Clinical trial NCT03728166: Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Keywords: venous thromboembolism
prevention
medical patients
hospital discharge
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Portola Pharmaceuticals
First posted: 2018-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: U.S.-based, single-center, randomized controlled trial
Primary purpose: PREVENTION

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.

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:

1. Age ≥60
2. Prior VTE
3. 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.

Eligibility 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

Primary outcomes:
measure: Frequency of prescription of extended-duration post-discharge thromboprophylaxis.
timeFrame: 90 days
Secondary outcomes:
measure: Frequency of symptomatic VTE at 90 days from randomization.
timeFrame: 90 days
measure: Frequency of major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization.
timeFrame: 90 days
measure: Frequency of all-cause mortality at 90 days
timeFrame: 90 days
measure: Frequency of all-cause rehospitalization at 90 days
timeFrame: 90 days
Other outcomes:
measure: Medication adherence
timeFrame: 35 days
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: BWH
name: Gregory Piazza, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27.