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Improving Transitions in Care for Children and Youth With Mental Health Concerns

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ClinicalTrials.gov Identifier: NCT02590302
Recruitment Status : Not yet recruiting
First Posted : October 29, 2015
Last Update Posted : July 31, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The overarching goal of this project is to improve timely access to appropriate mental health (MH) care for children and youth. The investigators will conduct and rigorously evaluate implementations of this pathway in four exemplar hospitals and associated CMHA dyads within a local health region. Outcomes-based validation of this pathway is important for effective adoption in other communities. A multiple baseline study design and conduct interrupted time-series analysis will be used to evaluate whether the EDMHCP has resulted in improved health care utilization, medical management, and health sector coordination. To ensure EDMHCP feasibility in various settings, implementation will occur in four exemplar hospital-community dyads with different workflows and patient populations.

Condition or disease Intervention/treatment
Mental Health Other: Implementation Phase

Detailed Description:

Commissioned by the Ontario Ministries of Health and Long Term Care(MOHLTC) and Child and Youth Services(MCYS), an expert-developed clinical pathway(CP) has been created with two main goals: 1) to guide risk assessment and disposition decision-making for children and youth presenting to the emergency department(ED) with MH concerns, and 2) to ensure seamless transition to follow-up services with community MH agencies(CMHAs) and providers. This pathway, referred to as the EDMHCP, is unique in undertaking to provide a seamless transition of care for children/youth and caregivers between hospital EDs and CMHAs.

Working with 4 exemplary hospital EDs and 2 Community Mental Health Agencies across Eastern Ontario, the investigators will conduct a 3-year mixed methods health services research project with three components to i) implement the EDMHCP using a theory driven, evidence-based approach, ii) evaluate EDMHCP effectiveness through measurement of relevant outcomes, and iii) conduct a process evaluation to document and assess the EDMHCP implementation strategy against the outcomes achieved.

This 3 year study will take place in five different phases, which include:

  • Preparation: Qualitative interviews with ED team members and strategy development
  • Implementation: Working with each ED team to implement the clinical pathway (including standardized assessments) within 8 months
  • Post-implementation: Qualitative interviews with ED team members
  • Data collection: 9-month pre/post chart audits of patients with mental health and caregiver satisfaction surveys
  • Follow up: to discuss findings, database creation, and dissemination strategy.

To ensure the findings directly impact relevant service delivery areas, the investigators have specifically recruited study team members with decision-making authority and/or influence on delivery of care for children and youth with MH concerns. This project will provide an implementation model for the EDMHCP to be used in any ED and CMHA setting, and will demonstrate decreased wait times and increased access with EDMHCP adoption. The findings will guide policy decision-making on access to timely and appropriate MH care and add to current knowledge of implementation science. In addition to knowledge translation via team member dissemination within their areas of influence, the investigators plan to disseminate the findings through presentation at scientific and healthcare conferences, and publication in relevant peer-reviewed journals.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3095 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Transitions in Care for Children and Youth With Mental Health Concerns: Implementation and Evaluation of an Emergency Department Mental Health Clinical Pathway
Anticipated Study Start Date : October 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Dyads receiving the Implementation Phase
Dyad 1 (CHEO-YSB) Dyad 2 (CGH-CCH) Dyad 3 (WDMH-CCH) Dyad 4 (QCH-YSB)
Other: Implementation Phase

Core Components of the implementation intervention include:

  • Hospital and CMHA project commitment
  • Site champion teams (from hospital and CMHA)
  • Memorandum of Agreement between Hospital and CMHA
  • Pre-intervention site visits
  • Education sessions
  • Posters/reminders
  • Instructional videos (HEADS ED video)

Completed pathway implementation includes EDMHCP site-customization and committee approvals, consequent planning and agreements among ED-CMHA partners, delivery of at least two educational workshops, and EDMHCP availability in the ED. An 8-month period for EDMHCP implementation, with negotiated interim target dates was set for each site.

Outcome Measures

Primary Outcome Measures :
  1. Proportion of patients receiving post-ED follow-up on the Services for Children and Adolescents Parent Interview questionnaire [ Time Frame: 24 hours or 7 days ]
    The primary clinical outcome is the proportion of patients that receive the post ED follow-up as per the clinical pathway recommendations as measured by the Services for Children and Adolescents Parent Interview questionnaire

  2. Proportion of patients with documented mental health recommendations in the medical chart [ Time Frame: 24 hours or 7 days ]
    The primary process outcome is the proportion of patients with documented MH-specific recommendations (as defined by the project team) in the medical chart.

