Venous ThromboembolismDC-eALERTNCT03728166
Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
A study testing Electronic alert in people with Venous Thromboembolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Electronic alert
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2019to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥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
Who cannot join
- Prescribed thromboprophylaxis at hospital discharge
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Gregory Piazza, MD, 857-307-1932, gpiazza@partners.org
Gregory Piazza, MD
About this study
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)
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Electronic alert
- Keywords
- venous thromboembolism, prevention, medical patients, hospital discharge
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic alertBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Alert | Experimental | 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. Receives: Behavioral: Electronic alert |
| No Alert | No intervention | No notification to the provider. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (4)
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.
Measured: 90 days
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.
Measured: 90 days
Frequency of all-cause mortality at 90 days
Any death confirmed by medical record
Measured: 90 days
Frequency of all-cause rehospitalization at 90 days
Any rehospitalization confirmed by medical record
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Feb 2019
- Primary completion31 Dec 2022
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- U.S.-based, single-center, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Portola Pharmaceuticals
- Responsible party
- Principal investigator, Gregory Piazza, MD, MS, Brigham and Women's Hospital
- Investigators
- Gregory Piazza, MD, MS, Principal investigator, BWH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728166
- Sponsor's protocol ID
- 2018P001727
- Acronym
- DC-eALERT
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2018
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27232649
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03728166
- Acronym / sponsor ID
- DC-eALERT / 2018P001727
- Conditions
- Venous Thromboembolism
- Keywords
- venous thromboembolism, prevention, medical patients, hospital discharge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Portola Pharmaceuticals
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- U.S.-based, single-center, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Alert | Experimental | Behavioral: Electronic alertOn-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 Alert | No intervention | –No notification to the provider. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -≥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
Key exclusion criteria (1 listed)
- Prescribed thromboprophylaxis at hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic alertOn-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. | Behavioural | Alert |
Primary outcome
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.
4 secondary outcomes
Frequency of symptomatic VTE at 90 days from randomization.
Time frame: 90 days
Frequency of major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization.
Time frame: 90 days
Frequency of all-cause mortality at 90 days
Time frame: 90 days
Frequency of all-cause rehospitalization at 90 days
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 27232649Cohen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Piazza, MD, MS principal investigator
BWH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic alert in people with Venous Thromboembolism, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory Piazza, MD, MS (6177326984, gpiazza@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of prescription of extended-duration post-discharge thromboprophylaxis. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03728166, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.