Mental HealthNCT02590302
Improving Transitions in Care for Children and Youth With Mental Health Concerns
A study testing Implementation Phase in people with Mental Health, run by Children's Hospital of Eastern Ontario at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Mental Health
- What is being tested?
- Implementation Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,095 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2017to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Children's Hopsital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Sheila Ledoux, 613-737-7600 ext. 4110, sledoux@cheo.on.ca
Andy Ng, 613-737-7600, anng@cheo.on.ca
- Recruiting
Winchester District Memorial Hospital
Winchester, Ontario
Crystal Doyle, MD
About this study
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
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.
Read the 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.
- Conditions
- Mental Health
- Being tested
- Implementation Phase
- Keywords
- Clinical pathway, Mental Health, Emergency Department, Paediatric, Risk assessment, Service integration, Transitions in care, Implementation, Scoring tools, Clinical Pathway Evaluation
- Medical subject headings
- Psychological Well-Being, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation PhaseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dyads receiving the Implementation Phase | Other | Dyad 1 (CHEO-YSB) Dyad 2 (CGH-CCH) Dyad 3 (WDMH-CCH) Dyad 4 (QCH-YSB) Receives: Other: Implementation Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
CP uptake in the ED will be measured through audits as the proportion of completed clinical pathway assessment forms filed in the health record
Measured: 9 months
Patient perspectives of post-ED mental health service using The Services for Children and Adolescents-Parent Interview
Post ED uptake of recommended community MH services will be measured by The Services for Children and Adolescents-Parent Interview
Measured: 7-10 days
Alignment of HEADS-ED assessment and mental health services
Alignment of recommended services documented in the patients health record (audit) to the HEADS-ED mental health screening tool assessment
Measured: 7-10 days
Decreased length of stay
ED length of stay will be obtained from health record and NACRS administrative database
Measured: 26 months
Patient satisfaction with ED visit measured by the Client Satisfaction Questionnaire
Patient/caregiver satisfaction with the ED visit will be measured by the Client Satisfaction Questionnaire
Measured: 7-10 days
Decreased number of hospital admissions obtained from health record and NACRS administrative database
Hospital Admission will be obtained from health record and NACRS administrative database
Measured: 26 months
Decreased number of ED Revisits from the health record and NACRS administrative database
ED revisits will be obtained from the health record and NACRS administrative database
Measured: 10 day and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start1 Dec 2017
- Primary completionSep 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,095 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care, Winchester District Memorial Hospital, Queensway Carleton Hospital, Youth Services Bureau, Cornwall Community Hospital
- Responsible party
- Principal investigator, Mona Jabbour, Children's Hospital of Eastern Ontario
- Investigators
- Mona Jabbour, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590302
- Sponsor's protocol ID
- ChildrensHEO
- Status last verified
- Jul 2018
- First submitted
- 20 Oct 2015
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22826567Children's Hospital of Eastern Ontario. Advocacy Mental Health. Ottawa, Canada: http://www.cheo.on.ca/en/mentalhealth. Accessed August 22, 2014.
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.
PubMed 16557505Kataoka 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.
PubMed 12202276Hacker 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.
PubMed 24525226Kirby, 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
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.
PubMed 17378860Hartmann 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.
PubMed 16795632Jabbour 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.
PubMed 23692634Zhang 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.
PubMed 19010644Wagner 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.
PubMed 12174032
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02590302
- Acronym / sponsor ID
- ChildrensHEO
- Conditions
- Mental Health
- Keywords
- Clinical pathway, Mental Health, Emergency Department, Paediatric, Risk assessment, Service integration, Transitions in care, Implementation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,095 participants (estimated)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care, Winchester District Memorial Hospital, Queensway Carleton Hospital, Youth Services Bureau, Cornwall Community Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dyads receiving the Implementation Phase | Other | Other: Implementation PhaseDyad 1 (CHEO-YSB) Dyad 2 (CGH-CCH) Dyad 3 (WDMH-CCH) Dyad 4 (QCH-YSB) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation PhaseCore 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. | Other | Dyads receiving the Implementation Phase |
Primary outcome
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
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.
7 secondary outcomes
Proportion of completed CP assessment forms filed in the health record to determine clinical pathway uptake in the Emergency Department
Time frame: 9 months
Patient perspectives of post-ED mental health service using The Services for Children and Adolescents-Parent Interview
Time frame: 7-10 days
Alignment of HEADS-ED assessment and mental health services
Time frame: 7-10 days
Decreased length of stay
Time frame: 26 months
Patient satisfaction with ED visit measured by the Client Satisfaction Questionnaire
Time frame: 7-10 days
Decreased number of hospital admissions obtained from health record and NACRS administrative database
Time frame: 26 months
Decreased number of ED Revisits from the health record and NACRS administrative database
Time frame: 10 day and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Background: PubMed 22826567Cappelli 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.
- BackgroundChildren's Hospital of Eastern Ontario. Advocacy Mental Health. Ottawa, Canada: http://www.cheo.on.ca/en/mentalhealth. Accessed August 22, 2014.
- Background: PubMed 16557505Graham 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.
- Background: PubMed 12202276Kataoka 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.
- Background: PubMed 24525226Hacker 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.
- BackgroundKirby, 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.
- BackgroundOntario 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.
- BackgroundOntario. 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.
- BackgroundProvincial 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.
- BackgroundOpen 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: PubMed 17378860Bosch 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.
- Background: PubMed 16795632Hartmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona Jabbour, MD principal investigator
Children's Hospital of Eastern Ontario
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Phase in people with Mental Health, run by Children's Hospital of Eastern Ontario at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Jabbour, MD (613-737-7600 ext. 3299, jabbour@cheo.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590302, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.