The "What Is Important to Us" Communication Intervention Pilot Clinical Trial

NCT06208332 | Recruiting Phase 2 DMC

• 1 other identifier: STUDY00004439
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Neurologic Disorder

Keywords

pediatric palliative care; communication; severe neurological impairment

Outcome Measures

Primary Outcomes (2)

• Feasibility

  Feasibility will be set at a benchmark of 70% and assessed by calculating: 1) the percent enrolled (total enrolled/total approached), plus a 95% confidence interval; and 2) the percent completion (parents completing intervention/total in intervention arm), plus a 95% confidence interval.

  enrollment and PICU discharge (assessed up to 4 weeks)

• Acceptability

  Acceptability will be set at a benchmark of 70% and assessed by computing the intervention recommendation percent (total number of intervention parents likely to very likely to recommend the intervention to other parents/total number of parents in the intervention arm), plus a 95% confidence interval.

  PICU discharge (assessed up to 4 weeks)

Secondary Outcomes (7)

• Perceived Stress Scale (PSS)

  enrollment and PICU discharge (assessed up to 4 weeks)

• Neuro-QOL Stigma Short-Form

  enrollment and PICU discharge (assessed up to 4 weeks)

• Benefit Finding Scale

  enrollment and PICU discharge (assessed up to 4 weeks)

• Connor Davidson Resilience Scale (CD-RISC 10)

  enrollment and PICU discharge (assessed up to 4 weeks)

• Human Connection Scale (HCS)

  enrollment and PICU discharge (assessed up to 4 weeks)

Study Arms (2)

"What Is Important to US" Communication Intervention

EXPERIMENTAL

The "What Is Important to Us" intervention is a photo-narrative invention that prompts parents to select a total of 1-3 photos that are then displayed at their child's ICU bedside representing: 1) who is important in our family; 2) what strengthens us as parents; 3) how we know our child is feeling well; and 4) what makes our child's hospitalization easier. Parents are encouraged to discuss the pictures with clinicians caring for their child. Clinicians caring for the child are sent the photos electronically along with suggested discussion prompts to use with parents.

Behavioral: "What Is Important to Us" Communication Intervention

Usual Care

NO INTERVENTION

Usual supportive care

Interventions

"What Is Important to Us" Communication Intervention BEHAVIORAL

The "What Is Important to Us" intervention is a photo-narrative invention that prompts parents to select a total of 1-3 photos that are then displayed at their child's ICU bedside representing: 1) who is important in our family; 2) what strengthens us as parents; 3) how we know our child is feeling well; and 4) what makes our child's hospitalization easier. Parents are encouraged to discuss the pictures with clinicians caring for their child. Clinicians caring for the child are sent the photos electronically along with suggested discussion prompts to use with parents..

"What Is Important to US" Communication Intervention

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized at study sites
• Ages 6 months through 25 years old
• Has had SNI for \>6 months, defined as permanent static or progressive central nervous system injury resulting in motor/cognitive impairment and medical complexity

You may not qualify if:

• Has never previously been home/discharged
• Has an expected hospital length of stay \<2 days
• Has a life expectancy of \<4 weeks
• Previous study participation
• Parents
• Parent/legally authorized representative of an eligible child with SNI
• Preferred language of care English and/or Spanish
• Clinicians
• Previous study participation

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (8)

• 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: 32951992 BACKGROUND

• 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: 21555495 BACKGROUND

• 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: 22272190 BACKGROUND

• 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: 23842588 BACKGROUND

• 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: 29174080 BACKGROUND

• 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: 24816425 BACKGROUND

• 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: 35141756 BACKGROUND

• 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.

  PMID: 40034723 DERIVED

MeSH Terms

Conditions

Critical Illness; Nervous System Diseases; Communication; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms

Study Officials

• Jori Bogetz, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jori Bogetz, MD

CONTACT

206-884-0572; jori.bogetz@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Research, Treuman Katz Center for Pediatric Bioethics and Palliative Care

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: February 18, 2026

Record last verified: 2025-05

Locations

US (1)