Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05713669
Status:
RECRUITING
Last Update Posted:
2025-04-04
First Post:
2023-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Resident Participation in Post-ICU Follow Up Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Total of 20 residents will be recruited (10 residents in the intervention arm; 10 residents in the control arm). One resident in each pair will be randomized to participate in a follow up encounter in the post-ICU clinic with the patient that residents have cared for (intervention) and one will have no follow up encounter (control). There will be 10 patients enrolled for the study and will not be randomized into any arm. Outcomes are based on the residents only.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-01-27', 'studyFirstSubmitQcDate': '2023-01-27', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Professional Fulfillment Scale', 'timeFrame': "Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit", 'description': 'The survey consists of 6 questions that are measured on a 5 point Likert scale (scored 0 to 4, with 4 representing higher fulfillment).'}, {'measure': 'Changes in the Burnout Scale', 'timeFrame': "Baseline (pre-post ICU follow-up visit), approximately 14 days post patient's follow-up visit", 'description': 'This scale has 4 questions that will indicate the level of burnout with scores from not at all =0 - extremely =4. A higher score indicates a higher sense of burnout.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Perceptions of critical care', 'Professional fulfillment.'], 'conditions': ['Professional Burnout']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to describe the impact of a meeting between patients that were admitted to the intensive care unit (ICU) and a provider that cared for the patients during the period of critical illness. The study team is aiming to describe the effect this meeting has on the physician that previously cared for the patient.\n\nThe study team hypothesizes that facilitating involvement in post-ICU clinic and creating longitudinal relationships between providers of critical care and survivors of critical illness will have positive effects on trainees, both in professional fulfillment and burnout scores and in perceptions of critical care.', 'detailedDescription': 'Physicians and patients that had been cared for in the ICU will be enrolled in this project. Residents that are recruited will be randomized to the encounter group or the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Patients:\n\n\\- Must be eligible for Post ICU Longitudinal Survivor Experience (PULSE) clinic follow up and/or have received referral to clinic\n\nInclusion criteria for Residents:\n\n* Must have completed at least one 2-week rotation in the medical ICU at the University of Michigan\n* Must have cared for an enrolled patient in the study\n\nExclusion Criteria for Patients:\n\n\\- Died during ICU stay\n\nExclusion Criteria for Residents:\n\n\\- Provided only "cross-cover" for the patient.'}, 'identificationModule': {'nctId': 'NCT05713669', 'briefTitle': 'Impact of Resident Participation in Post-ICU Follow Up Clinic', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Impact of Resident Participation in Post-ICU Follow Up Clinic', 'orgStudyIdInfo': {'id': 'HUM00225631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Residents meet ICU patients during follow-up visit (encounter)', 'description': 'Residents will be paired according to the patient that were cared.', 'interventionNames': ['Behavioral: Encounter visit with Patients']}, {'type': 'OTHER', 'label': 'Residents in the non-encounter group', 'description': 'Residents will not meet with patients that were in the ICU.', 'interventionNames': ['Behavioral: Non-encounter surveys']}], 'interventions': [{'name': 'Encounter visit with Patients', 'type': 'BEHAVIORAL', 'description': 'Participants in this encounter group will be asked to complete a pre and post-intervention survey, participate in a meeting with a former ICU patient at a post-ICU clinic, and undergo an in-person interview within fourteen days following the encounter.', 'armGroupLabels': ['Residents meet ICU patients during follow-up visit (encounter)']}, {'name': 'Non-encounter surveys', 'type': 'BEHAVIORAL', 'description': 'Surveys will be completed pre and post patient follow-up.', 'armGroupLabels': ['Residents in the non-encounter group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maddie Lagina, MD', 'role': 'CONTACT', 'email': 'laginam@med.umich.edu', 'phone': '734-763-9077'}, {'name': 'Maddie Lagina, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jakob McSparron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'centralContacts': [{'name': 'Maddie Lagina, MD', 'role': 'CONTACT', 'email': 'laginam@med.umich.edu', 'phone': '734-763-9077'}, {'name': 'Jakob McSparron, MD', 'role': 'CONTACT', 'email': 'jmcsparr@med.umich.edu', 'phone': '734-763-9077'}], 'overallOfficials': [{'name': 'Jakob McSparron, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Jakob McSparron', 'investigatorAffiliation': 'University of Michigan'}}}}