Critical Illness Clinical Trial
Official title:
Photo-Narrative Pilot Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 30, 2027 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months and older |
Eligibility | Patients Inclusion Criteria: - ages 3 months-25 years - severe neurological impairment (including congenital/chromosomal, chronic central nervous system static or progressive conditions, or child >6 months after severe traumatic brain injury - admitted to the pediatric ICU at Seattle Children's and with medical team permission to approach - expected length of stay >1 week - life expectancy >4 weeks - previous discharge home Parents Inclusion Criteria: - parent/legal guardian - English and/or Spanish speaking (most common languages spoken at SCH making up 95% of patients and families) - >18 years of age Clinicians Inclusion Criteria: - licensed physicians, fellows, residents, advanced practice nurse practitioners, nurses, or respiratory therapists - working in the pediatric ICU at Seattle Children's Hospital |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Seattle Children's Hospital |
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility | Defined as >70% enrollment [enrolled parents/total approached] and completion [parents completing intervention/total randomized to the intervention]. | 30 months | |
Primary | Acceptability | Defined as >70% of the intervention parents likely or very likely to recommend the intervention to others/total randomized]. | 30 month |
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