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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥60

Prior VTE OR

History of cancer

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Electronic alert

    Behavioral

    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.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: AlertExperimental treatment 1 intervention
Group B: No AlertNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Frequency of prescription of extended-duration post-discharge thromboprophylaxis.

Investigators will review the order entry section of the Electronic Health Record (EPIC) to make this determination.

Time frame
90 days

Secondary outcomes

1

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.

Time frame
90 days
2

Frequency of 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.

Time frame
90 days
3

Frequency of all-cause mortality at 90 days

Any death confirmed by medical record

Time frame
90 days
4

Frequency of all-cause rehospitalization at 90 days

Any rehospitalization confirmed by medical record

Time frame
90 days

Other outcomes

1

Medication adherence

The proportion of patients who completed the 35-day course of post-discharge thromboprophylaxis.

Time frame
35 days

Sponsors and contacts

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Brigham and Women's Hospital

Lead sponsor

Portola Pharmaceuticals

Collaborator