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

Mental Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04902391
• Other study ID #: REB20-1825
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2022
• Est. completion date: August 1, 2025

Study information

• Verified date: September 2023
• Source: University of Calgary
• Contact: Stephen Freedman, MDCM, MSc
• Phone: 403-955-7749
• Email: Stephen.Freedman[@]ahs.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6800
• Est. completion date: August 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Emergency Psychiatric
• Mental Disorders
• Mental Health
• Pediatrics

Intervention

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.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Children's Hospital	Montréal	Quebec
Canada	Janeway Children's Hospital	Saint John's	Newfoundland and Labrador
Canada	Jim Pattison Children's Hospital	Saskatoon	Saskatchewan
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	The Children's Hospital of Winnipeg	Winnipeg	Manitoba

Sponsors (10)

Lead Sponsor	Collaborator
University of Calgary	Dalhousie University, McGill University, McMaster University, Memorial University of Newfoundland, University of Alberta, University of Manitoba, University of Saskatchewan, University of Toronto, Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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)