Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT06208332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Photo-Narrative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-02', 'size': 388761, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-12-08T18:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '30 months', 'description': 'Defined as \\>70% enrollment \\[enrolled parents/total approached\\] and completion \\[parents completing intervention/total randomized to the intervention\\].'}, {'measure': 'Acceptability', 'timeFrame': '30 month', 'description': 'Defined as \\>70% of the intervention parents likely or very likely to recommend the intervention to others/total randomized\\].'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric palliative care', 'communication', 'severe neurological impairment'], 'conditions': ['Child Development Disorder', 'Critical Illness', 'Neurologic Disorder']}, 'referencesModule': {'references': [{'pmid': '32951992', 'type': 'BACKGROUND', 'citation': 'Allen J, Brenner M, Hauer J, Molloy E, McDonald D. Severe Neurological Impairment: A delphi consensus-based definition. Eur J Paediatr Neurol. 2020 Nov;29:81-86. doi: 10.1016/j.ejpn.2020.09.001. Epub 2020 Sep 11.'}, {'pmid': '21555495', 'type': 'BACKGROUND', 'citation': 'Feudtner C, Kang TI, Hexem KR, Friedrichsdorf SJ, Osenga K, Siden H, Friebert SE, Hays RM, Dussel V, Wolfe J. Pediatric palliative care patients: a prospective multicenter cohort study. Pediatrics. 2011 Jun;127(6):1094-101. doi: 10.1542/peds.2010-3225. Epub 2011 May 9.'}, {'pmid': '22272190', 'type': 'BACKGROUND', 'citation': 'Berry JG, Poduri A, Bonkowsky JL, Zhou J, Graham DA, Welch C, Putney H, Srivastava R. Trends in resource utilization by children with neurological impairment in the United States inpatient health care system: a repeat cross-sectional study. PLoS Med. 2012 Jan;9(1):e1001158. doi: 10.1371/journal.pmed.1001158. Epub 2012 Jan 17.'}, {'pmid': '23842588', 'type': 'BACKGROUND', 'citation': 'Moreau JF, Fink EL, Hartman ME, Angus DC, Bell MJ, Linde-Zwirble WT, Watson RS. Hospitalizations of children with neurologic disorders in the United States. Pediatr Crit Care Med. 2013 Oct;14(8):801-10. doi: 10.1097/PCC.0b013e31828aa71f.'}, {'pmid': '29174080', 'type': 'BACKGROUND', 'citation': 'DeCourcey DD, Silverman M, Oladunjoye A, Balkin EM, Wolfe J. Patterns of Care at the End of Life for Children and Young Adults with Life-Threatening Complex Chronic Conditions. J Pediatr. 2018 Feb;193:196-203.e2. doi: 10.1016/j.jpeds.2017.09.078. Epub 2017 Nov 22.'}, {'pmid': '24816425', 'type': 'BACKGROUND', 'citation': 'Nolan R, Luther B, Young P, Murphy NA. Differing perceptions regarding quality of life and inpatient treatment goals for children with severe disabilities. Acad Pediatr. 2014 Nov-Dec;14(6):574-80. doi: 10.1016/j.acap.2014.02.012. Epub 2014 May 6.'}, {'pmid': '35141756', 'type': 'BACKGROUND', 'citation': 'Bogetz JF, Trowbridge A, Lewis H, Jonas D, Hauer J, Rosenberg AR. Forming Clinician-Parent Therapeutic Alliance for Children With Severe Neurologic Impairment. Hosp Pediatr. 2022 Mar 1;12(3):282-292. doi: 10.1542/hpeds.2021-006316.'}, {'pmid': '40034723', 'type': 'DERIVED', 'citation': 'Bogetz J, Ayala E, Anderson J, Morris L, Barton KS, Bradford MC, Zhou C, Yi-Frazier J, Watson RS, Rosenberg AR. A photo-narrative intervention protocol for clinicians and parents of children with severe neurological impairment in the PICU. Contemp Clin Trials Commun. 2025 Feb 11;44:101455. doi: 10.1016/j.conctc.2025.101455. eCollection 2025 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to conduct a pilot randomized controlled trial (RCT) of a photo-narrative communication intervention developed by our study team with patients/parents of children with severe neurological impairment (SNI) and their pediatric intensive care unit (PICU) clinicians to assess feasibility, acceptability, and early efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Patients\n\nInclusion Criteria:\n\n* ages 3 months-25 years\n* severe neurological impairment (including congenital/chromosomal, chronic central nervous system static or progressive conditions, or child \\>6 months after severe traumatic brain injury\n* admitted to the pediatric ICU at Seattle Children's and with medical team permission to approach\n* expected length of stay \\>1 week\n* life expectancy \\>4 weeks\n* previous discharge home\n\nParents\n\nInclusion Criteria:\n\n* parent/legal guardian\n* English and/or Spanish speaking (most common languages spoken at SCH making up 95% of patients and families)\n* \\>18 years of age\n\nClinicians\n\nInclusion Criteria:\n\n* licensed physicians, fellows, residents, advanced practice nurse practitioners, nurses, or respiratory therapists\n* working in the pediatric ICU at Seattle Children's Hospital"}, 'identificationModule': {'nctId': 'NCT06208332', 'briefTitle': 'Photo-Narrative Study', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Photo-Narrative Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'STUDY00004439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Photo-Narrative', 'interventionNames': ['Behavioral: Photo-Narrative']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care'}], 'interventions': [{'name': 'Photo-Narrative', 'type': 'BEHAVIORAL', 'description': "Photo-Narratives include 1-3 photos of the pediatric patient and their family to tell a story about palliative care topics that are shared with the child's clinicians.", 'armGroupLabels': ['Photo-Narrative']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jori Bogetz, MD', 'role': 'CONTACT', 'email': 'jori.bogetz@seattlechildrens.org', 'phone': '206-884-0572'}], 'overallOfficials': [{'name': 'Jori Bogetz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seattle Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}