Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-03-03 @ 5:04 PM
Study NCT ID:
NCT05656560
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-30
First Post:
2022-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-20', 'size': 372088, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-06T14:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 786}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2022-11-17', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The percentage of HRPP patients with a hospitalization or emergency department (ED) visit for seizure.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing benzodiazepines and anticonvulsants'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for pain.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing tricyclic antidepressants, gabapentinoids, serotonin and norepinephrine reuptake inhibitors, opioids, and NSAIDs'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for depression or suicidality', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for anxiety.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing benzodiazepines, serotonin and norepinephrine reuptake inhibitors and selective serotonin reuptake inhibitors'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for sedative withdrawal.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing benzodiazepines and Z-drugs (GABA receptor modulators)'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for opioid withdrawal.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing opioids'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for behavioral disturbance in dementia or psychosis.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing antipsychotics'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for hyperglycemia.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing glyburide, glimepiride, and thiazolidinediones'}, {'measure': 'The percentage of HRPP patients with a hospitalization or ED visit for tachycardia (other than ventricular) or hypertensive emergency.', 'timeFrame': '18 months', 'description': 'Safety measure for discontinuing or reducing non-dihydropyridine calcium channel blockers'}], 'primaryOutcomes': [{'measure': 'The percentage of HRPP with any (1 or more) of the 7 measures of high risk polypharmacy. (Composite measure)', 'timeFrame': '18 months', 'description': 'The composite of the 7 high-risk polypharmacy measures (Secondary outcomes #6-12)'}], 'secondaryOutcomes': [{'measure': 'The rate of Emergency Department visits per patient -all cause', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter during the look back period.'}, {'measure': 'The rate of Emergency Department visits per patient-Adverse drug event (ADE)-specific', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP. Numerator: Patients with an emergency department encounter for ADE during the look back period.'}, {'measure': 'The rate of hospital admissions per patient-all cause', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for any reason during the look back period.'}, {'measure': 'The rate of hospital admissions per patient-ADE-specific', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP. Numerator: Patients with an inpatient admission for ADE during the look back period.'}, {'measure': 'The percentage of HRPP patients with a fall condition-drug interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adult patients with HRPP with a fall marker. Numerator: Patients with an active eligible fall risk medication on medication list.'}, {'measure': 'The percentage of HRPP patients with a fall drug-drug interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adult patients with HRPP. Numerator: Patients with greater than or equal to 3 active eligible fall risk medications.'}, {'measure': 'The percentage of HRPP patients with Heart failure-NSAID interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adult patients with HRPP with a CHF marker. Numerator: Patients with an active eligible NSAID medication.'}, {'measure': 'The percentage of HRPP patients with Heart Failure-thiazolidinedione interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP with a CHF marker. Numerator: Patients with an active eligible thiazolidinedione medication.'}, {'measure': 'The percentage of HRPP patients with Heart failure with reduced ejection fraction- non-dihydropyridine calcium channel blocker interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP with CHFlowEF marker. Numerator: Patients with an active eligible calcium channel blocker medication.'}, {'measure': 'The percentage of HRPP patients with CKD-glyburide/glimepiride interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP with most-recent eGFR \\<60. Numerator: Patients with an active eligible glyburide-containing medication.'}, {'measure': 'The percentage of HRPP patients with CKD-NSAID interaction', 'timeFrame': '18 months', 'description': 'Denominator: All older adults with HRPP with most-recent eGFR \\< 30. Numerator: Patients with an active eligible NSAID medication.