Clinical trial NCT06208332: Photo-Narrative Study
Official title: Photo-Narrative Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Child Development Disorder
Critical Illness
Neurologic Disorder
Keywords: pediatric palliative care
communication
severe neurological impairment
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility
timeFrame: 30 months
measure: Acceptability
timeFrame: 30 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seattle Children's Hospital
name: Jori Bogetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.