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

University of Calgary

Status: Active, not recruiting

Conditions: Pediatrics; Mental Disorders; Emergency Psychiatric; Mental Health

Treatments: Other: Health Services

Study type: Interventional

Funder types: Other

Identifiers

NCT04902391

REB20-1825

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,800 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,800 participants in 2 patient groups

Acute Mental Health Care Bundle

Experimental group

Description:

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.

Treatment:

Other: Health Services

Usual ED-Based Mental Health Care

No Intervention group

Description:

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.