Family and Patient Outcomes After Pediatric Intensive Care (FOREVER)
NCT ID: NCT04961697
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
431 participants
INTERVENTIONAL
2019-12-20
2021-12-16
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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PICU with diaries
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.
Hospital diaries
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 without diaries
This group of critically ill patients and family members will not receive diaries, but will also be submitted to usual PICU routine care.
No interventions assigned to this group
Interventions
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Hospital diaries
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
29 Days
12 Years
ALL
No
Sponsors
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Rio de Janeiro State Research Supporting Foundation (FAPERJ)
OTHER_GOV
D'Or Institute for Research and Education
OTHER
Responsible Party
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Principal Investigators
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Fernanda Lima-Setta
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education
Locations
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D'Or Institute for Research and Education
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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FOREVER
Identifier Type: -
Identifier Source: org_study_id