An interventional study of Assigned to palliative care team and Usual Care in Reducing Post Traumatic Stress, sponsored by Ross Hays. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-20.
Sponsored by Ross Hays · Not applicable, Interventional, and Health services research
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.
This is the only study on the registry with Ross Hays as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No treatment for this group
Behavioral: Usual Care
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
Communication and Support through the palliative care team assigned to intervention participants.
usual hospital care, not assigned to palliative care team
Post Traumatic Stress Disorder
PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale.
Time frame: 90 days after baseline
Acute Stress Disorder
Will be measured using the Acute Stress Disorder Scale
Time frame: Baseline, and up to 90 days after
Communication Satisfaction
Questions will be asked about family satisfaction with provider communication.
Time frame: Baseline, and up to 90 days after
Conflict
Questions will be asked about conflict with providers.
Time frame: Baseline and up to 90 days after
Mental Health Symptoms
Will be measured with the PHQ-9 (Depression) and GAD-7 (Anxiety) scales.
Time frame: Baseline and up to 90 days after
Family Relationship
Will be measured using the Family relationship index
Time frame: Baseline and up to 90 days after
Social Support
Will be measured using the Perceived Social Support scale.
Time frame: Baseline and up to 90 days after
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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