An Innovative Model of Pediatric Acute Mental Health and Addictions Care

Mental Health Clinical Trial

Official title:

An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292379
• Other study ID #: Pro00092862
• Secondary ID: REB19-0357
• Status: Completed
• Start date: January 29, 2020
• Est. completion date: January 24, 2023

Study information

• Verified date: September 2022
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.

Description:

The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, emergency mental health and addictions care. This care bundle will provide high value to families, matching resources and services to need while eliminating healthcare inefficiencies and closing care gaps. The bundle will introduce two well-established tools for healthcare providers to use in EDs, walk-in clinics, and urgent mental health care appointments. These tools are the 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).

The bundle will also introduce new processes to improve healthcare system efficiencies, navigation and transitions between healthcare sectors. For families who receive care in the ED, the investigators will remove the physician gatekeeper role so that children/youth who are screened as low-risk will be offered a follow-up appointment in an urgent mental health care clinic within 24-48 hours. Those who screen as high-risk will see a mental health specialist and undergo a HEADS-ED assessment. Families who follow up in the clinic will receive care that applies a Choice And Partnership Approach (CAPA). CAPA is a collaborative approach to healthcare, where healthcare providers work in partnership with children/youth and their parents to identify choices for care that best match individual needs and preferences.

Study Goal: The investigators' goal is the right care, with the right people, at the right place and time.

Study Design: To measure the bundle's impact, the investigators will use an interrupted time series (ITS) design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1992
• Est. completion date: January 24, 2023
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patient is under 18 years of age

• Patient came to the emergency department with a mental health and/or addiction concern

• Patient presented with one of the following CEDIS complaints:

Anxiety, bizarre behaviour, concern for patient's welfare, deliberate self-harm, depression/suicidal, homicidal behaviour, insomnia, pediatric disruptive behaviour, situational crisis, violent behaviour

Exclusion Criteria:

• Brought to the ED by police, peace officer or EMS?

• Held under Form 10

• Features of schizophrenia, schizotypal and delusional disorders (e.g., hallucinations, delusions, active psychosis)

• Behavioural syndromes or other medical concerns requiring medical clearance (e.g., eating disorders)

• Significant self-harm requiring medical clearance (e.g., deep laceration, ingestion, hanging)

• Barriers to communication at triage (e.g., language)

• Previous participation in the study

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	Stollery Children's Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Death by suicide within 30 days of the index ED visit	Measured using coroner's data	30 days after the index ED visit
Primary	Patient wellbeing at 30 days	Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients =14 years of age, and the Stirling Children's Wellbeing Scale (SCWBS) for patients <14 years of age.; For the WEMWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.; For the SCWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.	30 days after the index emergency department (ED) visit
Secondary	Patient wellbeing at 90 and 180 days	Measured in survey completed by the participant using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) for patients =14 years of age, and the Stirling Children's Wellbeing Scale (SCWBS) for patients <14 years of age.; For the WEMWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.; For the SCWBS, each item is scored on a range from 1 to 5. The resulting 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 defined as a decrease by 5 or more points.	90 days, and 180 days after the index ED visit
Secondary	Family functioning	Measured in survey completed by the participant using the 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	Satisfaction with acute mental health and addictions ED care	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	Proportion of children/youth admitted to child mental health service (child and adolescent psychiatry, mental health team, etc.)	Measured using data collected in the patient electronic medical record	Index ED visit (Day 0)
Secondary	Length of ED stay for discharged patients with any mental health presenting complaint	Measured using data collected in the patient electronic medical record. ED Length of stay is defined as the time between patient triage and discharge from the emergency department	Hours spent in the ED, measured at the index ED visit (Day 0)
Secondary	Proportion of ED revisits within 72 hours and 30 days for mental health and substance use disorders	Measured using data collected in the patient electronic medical record	72 hours and 30 days after the index ED visit (Day 0)