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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2025
  • participants needed
    6800
  • sponsor
    University of Calgary
Updated on 26 May 2022

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.

Details
Condition Mental Health, Mental Disorders, Pediatrics, Emergency Psychiatric
Treatment Health Services
Clinical Study IdentifierNCT04902391
SponsorUniversity of Calgary
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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 by police, peace officers, or EMS
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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