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.
