Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:16 PM
Study NCT ID:
NCT04441632
Status:
COMPLETED
Last Update Posted:
2020-08-12
First Post:
2020-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Positive Attitudes on Behavior and Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D025461', 'term': 'Feedback, Physiological'}], 'ancestors': [{'id': 'D006706', 'term': 'Homeostasis'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-11', 'studyFirstSubmitDate': '2020-06-18', 'studyFirstSubmitQcDate': '2020-06-18', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teamwork climate, as measured by selected items from the validated Safety Attitude Questionnaire (SAQ)', 'timeFrame': '4 weeks', 'description': "The SAQ measures teamwork climate, safety climate, job satisfaction, stress recognition, perceptions of management, and working conditions. The six items assessing teamwork climate will be used. 5 point likert scale is used. Mean of the items - 1 \\* 25 will convert each participant's results to a 100 point scale (0, 25, 50, 75, 100 points)."}, {'measure': 'Resiliency, as measured by the validated Brief Resilience Scale (BRS)', 'timeFrame': '4 weeks', 'description': 'The BRS is comprised of 6 items on a likert scale. Responses varying from 1-5 for all six items give a total range of 6-30. This sum will be divided by the total number of questions for a final score.'}, {'measure': 'Burnout, as validated by the single-item burnout scale inventory', 'timeFrame': '4 weeks', 'description': 'This single item inventory provides 5 definitions of burnout that the participant will choose that most closely fits their personal level of burnout at the moment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wellness', 'healthcare', 'burnout', 'COVID'], 'conditions': ['Burnout', 'Stress, Emotional']}, 'descriptionModule': {'briefSummary': 'The COVID-19 pandemic has undoubtedly elevated levels of stress to people all over the globe, but none more than to the providers on the front-line. The purpose of the study is to first, assess the effects of the pandemic on burnout, team cohesion, and resiliency among healthcare providers battling COVID-19 together in a medical ICU (MICU). Secondly, the investigators hope to then assess the effects of simple positive feedback on transforming culture and attitudes during times of major stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Front-line healthcare providers in the Medical Intensive Care Unit (MICU): nurses, respiratory therapists, resident physicians, fellow physicians, and attending physicians\n\nExclusion Criteria:\n\n* Healthcare providers providing only consultatory care in the MICU\n* Front-line healthcare providers not working in the MICU during the study period'}, 'identificationModule': {'nctId': 'NCT04441632', 'acronym': 'TEAM-ICU', 'briefTitle': 'Effect of Positive Attitudes on Behavior and Wellness', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'The Impact of Positive Reinforcement on Teamwork Climate, Resiliency, and Burnout During the COVID-19 Pandemic: the TEAM-ICU Study (Transforming Employee Attitudes Via Messaging Strengthens Interconnection, Communication, and Unity)', 'orgStudyIdInfo': {'id': 'STUDY00000786'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Positive feedback', 'description': 'Participants in the study will provide consistent positive feedback to the colleagues they work with in the medical ICU (MICU) over a 4 week duration.', 'interventionNames': ['Behavioral: Positive feedback']}], 'interventions': [{'name': 'Positive feedback', 'type': 'BEHAVIORAL', 'description': 'Participants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period).', 'armGroupLabels': ['Positive feedback']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Jack Green, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics', 'investigatorFullName': 'Jack Green', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}