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| Name | Class |
|---|---|
| University of Alberta | OTHER |
| University of Saskatchewan | OTHER |
| University of Manitoba | OTHER |
| McMaster University |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Mental Health Care Bundle | Experimental | We developed an evidence-based bundle of care to address current gaps in care. The bundle: 1) brings together multiple evidence-based assessment tools (ASQ, HEADS-ED) to ensure efficient, high-value ED-based care; 2) removes barriers to assessment and builds connections to care: Assessments are conducted by a mental health care provider and families have access to urgent follow-up care; and 3) prioritizes family engagement: A shared decision-making framework (Choice and Partnership) is used to promote children and youth as stewards of their care and support partnership between EDs and follow-up services with the duration of care determined collaboratively by the patient and their provider. |
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| Usual ED-Based Mental Health Care | No Intervention | Local standards of ED-based mental health care will be delivered at control sites. Site leads have determined that this care does not involve the 3 specific core innovations in the bundle. Local care standards are similar across study sites and include use of CTAS score at triage (but no mental health risk assessment tool), ED physician medical clearance and assessment of consultation need, and no consistent mental health follow-up plan. Sites that are randomized to the control arm will not adopt core bundle elements. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Services | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days after the index emergency department (ED) visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Age 8 to 17.99 years
Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:
Exclusion Criteria:
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)
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Freedman, MDCM, MSc | University of Calgary | Principal Investigator |
| Amanda Newton, PhD | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Winnipeg | Winnipeg | Manitoba | R3E 0Z3 | Canada | ||
| Janeway Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35715176 | Derived | Rasiah J, Freedman S, Macdonald L, Prisnie K, Eltorki M, Finkelstein Y, Hopkin G, Santana MJ, Thull-Freedman J, Stang A, Prebeg M, Gagnon IJ, Steele M, Mater A, Katz L, Greenfield B, Plotnick L, Monga S, Lipman EL, Wright B, Dimitropoulos G, Porter R, Hurley K, Al Hamarneh YN, Newton A. Evaluation of parent and youth experiences in advisory groups as part of a mental healthcare clinical trial: protocol for a mixed-method study. BMJ Open. 2022 Jun 17;12(6):e059689. doi: 10.1136/bmjopen-2021-059689. |
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IPD will not be shared with other researchers.
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| OTHER |
| Western University, Canada | OTHER |
| University of Toronto | OTHER |
| McGill University | OTHER |
| Dalhousie University | OTHER |
| Memorial University of Newfoundland | OTHER |
Pragmatic, parallel arm cluster randomized trial
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| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | Measured based on admissions following the index ED visit (Day 0) |
| St. John's |
| Newfoundland and Labrador |
| A1B 3V6 |
| Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | Canada |
| Jim Pattison Children's Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D006296 | Health Services |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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