Family and Patient Outcomes After Pediatric Intensive Care (FOREVER) (NCT04961697) | Clinical Trial Compass
CompletedNot Applicable
Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)
Brazil431 participantsStarted 2019-12-20
Plain-language summary
This study aims to evaluate in the Brazilian context, the impact of the implementation of a diary program on patient and family-centered outcomes after PICU discharge. The intervention investigated will be the use of hospital diaries for the critically ill child in a cross-over study, randomized by clusters in four PICUs of Rio de Janeiro. Family members of children aged 29 days to 12 years, admitted for more than 36 hours will be included and data collection will take place upon admission, at PICU discharge and 60 days after discharge from the PICU.
Family-centered outcomes assessed will be: satisfaction with care, anxiety and depression at discharge, incidence of anxiety, depression, PTSD, burden and quality of life in follow-up. Patient-centered outcomes will be assessed in children at discharge and follow-up - quality of life and incidence of new morbidities will be evaluated. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis. Burnout Syndrome in PICU health professionals will be assessed before and after the intervention as a proxy of intervention security for PICU staff.
Who can participate
Age range
29 Days – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients between age limits admitted in PICU for clinical or surgical reasons with 36 or more hours of stay and their main family member.
* Physicians, registered nurses, nurse technicians, physical therapists and other professionals working in participants PICU involved in caring for patients and their families and taking notes in the diaries
Exclusion Criteria:
* Patients admitted for monitorization or elective low-complexity surgeries
* Patients readmitted between the first admission and the first follow-up visit
* Patients in palliative care
* Families with linguistic or comprehension barriers
* Families residencies situated outside Rio de Janeiro metropolitan region
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This FOREVER study has already completed — does that mean my doctor can access the findings about how families experience anxiety, depression, and PTSD after a child's pediatric ICU stay, and would those results be relevant to our situation?
2Since this study tracked real outcomes in family members of critically ill children — not just the child themselves — should our family be screened for anxiety or PTSD symptoms, and is that something my doctor or the care team can help arrange?
3The trial focused on quality of life and mental health for both patients and families after a pediatric ICU admission — are there support programs or follow-up resources at this hospital that address those same concerns for us?
4Given that this was an observational study measuring how often these mental health issues occur rather than testing a treatment, does my doctor know of any active intervention trials or support services specifically designed to help families cope after a pediatric intensive care experience?
5Are the findings from this study something my doctor would recommend I review, and could they help me understand what the results might mean for deciding whether our family needs formal mental health follow-up care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of anxiety symptoms in family member from critically ill child.
Timeframe: 45-60 days after PICU discharge
2
Incidence of depression symptoms in family member from critically ill child.
Timeframe: 45-60 days after PICU discharge
3
Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.