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Family Communication and Support in the Pediatric Intensive Care Unit

Improving Family Outcomes With a Communication Intervention in the Pediatric ICU

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02144779
Enrollment
220
Registered
2014-05-22
Start date
2009-09-30
Completion date
2015-10-31
Last updated
2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reducing Post Traumatic Stress

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.

Interventions

BEHAVIORALAssigned to palliative care team

Communication and Support through the palliative care team assigned to intervention participants.

BEHAVIORALUsual Care

usual hospital care, not assigned to palliative care team

Sponsors

Ross Hays
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post Traumatic Stress Disorder90 days after baselinePTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale.

Secondary

MeasureTime frameDescription
Acute Stress DisorderBaseline, and up to 90 days afterWill be measured using the Acute Stress Disorder Scale
Communication SatisfactionBaseline, and up to 90 days afterQuestions will be asked about family satisfaction with provider communication.
ConflictBaseline and up to 90 days afterQuestions will be asked about conflict with providers.

Other

MeasureTime frameDescription
Family RelationshipBaseline and up to 90 days afterWill be measured using the Family relationship index
Social SupportBaseline and up to 90 days afterWill be measured using the Perceived Social Support scale.
Mental Health SymptomsBaseline and up to 90 days afterWill be measured with the PHQ-9 (Depression) and GAD-7 (Anxiety) scales.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026