NCT02590302

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,095

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

9 months

First QC Date

October 20, 2015

Last Update Submit

July 17, 2018

Conditions

Keywords

Clinical pathwayMental HealthEmergency DepartmentPaediatricRisk assessmentService integrationTransitions in careImplementationScoring toolsClinical Pathway Evaluation

Outcome Measures

Primary Outcomes (2)

  • Proportion of patients receiving post-ED follow-up on the Services for Children and Adolescents Parent Interview questionnaire

    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

    24 hours or 7 days

  • Proportion of patients with documented mental health recommendations in the medical chart

    The primary process outcome is the proportion of patients with documented MH-specific recommendations (as defined by the project team) in the medical chart.

    24 hours or 7 days

Secondary Outcomes (7)

  • Proportion of completed CP assessment forms filed in the health record to determine clinical pathway uptake in the Emergency Department

    9 months

  • Patient perspectives of post-ED mental health service using The Services for Children and Adolescents-Parent Interview

    7-10 days

  • Alignment of HEADS-ED assessment and mental health services

    7-10 days

  • Decreased length of stay

    26 months

  • Patient satisfaction with ED visit measured by the Client Satisfaction Questionnaire

    7-10 days

  • +2 more secondary outcomes

Study Arms (1)

Dyads receiving the Implementation Phase

OTHER

Dyad 1 (CHEO-YSB) Dyad 2 (CGH-CCH) Dyad 3 (WDMH-CCH) Dyad 4 (QCH-YSB)

Other: Implementation Phase

Interventions

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.

Dyads receiving the Implementation Phase

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hopsital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, Canada

RECRUITING

Related Publications (31)

  • Cappelli M, Gray C, Zemek R, Cloutier P, Kennedy A, Glennie E, Doucet G, Lyons JS. The HEADS-ED: a rapid mental health screening tool for pediatric patients in the emergency department. Pediatrics. 2012 Aug;130(2):e321-7. doi: 10.1542/peds.2011-3798. Epub 2012 Jul 23.

    PMID: 22826567BACKGROUND
  • Children's Hospital of Eastern Ontario. Advocacy Mental Health. Ottawa, Canada: http://www.cheo.on.ca/en/mentalhealth. Accessed August 22, 2014.

    BACKGROUND
  • Graham ID, Logan J, Harrison MB, Straus SE, Tetroe J, Caswell W, Robinson N. Lost in knowledge translation: time for a map? J Contin Educ Health Prof. 2006 Winter;26(1):13-24. doi: 10.1002/chp.47.

    PMID: 16557505BACKGROUND
  • Kataoka SH, Zhang L, Wells KB. Unmet need for mental health care among U.S. children: variation by ethnicity and insurance status. Am J Psychiatry. 2002 Sep;159(9):1548-55. doi: 10.1176/appi.ajp.159.9.1548.

    PMID: 12202276BACKGROUND
  • Hacker K, Arsenault L, Franco I, Shaligram D, Sidor M, Olfson M, Goldstein J. Referral and follow-up after mental health screening in commercially insured adolescents. J Adolesc Health. 2014 Jul;55(1):17-23. doi: 10.1016/j.jadohealth.2013.12.012. Epub 2014 Feb 11.

    PMID: 24525226BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • Bosch M, van der Weijden T, Wensing M, Grol R. Tailoring quality improvement interventions to identified barriers: a multiple case analysis. J Eval Clin Pract. 2007 Apr;13(2):161-8. doi: 10.1111/j.1365-2753.2006.00660.x.

    PMID: 17378860BACKGROUND
  • Hartmann DP, Gottman JM, Jones RR, Gardner W, Kazdin AE, Vaught RS. Interrupted time-series analysis and its application to behavioral data. J Appl Behav Anal. 1980 Winter;13(4):543-59. doi: 10.1901/jaba.1980.13-543.

    PMID: 16795632BACKGROUND
  • Jabbour M, Curran J, Scott SD, Guttman A, Rotter T, Ducharme FM, Lougheed MD, McNaughton-Filion ML, Newton A, Shafir M, Paprica A, Klassen T, Taljaard M, Grimshaw J, Johnson DW. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 May 22;8:55. doi: 10.1186/1748-5908-8-55.

    PMID: 23692634BACKGROUND
  • Zhang F, Wagner AK, Soumerai SB, Ross-Degnan D. Methods for estimating confidence intervals in interrupted time series analyses of health interventions. J Clin Epidemiol. 2009 Feb;62(2):143-8. doi: 10.1016/j.jclinepi.2008.08.007. Epub 2008 Nov 17.

    PMID: 19010644BACKGROUND
  • Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther. 2002 Aug;27(4):299-309. doi: 10.1046/j.1365-2710.2002.00430.x.

