- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292379
An Innovative Model of Pediatric Acute Mental Health and Addictions Care
An Innovative Model of Pediatric Acute Mental Health and Addictions Care to Increase Value to Children,Youth, and the Healthcare System
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T3B 6A8
- Alberta Children's Hospital
-
Edmonton, Alberta, Canada, T6G 2B7
- Stollery Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
30 days after the index emergency department (ED) visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
90 days, and 180 days after the index ED visit
|
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.
|
30 days after the index ED visit
|
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.
|
72 hours after the index ED visit
|
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
|
Index ED visit (Day 0)
|
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
|
Hours spent in the ED, measured at the index ED visit (Day 0)
|
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
|
72 hours and 30 days after the index ED visit (Day 0)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
30 days after the index ED visit
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Amanda Newton, PhD, University of Alberta
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00092862
- REB19-0357 (Other Identifier: University of Calgary)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Disorders
-
Kansas State UniversityAugusta University; Dartmouth College; University of CincinnatiEnrolling by invitationMental Disorders, Severe | Mental Illness PersistentUnited States
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
University of ManchesterEuropean Research CouncilRecruitingMental Disorders, SevereUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Active, not recruitingMental Disorders, SevereSpain
-
University of North Carolina, Chapel HillU.S. Department of JusticeCompletedMental Disorders, SevereUnited States
-
Liga Romana pentru Sanatate MintalaPsychiatric Hospital for Chronic Patients Siret, Suceava, RomaniaUnknown