Secondary Outcome Measures :
  1. Proportion of completed CP assessment forms filed in the health record to determine clinical pathway uptake in the Emergency Department [ Time Frame: 9 months ]
    CP uptake in the ED will be measured through audits as the proportion of completed clinical pathway assessment forms filed in the health record

  2. Patient perspectives of post-ED mental health service using The Services for Children and Adolescents-Parent Interview [ Time Frame: 7-10 days ]
    Post ED uptake of recommended community MH services will be measured by The Services for Children and Adolescents-Parent Interview

  3. Alignment of HEADS-ED assessment and mental health services [ Time Frame: 7-10 days ]
    Alignment of recommended services documented in the patients health record (audit) to the HEADS-ED mental health screening tool assessment

  4. Decreased length of stay [ Time Frame: 26 months ]
    ED length of stay will be obtained from health record and NACRS administrative database

  5. Patient satisfaction with ED visit measured by the Client Satisfaction Questionnaire [ Time Frame: 7-10 days ]
    Patient/caregiver satisfaction with the ED visit will be measured by the Client Satisfaction Questionnaire

  6. Decreased number of hospital admissions obtained from health record and NACRS administrative database [ Time Frame: 26 months ]
    Hospital Admission will be obtained from health record and NACRS administrative database

  7. Decreased number of ED Revisits from the health record and NACRS administrative database [ Time Frame: 10 day and 3 months ]
    ED revisits will be obtained from the health record and NACRS administrative database

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages > 5.99 and < 18 years
  • Presented to the ED of the four chosen hospitals within a selected 8 month time frame (between January, 2016 to May 2017)
  • Mental health issue as their primary complaint (all complaints identified at triage as involving MH [psychosocial, emotional, behavioural])
  • Proficient in English.

Exclusion Criteria:

  • CTAS of 1 (Resuscitation)
  • Patient is not medically stable
  • Intubation/PICU care required
  • Direct admission to hospital for ongoing medical management and observation
  • Patients presenting with head injury or post-concussional syndrome
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590302

Contact: Mona Jabbour, MD 613-737-7600 ext 3299 jabbour@cheo.on.ca
Contact: Cappelli Mario, PhD 613-737-7600 ext 3916 cappelli@cheo.on.ca

Canada, Ontario
Children's Hopsital of Eastern Ontario Not yet recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: Sheila Ledoux    613-737-7600 ext 4110    sledoux@cheo.on.ca   
Contact: Andy Ng    613-737-7600    anng@cheo.on.ca   
Principal Investigator: Mona Jabbour, MD         
Principal Investigator: Mario Cappelli, PhD         
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
Winchester District Memorial Hospital
Cornwall Community Hospital
Queensway Carleton Hospital
Youth Services Bureau
Principal Investigator: Mona Jabbour, MD Children's Hospital of Eastern Ontario
More Information

Children's Hospital of Eastern Ontario. Advocacy Mental Health. Ottawa, Canada: http://www.cheo.on.ca/en/mentalhealth. Accessed August 22, 2014.
Kirby, M.J.L., Keon, W.J. (2006). Out of the Shadows at Last: Transforming mental health, mental illness and addiction services in Canada. The Standing Senate Committee on Social Affairs, Science and Technology.
Ontario Ministry of Health and Long-Term Care. Ontario's action plan for health care: Better patient care through better value from our health care dollars. Toronto, Canada: Government of Ontario; 2012. Available at: http://www.health.gov.on.ca/en/ms/ecfa/ healthy_change/docs/rep_healthychange.pdf. Accessed August 22, 2014.
Ontario. Legislative Assembly. Select Committee on Mental Health and Addictions Final report, navigating the journey to wellness : the comprehensive mental health and addictions action plan for Ontarians; 2010 Available at: http://www.ontla.on.ca/committee-proceedings/committeereports/ files_pdf/Select%20Report%20ENG.pdf Accessed October 15, 2014.
Provincial Council for Maternal and Child Health. Implementation Toolkit: Emergency Department Clinical Pathway for Children & Youth with Mental Health Conditions. Prov Counc Matern Child Heal. Available at: http://pcmch.on.ca/sites/default/files/Toolkit- ED_Clinical_Pathway-Tookit_ Sept_ 30_2013-FINAL_0.pdf. Accessed January 14, 2014.
Open Minds, Healthy Minds. (2011). Ontario's comprehensive mental health and addictions strategy. Ottawa (ON): Government of Ontario. Available at: http://www.health.gov.on.ca/en/common/ministry/publications/reports/mental_health201 1/mentalhealth_rep2011.pdf Accessed October 15, 2014
Michie, S., Johnston, M., Harderman, W., & Eccles, M. (2008). From theory to intervention: Mapping theoretically derived behavioral determinants to behavior change techniques. Applied Psychology, 57(4), 660-680.
Newton, A. S., Rosychuk, R. J., Ali, S., Cawthorpe, D., Curran, J., Dong, K., … Urichuk, L. (2011). The Emergency Department Compass: Children's Mental Health. Pediatric mental health emergencies in Alberta, Canada: Emergency department visits by children and youth aged 0 to 17 years, 2002-2008. Edmonton, AB.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mona Jabbour, Vice-Chief/Chair, Department of Pediatrics, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT02590302     History of Changes
Other Study ID Numbers: ChildrensHEO
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mona Jabbour, Children's Hospital of Eastern Ontario:
Clinical pathway
Mental Health
Emergency Department
Risk assessment
Service integration
Transitions in care
Scoring tools
Clinical Pathway Evaluation