    PMID: 12174032BACKGROUND
  • Scott SD, Grimshaw J, Klassen TP, Nettel-Aguirre A, Johnson DW. Understanding implementation processes of clinical pathways and clinical practice guidelines in pediatric contexts: a study protocol. Implement Sci. 2011 Dec 28;6:133. doi: 10.1186/1748-5908-6-133.

    PMID: 22204440BACKGROUND
  • Lougheed MD, Olajos-Clow J, Szpiro K, Moyse P, Julien B, Wang M, Day AG; Ontario Respiratory Outcomes Research Network. Multicentre evaluation of an emergency department asthma care pathway for adults. CJEM. 2009 May;11(3):215-29. doi: 10.1017/s1481803500011234.

    PMID: 19523270BACKGROUND
  • Szpiro KA, Harrison MB, VanDenKerkhof EG, Lougheed MD. Asthma education delivered in an emergency department and an asthma education center: a feasibility study. Adv Emerg Nurs J. 2009 Jan-Mar;31(1):73-85. doi: 10.1097/TME.0b013e31818bf23d.

    PMID: 20118856BACKGROUND
  • Bhogal S, Bourbeau J, McGillivray D, Benedetti A, Bartlett S, Ducharme F. Adherence to pediatric asthma guidelines in the emergency department: a survey of knowledge, attitudes and behaviour among health care professionals. Can Respir J. 2010 Jul-Aug;17(4):175-82. doi: 10.1155/2010/274865.

    PMID: 20808976BACKGROUND
  • Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A; "Psychological Theory" Group. Making psychological theory useful for implementing evidence based practice: a consensus approach. Qual Saf Health Care. 2005 Feb;14(1):26-33. doi: 10.1136/qshc.2004.011155.

    PMID: 15692000BACKGROUND
  • 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.

    BACKGROUND
  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PMID: 21513547BACKGROUND
  • Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

    PMID: 10245370BACKGROUND
  • Jensen PS, Eaton Hoagwood K, Roper M, Arnold LE, Odbert C, Crowe M, Molina BS, Hechtman L, Hinshaw SP, Hoza B, Newcorn J, Swanson J, Wells K. The services for children and adolescents-parent interview: development and performance characteristics. J Am Acad Child Adolesc Psychiatry. 2004 Nov;43(11):1334-44. doi: 10.1097/01.chi.0000139557.16830.4e.

    PMID: 15502592BACKGROUND
  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PMID: 18929686BACKGROUND
  • American Academy of Pediatrics; Committee on Pediatric Emergency Medicine; American College of Emergency Physicians; Pediatric Committee; Emergency Nurses Association Pediatric Committee. Joint policy statement--guidelines for care of children in the emergency department. Pediatrics. 2009 Oct;124(4):1233-43. doi: 10.1542/peds.2009-1807. Epub 2009 Sep 21.

    PMID: 19770172BACKGROUND
  • Newton AS, Rathee S, Grewal S, Dow N, Rosychuk RJ. Children's Mental Health Visits to the Emergency Department: Factors Affecting Wait Times and Length of Stay. Emerg Med Int. 2014;2014:897904. doi: 10.1155/2014/897904. Epub 2014 Jan 19.

    PMID: 24563785BACKGROUND
  • 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.

    BACKGROUND
  • Chandra A, Minkovitz CS. Stigma starts early: gender differences in teen willingness to use mental health services. J Adolesc Health. 2006 Jun;38(6):754.e1-8. doi: 10.1016/j.jadohealth.2005.08.011.

    PMID: 16730608BACKGROUND
  • Tucci A, Cloutier P, Polihronis C, Kennedy A, Zemek R, Gray C, Reid S, Pajer K, Gardner W, Barrowman N, Cappelli M, Jabbour M. Improving transitions in care for children and youth with mental health concerns: implementation and evaluation of an emergency department mental health clinical pathway. BMC Health Serv Res. 2025 Mar 31;25(1):475. doi: 10.1186/s12913-025-12524-z.

  • Jabbour M, Reid S, Polihronis C, Cloutier P, Gardner W, Kennedy A, Gray C, Zemek R, Pajer K, Barrowman N, Cappelli M. Improving mental health care transitions for children and youth: a protocol to implement and evaluate an emergency department clinical pathway. Implement Sci. 2016 Jul 7;11(1):90. doi: 10.1186/s13012-016-0456-9.

MeSH Terms

Conditions

Psychological Well-BeingEmergencies

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mona Jabbour, MD

    Children's Hospital of Eastern Ontario

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mona Jabbour, MD

CONTACT

Cappelli Mario, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-Chief/Chair, Department of Pediatrics

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 29, 2015

Study Start

December 1, 2017

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations