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

Обзор

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.

Подробное описание

Pilot randomized controlled trial of the "What Is Important to Us" communication intervention. Parents of children with severe neurological impairment in the ICU and their clinicians will be enrolled at the time of the child's ICU admission (baseline) and complete pre-intervention surveys before randomization. Intervention-arm parents and clinicians will complete the "What Is Important to Us" intervention. Post-intervention (within 1 week of ICU discharge) surveys will be completed by parents and clinicians. The control-arm parents will receive usual care (including standard psychosocial supports such as social work). Control-arm parents and clinicians will complete study surveys at the same timepoints. Semi-structured interviews will be completed with intervention-arm parents and clinicians following survey completion to guide further intervention enhancements and future work.

Вмешательства

• Поведенческое "What Is Important to Us" Communication Intervention
  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 e

Первичные конечные точки

• Feasibility [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Acceptability [Срок оценки: PICU discharge (assessed up to 4 weeks)]

Вторичные конечные точки (7)

• Perceived Stress Scale (PSS) [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Neuro-QOL Stigma Short-Form [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Benefit Finding Scale [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Connor Davidson Resilience Scale (CD-RISC 10) [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Human Connection Scale (HCS) [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Climate of Respect Evaluation in Intensive Care Units (CORE-ICU) [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]
• Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections [Срок оценки: enrollment and PICU discharge (assessed up to 4 weeks)]

Критерии участия

Children with SNI

Inclusion

• 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

Exclusion

• 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

Inclusion

• Parent/legally authorized representative of an eligible child with SNI
• Preferred language of care English and/or Spanish

Clinicians

Inclusion -Licensed physicians, nurses, advanced practice providers, respiratory therapists at study site

Exclusion

-Previous study participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Seattle Children's Hospital — Seattle

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06208332 · STUDY00004439

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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