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

NCT03489382 | Withdrawn DMC

• 1 other identifier: CTO-0790-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Intentional Self-Harm; Suicide

Keywords

self-harm; problem-solving therapy; emergency department; e-therapy; suicide prevention

Outcome Measures

Primary Outcomes (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)

  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.

  Baseline; 12 Months.

Secondary Outcomes (12)

• Change in the Number of Deaths by Suicide at a Study Site

  Baseline; 12 Months.

• Change in Number of Re-Presentations to Any Emergency Department for Self-Harm

  Baseline; 12 Months.

• Change in Number of Re-Presentations to Any Emergency Department for Any Reason

  Baseline; 12 Months.

• Change in Number of Admissions to Any Hospital in Ontario for Any Reason

  Baseline; 12 Months.

• Change in Number of Hospital Outpatient Appointments in Ontario for Any Reason

  Baseline; 12 Months.

Study Arms (2)

Control

NO INTERVENTION

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.

Smartphone Assisted PST

EXPERIMENTAL

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

Interventions

Smartphone Assisted PST OTHER

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.

Smartphone Assisted PST

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Ottawa: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

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MeSH Terms

Conditions

Self-Injurious Behavior; Suicide; Emergencies; Suicide Prevention

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Hatcher, MD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

• Marnin Heisel, PhD

  University of Western Ontario, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All data linkage and analyses will be conducted by statisticians who are blind to the study site allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Multi-Centre Cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: April 5, 2018
• Study Start: March 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)