Clinical trial NCT03489382: The BEACON Study: Smartphone-Assisted Problem-Solving Therapy in Men Presenting to the ED With Self-Harm (Protocol A)
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intentional Self-Harm
Suicide
Keywords: self-harm
problem-solving therapy
emergency department
e-therapy
suicide prevention
Lead sponsor: University of Ottawa
Sponsor class: OTHER
Collaborators: name: Ottawa Hospital Research Institute
First posted: 2018-04-05
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-Centre Cluster Randomized Controlled Trial
Primary purpose: TREATMENT

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.

Detailed description: Self-harm is defined as intentional self-poisoning or self-injury, whether or not there is evidence that the act was intended to result in death. In the past, the term used was 'attempted suicide.' However, peoples' motives for harming themselves are highly variable, a person may have more than one motive and motivation is hard to assess. In line with usual public policy in health and social care, the investigators use the term 'self-harm' describing a behaviour - avoiding the word 'deliberate' because many service users or consumers dislike its connotations.

In Ontario, the number of people who present to hospital emergency departments with self-harm is difficult to accurately assess, but the best estimate is about 30,000 each year. The most common form of self-harm seen in emergency departments (around 80% of episodes) is the intentional consumption of an excess of a medicinal or toxic product, whether or not there is evidence that the act was intended to result in death. Injuries, most commonly self-cutting, form 15-20% of episodes.

Two-thirds of people attending emergency departments because of self-harm are under 35 years of age. They are high users of health and social care services. Self-harm has a strong association with suicide: 7 patients per 1000 (about 1%) die by suicide in the year after attending emergency departments with a non-fatal episode (60 times the general population risk), rising to as many as 30 patients per 1000 over the next 15 years. In a recent longitudinal study conducted at the University of Toronto, "all-cause mortality following a first episode of self-poisoning was 1107 per 100,000 person-years... \[with\] nearly half of all deaths being suicides, accidents or undetermined intent." About a quarter of suicides are preceded by a hospital visit due to non-fatal self-harm in the previous year. It is the major identifiable risk factor for suicide. Mortality from non-suicidal causes is also high, with significantly more than the expected numbers of deaths from natural causes and from accidents. Whilst four of ten people who present with self-harm are men, they form nearly two thirds of suicides after an episode and are far more likely than women to die of premature death from other causes. The premature deaths are greatly over-represented among young people and the life years lost to the community are many.

Repetition of non-fatal self-harm stands at around 20% annually and is associated with much distress and many unresolved interpersonal problems. It is likely that any reduction in repetition of self-harm will be mirrored by a fall in subsequent suicides. The Canadian Association for Suicide Prevention blueprint for a National Suicide Prevention Strategy (CASP) has identified those who have presented to hospital with non-fatal self-harm as a high risk target group to reduce suicide.

People attending emergency departments after self-harm receive a variable standard of care in Ontario. Many are not assessed for psychological needs, and the little psychological therapy available is not usually covered by Ontario Health Insurance (OHIP). Local data from hospitals in Ottawa show that only 4 out of 10 men who present with intentional self-harm are seen by a mental health professional. Few are offered an evidence-based treatment aimed at reducing their risk of suicide or repeated self-harm. At present, assessment for self-harm in adults in Ontario is highly variable and there is no standard protocol for therapy. Assessment of suicide risk is currently a Required Operating Practice for Canadian Hospital accreditation; however, individuals identified as at-risk for suicide rarely receive recommended care.

Specialist services offer intensive and lengthy treatment for the minority of people who self-harm diagnosed with personality disorders, such as dialectical behavior therapy or mindfulness based therapy. The evidence for the effectiveness of these specialist therapies comes almost entirely from studies in women.

The investigators have received funding for a multicentre cluster randomized trial from the Ontario Strategy for Patient Oriented Research (SPOR) Support for People and Patient Oriented Research and Trials (SUPPORT) Unit funded by Canadian Institutes for Health Research (CIHR), the Ontario Ministry of Health and Long-Terms Care (MOHLTC), and the Ontario Ministry of Research, Innovation and Science (MRIS), comparing the delivery of smart phone assisted problem solving therapy with treatment as usual in men who present with self-harm. The rationale for focusing on men is that most suicides are in men and previous trials have found that providing generic treatments to everyone does not work. The intervention will build on previous work by trying to extend the range and intensity of therapy. The investigators will do this by supplementing it with a sophisticated smart phone application that has already demonstrated its effectiveness in men with substance abuse disorders. The investigators will be offering an intervention specifically designed for men who self-harm, as they are hard to engage and are more likely than women to have substance abuse problems.

