A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 6,800
- 试验地点
- 16
- 主要终点
- Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
研究概览
简要总结
The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.
详细描述
The investigators we co-designed, with parents and youth, an acute mental health care bundle-a set of evidence informed practices collectively used to improve the quality of care. The bundle of care includes:
- Triage-based evaluation of risk for suicide [Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education & Employment; Activities & Peers; Drugs & Alcohol; Suicidality; Emotions & Behaviours; Discharge or Current Resources]
- Focused mental health team psychosocial evaluation to guide decision-making
- Choice And Partnership Approach (CAPA) to care
This bundle of care also strives to remove the ED physician as the gatekeeper to mental health care and will facilitate, ideally, 24-48 hour urgent mental health follow-up (booked before the child/family leave the ED), with up to 96 hours to coordinate follow-up for patients attending the ED on weekends.
Primary Research Objective: To determine, in an 8-site, hybrid Type I cluster randomized effectiveness-implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking ED care for mental health and substance use concerns.
Secondary Research Objectives: (1) To determine if the bundle improves wellbeing, satisfaction with care, family functioning, and health care delivery; (2) To identify modifiable barriers, constraints, and enablers of bundle implementation fidelity and effectiveness; (3) To test if trial intervention effects are moderated by sociodemographic characteristics (sex, gender, ethnicity, culture, education, and socioeconomic status); and (4) To assess the cost-effectiveness of the approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8 to 17.99 years
- •Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
- •Anxiety/situational crisis and/or hyperventilation
- •Bizarre/paranoid behaviour
- •Concern for patient's welfare
- •Depression/suicidal/deliberate self-harm
- •Hallucinations/delusions
- •Violent/homicidal behaviour
- •Pediatric disruptive behaviour
排除标准
- •Brought to the ED under provincial mental health legislation
- •Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion)
- •Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.)
- •Other co-morbid medical concerns requiring oversight and/or medical clearance from an emergency physician (e.g., confusion/disorientation, substance withdrawal, other medical complaints, etc.)
- •Substance misuse/intoxication or altered level of consciousness
- •Exhibiting a behavioural syndrome associated with physiologic disturbances (e.g., anorexia)
- •Children/youth will also be excluded based on language barriers:
- •Language barrier (i.e., patient and parent/legal guardian must be fluent in either English or French)
结局指标
主要结局
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
时间窗: 30 days after the index emergency department (ED) visit
Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients ≥13 years Each item is scored on a range from 1 to 5. The total score will be between 14 and 70, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 45. A substantial decrease in wellbeing is a decrease by 5 or more points.
Stirling Children's Wellbeing Scale 30 days after the index ED visit
时间窗: 30 days after the index emergency department (ED) visit
Measured in survey completed by the participant using the Stirling Children's Wellbeing Scale (SCWBS) for patients \<13 years. Each item is scored on a range from 1 to 5. The total score will be between 12 and 60, with lower scores indicating poor wellbeing, and higher scores indicating greater wellbeing. Very low wellbeing is defined as a score of ≤ 30. A substantial decrease in wellbeing is a decrease by 5 or more points. As these scales used for the primary outcomes measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
次要结局
- Median duration of the index ED visits(Hours spent in the ED, measured at the index ED visit (Day 0))
- Proportion of children and youth that revisited the emergency department for a mental health complaint related to their index emergency department visit within 7 and 30 days of the index visit(7 and 30 days after the index ED visit)
- Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index ED visit(180 days after the index ED visit)
- Stirling Children's Wellbeing Scale at 180 days after the index ED visit(180 days after the index ED visit)
- Proportion of emergency department visits for mental healthcare that concluded in hospital admission(Measured based on admissions following the index ED visit (Day 0))
- Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10(72 hours after the index ED visit)
- Quality of life as measured by the Beach Center Family Quality of Life Scale(30 days after the index ED visit)
- Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index ED visit(90 after the index ED visit)
- Stirling Children's Wellbeing Scale at 90 days after the index ED visit(90 after the index ED visit)