An Innovative Model of Pediatric Acute Mental Health and Addictions Care

NCT ID: NCT04292379

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1992 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-29

Study Completion Date

2023-01-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Mental Health Mental Disorders Pediatrics Emergency Psychiatric

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a quasi-experimental study design conducted in three phases. Phase 1 involves standard care. Phase 2 involves introducing a new care bundle to clinical practice using quality improvement and change management strategies. Phase 3 involves delivery of the care bundle.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard care

Mental health visits involve an assessment by a triage nurse who classifies visit urgency into one of five acuity levels using the Canadian Triage and Acuity Scale (CTAS) score. Following triage, children could be assessed by a range of health care providers: emergency department nurse, emergency department physician, mental health nurse, and/or a child and adolescent psychiatrist. Standardized tools are not typically used to guide assessments. Most discharge instructions require families to organize the child's follow-up care.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard procedures and assessments

Care Bundle

The bundle standardized suicide risk screening at triage, introduced a focused mental health assessment to guide discussions across health care providers, and included a booked follow-up appointment after the emergency department visit.

Group Type EXPERIMENTAL

Care Bundle

Intervention Type OTHER

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

Interventions

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Standard care

Standard procedures and assessments

Intervention Type OTHER

Care Bundle

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

University of Alberta

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Newton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

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Alberta Children's Hospital

Calgary, Alberta, Canada

Site Status

Stollery Children's Hospital

Edmonton, Alberta, Canada

Site Status

Countries

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Canada

References

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Newton AS, Thull-Freedman J, Xie J, Lightbody T, Woods J, Stang A, Winston K, Larson J, Wright B, Stubbs M, Morrissette M, Freedman SB; Pediatric Emergency Research Canada (PERC). Outcomes Following a Mental Health Care Intervention for Children in the Emergency Department: A Nonrandomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2461972. doi: 10.1001/jamanetworkopen.2024.61972.

Reference Type DERIVED
PMID: 40009377 (View on PubMed)

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):e001106. doi: 10.1136/bmjoq-2020-001106.

Reference Type DERIVED
PMID: 33318032 (View on PubMed)

Other Identifiers

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REB19-0357

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00092862

Identifier Type: -

Identifier Source: org_study_id

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