Skip to main content
Clinical Trials/NCT02144779
NCT02144779
Completed
N/A

Improving Family Outcomes With a Communication Intervention in the Pediatric ICU

Ross Hays1 site in 1 country220 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Reducing Post Traumatic Stress
Sponsor
Ross Hays
Enrollment
220
Locations
1
Primary Endpoint
Post Traumatic Stress Disorder
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ross Hays
Responsible Party
Sponsor Investigator
Principal Investigator

Ross Hays

MD

Seattle Children's Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post Traumatic Stress Disorder

Time Frame: 90 days after baseline

PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale.

Secondary Outcomes

  • Acute Stress Disorder(Baseline, and up to 90 days after)
  • Communication Satisfaction(Baseline, and up to 90 days after)
  • Conflict(Baseline and up to 90 days after)

Study Sites (1)

Loading locations...

Similar Trials