Clinical trial NCT04961697: Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)
Official title: Family and Patient Outcomes After Pediatric Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Intensive Care Syndrome
Anxiety
Depression
Stress Disorders, Post-Traumatic
Quality of Life
Satisfaction, Patient
Keywords: Post-Intensive Care Syndrome
Anxiety
Depression
Post-Traumatic Stress Disorder
Health-related Quality of Life
Satisfaction with Care
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2021-07-14
Enrollment: 430
Sex: ALL
Minimum age (years): 29
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of anxiety symptoms in family member from critically ill child.
timeFrame: 45-60 days after PICU discharge
measure: Incidence of depression symptoms in family member from critically ill child.
timeFrame: 45-60 days after PICU discharge
measure: Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.
timeFrame: 45-60 days after PICU discharge
Secondary outcomes:
measure: Evaluate family satisfaction with PICU care as measured by EMpowerment of PArents in THe Intensive Care 30 (EMPATHIC-30) questionnaire.
timeFrame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
measure: Evaluate alterations in family quality of life as measured by Short Form 12 (SF-12) questionnaire
timeFrame: 45-60 days after PICU discharge
measure: Incidence of Anxiety and Depression in family members of a critically ill child using HADS instrument upon PICU discharge.
timeFrame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
measure: Incidence of New Morbidity in critically ill children at PICU discharge.
timeFrame: Until 72 hours after the patient discharge from Pediatric Intensive Care Unit
measure: Incidence of New Morbidity in critically ill children after PICU discharge.
timeFrame: 45-60 days after PICU discharge
measure: Evaluate alterations in critically ill children Quality of Life as measured by Pediatric Quality of Life Questionnaire (PedsQL).
timeFrame: 45-60 days after PICU discharge
measure: Prevalence of Burden in the main family member after PICU discharge measured with Zarit Burden Scale.
timeFrame: 45-60 days after PICU discharge
measure: Perceptions of health professionals regarding the use of PICU diaries
timeFrame: One-month after the intervention period, which ends after the inclusion of 50 patient's family-members.
measure: Perceptions of parents and main family members of a critically ill child regarding the use of PICU diaries
timeFrame: 45-60 days after PICU discharge upon intervention period
measure: Evaluate alterations in the three dimensions of the Maslach Burnout Inventory - emotional exhaustion, depersonalization and personal accomplishment - in PICU health professional.
timeFrame: One month before the beginning of the intervention in the PICU and one-month after the end of intervention period, which ends after the inclusion of 50 patient's family-members.
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: D'Or Institute for Research and Education
Study officials:
affiliation: D'Or Institute for Research and Education
name: Fernanda Lima-Setta
role: PRINCIPAL_INVESTIGATOR
References:
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