Mental Health Care Bundle for Pediatric Psychiatric Emergency
Recruiting in Palo Alto (17 mi)
+7 other locations
Overseen ByStephen Freedman, MDCM, MSc
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Calgary
Disqualifiers: Schizophrenia, Psychosis, Self-harm, Substance misuse, others
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
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.
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.
12345Is 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.
13467How 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.
12489Eligibility Criteria
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
+4 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Acute Mental Health Care BundleExperimental Treatment1 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 CareActive Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Children's Hospital of WinnipegWinnipeg, Canada
London Health Sciences CentreLondon, Canada
Janeway Children's HospitalSaint John's, Canada
The Hospital for Sick ChildrenToronto, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
University of CalgaryLead Sponsor
University of Western Ontario, CanadaCollaborator
Memorial University of NewfoundlandCollaborator
Western University, CanadaCollaborator
University of TorontoCollaborator
McGill UniversityCollaborator
Dalhousie UniversityCollaborator
University of AlbertaCollaborator
University of SaskatchewanCollaborator
University of ManitobaCollaborator
References
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]Children and youth with mental health and addiction crises are a vulnerable patient group that often are brought to the hospital for emergency department care. We propose to evaluate the effect of a novel, acute care bundle that standardises a patient-centred approach to care.
Use of quality improvement methods to enhance implementation of a mental health care bundle in a pediatric emergency department. [2023]We used quality improvement methods to implement a care bundle for children presenting to a pediatric emergency department (ED) with mental health concerns. A bundle novelty was that it included an option for assessment in a partnered clinic, not in the ED, to families of children assessed as having no medical or safety concerns. The primary aim of this study was to establish successful implementation of the bundle prior to studying its impact.
Models of integrated care for young people experiencing medical emergencies related to mental illness: a realist systematic review. [2023]Mental illness heightens risk of medical emergencies, emergency hospitalisation, and readmissions. Innovations for integrated medical-psychiatric care within paediatric emergency settings may help adolescents with acute mental disorders to get well quicker and stay well enough to remain out of hospital. We assessed models of integrated acute care for adolescents experiencing medical emergencies related to mental illness (MHR). We conducted a systematic review by searching MEDLINE, PsychINFO, Embase, and Web of Science for quantitative studies within paediatric emergency medicine, internationally. We included populations aged 8-25 years. Our outcomes were length of hospital stay (LOS), emergency hospital admissions, and rehospitalisation. Limits were imposed on dates: 1990 to June 2021. We present a narrative synthesis. This study is registered on PROSPERO: 254,359. 1667 studies were screened, 22 met eligibility, comprising 39,346 patients. Emergency triage innovations reduced admissions between 4 and 16%, including multidisciplinary staffing and training for psychiatric assessment (F(3,42) = 4.6, P < 0.05, N = 682), and telepsychiatry consultations (aOR = 0.41, 95% CI 0.28-0.58; P < 0.001, N = 597). Psychological therapies delivered in emergency departments reduced admissions 8-40%, including psychoeducation (aOR = 0.35, 95% CI 0.17-0.71, P < 0.01, N = 212), risk-reduction counselling for suicide prevention (OR = 2.78, 95% CI 0.55-14.10, N = 348), and telephone follow-up (OR = 0.45, 95% CI 0.33-0.60, P < 0.001, N = 980). Innovations on acute wards reduced readmissions, including guided meal supervision for eating disorders (P = 0.27), therapeutic skills for anxiety disorders, and a dedicated psychiatric crisis unit (22.2 vs 8.5% (P = 0.008). Integrated pathway innovations reduced readmissions between 8 and 37% including family-based therapy (FBT) for eating disorders (X2(1,326) = 8.40, P = 0.004, N = 326), and risk-targeted telephone follow-up or outpatients for all mental disorders (29.5 vs. 5%, P = 0.03, N = 1316). Studies occurred in the USA, Canada, or Australia. Integrated care pathways to psychiatric consultations, psychological therapies, and multidisciplinary follow-up within emergency paediatric services prevented lengthy and repeat hospitalisation for MHR emergencies. Only six of 22 studies adjusted for illness severity and clinical history between before- and after-intervention cohorts and only one reported socio-demographic intervention effects.
