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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mental Disorders; Mental Health; Pediatrics; Emergency Psychiatric
• Intervention / Treatment: Other: Health Services

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:

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
• Enrollment (Estimated): 6800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Freedman, MDCM, MSc; Phone Number: 403-955-7749; Email: Stephen.Freedman@ahs.ca
• Study Contact Backup: Name: Amanda Newton, PhD; Phone Number: 780-248-5581; Email: an6@ualberta.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0Z3
      • Recruiting
      • The Children's Hospital of Winnipeg
      • Contact: Scott Sawyer, MD; Phone Number: 204-787-2433; Email: ssawyer@hsc.mb.ca
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Recruiting
      • Janeway Children's Hospital
      • Contact: Robert Porter, MD; Phone Number: 709-777-4239; Email: rporter@mun.ca
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Recruiting
      • IWK Health Centre
      • Contact: Jonathan Cherry, MD; Phone Number: 902-470-8003; Email: jonathan.cherry@iwk.nshealth.ca
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Recruiting
      • McMaster Children's Hospital
      • Contact: Mohamed Eltorki, MD; Phone Number: 905-521-2100; Email: eltorkim@mcmaster.ca
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
      • Contact: Gary Joubert, MD; Phone Number: 58134 519-685-8500; Email: gary.joubert@lhsc.on.ca
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Yaron Finkelstein, MD; Phone Number: 416-813-5317; Email: yaron.finkelstein@sickkids.ca
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Montreal Children's Hospital
      • Contact: Laurie Plotnick, MD; Phone Number: 514-412-4499; Email: laurie.plotnick@mcgill.ca
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Recruiting
      • Jim Pattison Children's Hospital
      • Contact: Ahmed Mater, MD; Phone Number: 306-655-2965; Email: mater999@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 8 to 17.99 years

2. Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories:

   1. Anxiety/situational crisis and/or hyperventilation
   2. Bizarre/paranoid behaviour
   3. Concern for patient's welfare
   4. Depression/suicidal/deliberate self-harm
   5. Hallucinations/delusions
   6. Violent/homicidal behaviour
   7. Insomnia
   8. Pediatric disruptive behaviour

Exclusion Criteria:

1. Brought to the ED under provincial mental health legislation
2. Exhibiting features of schizophrenia, schizotypal, delusional disorders, or psychosis (e.g., hallucinations/delusions complaint should be reviewed carefully for this exclusion criterion)
3. Significant self-harm act (i.e., suicide attempt requiring medical clearance, excluding ideation or minor superficial wounds; e.g., laceration/puncture, overdose ingestion, etc.)
4. 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.)
5. Substance misuse/intoxication or altered level of consciousness

6. Exhibiting a behavioural syndrome associated with physiologic disturbances (e.g., anorexia)

   Children/youth will also be excluded based on language barriers:

7. Language barrier (i.e., patient and parent/legal guardian must be fluent in either English or French)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute Mental Health Care Bundle; 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; 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.
No Intervention: Usual ED-Based Mental Health Care; 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)

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of Manitoba; McGill University; University of Alberta; McMaster University; University of Toronto; Dalhousie University; Western University, Canada; University of Saskatchewan; Memorial University of Newfoundland
• Investigators: Principal Investigator: Amanda Newton, PhD, University of Alberta; Principal Investigator: Stephen Freedman, MDCM, MSc, University of Calgary

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Psychiatric Services; Healthcare Delivery
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Mental Disorders
• Other Study ID Numbers: REB20-1825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No