NCT04902391

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,800 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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: 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.

Conditions

• Mental Health
• Mental Disorders
• Pediatrics
• Emergency Psychiatric

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-09
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2021-05-26
• Last updated: 2025-07-17

Locations

8 sites across 1 country: Canada