ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 118 for:    Recruiting, Not yet recruiting, Available Studies | "Self-Injurious Behavior"

The BEACON Study: Smartphone-Assisted Problem-Solving Therapy in Men Presenting to the ED With Self-Harm (Protocol A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03489382
Recruitment Status : Not yet recruiting
First Posted : April 5, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
Dr. Simon Hatcher, University of Ottawa

Brief Summary:
This study evaluates the effectiveness of a smartphone-assisted problem-solving therapy (PST) service across Emergency Departments in Ontario. A total of 25 Emergency Departments have been randomized to either usual care or the smartphone-assisted PST service intervention. The main cluster randomized controlled trial will use data collected from the Institute of Clinical Evaluative Sciences (ICES) to assess the impact of this service on suicides and re-presentations to hospital for self-harm as well as other health service use one-year post study launch.

Condition or disease Intervention/treatment Phase
Intentional Self-Harm Suicide Other: Smartphone Assisted PST Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-Centre Cluster Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: All data linkage and analyses will be conducted by statisticians who are blind to the study site allocations.
Primary Purpose: Treatment
Official Title: The BEACON Study: Protocol for Cluster RCT of a Service to Deliver Smartphone-Assisted Problem-Solving Therapy Compared to Usual Care in Men Who Present With Intentional Self-Harm to the ED in Ontario (Protocol A)
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-harm Suicide

Arm Intervention/treatment
No Intervention: Control
Emergency Departments providing usual care, which includes assessment in hospital followed by placement on a wait list for psychiatric services and access to regional community resources for suicide prevention.
Experimental: Smartphone Assisted PST
Emergency Departments providing the option to refer men who self-harm to a service that will deliver smartphone-assisted problem solving therapy.
Other: Smartphone Assisted PST

Emergency Departments randomized to the study intervention will receive:

  1. Staff education incorporated into regular teaching rounds at least twice a year about the management of self-harm in the Emergency Department. This will include the dissemination of guidelines on how to ask questions about suicide, assessment of suicide risk, the creation of a management plan and how to refer patients to local mental health resources, including the study.
  2. Written materials developed by service users for men who self-harm that outline local resources, distress centre helplines, and follow-up arrangements.
  3. The option to refer men who self-harm to a service that will deliver smartphone-assisted PST specifically designed for men.




Primary Outcome Measures :
  1. Change in Number of Deaths by Suicide and/or Re-Presentations to Any Emergency Department (ED) in Ontario for Self-Harm - Data from the Institute for Clinical Evaluative Sciences (ICES) [ Time Frame: Baseline; 12 Months. ]
    The total number of documented suicides and/or re-presentations to any Ontario ED for self-harm will be captured by means of routinely collected administrative health data. For total number of suicides the Vital Statistics - Death database will be used. The incidence of suicide will be measured using codes drawn from the International Classification of Disease - Clinical Modification (10th edition). For the total number of re-presentations to any ED in Ontario the National Ambulatory Care Reporting System (NACRS) database will be used. Re-presentations to any ED for self-harm will also be measured using the same coding system. These numbers will be combined into a single measure, providing us with the proportion of ED visits resulting in a death by suicide or representation to an ED for self-harm, as compared to the total number of ED visits occurring at an intervention or control site. Proportions for each site will be compared to a measure taken 12 months after baseline.


Secondary Outcome Measures :
  1. Change in the Number of Deaths by Suicide at a Study Site [ Time Frame: Baseline; 12 Months. ]
    The total number of documented suicides will be captured for each study site by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Vital Statistics - Death database. The incidence of suicide will be measured using codes drawn from the International Classification of Disease - Clinical Modification (10th edition), and then compared against the total number of documented suicides for each study site 12 months later.

  2. Change in Number of Re-Presentations to Any Emergency Department for Self-Harm [ Time Frame: Baseline; 12 Months. ]
    The total number of documented re-presentations to any Emergency Department in Ontario for self-harm will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the National Ambulatory Care Reporting System (NACRS) database. The incidence of re-presentations to any Emergency Department in Ontario for self-harm will be measured using codes drawn from the International Classification of Disease - Clinical Modification (10th edition). This measure will be compared against the total number of re-presentations to any Emergency Department in Ontario for self-harm, as measured 12 months after baseline.

  3. Change in Number of Re-Presentations to Any Emergency Department for Any Reason [ Time Frame: Baseline; 12 Months. ]
    The total number of documented re-presentations to any Emergency Department in Ontario for any reason will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the National Ambulatory Care Reporting System (NACRS) database. The incidence of re-presentations to any Emergency Department in Ontario for any reason will be measured using codes drawn from the International Classification of Disease - Clinical Modification (10th edition). This measure will be compared against the total number of re-presentations to any Emergency Department in Ontario for self-harm, as measured 12 months after baseline.

  4. Change in Number of Admissions to Any Hospital in Ontario for Any Reason [ Time Frame: Baseline; 12 Months. ]
    The total number of documented presentations to any hospital in Ontario for any reason will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the National Ambulatory Care Reporting System (NACRS) database. This number will be compared against the total number of admissions to any hospital in Ontario for any reason, as measured 12 months after baseline.

