A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle

Conditions
-----------------
Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric

Intervention / Treatment
-----------------
* Other: Health Services


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Anxiety/situational crisis and/or hyperventilation Bizarre/paranoid behaviour Concern for patient's welfare Depression/suicidal/deliberate self-harm Hallucinations/delusions Violent/homicidal behaviour Insomnia Pediatric disruptive behaviour 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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic, parallel arm cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute Mental Health Care Bundle<br>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. | Other: Health Services<br>* 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.<br>|
| No Intervention: Usual ED-Based Mental Health Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Emergency Psychiatric Services, Healthcare Delivery