Critical Illness, Neurologic Disorder
Conditions
Keywords
pediatric palliative care, communication, severe neurological impairment
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.
Detailed description
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.
Interventions
BEHAVIORAL"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 electronically along with suggested discussion prompts to use with parents..
Sponsors
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | enrollment and PICU discharge (assessed up to 4 weeks) | 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. |
| Acceptability | PICU discharge (assessed up to 4 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale (PSS) | enrollment and PICU discharge (assessed up to 4 weeks) | 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. |
| Neuro-QOL Stigma Short-Form | enrollment and PICU discharge (assessed up to 4 weeks) | 8-item measure of stigma associated with neurological illness; 5-point Likert scale; higher scores suggest more perceived stigma. |
| Benefit Finding Scale | enrollment and PICU discharge (assessed up to 4 weeks) | 14-item measure of areas of personal growth; 5-point Likert scale (range 10-49); higher scores suggest more benefit finding. |
| Connor Davidson Resilience Scale (CD-RISC 10) | enrollment and PICU discharge (assessed up to 4 weeks) | 10-item measure of self-perceived resilience; 5-point Likert scale (range 0-40); higher scores suggesting greater resilience. |
| Human Connection Scale (HCS) | enrollment and PICU discharge (assessed up to 4 weeks) | 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. |
| Climate of Respect Evaluation in Intensive Care Units (CORE-ICU) | enrollment and PICU discharge (assessed up to 4 weeks) | 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). |
| Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections | enrollment and PICU discharge (assessed up to 4 weeks) | 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. |
Countries
United States
Contacts
CONTACTJori Bogetz, MD
PRINCIPAL_INVESTIGATORJori Bogetz, MD
Seattle Children's Hospital
Outcome results
None listed