Given the complexity of the proposed study, the investigators have separated the overarching research proposal into two parts, designated "Protocol A" and "Protocol B." Protocol A refers to a comprehensive secondary analysis the investigators will be carrying out using data from the Institute for Clinical Evaluative Sciences (ICES), and Protocol B refers to the active components of the intervention, those carried out with human subjects receiving six sessions of blended, problem solving therapy as opposed to routine care. The following description outlines the research protocol developed under the heading "Protocol A."

Data collected from the ICES will be used to assess the impact of our intervention on suicides and re-presentations to hospital for self-harm, as well as providing an estimation of the intervention's economic impact on the Ontario healthcare system. This data is routinely collected and housed by ICES, and access to all outcome data has been agreed upon in advance of the study launch. Given that this component of the study focuses on the evaluation of the intervention based on routinely collected population-level data, there will be no individual participant recruitment; instead, the unit of analysis will be the individual patient, with eligibility determined by the patient's presentation at either an intervention or control site's Emergency Department for self-harm. To minimize the risk of imbalances between the study arms, allocation of a site to an intervention or control arm was completed using covariate constrained allocation, based on geographic and catchment area, the availability of onsite psychiatric services assessing Emergency Department visitors, rates of representation for self-harm, and facility size, defined by the average number of presentations for self-harm over a three year period. Dichotomous primary and secondary outcome measures will be compared according to study arm, using frequencies and percentages.

The main study outcome measure for Protocol A consists of a composite measure, combining the incidence of suicide and/or representations to any Emergency Department in Ontario for self-harm in the year following the index episode of self-harm. Secondary objectives include: representation to any Emergency Department in Ontario for any reason, admission to any hospital in Ontario for any reason, hospital appointments in Ontario for any reason, primary care appointments in Ontario for any reason, mortality for reasons other than suicide, total healthcare costs, physician healthcare costs, Emergency Department health care costs, hospitalization healthcare costs, and other healthcare costs. All economic analyses will be similarly carried out with the province of Ontario considered as the population of interest. The primary composite outcome measure will be compared between the intervention and control sites using generalized linear mixed effect regression, accounting for the pre-and post-intervention measures using repeated cross-sectional analysis. Differences between the arms will be expressed as absolute and relative differences in proportions together with 95% confidence intervals. Models will account for clustering at the level of the Emergency Department and over time using random effects. Additional analyses will adjust for individual prognostic variable including age, ethnicity, pre-specified comorbidities, and repeat as compared to first-time presentations for self-harm.

The investigators will conduct a cost-utility analysis from a health system's perspective using a decision analytic model. Costs associated with the intervention will be summarized over a one-year period using a micro-costing technique. This will involve identifying, costing and valuing all resources used. An incremental cost per one additional quality-adjusted life year (QALY) gained will be estimated using one-way and probabilistic sensitivity analyses. This cost-utility analysis will adhere to the best practices for conducting and reporting of health economic evaluations.

Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline; 12 Months.
Secondary outcomes:
measure: Change in the Number of Deaths by Suicide at a Study Site
timeFrame: Baseline; 12 Months.
measure: Change in Number of Re-Presentations to Any Emergency Department for Self-Harm
timeFrame: Baseline; 12 Months.
measure: Change in Number of Re-Presentations to Any Emergency Department for Any Reason
timeFrame: Baseline; 12 Months.
measure: Change in Number of Admissions to Any Hospital in Ontario for Any Reason
timeFrame: Baseline; 12 Months.
measure: Change in Number of Hospital Outpatient Appointments in Ontario for Any Reason
timeFrame: Baseline; 12 Months.
measure: Change in Number of Primary Care Appointments
timeFrame: Baseline; 12 Months.
measure: Change in Total Number of Deaths for Reasons Other Than Suicide
timeFrame: Baseline; 12 Months.
measure: Change in Total Ontario Health Care Costs - Micro-Costing Analysis of Health-Care Resources Used in Treating Self-Harm and Suicide
timeFrame: Baseline; 12 Months.
measure: Change in Ontario Physician Health Care Costs - Micro-Costing Analysis of Physician Health-Care Costs in Treating Self-Harm and Suicide
timeFrame: Baseline; 12 Months.
measure: Change in Ontario Emergency Department Health Care Costs
timeFrame: Baseline; 12 Months.
measure: Change in Ontario Hospitalization Health Care Costs
timeFrame: Baseline; 12 Months.
measure: Change in Other Ontario Health Care Costs
timeFrame: Baseline; 12 Months.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
Study officials:
affiliation: University of Ottawa
name: Simon Hatcher, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Western Ontario, Canada
name: Marnin Heisel, PhD
role: PRINCIPAL_INVESTIGATOR
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