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['clinical decision support', 'electronic health record', 'behavioral economics', 'high-risk geriatric polypharmacy'], 'conditions': ['Polypharmacy']}, 'descriptionModule': {'briefSummary': 'High-risk polypharmacy is common among older adults in the United States, is particularly dangerous for individuals with dementia or cognitive impairment, and is associated with harms such as adverse drug reactions, falls, and higher costs of care. This project aims to test in a pragmatic clinic-randomized controlled trial two electronic health record-based behavioral economic nudges to help clinicians reduce high-risk polypharmacy among their older adult patients and in the subgroup with dementia or cognitive impairment.\n\nThe main questions this trial aims to answer are:\n\nAim 1: To evaluate the effects of an EHR-based commitment nudge, a justification nudge, and the combination of both nudges on a composite measure of high-risk polypharmacy via a pragmatic randomized controlled trial. The investigators will use cluster randomization in which primary care clinics are randomized to receive 0, 1, or 2 nudges using a factorial design. The nudges will run for 18 months, followed by 12 months of observation to assess persistence of effects.\n\nAim 2: To qualitatively and quantitatively assess clinician experiences with the EHR-based nudges, including their acceptability and effects on workflow. At the conclusion of the intervention period, the investigators will perform semi-structured interviews and field a clinician survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Northwestern Medicine or UPMC primary care clinic: Internal Medicine, Family Medicine, or General Practice or Geriatrics\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05656560', 'acronym': 'HRPP', 'briefTitle': 'Reducing High-Risk Geriatric Polypharmacy Via EHR Nudges R01 Trial', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Reducing High Risk Polypharmacy Using Behavioral Economics Through Electronic Health Records', 'orgStudyIdInfo': {'id': 'STU00213231'}, 'secondaryIdInfos': [{'id': 'R01AG070054', 'link': 'https://reporter.nih.gov/quickSearch/R01AG070054', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinician education only', 'description': 'Online clinician education', 'interventionNames': ['Other: Clinician education']}, {'type': 'EXPERIMENTAL', 'label': 'Commitment nudge', 'description': "The commitment nudge will be an EHR alert that is triggered when a clinician renews or orders a qualifying medication in any Epic encounter (including non-face-to-face encounters) for a patient aged 65 or greater who meets criteria for high-risk polypharmacy. When triggered, the commitment nudge will offer the clinician a choice option that sets a reminder to discuss polypharmacy at the patient's next visit date.", 'interventionNames': ['Behavioral: Clinical decision support (CDS)-Commitment nudge', 'Other: Clinician education']}, {'type': 'EXPERIMENTAL', 'label': 'Justification nudge', 'description': 'The justification nudge will be an EHR alert triggered for patients with high-risk polypharmacy when a clinician begins to renew or newly prescribe a medication that causes a high-risk criterion to be fulfilled (i.e., a medication meeting causing 1 of the 7 high-risk polypharmacy criteria/primary study measures to be met). This alert will inform the clinician of the high-risk nature of the prescription and request a free-text justification for starting or renewing the medication. This written justification will appear in the EHR in a section of that encounter that other EHR users can see.', 'interventionNames': ['Other: Clinician education', 'Behavioral: Clinical decision support (CDS)-Justification nudge']}, {'type': 'EXPERIMENTAL', 'label': 'Commitment nudge + Justification nudge', 'description': 'This study arm will receive both the commitment nudge and the justification nudge.', 'interventionNames': ['Behavioral: Clinical decision support (CDS)-Commitment nudge', 'Other: Clinician education', 'Behavioral: Clinical decision support (CDS)-Justification nudge']}], 'interventions': [{'name': 'Clinical decision support (CDS)-Commitment nudge', 'type': 'BEHAVIORAL', 'otherNames': ['Commitment nudge'], 'description': 'EHR clinical decision support alerts-clinician commitment to discuss high risk polypharmacy', 'armGroupLabels': ['Commitment nudge', 'Commitment nudge + Justification nudge']}, {'name': 'Clinician education', 'type': 'OTHER', 'description': 'Brief, online education module for primary care clinicians', 'armGroupLabels': ['Clinician education only', 'Commitment nudge', 'Commitment nudge + Justification nudge', 'Justification nudge']}, {'name': 'Clinical decision support (CDS)-Justification nudge', 'type': 'BEHAVIORAL', 'otherNames': ['Justification nudge'], 'description': 'EHR clinical decision support alerts-clinician rational for high risk polypharmacy', 'armGroupLabels': ['Commitment nudge + Justification nudge', 'Justification nudge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}, {'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor; Director, Center for Primary Care Innovation', 'investigatorFullName': 'Stephen Persell, MD, MPH', 'investigatorAffiliation': 'Northwestern University'}}}}