An Innovative Model of Pediatric Acute Mental Health and Addictions Care

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT04292379
Collaborator
University of Calgary (Other)
7,984
2
31.1
3992
128.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    7984 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System
    Actual Study Start Date :
    Jan 29, 2020
    Anticipated Primary Completion Date :
    Jun 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Patient wellbeing at 30 days [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 Outcome Measures

    1. Patient wellbeing at 90 and 180 days [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 [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 [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.) [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 [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 [72 hours and 30 days after the index ED visit (Day 0)]

      Measured using data collected in the patient electronic medical record

    Other Outcome Measures

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

      Measured using coroner's data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alberta Children's Hospital Calgary Alberta Canada T3B 6A8
    2 Stollery Children's Hospital Edmonton Alberta Canada T6G 2B7

    Sponsors and Collaborators

    • University of Alberta
    • University of Calgary

    Investigators

    • Principal Investigator: Amanda Newton, PhD, University of Alberta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT04292379
    Other Study ID Numbers:
    • Pro00092862
    • REB19-0357
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Alberta
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021