Mental Health Care Bundle for Pediatric Psychiatric Emergency

Recruiting at 7 trial locations

Overseen By Stephen Freedman, MDCM, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Disqualifiers: Schizophrenia, Psychosis, Self-harm, Substance misuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

Duration: 4 weeks

6800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators will determine, in an 8-site, hybrid Type 1 cluster randomized effectiveness implementation trial, if an acute mental health care bundle, compared to standard care, improves wellbeing at 30 days in children and youth seeking emergency department care for mental health and substance use concerns.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is the Mental Health Care Bundle for Pediatric Psychiatric Emergency safe for children?

The research suggests that the care bundle is designed to improve safety by standardizing care and reducing safety events like self-harm or aggression among children with mental health needs. It aims to provide a safer environment for both patients and healthcare providers. ^{1 2 3 4 5}

How is the Acute Pediatric Mental Health and Addiction Care Bundle treatment different from other treatments for pediatric psychiatric emergencies?

This treatment is unique because it standardizes a patient-centered approach specifically for pediatric mental health emergencies, which is not commonly used in emergency departments. It includes an option for assessment outside the emergency department for children without immediate medical or safety concerns, aiming to improve well-being and provide cost-effective care. ^{1 2 6 7 8}

What data supports the effectiveness of the Mental Health Care Bundle for Pediatric Psychiatric Emergency treatment?

Research shows that using integrated care models in pediatric emergency settings can reduce hospital admissions and readmissions for mental health crises. These models include multidisciplinary staffing, telepsychiatry consultations, and psychological therapies, which are similar to the components of the care bundle being studied. ^{1 2 5 8 9}

Who Is on the Research Team?

Stephen Freedman, MDCM, MSc

Principal Investigator

University of Calgary

Amanda Newton, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children and teens aged 8 to nearly 18 who are experiencing a mental health crisis, such as anxiety, behavioral issues, or thoughts of self-harm. They must speak English or French. It's not for those with schizophrenia-like symptoms, significant self-harm requiring medical attention, substance misuse/intoxication, or other serious medical concerns.

Inclusion Criteria

I am between 8 and 17 years old.

Chief triage concern of at least one of the following (or comparable) mental health CEDIS triage categories: Anxiety/situational crisis and/or hyperventilation, Bizarre/paranoid behaviour, Concern for patient's welfare, Depression/suicidal/deliberate self-harm, Hallucinations/delusions, Violent/homicidal behaviour, Insomnia, Pediatric disruptive behaviour

Exclusion Criteria

I have symptoms of schizophrenia or related disorders.

I am experiencing changes in my behavior and physical health, like loss of appetite.

Substance misuse/intoxication or altered level of consciousness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an acute mental health care bundle, including triage-based evaluation and psychosocial evaluation, with urgent follow-up care facilitated within 24-48 hours.

4 weeks

Multiple visits as needed for urgent follow-up

Follow-up

Participants are monitored for wellbeing and satisfaction with care at 30, 90, and 180 days after the index ED visit.

6 months

Follow-up assessments at 30, 90, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Acute Pediatric Mental Health and Addiction Care Bundle

Trial Overview The study compares an acute mental health care bundle with standard care in emergency departments across Canada. The goal is to see if the new approach better improves wellbeing after 30 days for young people facing mental health and addiction issues.

How Is the Trial Designed?

Group I: Acute Mental Health Care Bundle Experimental Treatment 1 Intervention

We developed an evidence-based bundle of care to address current gaps in care. The bundle: 1) brings together multiple evidence-based assessment tools (ASQ, HEADS-ED) to ensure efficient, high-value ED-based care; 2) removes barriers to assessment and builds connections to care: Assessments are conducted by a mental health care provider and families have access to urgent follow-up care; and 3) prioritizes family engagement: A shared decision-making framework (Choice and Partnership) is used to promote children and youth as stewards of their care and support partnership between EDs and follow-up services with the duration of care determined collaboratively by the patient and their provider.

Group II: Usual ED-Based Mental Health Care Active Control 1 Intervention

Local standards of ED-based mental health care will be delivered at control sites. Site leads have determined that this care does not involve the 3 specific core innovations in the bundle. Local care standards are similar across study sites and include use of CTAS score at triage (but no mental health risk assessment tool), ED physician medical clearance and assessment of consultation need, and no consistent mental health follow-up plan. Sites that are randomized to the control arm will not adopt core bundle elements.

Acute Pediatric Mental Health and Addiction Care Bundle is already approved in Canada for the following indications:

Approved in Canada as Acute Pediatric Mental Health and Addiction Care Bundle for:

• Pediatric mental health and addiction care

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Memorial University of Newfoundland

Collaborator

Trials

73

Recruited

1,836,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

University of Toronto

Collaborator

Trials

739

Recruited

1,125,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

University of Saskatchewan

Collaborator

Trials

261

Recruited

156,000+

University of Manitoba

Collaborator

Trials

628

Recruited

209,000+

Published Research Related to This Trial

This study evaluates a new care approach for children and youth facing mental health and addiction crises in two pediatric emergency departments in Alberta, Canada, over a 29-month period.

