Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-20 @ 4:45 PM
Study NCT ID:
NCT04028557
Status:
COMPLETED
Last Update Posted:
2022-05-06
First Post:
2019-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Implementation Model for Clinical Decision Support for Heart Failure Prescribing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-04', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-18', 'lastUpdatePostDateStruct': {'date': '2022-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in prescription of Beta blocker (BB)', 'timeFrame': '6 months post CDS implementation', 'description': 'Number of prescriptions of an evidence based BB during a primary care office visit.'}], 'secondaryOutcomes': [{'measure': 'Patient Reach', 'timeFrame': '6 months post CDS implementation', 'description': 'The proportion of unique patients with heart failure who were seen by primary care and not taking an evidence based BB who the CDS fired for.'}, {'measure': 'Clinician Adoption', 'timeFrame': '6 months post CDS implementation', 'description': 'The proportion of CDS who were not outright dismissed by the clinician.'}, {'measure': 'Factors Influencing Clinician Adoption of the CDS per Qualitative Interviews', 'timeFrame': '6 months post CDS implementation', 'description': 'Clinician-reported factors that influence adoption of the CDS.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Decision Support Systems, Clinical', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '33749610', 'type': 'DERIVED', 'citation': 'Trinkley KE, Kroehl ME, Kahn MG, Allen LA, Bennett TD, Hale G, Haugen H, Heckman S, Kao DP, Kim J, Matlock DM, Malone DC, Page Nd RL, Stine J, Suresh K, Wells L, Lin CT. Applying Clinical Decision Support Design Best Practices With the Practical Robust Implementation and Sustainability Model Versus Reliance on Commercially Available Clinical Decision Support Tools: Randomized Controlled Trial. JMIR Med Inform. 2021 Mar 22;9(3):e24359. doi: 10.2196/24359.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this proposal is to compare clinical outcomes, implementation metrics (i.e., patient reach and clinician adoption), and clinician preferences of two designs (customized vs. commercial) of a clinical decision support (CDS). Beta blocker prescribing for patients with heart failure will be used as a test case. The best practices in CDS design, including the user-centered design will be incorporated into the customized CDS and compared to a commercially-available CDS in the electronic health record using a cluster randomized trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Study subjects are providers\n\nInclusion Criteria:\n\n* Prescribing primary care clinicians at University of Colorado Health (UCHealth) who provide care for patients with heart failure and reduced ejection fraction\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04028557', 'briefTitle': 'An Implementation Model for Clinical Decision Support for Heart Failure Prescribing', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Development and Validation of an Integrated Implementation Model for Clinical Decision Support for Heart Failure Prescribing', 'orgStudyIdInfo': {'id': '19-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Customized CDS', 'description': 'The customized CDS will be designed and implemented with comprehensive application of known best practice principles in CDS design. The recommendation will be to initiate an evidence-based beta blocker for heart failure.', 'interventionNames': ['Other: Decision Support Systems, Clinical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Commercial CDS', 'description': 'The commercial CDS is available to all institutions using the Epic electronic health record vendor, but violates some CDS design best practices, notably not being tailored to the end users of a given health system. The recommendation will be to initiate an evidence-based beta blocker for heart failure.', 'interventionNames': ['Other: Decision Support Systems, Clinical']}], 'interventions': [{'name': 'Decision Support Systems, Clinical', 'type': 'OTHER', 'otherNames': ['CDS'], 'description': 'Active computerized clinical decision support alert within the electronic health record that recommends initiation of an evidence-based beta blocker for heart failure and reduced ejection fraction.', 'armGroupLabels': ['Commercial CDS', 'Customized CDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Katy E Trinkley, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}