The "What Is Important to Us" Communication Intervention Pilot Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None (Participant)
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with SNI
- •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
- •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
- •Parent/legally authorized representative of an eligible child with SNI
- •Preferred language of care English and/or Spanish
- •Inclusion -Licensed physicians, nurses, advanced practice providers, respiratory therapists at study site
- •Previous study participation
排除标准
- 未提供
研究组 & 干预措施
"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.
干预措施: "What Is Important to Us" Communication Intervention (Behavioral)
Usual Care
Usual supportive care
结局指标
主要结局
Feasibility
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Climate of Respect Evaluation in Intensive Care Units (CORE-ICU)(enrollment and PICU discharge (assessed up to 4 weeks))
- Interpersonal Reactivity Index (IRI) Empathetic Concern and Perspective-taking Subsections(enrollment and PICU discharge (assessed up to 4 weeks))
研究者
Jori Bogetz
Director, Research, Treuman Katz Center for Pediatric Bioethics and Palliative Care
Seattle Children's Hospital