Family and Patient Outcomes After Pediatric Intensive Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 431
- 试验地点
- 2
- 主要终点
- Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Since the intervention is the use of hospital diaries there will be masking in the outpatient follow-up data collection and posterior data analysis.
入排标准
- 年龄范围
- 29 Days 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of PTSD (Posttraumatic Stress Disorder) in family member from critically ill child.
时间窗: 45-60 days after PICU discharge
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.
Incidence of anxiety symptoms in family member from critically ill child.
时间窗: 45-60 days after PICU discharge
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.
Incidence of depression symptoms in family member from critically ill child.
时间窗: 45-60 days after PICU discharge
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.
次要结局
- Incidence of New Morbidity in critically ill children after PICU discharge.(45-60 days after PICU discharge)
- Evaluate alterations in critically ill children Quality of Life as measured by Pediatric Quality of Life Questionnaire (PedsQL).(45-60 days after PICU discharge)
- 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)
- 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)
- Perceptions of health professionals regarding the use of PICU diaries(One-month after the intervention period, which ends after the inclusion of 50 patient's family-members.)
- Evaluate alterations in family quality of life as measured by Short Form 12 (SF-12) questionnaire(45-60 days after PICU discharge)
- Perceptions of parents and main family members of a critically ill child regarding the use of PICU diaries(45-60 days after PICU discharge upon intervention period)
- Evaluate alterations in the three dimensions of the Maslach Burnout Inventory - emotional exhaustion, depersonalization and personal accomplishment - in PICU health professional.(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.)
- Prevalence of Burden in the main family member after PICU discharge measured with Zarit Burden Scale.(45-60 days after PICU discharge)