The care bundle includes standardized risk assessments and shared decision-making strategies, aiming to improve child/youth well-being and family functioning after emergency visits, with outcomes measured at 1, 3, and 6 months post-visit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. Freedman, S., Thull-Freedman, J., Lightbody, T., et al.[2021]

The implementation of a new care bundle in a pediatric emergency department successfully standardized mental health assessments, achieving over 80% compliance with the Ask Suicide-Screening Questions and HEADS-ED tools within 5 months.

The care bundle also provided timely follow-up for low-risk children, with 89.3% of families receiving urgent appointments within 96 hours, demonstrating an effective alternative to emergency department assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of quality improvement methods to enhance implementation of a mental health care bundle in a pediatric emergency department. Lightbody, T., Thull-Freedman, J., Freedman, SB., et al.[2023]

Innovative integrated care models in pediatric emergency settings, such as multidisciplinary staffing and telepsychiatry consultations, have been shown to reduce emergency hospital admissions for adolescents with mental health-related medical emergencies by 4 to 16%.

Psychological therapies delivered in emergency departments, including psychoeducation and risk-reduction counseling, significantly decreased admissions by 8 to 40%, highlighting the effectiveness of immediate mental health interventions in preventing hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Models of integrated care for young people experiencing medical emergencies related to mental illness: a realist systematic review. Otis, M., Barber, S., Amet, M., et al.[2023]

Emergency department visits for child and youth mental health care have significantly increased, highlighting the need for improved assessment and treatment protocols during these critical visits.

A new trial will evaluate a co-designed mental health care bundle aimed at enhancing the well-being of children and youth 30 days after emergency care, with the expectation that it will outperform current care methods and offer cost-effective benefits to the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial. Newton, AS., Prisnie, K., Macdonald, LA., et al.[2022]

In a study of 1409 pediatric mental health presentations, a pediatric emergency department (PED) with an on-site inpatient psychiatric unit (PAPED) had a significantly higher admission rate (41.3%) compared to one without (NOPED) at 18.8%.

Patients at the NOPED experienced longer lengths of stay (LOS) in the emergency department, averaging 15.6 hours, compared to 6.3 hours at the PAPED, indicating that having an inpatient unit may facilitate quicker mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Inpatient Psychiatric Unit on Pediatric Emergency Mental Health Care. Sheridan, DC., Johnson, KP., Fu, R., et al.[2022]

The implementation of a behavioral health (BH) intervention bundle in medical units led to a 28% decrease in reported safety events among pediatric patients, although this change was not statistically significant.

Despite the intervention, many staff members felt that the BH bundle impeded workflow and expressed discomfort in caring for BH patients, highlighting the need for better institutional support and coordination in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing a Behavioral Health Bundle to Improve Patient and Clinician Safety for Hospitalized Children. Nicome, R., Lo, HY., Gupta, S., et al.[2022]

The SAFER Mental Health care bundle, designed for both adults (SAFER-MH) and youth (SAFER-YMH), aims to improve discharge processes in inpatient mental health settings by enhancing information sharing and patient involvement, addressing safety concerns expressed by patients.

This study will assess the feasibility and acceptability of the SAFER interventions over a 6-week period using both quantitative and qualitative methods, with the goal of determining if a larger effectiveness trial is viable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study. Tyler, N., Angelakis, I., Keers, RN., et al.[2023]

Pediatric mental health emergencies are on the rise, leading to emergency departments becoming crucial care points due to a lack of mental health services.

Akron Children's Hospital has created an innovative behavioral health unit that utilizes a multidisciplinary team approach, combining various expertises to improve care for children facing mental health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dedicated pediatric behavioral health unit: serving the unique and individual needs of children in behavioral health crisis. Grover, P., Lee, T.[2013]

The implementation of the Child & Adolescent Rapid Emergency Stabilization (CARES) program significantly reduced the average length of stay (LOS) for pediatric psychiatric patients in the emergency department from 19.7 hours to 10.8 hours, indicating improved efficiency in handling psychiatric emergencies.

Post-CARES, there was a notable decrease in costs associated with psychiatric ED visits, with average charges per patient dropping by $905 and total costs decreasing by 38.7%, resulting in total savings of over $1 million in the year following the program's launch.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CARES: improving the care and disposition of psychiatric patients in the pediatric emergency department. Rogers, SC., Griffin, LC., Masso, PD., et al.[2015]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Introducing an innovative model of acute paediatric mental health and addictions care to paediatric emergency departments: a protocol for a multicentre prospective cohort study. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Use of quality improvement methods to enhance implementation of a mental health care bundle in a pediatric emergency department. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Models of integrated care for young people experiencing medical emergencies related to mental illness: a realist systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of an Inpatient Psychiatric Unit on Pediatric Emergency Mental Health Care. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Utilizing a Behavioral Health Bundle to Improve Patient and Clinician Safety for Hospitalized Children. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating a co-designed care bundle to improve patient safety at discharge from adult and adolescent mental health services (SAFER-MH and SAFER-YMH): protocol for a non-randomised feasibility study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Dedicated pediatric behavioral health unit: serving the unique and individual needs of children in behavioral health crisis. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

CARES: improving the care and disposition of psychiatric patients in the pediatric emergency department. [2015]