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.
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: 1. Triage-based evaluation of risk for suicide \[Ask Suicide-Screening Questions (ASQ) and HEADS-ED, an assessment mnemonic (Home; Education \& Employment; Activities \& Peers; Drugs \& Alcohol; Suicidality; Emotions \& Behaviours; Discharge or Current Resources\] 2. Focused mental health team psychosocial evaluation to guide decision-making 3. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
The Acute Mental Health Care Bundle consists of 3 core elements, including: (1) ED triage, (2) ED assessment and care, and (3) follow-up care.
The Children's Hospital of Winnipeg
Winnipeg, Manitoba, Canada
Janeway Children's Hospital
St. John's, Newfoundland and Labrador, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index 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.
Time frame: 30 days after the index emergency department (ED) visit
Stirling Children's Wellbeing Scale 30 days after the index 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.
Time frame: 30 days after the index emergency department (ED) visit
Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10
Measured in survey completed by the participant using the Service Satisfaction Scale 10 (SSS-10). The scale consists of 12 items (parent version) or 10 items (youth version). Items are scored on a 5-point response scale with a total possible score of 60 (parent) or 50 (youth). Higher scores indicate higher satisfaction.
Time frame: 72 hours after the index ED visit
Quality of life as measured by the Beach Center Family Quality of Life Scale
Measured in survey completed by the participant using the Beach Center Family Quality of Life Scale (FQOL). The 25-item scale uses a 5-point rating with a maximum score of 125 indicating highest quality of life.
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Enrollment
6,800
London Health Sciences Centre
London, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, Canada
Time frame: 30 days after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index 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.
Time frame: 90 after the index ED visit
Stirling Children's Wellbeing Scale at 90 days after the index 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 the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
Time frame: 90 after the index ED visit
Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index 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.
Time frame: 180 days after the index ED visit
Stirling Children's Wellbeing Scale at 180 days after the index 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 the WEMWBS and SCWBS measure the same construct, data will be standardized and combined across age groups to derive a single measure of wellbeing.
Time frame: 180 days after the index ED visit
Median duration of the index ED visits
Measured using data collected in the patient electronic medical record. ED Length of stay is defined as the time interval between triage and discharge
Time frame: 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
Measured using data collected in the patient electronic medical record.
Time frame: 7 and 30 days after the index ED visit
Proportion of emergency department visits for mental healthcare that concluded in hospital admission
Measured using data collected in the patient electronic medical record.
Time frame: Measured based on admissions following the index ED visit (Day 0)