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Completed

NCT Number: NCT02144779

Family Communication and Support in the Pediatric Intensive Care Unit

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Childrens Hospital

Seattle, Washington, 98105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Assigned to palliative care team

Behavioral

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

Usual Care

Behavioral

usual hospital care, not assigned to palliative care team

Primary outcomes

  1. 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

  1. Acute Stress Disorder

    Time frame: Baseline, and up to 90 days after

    Will be measured using the Acute Stress Disorder Scale

  2. Communication Satisfaction

    Time frame: Baseline, and up to 90 days after

    Questions will be asked about family satisfaction with provider communication.

  3. Conflict

    Time frame: Baseline and up to 90 days after

    Questions will be asked about conflict with providers.

Other outcomes

  1. Mental Health Symptoms

    Time frame: Baseline and up to 90 days after

    Will be measured with the PHQ-9 (Depression) and GAD-7 (Anxiety) scales.

  2. Family Relationship

    Time frame: Baseline and up to 90 days after

    Will be measured using the Family relationship index

  3. Social Support

    Time frame: Baseline and up to 90 days after

    Will be measured using the Perceived Social Support scale.

Sponsors and collaborators

Lead sponsor

Ross Hays

Other

Registry information

Official study title

Improving Family Outcomes With a Communication Intervention in the Pediatric ICU

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 22, 2014
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.