Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT06232551
Status:
RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057286', 'term': 'Electronic Health Records'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cluster-randomized, Type II hybrid implementation effectiveness study with step-wedge implementation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 152000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-15', 'studyFirstSubmitDate': '2024-01-18', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome (implementation)', 'timeFrame': 'From discharge to 7 days after discharge', 'description': 'Proportion of rivaroxaban prescriptions sent during the intervention phase, compared to the baseline phase'}, {'measure': 'Primary clinical efficacy outcome (effectiveness)', 'timeFrame': 'From enrollment until 90 days after enrollment', 'description': 'Composite of 90-day venous thromboembolism, myocardial infarction, non-hemorrhagic stroke, or death during the intervention phase for those patients for whom an alert was generated, compared to eligible at-risk patients during the baseline phase for whom no alert was generated'}, {'measure': 'Primary clinical safety outcome', 'timeFrame': 'From enrollment until 30 days after enrollment', 'description': '30 day major bleeding during the intervention phase for those patients for whom an alert was generated and a prescription was sent, compared to eligible at-risk patients during the baseline phase for whom no alert was generated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['post-discharge', 'extended duration thromboprophylaxis', 'rivaroxaban', 'direct oral anticoagulant', 'medical patient'], 'conditions': ['Venous Thromboembolic Disease', 'Pulmonary Embolism and Thrombosis', 'Deep Vein Thrombosis', 'Hospitalism']}, 'referencesModule': {'references': [{'pmid': '37235947', 'type': 'BACKGROUND', 'citation': 'Hyder SN, Han HB, Ash S, Horne BD, Stevens SM, Woller SC, Barnes GD. Predicting post-discharge venous thromboembolism and bleeding among medical patients: External validation of a novel risk score utilizing ubiquitous biomarkers. Thromb Res. 2023 Jul;227:45-50. doi: 10.1016/j.thromres.2023.05.011. Epub 2023 May 19.'}, {'pmid': '35873221', 'type': 'BACKGROUND', 'citation': 'Woller SC, Stevens SM, Bledsoe JR, Fazili M, Lloyd JF, Snow GL, Horne BD. Biomarker derived risk scores predict venous thromboembolism and major bleeding among patients with COVID-19. Res Pract Thromb Haemost. 2022 Jul 21;6(5):e12765. doi: 10.1002/rth2.12765. eCollection 2022 Jul.'}, {'pmid': '34263106', 'type': 'BACKGROUND', 'citation': 'Woller SC, Stevens SM, Fazili M, Lloyd JF, Wilson EL, Snow GL, Bledsoe JR, Horne BD. Post-discharge thrombosis and bleeding in medical patients: A novel risk score derived from ubiquitous biomarkers. Res Pract Thromb Haemost. 2021 Jul 7;5(5):e12560. doi: 10.1002/rth2.12560. eCollection 2021 Jul.'}]}, 'descriptionModule': {'briefSummary': 'A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal.\n\nThe purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low.\n\nThe pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.', 'detailedDescription': 'The goal of this prospective, cluster, randomized, type II hybrid step wedge, implementation/effectiveness study is to compare the rates of rivaroxaban prescription for extended duration thromboprophylaxis (EDT) in discharging medical patients during the baseline period when no alert informs decision-making to guide EDT, versus EDT prescription during the intervention period when an alert to the discharging clinician is delivered.\n\nGrouped sequential hospitals will be introduced to the intervention randomly in a step wedge fashion.\n\nAim 1 is to assess the implementation of the alert to discharging clinicians caring for eligible hospitalized medical patients. The primary outcome for Aim 1 is the comparative rate of prescription of EDT (rivaroxaban 10 mg daily for 30 days) during the baseline period versus the intervention period among eligible patients.\n\nSecondary outcomes for Aim 1 will capture interactions with the alert.\n\nAim 2 is to assess the impact of the alert on important patient clinical outcomes.\n\nThe primary efficacy outcome for Aim 2 is the composite of 90-day venous thromboembolism, non-hemorrhagic stroke, myocardial infarction and death.