An Innovative Model of Pediatric Emergency Department Mental Health Care: Protocol for a Multicenter Type 1 Effectiveness-Implementation Cluster Randomized Trial. [2022]Over the past decade, visits to American and Canadian emergency departments (EDs) for child and youth mental health care have increased substantially.1,2 Acute mental health crises can occur as a result of a variety of concerns, including those that are life threatening (eg, suicide attempts), pose safety concerns (eg, suicidal intentions, aggressive behaviors, alcohol and other drug use), and are physically distressing to the child or youth (eg, panic attacks). ED health care providers play a vital role in assessing the safety and well-being of the child or youth and referring them to services for ongoing care.3,4 During the ED visit, assessment and care should pinpoint risks, inform treatment, and consider family needs and preferences as part of a patient-centered approach. Yet, this approach to care is not widely adopted in EDs. Most EDs do not require the use of pediatric-specific mental health tools to guide assessments or have patient-centered procedures in place to guide the care of patients with mental health emergencies.5-7 Our team believes these limitations have led to the provision of acute mental health care that can lack sufficient quality and efficiency. This study protocol describes a trial designed to evaluate if a novel mental health care bundle that was co-designed with parents and youth results in greater improvements in the well-being of children and youth 30 days after seeking ED care for mental health and/or substance misuse concerns compared with existing care protocols. We hypothesize that the bundle will positively impact child and youth well-being, while also providing cost-effective health care system benefits.
Impact of an Inpatient Psychiatric Unit on Pediatric Emergency Mental Health Care. [2022]Mental health complaints are a frequent presentation to the pediatric emergency department (PED). It is unclear if having an on-site inpatient pediatric psychiatric unit impacts pediatric mental health care in the acute setting. The objective of this study was to compare PED mental health care between a pediatric tertiary care center with an associated inpatient child psychiatric unit (PAPED) and one that does not (NOPED) with the hypothesis that children have longer lengths of stay (LOS) at the PED without an inpatient unit.
Utilizing a Behavioral Health Bundle to Improve Patient and Clinician Safety for Hospitalized Children. [2022]Due to limited psychiatric hospital availability, increasing numbers of pediatric patients with behavioral health (BH) needs are hospitalized in medical units in the US Patients and staff are at increased risk for safety events like self-harm or aggression. Our study aimed to decrease safety events by 25% over a year among hospitalized children with BH diagnoses by implementing an intervention bundle.
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]Patients being discharged from inpatient mental wards often describe safety risks in terms of inadequate information sharing and involvement in discharge decisions. Through stakeholder engagement, we co-designed, developed and adapted two versions of a care bundle intervention, the SAFER Mental Health care bundle for adult and youth inpatient mental health settings (SAFER-MH and SAFER-YMH, respectively), that look to address these concerns through the introduction of new or improved processes of care.
Dedicated pediatric behavioral health unit: serving the unique and individual needs of children in behavioral health crisis. [2013]Pediatric mental health emergencies are an increasing part of emergency medical practice because emergency departments have become the safety net for a fragmented mental health infrastructure that is experiencing critical shortages in services in all sectors. The emergency services for behavioral health unit at Akron Children's Hospital is an innovative model for delivering care to pediatric patients with mental health emergencies. A multidisciplinary team using the expertise of emergency services, psychiatry, social work, parent advisory counsel, security services, and engineering/architecture developed the emergency services for behavioral health unit blueprint, process, and staffing model.
CARES: improving the care and disposition of psychiatric patients in the pediatric emergency department. [2015]Pediatric psychiatric emergencies are a nationwide crisis and have contributed to an increase in behavioral health emergency department (ED) visits. A collaborative response to this crisis was the creation of the Child & Adolescent Rapid Emergency Stabilization (CARES) program. The objective of this study is to determine how the CARES unit influenced length of stay (LOS) and costs for psychiatric patients in the pediatric ED.