  5. Change in Number of Hospital Outpatient Appointments in Ontario for Any Reason [ Time Frame: Baseline; 12 Months. ]
    The total number of documented presentations hospital outpatient appointments in Ontario for any reason will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Ontario Health Insurance Plan (OHIP) database. This number will be compared against the total number of admissions to any hospital in Ontario for any reason, as measured 12 months after baseline.

  6. Change in Number of Primary Care Appointments [ Time Frame: Baseline; 12 Months. ]
    The total number of documented primary care appointments in Ontario will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Ontario Health Insurance Plan (OHIP) database. This number will be compared against the total number of primary care appointments in Ontario, as measured 12 months after baseline.

  7. Change in Total Number of Deaths for Reasons Other Than Suicide [ Time Frame: Baseline; 12 Months. ]
    The total number of documented deaths for reasons other than suicide in Ontario will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Office of the Registrar General - Deaths (ORGD) database. This number will be compared against the total number of deaths for reasons other than suicide in Ontario, as measured 12 months after baseline.

  8. Change in Total Ontario Health Care Costs - Micro-Costing Analysis of Health-Care Resources Used in Treating Self-Harm and Suicide [ Time Frame: Baseline; 12 Months. ]
    Changes in total health care costs used to treat self-harm and suicide in Ontario will be captured by means of data obtained from ICES databases. Databases: Ontario Health Insurance Plan; Discharge Abstract Database; National Ambulatory Care Reporting System; National Rehabilitation Reporting System; Continuing Care Reporting System; Ontario Mental Health Reporting System; Ontario Drug Benefit Claims; and the Assistive Devices Program. Resource costs assessed will include: physician visits, inpatient hospital admissions, home care and rehabilitation claims, use of laboratory services, and prescription drug claims for those with high drug costs as compared to income. Total costs for the intervention will also be assessed. This will include costs for training, data plans, materials, and costs associated with health care use over the one-year period. A one-year time horizon will be adopted in a base case analysis, and a lifetime horizon will be used in a scenario analysis.

  9. Change in Ontario Physician Health Care Costs - Micro-Costing Analysis of Physician Health-Care Costs in Treating Self-Harm and Suicide [ Time Frame: Baseline; 12 Months. ]
    Changes in physician health care costs in Ontario for treating self-harm and suicide in Ontario will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Ontario Health Insurance Plan (OHIP) Claims Database. This analysis will examine the cost of primary care and specialist consultations for treating self-harm and suicide in Ontario. Cost comparisons will adopt a one-year time horizon for a base case analysis, and a lifetime horizon for a scenario analysis.

  10. Change in Ontario Emergency Department Health Care Costs [ Time Frame: Baseline; 12 Months. ]
    Changes in Emergency Department health care costs in Ontario for treating self-harm and suicide will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the National Ambulatory Care Reporting System (NACRS) database. This analysis will examine the cost of Ontario Emergency Department health care costs for treating self-harm and suicide. Cost comparisons will adopt a one-year time horizon for a base case analysis, and a lifetime horizon for a scenario analysis.

  11. Change in Ontario Hospitalization Health Care Costs [ Time Frame: Baseline; 12 Months. ]
    Changes in hospitalization health care costs in Ontario for treating self-harm and suicide will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the Discharge Abstract Database (DAD). This analysis will examine the cost of hospitalizations for treating self-harm and suicide in Ontario, including services provided by mental health institutions, and those provided during emergency and ambulatory care visits. Cost comparisons will adopt a one-year time horizon for a base case analysis, and a lifetime horizon for a scenario analysis.

  12. Change in Other Ontario Health Care Costs [ Time Frame: Baseline; 12 Months. ]
    Other Ontario health care costs will be captured by means of routinely collected administrative health data obtained from the Institute for Clinical Evaluative Sciences (ICES) using the following databases: National Rehabilitation Reporting System (NRS); Continuing Care Reporting System (CCRS); Ontario Mental Health Reporting System (OMHRS); Ontario Drug Benefit Claims (ODB); and the Assistive Devices Program (ADP). This analysis will examine the other Ontario health care costs accrued in the treatment of self-harm and suicide, specifically the cost of home care and rehabilitation claims, cost of laboratory services, and prescription drug claims for those with high drug costs compared to income. Cost comparisons will adopt a one-year time horizon for a base case analysis, and a lifetime horizon for a scenario analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has presented with an index episode of intentional self-harm at an eligible Emergency Department in Ontario, Canada.
  • Patient is biologically male.
  • Patient is 18 years of age or older.
  • Patient has a valid OHIP number.

Exclusion Criteria:

  • Patient has presented to the Emergency Department for a reason other than intentional self-harm at an eligible Emergency Department in Ontario, Canada.
  • Patient is biologically female.
  • Patient is under 18 years of age.
  • Patient does not have a valid OHIP number.

