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Completed

NCT Number: NCT04292379

An Innovative Model of Pediatric Acute Mental Health and Addictions Care

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

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Key information

Conditions

Mental Health Behavior Emergency Psychiatric Mental Disorders Pediatrics Personal Satisfaction Psychological Well-Being

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Other

Standard procedures and assessments

Care bundle

Other

Suicide risk screening tool, mental health assessment tool, follow-up appointment

Primary outcomes

  1. Patient wellbeing at 30 days

    Time frame: 30 days after the index emergency department (ED) visit

    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.

Secondary outcomes

  1. Patient wellbeing at 90 and 180 days

    Time frame: 90 days, and 180 days after the index ED visit

    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.

  2. Family functioning

    Time frame: 30 days after the index ED visit

    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.

  3. Satisfaction with acute mental health and addictions ED care

    Time frame: 72 hours after the index ED visit

    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.

  4. Proportion of children/youth admitted to child mental health service (child and adolescent psychiatry, mental health team, etc.)

    Time frame: Index ED visit (Day 0)

    Measured using data collected in the patient electronic medical record

  5. Length of ED stay for discharged patients with any mental health presenting complaint

    Time frame: Hours spent in the ED, measured at the index ED visit (Day 0)

    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

  6. Proportion of ED revisits within 72 hours and 30 days for mental health and substance use disorders

    Time frame: 72 hours and 30 days after the index ED visit (Day 0)

    Measured using data collected in the patient electronic medical record

Other outcomes

  1. Death by suicide within 30 days of the index ED visit

    Time frame: 30 days after the index ED visit

    Measured using coroner's data

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • University of Calgary

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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