Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)

NCT04961697 | Completed

• 1 other identifier: FOREVER
• Study Type: interventional
• Target: 431
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic; Quality of Life; Satisfaction, Patient; Post-Intensive Care Syndrome; Anxiety; Depression

Keywords

Post-Intensive Care Syndrome; Anxiety; Depression; Post-Traumatic Stress Disorder; Health-related Quality of Life; Satisfaction with Care

Outcome Measures

Primary Outcomes (3)

• Incidence of anxiety symptoms in family member from critically ill child.

  Proportion of main family member positive for anxiety symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of anxiety symptoms will be determined when 9 or more points on each subscale.

  45-60 days after PICU discharge

• Incidence of depression symptoms in family member from critically ill child.

  Proportion of main family member positive for depression symptoms as measured by HADS (Hospital Anxiety and Depression Scale from Zigmond and Snaith), a self-report standardized 14-item questionnaire covering an anxiety 7-question subscale and a depression 7-question subscale. Each subscale includes Likert-scaled questions ranging from 0 to 3. Presence of depression symptoms will be determined when 9 or more points on each subscale.

  45-60 days after PICU discharge

• Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.

  Proportion of main family member positive for PTSD as measured by PCL-5 (Posttraumatic Stress Disorder Checklist for DSM-V - Diagnostic and Statistical Manual of Mental Disorders - V from Weathers et al), a self-report standardized 20-item questionnaire covering four dimensions of symptoms: intrusions, avoidance, negative alterations in cognitions and mood and alterations in arousal and reactivity. Each subscale includes Likert-scaled questions ranging from 0 (not at all) to 4 (extremely). Presence of PTSD symptoms when 33 or more total points or positivity in each DSM-V dimension.

  45-60 days after PICU discharge

Secondary Outcomes (10)

• Evaluate family satisfaction with PICU care as measured by EMpowerment of PArents in THe Intensive Care 30 (EMPATHIC-30) questionnaire.

  Until 72 hours after the patient discharge from Pediatric Intensive Care Unit

• Evaluate alterations in family quality of life as measured by Short Form 12 (SF-12) questionnaire

  45-60 days after PICU discharge

• Incidence of Anxiety and Depression in family members of a critically ill child using HADS instrument upon PICU discharge.

  Until 72 hours after the patient discharge from Pediatric Intensive Care Unit

• Incidence of New Morbidity in critically ill children at PICU discharge.

  Until 72 hours after the patient discharge from Pediatric Intensive Care Unit

• Incidence of New Morbidity in critically ill children after PICU discharge.

  45-60 days after PICU discharge

Study Arms (2)

PICU with diaries

EXPERIMENTAL

The main family member of a critically ill child will receive a diary upon PICU admission. Except for the diaries intervention, this group of patients will be submitted to usual PICU routine care.

Behavioral: Hospital diaries

PICU without diaries

NO INTERVENTION

This group of critically ill patients and family members will not receive diaries, but will also be submitted to usual PICU routine care.

Interventions

Hospital diaries BEHAVIORAL

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.

PICU with diaries

Eligibility Criteria

• Age: 29 Days - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

D'Or Institute for Research and Education

Rio de Janeiro, Rio de Janeiro, 22281-100, Brazil

Location

Related Publications (10)

• Harvey MA. The truth about consequences--post-intensive care syndrome in intensive care unit survivors and their families. Crit Care Med. 2012 Aug;40(8):2506-7. doi: 10.1097/CCM.0b013e318258e943. No abstract available.

  PMID: 22809925 BACKGROUND

• Huggins EL, Bloom SL, Stollings JL, Camp M, Sevin CM, Jackson JC. A Clinic Model: Post-Intensive Care Syndrome and Post-Intensive Care Syndrome-Family. AACN Adv Crit Care. 2016 Apr-Jun;27(2):204-11. doi: 10.4037/aacnacc2016611.

  PMID: 27153309 BACKGROUND

• Myers EA, Smith DA, Allen SR, Kaplan LJ. Post-ICU syndrome: Rescuing the undiagnosed. JAAPA. 2016 Apr;29(4):34-7. doi: 10.1097/01.JAA.0000481401.21841.32.

  PMID: 27023654 BACKGROUND

• Svenningsen H, Langhorn L, Agard AS, Dreyer P. Post-ICU symptoms, consequences, and follow-up: an integrative review. Nurs Crit Care. 2017 Jul;22(4):212-220. doi: 10.1111/nicc.12165. Epub 2015 Feb 17.

  PMID: 25688675 BACKGROUND

• Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.

  PMID: 27984278 BACKGROUND

• Needham DM, Davidson J, Cohen H, Hopkins RO, Weinert C, Wunsch H, Zawistowski C, Bemis-Dougherty A, Berney SC, Bienvenu OJ, Brady SL, Brodsky MB, Denehy L, Elliott D, Flatley C, Harabin AL, Jones C, Louis D, Meltzer W, Muldoon SR, Palmer JB, Perme C, Robinson M, Schmidt DM, Scruth E, Spill GR, Storey CP, Render M, Votto J, Harvey MA. Improving long-term outcomes after discharge from intensive care unit: report from a stakeholders' conference. Crit Care Med. 2012 Feb;40(2):502-9. doi: 10.1097/CCM.0b013e318232da75.

  PMID: 21946660 BACKGROUND

• Elliott D, Davidson JE, Harvey MA, Bemis-Dougherty A, Hopkins RO, Iwashyna TJ, Wagner J, Weinert C, Wunsch H, Bienvenu OJ, Black G, Brady S, Brodsky MB, Deutschman C, Doepp D, Flatley C, Fosnight S, Gittler M, Gomez BT, Hyzy R, Louis D, Mandel R, Maxwell C, Muldoon SR, Perme CS, Reilly C, Robinson MR, Rubin E, Schmidt DM, Schuller J, Scruth E, Siegal E, Spill GR, Sprenger S, Straumanis JP, Sutton P, Swoboda SM, Twaddle ML, Needham DM. Exploring the scope of post-intensive care syndrome therapy and care: engagement of non-critical care providers and survivors in a second stakeholders meeting. Crit Care Med. 2014 Dec;42(12):2518-26. doi: 10.1097/CCM.0000000000000525.

  PMID: 25083984 BACKGROUND

• Jezierska N. Psychological reactions in family members of patients hospitalised in intensive care units. Anaesthesiol Intensive Ther. 2014 Jan-Mar;46(1):42-5. doi: 10.5603/AIT.2014.0009.

  PMID: 24643927 BACKGROUND

• Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.

  PMID: 22080636 BACKGROUND

• Goldfarb MJ, Bibas L, Bartlett V, Jones H, Khan N. Outcomes of Patient- and Family-Centered Care Interventions in the ICU: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Oct;45(10):1751-1761. doi: 10.1097/CCM.0000000000002624.

  PMID: 28749855 BACKGROUND

MeSH Terms

Conditions

postintensive care syndrome; Anxiety Disorders; Depression; Stress Disorders, Post-Traumatic; Patient Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Fernanda Lima-Setta

  D'Or Institute for Research and Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the intervention is the use of hospital diaries there will be masking in the outpatient follow-up data collection and posterior data analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 14, 2021
• Study Start: December 20, 2019
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

BR (1)