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An Innovative Model of Pediatric Acute Mental Health and Addictions Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04292379
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
University of Alberta

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
Mental Health Mental Disorders Pediatrics Emergency Psychiatric

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.

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Study Type : Observational
Estimated 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 : January 29, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : September 2022





Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients less than 18 years of age that present to the emergency department with a mental health complaint, and do not require medical clearance by an emergency department physician.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292379


Contacts
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Contact: Amanda Newton, PhD 780-248-5581 an6@ualberta.ca
Contact: Stephen Freedman, MDCM, MSc 403-955-7749 Stephen.Freedman@ahs.ca

Locations
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Canada, Alberta
Alberta Children's Hospital Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact: Stephen Freedman, MDCM, MSc    403-955-7740    Stephen.Freedman@ahs.ca   
Contact: Kassi Prisnie, MSc    403-955-3187    Kassi.Prisnie@ahs.ca   
Principal Investigator: Stephen Freedman, MDCM, MSc         
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Bruce Wright, MD    780-248-5575    Bruce.Wright2@ahs.ca   
Contact: Nicole Gehring, BSc    780-248-5581    ngehring@ualberta.ca   
Principal Investigator: Amanda Newton, PhD         
Sponsors and Collaborators
University of Alberta
University of Calgary
Investigators
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Principal Investigator: Amanda Newton, PhD University of Alberta
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04292379    
Other Study ID Numbers: Pro00092862
REB19-0357 ( Other Identifier: University of Calgary )
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Emergency Psychiatric Services
Healthcare Delivery
Additional relevant MeSH terms:
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Emergencies
Mental Disorders
Disease Attributes
Pathologic Processes