Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT) (DC-eALERT)
Randomized Controlled Trial of Computerized Decision Support for Prevention of Venous Thromboembolism in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Design: U.S.-based, single-center, randomized controlled trial
Background: Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care (from before admission to after discharge). In the APEX Trial of 7513 hospitalized patients with acute medical illness, reduced mobility, and risk factors for VTE, extended-duration post-discharge thromboprophylaxis with oral betrixaban for 35 to 42 days reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death by 24% in the overall study population compared with 10-14 days of enoxaparin. The integration of oral betrixaban with a computerized decision support (CDS) tool has the potential to increase the appropriate prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness.
Study Design: 400-patient U.S.-based single-center Quality Improvement Initiative in the form of a randomized controlled trial focused on the feasibility of implementation of this electronic alert-based CDS (EPIC BPA) (Figure 1). The allocation ratio will be 1:1 for an electronic alert-based CDS (EPIC BPA) notification versus no notification.
Study Population: Patients are eligible if they are ≥40 years of age, are hospitalized for acute medical illness (heart failure, respiratory failure, infectious disease, rheumatic disease, or ischemic stroke), have reduced mobility, and have one additional risk factor for VTE:
- Age ≥60
- Prior VTE
- History of cancer
Eligible patients are not prescribed thromboprophylaxis at hospital discharge.
Intervention: An EPIC Electronic Health Record (EHR) Best Practice Advisory (BPA) will identify patients hospitalized with medical illness who are not ordered for extended-duration, post-discharge thromboprophylaxis 48 hours after admission. A 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. A second on-screen electronic alert will be issued if extended-duration, post-discharge thromboprophylaxis has still not been ordered that again notifies the provider about the increased risk for VTE after discharge and indication for thromboprophylaxis.
Primary Efficacy Outcome: Prescription of extended-duration post-discharge thromboprophylaxis. Investigators will review the order entry section of the Electronic Health Record (EPIC) to make this determination.
Secondary Efficacy Outcome: Frequency of symptomatic VTE at 90 days from randomization. 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.
Primary Safety Outcome: Major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization. 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.
Follow-Up: Follow-up will consist of Electronic Health Record review at 90 days from randomization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gregory Piazza, MD, MS
- Phone Number: 6177326984
- Email: gpiazza@bwh.harvard.edu
Study Contact Backup
- Name: Claire E Galvin, BS
- Phone Number: 6177326984
- Email: cegalvin@bwh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham and Women's Hospital
-
Contact:
- Gregory Piazza, MD
- Phone Number: 857-307-1932
- Email: gpiazza@partners.org
-
Principal Investigator:
- Gregory Piazza, MD
-
Principal Investigator:
- Samuel Z Goldhaber, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
90 days
|
|
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.
|
90 days
|
|
Frequency of all-cause mortality at 90 days
Time Frame: 90 days
|
Any death confirmed by medical record
|
90 days
|
|
Frequency of all-cause rehospitalization at 90 days
Time Frame: 90 days
|
Any rehospitalization confirmed by medical record
|
90 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medication adherence
Time Frame: 35 days
|
The proportion of patients who completed the 35-day course of post-discharge thromboprophylaxis.
|
35 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gregory Piazza, MD, MS, BWH
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018P001727
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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