An Innovative Model of Pediatric Acute Mental Health and Addictions Care

NCT04292379 | Completed

• 2 other identifiers: Pro00092862REB19-0357
• Study Type: interventional
• Target: 1,992
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Mental Health; Mental Disorders; Pediatrics; Emergency Psychiatric

Keywords

Emergency Psychiatric Services; Healthcare Delivery

Outcome Measures

Primary Outcomes (1)

• Patient wellbeing at 30 days

  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 Outcomes (6)

• Patient wellbeing at 90 and 180 days

  90 days, and 180 days after the index ED visit

• Family functioning

  30 days after the index ED visit

• Satisfaction with acute mental health and addictions ED care

  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.)

  Index ED visit (Day 0)

• 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)

Other Outcomes (1)

• Death by suicide within 30 days of the index ED visit

  30 days after the index ED visit

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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.

Other: Standard care

Care Bundle

EXPERIMENTAL

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.

Other: Care Bundle

Interventions

Standard care OTHER

Standard procedures and assessments

Standard care

Care Bundle OTHER

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

Care Bundle

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• University of Calgary: collaborator

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

• 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.

  PMID: 40009377 DERIVED

• 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.

  PMID: 33318032 DERIVED

MeSH Terms

Conditions

Psychological Well-Being; Mental Disorders

Interventions

Standard of Care; Patient Care Bundles

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics

Study Officials

• Amanda Newton, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 3, 2020
• Study Start: January 29, 2020
• Primary Completion: June 20, 2022
• Study Completion: January 24, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)