Family Communication and Support in the Pediatric Intensive Care Unit

Improving Family Outcomes With a Communication Intervention in the Pediatric ICU

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.

Study Overview

• Status: Completed
• Conditions: Reducing Post Traumatic Stress
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Assigned to palliative care team

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; No treatment for this group	Behavioral: Usual Care; usual hospital care, not assigned to palliative care team
Experimental: Assigned to palliative care team; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health Symptoms	Will be measured with the PHQ-9 (Depression) and GAD-7 (Anxiety) scales.	Baseline and up to 90 days after
Family Relationship	Will be measured using the Family relationship index	Baseline and up to 90 days after
Social Support	Will be measured using the Perceived Social Support scale.	Baseline and up to 90 days after

Collaborators and Investigators

• Sponsor: Ross Hays
• Investigators: Principal Investigator: Ross Hays, MD, Seattle Childrens Hospital

Publications and helpful links

General Publications

• Doorenbos A, Lindhorst T, Starks H, Aisenberg E, Curtis JR, Hays R. Palliative care in the pediatric ICU: challenges and opportunities for family-centered practice. J Soc Work End Life Palliat Care. 2012;8(4):297-315. doi: 10.1080/15524256.2012.732461.
• Doorenbos AZ, Starks H, Bourget E, McMullan DM, Lewis-Newby M, Rue TC, Lindhorst T, Aisenberg E, Oman N, Curtis JR, Hays R; Seattle Ethics in ECLS (SEE) Consortium, Clark JD, Baden HP, Brogan TV, Di Gennaro JL, Mazor R, Roberts JS, Turnbull J, Wilfond BS. Examining palliative care team involvement in automatic consultations for children on extracorporeal life support in the pediatric intensive care unit. J Palliat Med. 2013 May;16(5):492-5. doi: 10.1089/jpm.2012.0536. Epub 2013 Mar 29.
• Iwata M, Han S, Hays R, Doorenbos AZ. Predictors of Depression and Anxiety in Family Members 3 Months After Child's Admission to a Pediatric ICU. Am J Hosp Palliat Care. 2019 Oct;36(10):841-850. doi: 10.1177/1049909119859517. Epub 2019 Jun 30.
• Starks H, Doorenbos A, Lindhorst T, Bourget E, Aisenberg E, Oman N, Rue T, Curtis JR, Hays R. The Family Communication Study: A randomized trial of prospective pediatric palliative care consultation, study methodology and perceptions of participation burden. Contemp Clin Trials. 2016 Jul;49:15-20. doi: 10.1016/j.cct.2016.05.004. Epub 2016 Jun 1.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 19, 2014
• First Posted (Estimate): May 22, 2014

Study Record Updates

• Last Update Posted (Estimate): November 20, 2015
• Last Update Submitted That Met QC Criteria: November 19, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 1RO1NRO11179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No