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

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ClinicalTrials.gov Identifier: NCT03728166
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : June 24, 2021
Sponsor:
Collaborator:
Portola Pharmaceuticals
Information provided by (Responsible Party):
Samuel Z.Goldhaber, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE October 30, 2018
First Posted Date  ICMJE November 1, 2018
Last Update Posted Date June 24, 2021
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
Frequency of prescription of extended-duration post-discharge thromboprophylaxis. [ Time Frame: 90 days ]
We will review the order entry section of the Electronic Health Record (EPIC) to make this determination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • 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.
  • 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.
  • Frequency of all-cause mortality at 90 days [ Time Frame: 90 days ]
    Any death confirmed by medical record
  • Frequency of all-cause rehospitalization at 90 days [ Time Frame: 90 days ]
    Any rehospitalization confirmed by medical record
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2018)
  • Frequency of symptomatic VTE at 90 days from randomization. [ Time Frame: 90 days ]
    We 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.
  • Frequency of major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization. [ Time Frame: 90 days ]
    We 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.
  • Frequency of all-cause mortality at 90 days [ Time Frame: 90 days ]
    Any death confirmed by medical record
  • Frequency of all-cause rehospitalization at 90 days [ Time Frame: 90 days ]
    Any rehospitalization confirmed by medical record
Current Other Pre-specified Outcome Measures
 (submitted: October 31, 2018)
Medication adherence [ Time Frame: 35 days ]
The proportion of patients who completed the 35-day course of post-discharge thromboprophylaxis.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
Official Title  ICMJE Randomized Controlled Trial of Computerized Decision Support for Prevention of Venous Thromboembolism in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
U.S.-based, single-center, randomized controlled trial
Masking: Single (Participant)
Masking Description:
Investigators will randomize patients by Attending Physician ID# to minimize the influence of an alert effect on the care of patients not randomized to the alert group but who have the same Attending Physician (thereby reducing what is called the "cluster-effect"). While investigators will randomize patients by Attending Physician of Record to minimize cluster-effect, the observational unit will be the patient.
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE Behavioral: Electronic 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Electronic alert
  • No Intervention: No Alert
    No notification to the provider.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2022
Estimated Primary Completion Date November 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gregory Piazza, MD, MS 6177326984 gpiazza@bwh.harvard.edu
Contact: Claire E Galvin, BS 6177326984 cegalvin@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728166
Other Study ID Numbers  ICMJE 2018P001727
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samuel Z.Goldhaber, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Portola Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Gregory Piazza, MD, MS BWH
PRS Account Brigham and Women's Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP