Mental Health Care Bundle for Pediatric Psychiatric Emergency

Not currently recruiting at 9 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a special mental health care bundle can better support children and teens in emergency situations compared to standard care. It focuses on improving the wellbeing of young people who visit the emergency department for mental health or substance use issues. The trial will compare two groups: one receiving usual emergency department care and the other receiving a new bundle, called the Acute Pediatric Mental Health and Addiction Care Bundle, which includes thorough assessments, family involvement, and follow-up care. Participants aged 8 to 17 who visit the emergency room for reasons such as anxiety, depression, or disruptive behavior are eligible.

As an unphased trial, this study offers participants the chance to contribute to innovative approaches in mental health care for young people.

Will I have to stop taking my current medications?

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

What prior data suggests that the Acute Pediatric Mental Health and Addiction Care Bundle is safe for children and youth?

Research has shown that the Acute Pediatric Mental Health and Addiction Care Bundle is designed for safety. This method standardizes care, reducing incidents such as self-harm or aggression. The care bundle employs tools like ASQ and HEADS-ED, proven assessments that ensure effective care in the emergency room. This approach removes obstacles to assessment and enhances connections to follow-up care. Overall, the bundle supports a safer and more efficient care process for children and teens in mental health crises. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Acute Mental Health Care Bundle because it addresses gaps in pediatric psychiatric emergency care by integrating multiple evidence-based assessment tools, like ASQ and HEADS-ED, to ensure efficient and high-value care. Unlike typical emergency department practices, this bundle removes barriers by having assessments conducted by mental health care providers and ensuring urgent follow-up care for families. It also emphasizes family engagement using a shared decision-making framework, which empowers children and youth to take charge of their care and strengthens partnerships between emergency departments and follow-up services.

What evidence suggests that the Acute Pediatric Mental Health and Addiction Care Bundle is effective for improving wellbeing in children and youth seeking emergency department care for mental health and substance use concerns?

Research has shown that the Acute Pediatric Mental Health and Addiction Care Bundle, which participants in this trial may receive, aims to improve mental health care for children in emergency settings. It achieves this by using proven assessment tools and encouraging better family involvement. The bundle combines several evidence-based tools, such as ASQ and HEADS-ED, to ensure a thorough evaluation. Initial findings suggest it helps remove obstacles and makes follow-up care easier to access. However, one study found that it did not improve children's well-being 30 days after an emergency visit. The bundle is designed to enhance satisfaction with care and family functioning, but more data is needed to confirm its effectiveness. ^{1 2 3 6 7}

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

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7737085/

Introducing an innovative model of acute paediatric mental ... The primary study end-point is child/youth well-being 1 month after the emergency department visit. Secondary outcomes include family ...

2. clinicaltrials.gov clinicaltrials.gov/show/NCT04902391

Study Details | NCT04902391 | A Patient-Partnered, Pan ... Secondary Research Objectives: (1) To determine if the bundle improves wellbeing, satisfaction with care, family functioning, and health care delivery; (2) To ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830757

Outcomes Following a Mental Health Care Intervention for ... Objectives To evaluate the outcomes of a novel mental health care bundle on child well-being, satisfaction with care, and health system metrics.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40009377/

Outcomes Following a Mental Health Care Intervention for ... In this study, the delivery of a care bundle was not associated with higher child well-being 30 days after an ED visit.

5. jaacap.org jaacap.org/article/S0890-8567(22)00187-3/abstract

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

6. withpower.com withpower.com/trial/mental-health-care-bundle-for-pediatric-psychiatric-emergency-b97f8

Mental Health Care Bundle for Pediatric Psychiatric ... 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 ...

7. annemergmed.com annemergmed.com/article/S0196-0644(23)00431-6/fulltext

The Management of Children and Youth With Pediatric ... Advance research related to the acute management of pediatric MBH disorders and potential prevention strategies for MBH emergencies (eg, acute psychiatric care ...