\n\nThe primary safety outcome for Aim 2 is 30-day major bleeding. Secondary outcomes for Aim 2 will be the net clinical benefit, defined as the primary outcome + the primary safety outcome during the baseline phase versus the intervention phase among all at risk patients, and all patients for which an alert leads to the prescription of EDT.\n\nAdditional secondary outcomes will report components of the primary efficacy and safety outcomes in various groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Discharging clinician must be in one of the following iCentra electronic health record (Cerner, Kansas City, MO) positions:\n\n * Physician, nurse practitioner, or physician assistant hospitalist\n * Physician internal medicine\n * Physician family medicine\n* Patient age ≥ 18 years.\n* The encounter must be inpatient.\n* A signed hospital discharge order must be present.\n* eVTE target population criteria (increased venous thromboembolism risk, low bleeding risk) must be met\n\nExclusion Criteria:\n\n* Pregnant during encounter\n* Discharge order completed by ineligible clinician type\n* Exclude all cases where the patient is being actively prescribed and intended to be discharged on the following qualifying anticoagulant medications, regardless of dose form or dosing regimen (i.e., they have an active prescription for one of these medications):\n\n * Apixaban\n * Dabigatran\n * Dalteparin\n * Enoxaparin\n * Edoxaban\n * Betrixaban\n * Fondaparinux\n * Rivaroxaban\n * Warfarin\n* Creatinine clearance \\<30 milliliters/minute based on last-available eligible serum creatinine value preceding discharge\n\n * Estimated creatine clearance based on actual body weight (preferred) ((140 - age years) \\* measured weight kilograms) / (72.0 \\* serum creatine milligrams/deciliter) (\\*0.85 if female)) = milliliters/minute\n * If measured body weight not available, then based on ideal body weight ((140 - age years) \\* ideal body weight kilograms) / (72.0 \\* serum creatine milligrams/deciliter) (\\*0.85 if female)) = milliliters/minute'}, 'identificationModule': {'nctId': 'NCT06232551', 'acronym': 'eVTE', 'briefTitle': 'Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'eVTE (Electronic Venous Thromboembolism): A Cluster, Randomized, Step-wedge Type II Hybrid Study of an Alert Recommending Extended Duration Thromboprophylaxis for At-risk Discharging Medical Patients to Prevent VTE.', 'orgStudyIdInfo': {'id': '1052468'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'At-risk patients for which an alert is sent during the intervention phase', 'description': 'Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), thereby meeting criteria for alerting during the intervention phase', 'interventionNames': ['Other: EHR (electronic health record) alert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'At-risk patients during the baseline phase', 'description': 'Patients found to be at an increased risk for VTE but a low risk for bleeding (based upon eVTE risk assessment), and who meet criteria for alerting, but for whom no alert is sent during the baseline phase', 'interventionNames': ['Other: No EHR (electronic health record) alert']}], 'interventions': [{'name': 'EHR (electronic health record) alert', 'type': 'OTHER', 'description': 'Pop-up alert that informs the discharging clinician that the patient meets criteria to be considered for extended duration thromboprophylaxis', 'armGroupLabels': ['At-risk patients for which an alert is sent during the intervention phase']}, {'name': 'No EHR (electronic health record) alert', 'type': 'OTHER', 'description': 'During the baseline phase while risk is assessed and stored, no alerting occurs', 'armGroupLabels': ['At-risk patients during the baseline phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott C. Woller, MD', 'role': 'CONTACT', 'email': 'scott.woller@imail.org', 'phone': '801-507-3376'}], 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'centralContacts': [{'name': 'Valerie Aston, MBA', 'role': 'CONTACT', 'email': 'valerie.aston@imail.org', 'phone': '801-507-4606'}, {'name': 'Carlos Barbagelata, MS', 'role': 'CONTACT', 'email': 'carlos.barbagelata@imail.org', 'phone': '801-507-4607'}], 'overallOfficials': [{'name': 'Scott C. Woller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scott C. Woller, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physician, thrombosis service, Intermountain Medical Center', 'investigatorFullName': 'Scott C. Woller, MD', 'investigatorAffiliation': 'Intermountain Health Care, Inc.'}}}}