Family Communication and Support in the Pediatric Intensive Care Unit

Study Overview
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Brief Summary
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This project is evaluating the effect of a standardized communication intervention in the pediatric intensive care unit (PICU) on long-term distress of family members of children in the PICU for 5 days or longer. The study hypothesis is that intervention families will have lower (better) acute stress disorder scores when their child is discharged from the PICU and lower (better) post-traumatic stress disorder scores at 3-month follow-up, as compared to the control group families. The investigators will recruit 220 families (110 in each of the control and intervention groups). Families who are randomized to the intervention group will receive routine visits from members of the PACT (palliative care) team at least three times/week to address psychosocial needs, keep families informed about their child's health status, and offer emotional and instrumental support and resources. Families in the control group will receive usual care in the PICU. The intervention will end whenever the child is discharged from the PICU, which usually happens within 3 weeks of enrollment. The investigators will assess family outcomes at discharge from the PICU and 90 days after study enrollment. The investigators will conduct two additional activities to learn more about the processes of care for those in both the intervention and control groups. First, during the intervention, the investigators will recruit 30 families (15 in each group) and ask permission to audio-record the family care conferences to assess communication styles and gain greater insight into the differences in practice with or without the participation of the intervention team. The investigators will obtain additional consent from participants in these family conferences who are not otherwise enrolled in the study. Second, after completion of the 3-month follow-up interview, a sub-sample of a different 30 families (again, 15 in each group) will be invited to participate in qualitative interviews to debrief about their experience in the study and the intervention (for those in that group). This will be a one-time interview scheduled within 60 days of recruitment for this part of the project.

Official Title
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Improving Family Outcomes With a Communication Intervention in the Pediatric ICU

Conditions
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Reducing Post Traumatic Stress

Intervention / Treatment
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* Behavioral: Assigned to palliative care team
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older actively involved in the life of the patient receiving care; and functionally fluent in English or Spanish. Exclusion Criteria: discharge plan in place for patient before day 4 previously received palliative care patient placed on extracorporeal membrane oxygenation (ECMO) no prior admission to ICU for same hospitalization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>No treatment for this group | Behavioral: Usual Care<br>* usual hospital care, not assigned to palliative care team<br>|
| Experimental: Assigned to palliative care team<br>The intervention group will be assigned to a palliative care team member that will facilitate communication and meetings between families and the medical team | Behavioral: Assigned to palliative care team<br>* Communication and Support through the palliative care team assigned to intervention participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Traumatic Stress Disorder | PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale. | 90 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Stress Disorder | Will be measured using the Acute Stress Disorder Scale | Baseline, and up to 90 days after | 
| Communication Satisfaction | Questions will be asked about family satisfaction with provider communication. | Baseline, and up to 90 days after | 
| Conflict | Questions will be asked about conflict with providers. | Baseline and up to 90 days after |