- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02590302
Improving Transitions in Care for Children and Youth With Mental Health Concerns
Improving Transitions in Care for Children and Youth With Mental Health Concerns: Implementation and Evaluation of an Emergency Department Mental Health Clinical Pathway
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- Recruiting
- Children's Hopsital of Eastern Ontario
-
Contact:
- Sheila Ledoux
- Phone Number: 4110 613-737-7600
- Email: sledoux@cheo.on.ca
-
Contact:
- Andy Ng
- Phone Number: 613-737-7600
- Email: anng@cheo.on.ca
-
Principal Investigator:
- Mona Jabbour, MD
-
Principal Investigator:
- Mario Cappelli, PhD
-
Winchester, Ontario, Canada
- Recruiting
- Winchester District Memorial Hospital
-
Contact:
- Crystal Doyle, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Dyads receiving the Implementation Phase
Dyad 1 (CHEO-YSB) Dyad 2 (CGH-CCH) Dyad 3 (WDMH-CCH) Dyad 4 (QCH-YSB)
|
Core Components of the implementation intervention include:
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours or 7 days
|
|
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.
|
24 hours or 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
9 months
|
|
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
|
7-10 days
|
|
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
|
7-10 days
|
|
Decreased length of stay
Time Frame: 26 months
|
ED length of stay will be obtained from health record and NACRS administrative database
|
26 months
|
|
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
|
7-10 days
|
|
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
|
26 months
|
|
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
|
10 day and 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mona Jabbour, MD, Children's Hospital of Eastern Ontario
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Children's Hospital of Eastern Ontario. Advocacy Mental Health. Ottawa, Canada: http://www.cheo.on.ca/en/mentalhealth. Accessed August 22, 2014.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ChildrensHEO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Implementation Phase
-
University of EdinburghNHS Lothian; NHS Greater Glasgow and ClydeCompletedMyocardial Infarction | Acute Coronary Syndrome
-
Washington University School of MedicineNational Cancer Institute (NCI); University of North Carolina, Chapel Hill; Nigerian...Active, not recruiting
-
Washington University School of MedicineNational Heart, Lung, and Blood Institute (NHLBI); University of North Carolina... and other collaboratorsRecruitingStroke | High Blood PressureNigeria
-
Hospices Civils de LyonRecruitingPeritoneal DiseasesUnited States, Canada, Switzerland
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedHIV/AIDS | Sexually Transmitted InfectionsNigeria
-
VA Office of Research and DevelopmentVA Palo Alto Health Care System; Louis Stokes VA Medical Center; Edward Hines... and other collaboratorsRecruitingSpinal Cord Injury | Pressure InjuryUnited States
-
Yale UniversityNational Institute of Allergy and Infectious Diseases (NIAID)CompletedTuberculosis | Tuberculosis, PulmonaryUganda
-
University of PittsburghNational Institute of Mental Health (NIMH)Completed
-
Medical University of LodzCompletedChronic Obstructive Pulmonary Disease (COPD)Poland
-
Iowa State UniversityKansas State University; Louisiana State University Health Sciences Center... and other collaboratorsCompletedHealth Promotion | Overweight and Obesity | Sedentary Behavior | Diet, Healthy | Healthy LifestyleUnited States