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An Innovative Model of Pediatric Acute Mental Health and Addictions Care

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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

Tracking Information
First Submitted Date February 27, 2020
First Posted Date March 3, 2020
Last Update Posted Date October 6, 2021
Actual Study Start Date January 29, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 3, 2020)
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.
Original Primary Outcome Measures
 (submitted: February 27, 2020)
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
Change History
Current Secondary Outcome Measures
 (submitted: September 3, 2020)
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: February 27, 2020)
  • 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
  • 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)
  • 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)
  • Proportion of children/youth admitted to child mental health service (child and adolescent psychiatry, mental health team, etc.) [ Time Frame: Index ED visit ]
    Measured using data collected in the patient electronic medical record
  • Length of ED stay for discharged patients with any mental health presenting complaint [ Time Frame: Index ED visit ]
    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
  • 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 ]
    Measured using data collected in the patient electronic medical record
Current Other Pre-specified Outcome Measures
 (submitted: February 27, 2020)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title An Innovative Model of Pediatric Acute Mental Health and Addictions Care
Official Title An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System
Brief Summary The investigators will implement and evaluate an integrated, evidence-based bundle of family-centred, pediatric emergency mental health and addictions care.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Mental Health
  • Mental Disorders
  • Pediatrics
  • Emergency Psychiatric
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Freedman S, Thull-Freedman J, Lightbody T, Prisnie K, Wright B, Coulombe A, Anderson LM, Stang AS, Mikrogianakis A, VanRiper L, Stubbs M, Newton A; Pediatric Emergency Research Canada (PERC). Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. BMJ Open Qual. 2020 Dec;9(4). pii: e001106. doi: 10.1136/bmjoq-2020-001106.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2020)
7984
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Years to 17 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Amanda Newton, PhD 780-248-5581 an6@ualberta.ca
Contact: Stephen Freedman, MDCM, MSc 403-955-7749 Stephen.Freedman@ahs.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04292379
Other Study ID Numbers Pro00092862
REB19-0357 ( Other Identifier: University of Calgary )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers.
Current Responsible Party University of Alberta
Original Responsible Party Same as current
Current Study Sponsor University of Alberta
Original Study Sponsor Same as current
Collaborators University of Calgary
Investigators
Principal Investigator: Amanda Newton, PhD University of Alberta
PRS Account University of Alberta
Verification Date October 2021