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)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All data linkage and analyses will be conducted by statisticians who are blind to the study site allocations.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Smartphone Assisted PST (Other)
结局指标
主要结局
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)
时间窗: 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.
次要结局
- 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.)
- Change in Number of Primary Care Appointments(Baseline; 12 Months.)
- Change in Total Number of Deaths for Reasons Other Than Suicide(Baseline; 12 Months.)
- Change in Total Ontario Health Care Costs - Micro-Costing Analysis of Health-Care Resources Used in Treating Self-Harm and Suicide(Baseline; 12 Months.)
- Change in Ontario Physician Health Care Costs - Micro-Costing Analysis of Physician Health-Care Costs in Treating Self-Harm and Suicide(Baseline; 12 Months.)
- Change in Ontario Emergency Department Health Care Costs(Baseline; 12 Months.)
- Change in Ontario Hospitalization Health Care Costs(Baseline; 12 Months.)
- Change in Other Ontario Health Care Costs(Baseline; 12 Months.)
研究者
Dr. Simon Hatcher
Scientist
University of Ottawa
