Ignite Creation Date:
2025-12-25 @ 3:22 AM
Ignite Modification Date:
2026-02-21 @ 11:44 AM
Study NCT ID:
NCT01873105
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2013-04-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The CARS Study: Communicating About Readiness (for Discharge)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Before/after implementation of a health team communication intervention. 2 samples.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 604}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-16', 'studyFirstSubmitDate': '2013-04-26', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Readmission', 'timeFrame': '30 days post discharge', 'description': 'Readmission within the 30 days after hospital discharge'}, {'measure': 'Emergency Department visits', 'timeFrame': '30 days post discharge', 'description': 'ED visits within the 30 days after hospital discharge'}], 'secondaryOutcomes': [{'measure': 'Post-discharge Coping Difficulty Scale', 'timeFrame': '14 to 21 days post-hospitalization', 'description': 'Coping difficulty after hospital discharge measured using the Post-Discharge Coping Difficulty Scale is collected via telephone followup between 14 and 21 days after hospital discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hospital Discharge Communication Processes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to improve the experience of discharge of adult medical surgical patients through improved discharge preparation communication between patients and care team members, with subsequent improvement in the post-discharge experience. Obtaining multiple perspectives on discharge readiness creates the opportunity for patient and care team to partner in identifying deficiencies in discharge readiness that warrant anticipatory, compensatory, or corrective interventions prior to discharge, with the goal of averting post-discharge problems and utilization. The results will also inform development and translation of tools for assessment of discharge readiness to clinical care environments.', 'detailedDescription': 'Specific Aims are to:\n\n1. Describe patterns of communication about discharge and collaboration among members of the health care team\n2. Conduct psychometric testing of 3 forms of the Readiness for Hospital Discharge Scale (RHDS - MD, RN, Patient)\n3. Describe relationships between care team communication, patient perceptions of quality of discharge preparation and perceived readiness for discharge, care team (RN and MD) assessments of discharge readiness, and post-discharge outcome ( post-discharge coping difficulty, Emergency Department (ED) use, and 30 day readmission.\n4. Determine the impact of an intervention with the inpatient care team to improve discharge preparation communication.\n\nH1: Patient perceptions of discharge readiness, post-discharge coping difficulty, ED use and readmission will improve following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures.\n\nH2: Care team members will report improved frequency and amount of discharge preparation communication following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures.\n\nH3: RN-MD collaboration will increase following a care team educational intervention about discharge preparation, compared to pre-intervention baseline measures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* inpatient care team members from 2 nursing units of an academic medical center: Attending physician, resident, medical students, mid-level providers, staff RNs, and case managers/discharge coordinators\n* adult medical-surgical patients admitted the 2 nursing units who are at least 18 years of age, speak English, and discharged directly home\n\nExclusion Criteria:\n\n* patient discharged home with hospice care\n* patients not discharged directly home\n* decisionally incapacitated patients'}, 'identificationModule': {'nctId': 'NCT01873105', 'briefTitle': 'The CARS Study: Communicating About Readiness (for Discharge)', 'organization': {'class': 'OTHER', 'fullName': 'Marquette University'}, 'officialTitle': 'The CARS Study: Communicating About Readiness (for Discharge)', 'orgStudyIdInfo': {'id': 'PRO00019092'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health team educational intervention', 'description': 'Agency for Healthcare Research and Quality (AHRQ) TeamSTEPPS approach will be used to redesign health team communication processes regarding preparation for discharge. This redesign will be followed by education for all health team members.', 'interventionNames': ['Other: Health Team Educational Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control pre-intervention', 'description': 'Usual care control before implementation of the health team communication intervention'}], 'interventions': [{'name': 'Health Team Educational Intervention', 'type': 'OTHER', 'description': 'AHRQ TeamStepps processes will be used to redesign health team discharge communication processes and an educational intervention for health care team members', 'armGroupLabels': ['Health team educational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Marianne Weiss, DNSc RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marquette Unoversity'}, {'name': 'Kristi Opper, MS RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Froedtert Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marquette University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Froedtert Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marianne Weiss', 'investigatorAffiliation': 'Marquette University'}}}}