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): NCT03489382


Contacts
Contact: Simon Hatcher, MD 613-798-5555 ext 73011 shatcher@uottawa.ca
Contact: Anna Rogic, MA 613-737-8899 ext 81209 spresearch@uottawa.ca

Locations
Canada, Ontario
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
University of Ottawa
Ottawa Hospital Research Institute
Investigators
Principal Investigator: Simon Hatcher, MD University of Ottawa
Principal Investigator: Marnin Heisel, PhD University of Western Ontario, Canada
  Study Documents (Full-Text)

Documents provided by Dr. Simon Hatcher, University of Ottawa:
Study Protocol  [PDF] December 1, 2017


Publications:
Self-Injury Hospitalizations Details for Ontario [Internet]. Ottawa (ON): The Canadian Institute for Health Information. c2018 - [cited 2017 Feb 20] Available from: https://yourhealthsystem.cihi.ca/hsp/indepth?lang=en#/indicator/042/2/C5001/
Health Indicators 2013 [Internet]. Ottawa (ON): The Canadian Institute for Health Information. c2013 - [cited 2017 Feb 20] Available from: https://secure.cihi.ca/free_products/HI2013_EN.pdf
Heisel MJ, Duberstein PR. Working sensitively and effectively to reduce suicide risk among older adults. In: Kleespies PM, editor. The Oxford handbook of behavioural emergencies and crises. Oxford: Oxford University Press; 2016. P. 335-359.
Bergmans Y, Bolton MJ, Hill A, editors. The CASP blueprint for a Canadian national suicide prevention strategy [Internet]. Winnipeg, MB: Canadian Association for Suicide Prevention; 2009 [cited 2017 Feb 20]. Available: https://suicideprevention.ca/wp-content/uploads/2016/09/SuicidePreventionBlueprint0909.pdf
Statistics Canada. Canadian coroner and medical examiner database: Annual report (82-214-X) [Internet]. Ottawa: Public Health Agency of Canada; c2012 [cited 2017 May 12] Available from: www.statcan.gc.ca/pub/82-214-x/82-214-x2012001-eng.pdf
Public Health Agency for Northern Ireland. Northern Ireland registry of self-harm western area: Six year summary report 2007-2012 [Internet]. Belfast: Public Health Agency; c2015 [cited February 20 2017] Available from: http://www.publichealth.hscni.net/sites/default/files/Western%20Trust%206-Year%20Report_0.pdf
Health Canada. Acting on what we know: Preventing youth suicide in First Nations. [Internet]. Ottawa: Government of Canada; c2010 [cited 2017 December 01] Available from: http://www.hc-sc.gc.ca/fniah-spnia/pubs/promotion/_suicide/prev_youth-jeunes/index-eng.php#tphp
ICD-10-CM: International classification of diseases, 10th revision, clinical modification [Internet]. Atlanta (GA): Center for Disease Control National Center for Health Statistics. C2016 - [cited 2017 May 11] Available from: https:www.cdc.gov/nchs/icd/icd10cm.htm
Thompson SC, Schlehofer MM. The many sides of control motivation for high, low and illusory control. Shah JY, Gardner WL, editors. Handbook of motivation science. New York: Guilford Press; 2008, pp 41-56.
Schull M, Vermeulen T, Stukel T, Fisher E. Follow-up and shared care following discharge from the Emergency Department for exacerbations of chronic disease. Can J Emerg Med. 2013; 13(Suppl 1):LOP05
Suicide Prevention Resource Center. Caring for adult patients with suicide risk: A consensus guide for emergency departments [Internet]. Waltham (MA): Education Development Center Inc.; 2015 [cited 2017 Feb 20]. Available from: http://www.sprc.org/sites/default/files/EDGuide_full.pdf
Suicide Prevention Resource Center. Preventing suicide among men in the middle years: Recommendations for suicide prevention programs [Internet]. Waltham (MA): Education Development Center Inc.; 2016 [cited 2017 Feb 20]. Available from: http://www.sprc.org/sites/default/files/resource-program/SPRC_MiMYReportFinal_0.pdf
Canadian Coalition for Seniors' Mental Health. National guidelines for seniors' mental health: The assessment of suicide risk and prevention of suicide. [Internet] Toronto: Canadian Coalition for Seniors' Mental Health; c2006 [cited 2017 Feb 20] Available from: https://ccsmh.ca/wp-content/uploads/2016/03/NatlGuideline_Suicide.pdf
Gold MR, Seigel JE, Russell LB, Weinstein MC, editors. Cost-effectiveness in health and medicine. New York: Oxford University Press; 1996.
Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies. 4th Ed. [Internet]. Ottawa: Canadian Agency for Drugs and Technologies in Health; c2017 [cited 2017 May 11] Available from: https://www.cadth.ca/guidelines-economic-evaluation-health-technologies-canada-4th-edition
Canadian Institutes of Health Research, Natural Science and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council. Tri-council policy statement: Ethical conduct for research involving humans. [Internet] Ottawa: Government of Canada; c2014 [cited 2017 May 11] Available from: www.pre.ethics.gc.ca/pdf/eng/tcps2-2014/TCPS_2_FINAL_Web.pdf

Responsible Party: Dr. Simon Hatcher, Scientist, University of Ottawa
ClinicalTrials.gov Identifier: NCT03489382     History of Changes
Other Study ID Numbers: CTO-0790-A
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Simon Hatcher, University of Ottawa:
self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms