Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-01 @ 1:08 AM
Study NCT ID:
NCT05241951
Status:
COMPLETED
Last Update Posted:
2025-11-24
First Post:
2022-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': "A parallel cluster-randomized controlled crossover trial design, with randomization occurring at the skilled nursing facility cluster level. The trial is conducted across four hospitals and 14 independent SNFs in Washington State. SNF's are stratified by patient volume before randomly assigned to either the PIT program or usual care."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1052}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-01-28', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication Related Problems', 'timeFrame': '30 days post hospital discharge', 'description': 'Number of medication related problems experienced by patients within 30 days post hospital discharge.'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': '30 Days post hospital discharge', 'description': 'Number of deaths experienced by patients within each cohort'}, {'measure': 'Readmissions', 'timeFrame': '30 Days', 'description': 'Number of readmissions within 30 days of index hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Care Transition', 'Medication-Related Problems', 'Post-Acute Care', 'Skilled Nursing Facility', 'Hospital Systems', 'Medication Safety'], 'conditions': ['Care Transition']}, 'referencesModule': {'references': [{'pmid': '39740951', 'type': 'DERIVED', 'citation': 'Hantouli MN, Monsell SE, Davidson GH, Chaing J, Comstock B, Dervish AA, Gionet NJ, Howard S, Jimenez N, Kim C, Liberman M, Lindo EG, Marcum ZA, Ong TD, Serrano E, Simons K, Sun LS, Zaslavsky O, Austin E; PIT Collaborative. Pharmacy Integrated Transitions (PIT) trial: a protocol for a pragmatic cluster-randomised crossover trial. BMJ Open. 2024 Dec 31;14(12):e088786. doi: 10.1136/bmjopen-2024-088786.'}], 'seeAlsoLinks': [{'url': 'http://www.becertain.org/', 'label': "Focused on evaluating the effectiveness and value of healthcare and keeping the patient's voice central, CERTAIN is a revolutionary approach to improving quality through actionable research."}]}, 'descriptionModule': {'briefSummary': "The Pharmacy Integrated Transitions (PIT) program, utilizes a crossover randomized control design to evaluate the impact of a clinical pharmacist in decreasing medication related problems during a patient's transition from hospital to skilled nursing facility (SNF).", 'detailedDescription': 'Standard hospital discharge processes (e.g. as recommended by the Joint Commission Center for Transforming Healthcare), include hospital staff completing a paper-based discharge summary and medication reconciliation form. To reduce the likelihood of medication-related problems during care transitions, the Pharmacy Integrated Transitions (PIT) program aims to improve the standard transition process by adding a coordinating transitional pharmacist to provide a structured synchronous "warm-handoff" between clinical teams at the hospital and the Skilled Nursing Facility, in addition to reconciling, adjusting, and monitoring medications during and after discharge from the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age and older\n* patients receiving inpatient care at University of Washington Mountlake, University of Washington Northwest, Harborview, and Valley Medical Center hospitals to one of 14 collaborating SNF's on a day when the PIT program pharmacist is conducting the intervention\n\nExclusion Criteria:\n\n* Under 18 years of age\n* patients with a discharge on hospice care\n* patients discharged on days that the pharmacist is not conducting the intervention"}, 'identificationModule': {'nctId': 'NCT05241951', 'briefTitle': 'Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Preventing Medication-Related Problems in Care Transitions to Skilled Nursing Facilities Using a Pharmacy Integrated Transitional Team', 'orgStudyIdInfo': {'id': 'STUDY00011018'}, 'secondaryIdInfos': [{'id': '1R01HS027805', 'link': 'https://reporter.nih.gov/quickSearch/1R01HS027805', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clinical Pharmacist in Transition of Care', 'description': 'A clinical pharmacist will be provided as a patient discharges from one of four University of Washington (UW) medical centers to one of 14 post acute skilled nursing facilities randomized to the intervention arm. The coordinating transitional pharmacist will conduct (1) a comprehensive medication review including medication reconciliation, adjustment, and monitoring during the transitional period from hospital to SNF, 2) a structured handoff between clinical teams at the hospital and SNF.', 'interventionNames': ['Other: Structured hand-off', 'Other: Medication reconciliation during transitional period', 'Other: Transitional medication monitoring', 'Other: Teleconsultation']}, {'type': 'NO_INTERVENTION', 'label': 'Patient transitions from hospital to post-acute care', 'description': 'Patient will transition from one of four University of Washington (UW) medical centers to one of 14 post-acute skilled nursing facilities randomized to the control arm. Patients will receive the standard discharge process.'}], 'interventions': [{'name': 'Structured hand-off', 'type': 'OTHER', 'otherNames': ['Standardized Checklist'], 'description': 'Use of standardized checklist to provide synchronous or asynchronous handoff that conveys medication recommendations to the SNF clinical teams', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}, {'name': 'Medication reconciliation during transitional period', 'type': 'OTHER', 'description': 'Comprehensive medication reconciliation conducted during transitional period between hospital and SNF, focused on SNF-specific requirements for medication delivery (e.g., stop dates, titration instructions)', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}, {'name': 'Transitional medication monitoring', 'type': 'OTHER', 'description': 'Review of medication orders during first 7 days of SNF admittance to address barriers to translation of medication orders and appropriate medication delivery', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}, {'name': 'Teleconsultation', 'type': 'OTHER', 'description': 'Ad hoc consultation to provide additional clarification to SNF clinical teams', 'armGroupLabels': ['Clinical Pharmacist in Transition of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Health System', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Giana Davidson, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine: Surgery', 'investigatorFullName': 'Giana Davidson', 'investigatorAffiliation': 'University of Washington'}}}}