Reducing Post Traumatic Stress Clinical Trial
Official title:
Improving Family Outcomes With a Communication Intervention in the Pediatric ICU
| Verified date | November 2015 |
| Source | Seattle Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| United States | Seattle Childrens Hospital | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Ross Hays |
United States,
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Mental Health Symptoms | Will be measured with the PHQ-9 (Depression) and GAD-7 (Anxiety) scales. | Baseline and up to 90 days after | No |
| Other | Family Relationship | Will be measured using the Family relationship index | Baseline and up to 90 days after | No |
| Other | Social Support | Will be measured using the Perceived Social Support scale. | Baseline and up to 90 days after | No |
| Primary | Post Traumatic Stress Disorder | PTSD will be measures using the Post Traumatic Stress Disorder (PCL-C) scale. | 90 days after baseline | No |
| Secondary | Acute Stress Disorder | Will be measured using the Acute Stress Disorder Scale | Baseline, and up to 90 days after | No |
| Secondary | Communication Satisfaction | Questions will be asked about family satisfaction with provider communication. | Baseline, and up to 90 days after | No |
| Secondary | Conflict | Questions will be asked about conflict with providers. | Baseline and up to 90 days after | No |