Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-22 @ 7:04 AM
Study NCT ID:
NCT04243356
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-13
First Post:
2020-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-11', 'studyFirstSubmitDate': '2020-01-23', 'studyFirstSubmitQcDate': '2020-01-23', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in medical ICU nurse fulfillment toward the ICU following an encounter with a former ICU patient in the post-ICU clinic using an adapted Stanford Professional Fulfillment Index', 'timeFrame': 'Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge)', '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). The scores for all 6 fulfillment questions are then averaged for a composite score for fulfillment (also ranging from 0-4). The surveys will be administered at the time of enrollment for both the encounter and control nurse groups. The post-intervention survey will be administered only to the encounter group immediately following the post-ICU clinic encounter.'}], 'secondaryOutcomes': [{'measure': 'Change in medical ICU nurse burnout following an encounter with a former ICU patient in the post-ICU clinic', 'timeFrame': 'Baseline, at the follow-up ICU clinic visit for the encounter group (approximately 2-4 weeks after discharge)', 'description': 'The survey includes 2 questions and is adapted from Maslach Burnout Inventory (MBI) and are single-item measures of emotional exhaustion and depersonalization.\n\nThe assessment of burnout are measured on a 7 point Likert scale (scored 0 to 6, with 6 representing higher burnout). The surveys will be administered at the time of enrollment for both the encounter and control nurse groups. The post-intervention survey will be administered only to the encounter group immediately following the post-ICU clinic encounter.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nurse-Patient Relations', 'Nurse Role']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to learn more about the impact of a longitudinal encounter between critical care nurses and former intensive care unit patients. This study will enroll 10 patients that had been admitted in an ICU to meet with a former nurse that had taken care of them in the ICU. The study will enroll 20 nurses that had taken care of these patients in the ICU. The study will randomize 10 nurses to be in the encounter group and 10 nurses to be assigned to the control group. Only nurses assigned to the encounter group will meet with the patients at their post-ICU clinic.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* Patients that were admitted to the ICU that are appropriate for follow-up.\n\nNurses:\n\nInclusion Criteria:\n\n* Registered nurse in an intensive care unit and took care of the enrolled patient'}, 'identificationModule': {'nctId': 'NCT04243356', 'briefTitle': 'Impact of Intensive Care Unit Nurse Participation in Post - ICU Follow Up Clinic', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Impact of Intensive Care Unit Nurse Participation in Post - ICU (Intensive Care Unit) Follow Up Clinic', 'orgStudyIdInfo': {'id': 'HUM00170939'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurse Encounter Group', 'description': 'Nurses that are assigned to this group will be asked to take surveys before and immediately following the post-ICU clinic encounter with a patient that they had cared for in the ICU during a follow-up care visit with the former ICU - patient.', 'interventionNames': ['Behavioral: Nurse Encounter Group']}, {'type': 'OTHER', 'label': 'Nurse Control Group', 'description': 'Nurses assigned to this group will only complete surveys and will not see a former patient in a post-ICU visit.', 'interventionNames': ['Other: Nurse control group']}], 'interventions': [{'name': 'Nurse Encounter Group', 'type': 'BEHAVIORAL', 'description': 'Nurses in this group will meet with former ICU patients in a post ICU clinic visit. This will be a structured meeting for approximately 15 minutes with the nurse and former patient. The encounter will be observed by a member of the research team. Surveys will be completed before and after the visits. Additionally, nurses will be interviewed 4-7 days after meeting with their former patients.', 'armGroupLabels': ['Nurse Encounter Group']}, {'name': 'Nurse control group', 'type': 'OTHER', 'description': 'This group will complete surveys.', 'armGroupLabels': ['Nurse Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], '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': 'Clinical Assistant Professor of Internal Medicine', 'investigatorFullName': 'Jakob McSparron', 'investigatorAffiliation': 'University of Michigan'}}}}