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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
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..
Seattle Children's Hospital
Seattle, Washington, United States
RECRUITINGFeasibility
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.
Time frame: 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.
Time frame: PICU discharge (assessed up to 4 weeks)
Perceived Stress Scale (PSS)
10-item measure of the degree to which participants appraise their situation as stressful; 5-point Likert scale (range 0- 40); scores 14-26 moderate and \>27 high levels of stress.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Neuro-QOL Stigma Short-Form
8-item measure of stigma associated with neurological illness; 5-point Likert scale; higher scores suggest more perceived stigma.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Benefit Finding Scale
14-item measure of areas of personal growth; 5-point Likert scale (range 10-49); higher scores suggest more benefit finding.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Connor Davidson Resilience Scale (CD-RISC 10)
10-item measure of self-perceived resilience; 5-point Likert scale (range 0-40); higher scores suggesting greater resilience.
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Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Human Connection Scale (HCS)
16-item measure of sense of fondness, mutual understanding, caring, and trust with clinicians; 4-point Likert scale (range 16-64); higher scores suggest greater therapeutic alliance.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Climate of Respect Evaluation in Intensive Care Units (CORE-ICU)
21-item measure of 3 domains of respect as perceived by patients/surrogates in the ICU; 5-point Likert scale; higher scores on overall (range 7-42) and respectful behaviors (range 10-60) suggest greater respect, and lower respect on the disrespectful behaviors subsection (range 4-24).
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)
Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections
The 7-item empathic concern scale measures feelings of sympathy towards other people and is strongly correlated with measures of concern for others. The 7-item perspective-taking scale measures the tendency to adopt the psychological point of view of other people. Items are rated on a 4-point Likert scale and have very good internal consistency (Cronbach alpha=.81-.87) and validity in clinicians.
Time frame: enrollment and PICU discharge (assessed up to 4 weeks)