Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2026-01-09 @ 9:15 AM
Study NCT ID:
NCT03808350
Status:
UNKNOWN
Last Update Posted:
2022-04-13
First Post:
2018-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Family Procedural Presence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2018-12-26', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient & Family Member Engagement', 'timeFrame': 'Time of ICU procedure to 48 hours afterwards', 'description': 'Engagement, as measured by the collaboRATE survey, administered to patients \\& family members within 48 hours after a procedure in the ICU'}], 'secondaryOutcomes': [{'measure': 'Patient & Family Member Stress', 'timeFrame': 'Time of ICU procedure to 48 hours afterwards', 'description': 'Perceived stress of patient \\& family members, assessed within 48 hours after a procedure in the ICU by the Perceived Stress Scale-4 (PSS-4), measured on a scale from 0 to 16 with high numbers indicating increased level of perceived stress.'}, {'measure': 'Clinician Stress', 'timeFrame': 'Time of ICU procedure to 48 hours afterwards', 'description': 'Clinician stress, as assessed within 48 hours after a procedure in ICU by the visual analog scale, measured on a scale from 1-100 with 100 indicating higher levels of clinician stress.'}, {'measure': 'Procedural Complication Rate', 'timeFrame': 'Through 7 days after the ICU procedure', 'description': 'Complications associated with procedures, including infections associated with central lines'}, {'measure': 'Trainee Satisfaction with Procedure Education', 'timeFrame': 'Time of ICU procedure to 24 hours afterwards', 'description': 'Satisfaction with the education experience among trainees performing procedures, as assessed within 24 hours by a Likert scale from 1-5 with 5 indicating increased satisfaction with education experience and 1 indicating dissatisfaction with education experience.'}, {'measure': 'Patient & Family Member Anxiety & Depression', 'timeFrame': '3 months after ICU procedure', 'description': 'Anxiety and depression for patients \\& family members, assessed at 3 months after the ICU procedure by the Hospital Anxiety and Depression Scale (HADS), measured from 0 to 42 with higher scores indicating more likelihood of anxiety or depression.'}, {'measure': 'Patient & Family Member PTSD', 'timeFrame': '3 months after ICU procedure', 'description': 'PTSD for patients \\& family members, assessed at 3 months after the ICU procedure by the Impact of Event Scale Revised (IES-R), measured from 4 to 88 with a score over 33 indicating likely presence of PTSD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient and Family Engagement']}, 'descriptionModule': {'briefSummary': "This study seeks to determine the effect of a quality improvement policy regarding allowing family members to remain in a patient's room during ICU procedures. The investigators hypothesized that our change in policy to invite family members to remain during procedures will improve patient \\& family engagement and improve long term psychological outcomes after an ICU admission. The study also seeks to determine if inviting family members to remain in a patient's room during ICU procedures will not increase clinician stress.", 'detailedDescription': 'This is a research study about the effect of a quality improvement policy change regarding family presence at ICU procedures on family and patient engagement, psychological outcomes and stress levels in clinicians. In the study, ICU patients, their family members and ICU clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a policy change and a second set during a second time period after policy change. The patients and family members will be asked survey questions after the procedure and 3 months later. This study will also evaluate the change in clinician stress related to this policy change, and clinicians will also answer survey questions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old or older\n* Able to read \\& speak English\n* Family member of a patient or a patient that has undergone one of these procedures at any point during the ICU stay (if the procedure occurs from Sunday at 8 am to Friday at 12 pm): intubation, central line placement, arterial line placement, bronchoscopy, thoracentesis, chest tube placement, paracentesis and lumbar puncture\n* Physician (both attending physicians and trainees) and nurses who work in the ICU during the study period.\n\nExclusion Criteria:\n\n* Patients for whom no family member can be identified\n* Non-English speaking individuals\n* Children (\\<18 years of age)\n* Participants with dementia, psychiatric disorder with psychosis, schizophrenia or known cognitive dysfunction (established from chart review, report and/or score greater than or equal to 3 on IQ Code screening).\n* Provider who does not want to participate'}, 'identificationModule': {'nctId': 'NCT03808350', 'briefTitle': 'Family Procedural Presence', 'organization': {'class': 'OTHER', 'fullName': 'Intermountain Health Care, Inc.'}, 'officialTitle': 'Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians', 'orgStudyIdInfo': {'id': '1050086'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Families Excluded From Presence at Procedures', 'description': 'Families not invited to remain for ICU procedures', 'interventionNames': ['Other: Placebo/Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Families Invited to Be Present at Procedures', 'description': 'Families invited to remain for ICU procedures', 'interventionNames': ['Procedure: Families Invited to Be Present at Procedures']}], 'interventions': [{'name': 'Families Invited to Be Present at Procedures', 'type': 'PROCEDURE', 'description': 'Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree', 'armGroupLabels': ['Families Invited to Be Present at Procedures']}, {'name': 'Placebo/Control', 'type': 'OTHER', 'description': 'Family members will not be invited to remain in the ICU room', 'armGroupLabels': ['Families Excluded From Presence at Procedures']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84107', 'city': 'Murray', 'state': 'Utah', 'country': 'United States', 'facility': 'Intermountain Medical Center', 'geoPoint': {'lat': 40.66689, 'lon': -111.88799}}], 'overallOfficials': [{'name': 'Sarah J Beesley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Intermountain Health Care, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Completely deidentified data may potentially be available to other researchers upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intermountain Health Care, Inc.', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pulmonologist - Shock Trauma ICU', 'investigatorFullName': 'Sarah Beesley', 'investigatorAffiliation': 'Intermountain Health Care, Inc.'}}}}