Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    400
  • sponsor
    D'Or Institute for Research and Education
Updated on 22 July 2021
depression
anxiety
depressed mood

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.

Description

More than one third of parents and patients admitted to Pediatric Intensive Care Units (PICU) develop Anxiety, Depression and Posttraumatic Stress Disorder (PTSD), with consequent decrease in quality of life and great social impact, known as Pediatric and Family Post-Intensive Care Syndrome (PICS and PICS-F). Strategies that minimize negative outcomes after discharge have been adopted, such as the use of hospital diaries to regularly record the impressions of family members and health professionals about the patient's evolution, hosting parents and encouraging their direct participation in care.

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 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, totaling 200 family members in the intervention group and 200 controls. 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 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. Quality of life and incidence of new morbidities will be evaluated in children at discharge and follow-up, as well as Burnout Syndrome in the health team. The association of clinical, social and demographic variables with family- and patient-centered outcomes will be investigated on an exploratory basis.

With this study, we aim to contribute to a better knowledge about different family-centered outcomes in intensive care, allowing reduction of health problems and the development of policies that seek to alleviate suffering, to humanize intensive environments and encourage participation of family members in child care during hospitalization.

Details
Condition Client satisfaction, Endogenous depression, Depression, Post-Traumatic Stress Disorder, Quality of life, ANXIETY NEUROSIS, Anxiety, Depressed, Anxiety Symptoms, Anxiety Disorders, Post Intensive Care Syndrome, depressive disorder, anxiety disorder, depressed mood, miserable, quality-of-life, depressive disorders, anxious
Treatment Hospital diaries
Clinical Study IdentifierNCT04961697
SponsorD'Or Institute for Research and Education
Last Modified on22 July 2021

Eligibility

Yes No Not Sure

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
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