Family Communication and Support in the Pediatric Intensive Care Unit

NCT ID: NCT02144779

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2015-10-31

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.

Conditions

Reducing Post Traumatic Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Usual care

No treatment for this group

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

usual hospital care, not assigned to palliative care team

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

Group Type: EXPERIMENTAL

Assigned to palliative care team

Intervention Type: BEHAVIORAL

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

Interventions

Assigned to palliative care team

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

Intervention Type: BEHAVIORAL

Usual Care

usual hospital care, not assigned to palliative care team

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ross Hays

OTHER

Sponsor Role: lead

Responsible Party

Ross Hays

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ross Hays, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Childrens Hospital

Locations

Seattle Childrens Hospital

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23194167 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23540309 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31256606 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27263074 (View on PubMed)

Other Identifiers

1RO1NRO11179

Identifier Type: -

Identifier Source: org_study_id