 90 days ]
    Investigators will review the notes and diagnostic testing sections of the Electronic Health Record (EPIC) to make this determination. The proposed study will not be powered to show a difference in clinical events, such as symptomatic VTE, with the electronic alert-based CDS but will provide estimates from which to plan a possible subsequent multi-center trial.

  2. Frequency of major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization. [ Time Frame: 90 days ]
    Investigators will review the notes and diagnostic testing sections of the Electronic Health Record (EPIC) to make this determination. The proposed study will not be powered to show a difference in clinical events, such as bleeding, with the electronic alert-based CDS but will provide estimates from which to plan a possible subsequent multi-center trial.

  3. Frequency of all-cause mortality at 90 days [ Time Frame: 90 days ]
    Any death confirmed by medical record

  4. Frequency of all-cause rehospitalization at 90 days [ Time Frame: 90 days ]
    Any rehospitalization confirmed by medical record


Other Outcome Measures:
  1. Medication adherence [ Time Frame: 35 days ]
    The proportion of patients who completed the 35-day course of post-discharge thromboprophylaxis.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-≥40 years of age, are hospitalized for acute medical illness (heart failure, respiratory failure, infectious disease, rheumatic disease, or ischemic stroke), have reduced mobility, are not prescribed thromboprophylaxis at hospital discharge, and have one additional risk factor for VTE:

  • Age ≥60
  • Prior VTE OR
  • History of cancer

Exclusion Criteria:

- Prescribed thromboprophylaxis at hospital discharge


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728166


Contacts
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Contact: Gregory Piazza, MD, MS 6177326984 gpiazza@bwh.harvard.edu
Contact: Claire E Galvin, BS 6177326984 cegalvin@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Gregory Piazza, MD    857-307-1932    gpiazza@partners.org   
Principal Investigator: Gregory Piazza, MD         
Principal Investigator: Samuel Z Goldhaber, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Portola Pharmaceuticals
Investigators
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Principal Investigator: Gregory Piazza, MD, MS BWH
Publications:
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Responsible Party: Samuel Z.Goldhaber, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03728166    
Other Study ID Numbers: 2018P001727
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Samuel Z.Goldhaber, MD, Brigham and Women's Hospital:
venous thromboembolism
prevention
medical patients
hospital discharge
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases