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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | No treatment for this group |
|
| Assigned to palliative care team | Experimental | The intervention group will be assigned to a palliative care team member that will facilitate communication and meetings between families and the medical team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assigned to palliative care team | Behavioral | Communication and Support through the palliative care team assigned to intervention participants. |
|
| 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 |
| 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. |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ross Hays, MD | Seattle Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Childrens Hospital | Seattle | Washington | 98105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23194167 | Background | 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. | |
| 23540309 | Background | 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. |
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| Usual Care | Behavioral | usual hospital care, not assigned to palliative care team |
|
| Baseline, and up to 90 days after |
| Conflict | Questions will be asked about conflict with providers. | Baseline and up to 90 days after |
| 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 |
| 31256606 | Derived | 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. |
| 27263074 | Derived | 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. |