Photo-Narrative Study

NCT ID: NCT06208332

Last Updated: 2024-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2027-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Child Development Disorder Critical Illness Neurologic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Photo-Narrative

Group Type EXPERIMENTAL

Photo-Narrative

Intervention Type BEHAVIORAL

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.

Usual Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Photo-Narrative

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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


* licensed physicians, fellows, residents, advanced practice nurse practitioners, nurses, or respiratory therapists
* working in the pediatric ICU at Seattle Children's Hospital
Minimum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jori Bogetz, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Central Contacts

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Jori Bogetz, MD

Role: CONTACT

206-884-0572

References

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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.

Reference Type BACKGROUND
PMID: 32951992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21555495 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22272190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23842588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29174080 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24816425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35141756 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40034723 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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STUDY00004439

Identifier Type: -

Identifier Source: org_study_id

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