Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)
Condition: Post-Intensive Care Syndrome; Anxiety; Depression; Stress Disorders, Post-Traumatic; Quality of Life; Satisfaction, Patient
MeSH terms: Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Hospital diaries
Intervention type(s): Behavioral
Intervention description(s): Diaries will be used by family members, PICU staff or even the patient himself. They will take daily notes expressing feelings and thoughts and describing events that might help chronologically to better understand the course of disease and PICU stay. Photographs and other important PICU memories may also be used in the diary.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a multicentric two-arm two-period crossover study: in the first phase each PICU will be randomized between intervention (PICU with diaries) and control (PICU without diaries), crossing over in the second phase after a washout period.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Post-Intensive Care Syndrome; Anxiety; Depression; Post-Traumatic Stress Disorder; Health-related Quality of Life; Satisfaction with Care