Clinical trial NCT04902391: A Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Acute Pediatric Mental Health and Addiction Care Bundle
Official title: A Multi-Disciplinary, Patient-Partnered, Pan-Canadian, Comparative Effectiveness Evaluation of an Innovative Acute Pediatric Mental Health and Addiction Care Bundle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Mental Disorders
Pediatrics
Emergency Psychiatric
Keywords: Emergency Psychiatric Services
Healthcare Delivery
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Alberta
name: University of Saskatchewan
name: University of Manitoba
name: McMaster University
name: Western University, Canada
name: University of Toronto
name: McGill University
name: Dalhousie University
name: Memorial University of Newfoundland
First posted: 2021-05-26
Enrollment: 6800
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, parallel arm cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Warwick-Edinburgh Mental Wellbeing Scale 30 days after the index ED visit
timeFrame: 30 days after the index emergency department (ED) visit
measure: Stirling Children's Wellbeing Scale 30 days after the index ED visit
timeFrame: 30 days after the index emergency department (ED) visit
Secondary outcomes:
measure: Satisfaction with acute mental health care services as measured by the Service Satisfaction Scale 10
timeFrame: 72 hours after the index ED visit
measure: Quality of life as measured by the Beach Center Family Quality of Life Scale
timeFrame: 30 days after the index ED visit
measure: Warwick-Edinburgh Mental Wellbeing Scale at 90 days after the index ED visit
timeFrame: 90 after the index ED visit
measure: Stirling Children's Wellbeing Scale at 90 days after the index ED visit
timeFrame: 90 after the index ED visit
measure: Warwick-Edinburgh Mental Wellbeing Scale at 180 days after the index ED visit
timeFrame: 180 days after the index ED visit
measure: Stirling Children's Wellbeing Scale at 180 days after the index ED visit
timeFrame: 180 days after the index ED visit
measure: Median duration of the index ED visits
timeFrame: Hours spent in the ED, measured at the index ED visit (Day 0)
measure: 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
timeFrame: 7 and 30 days after the index ED visit
measure: Proportion of emergency department visits for mental healthcare that concluded in hospital admission
timeFrame: Measured based on admissions following the index ED visit (Day 0)
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: The Children's Hospital of Winnipeg
state: Manitoba
city: Saint John's
country: Canada
facility: Janeway Children's Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Saskatoon
country: Canada
facility: Jim Pattison Children's Hospital
state: Saskatchewan
Study officials:
affiliation: University of Calgary
name: Stephen Freedman, MDCM, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Amanda Newton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.