Brief Admission Skane: Can Brief Admission Replace General Admission for Individuals With Self-harm and Acute Risk of Suicide
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Number of days with hospital admission
研究概览
简要总结
The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU.
详细描述
When individuals with recurrent self-harm and suicidal behaviour seek acute admission to hospital due to a crisis and associated increased suicidal ideation, recommendations for clinical care are still conflicting. The risk for iatrogenic effects of inpatient care are considerable, and long hospital admissions without a clear treatment structure may predict decompensation in functioning. This has resulted in a clinical practice of avoiding admission for individuals diagnosed with Borderline Personality Disorder (BPD).
Brief admission (BA) as an intervention has a longstanding history in the delivery of mental health services in the Netherlands. The core elements of brief admission were determined through consultation with Dutch researchers, interviews with individuals with experience, Dutch clinicians familiar with Brief Admission, and local guidelines from hospitals familiar with implementing this crisis management intervention. Core elements of the intervention were standardized into a protocol, and an educational manual was developed to train clinicians involved in the trial. An objectively rated fidelity measure was developed in order to ensure adherence.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current episodes of self-harm and/or recurrent suicidality.
- •Fulfilling at least three criteria for borderline personality disorder.
- •Admitted to psychiatric hospital for acute care for at least 7 days or presenting to the psychiatric emergency department at least 3 times during the last six months.
排除标准
- •No regular contact with outpatient psychiatric services.
- •Homelessness. Housing crises are outside the scope of this RCT.
- •Medical disorder from other organs that significantly contributes to inclusion criteria (e.g. if self-harm only occurs during episodes of hypoglycemia in a diabetic patient).
研究组 & 干预措施
Brief Admission
Participants randomised to Brief admission (BA) will have the possibility of admitting themselves to hospital for a maximum duration of three consecutive days at a maximum frequency of three times per month. Apart from BA they have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital).
干预措施: Brief Admission (Other)
Control
Participants randomized to Treatment as Usual will receive no intervention from the study protocol, except the baseline assessments and repeated assessments administered on the same schedule as described above for the treatment group. They will not be given the evaluation measures that are specific to the intervention. Participants have access to all psychiatric care that they would have if they had not participated in the study (including general admission to hospital).
结局指标
主要结局
Number of days with hospital admission
时间窗: Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively
Number of days with Brief admission, general admission, forced (involuntary) admission
次要结局
- Severity of self-harming behaviours(Change in severity between baseline, 6 months and 12 months prospectively.)
- Frequency of forced acts (e.g. restraints and forced medication)(Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively)
- Individuals' Experiences of the intervention(Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.)
- Clinicians' Experiences of the intervention(Data collected at each Brief Admission during a period of 140 weeks. A Brief Admission is defined as a hospital admission according to the procedure defined in the Brief Admission Skane Standardised Protocol.)
- Frequency of all self-harming behaviours including suicide attempts(Change in frequency between baseline, 6 months and 12 months prospectively.)
- Level of functioning in activities of daily life(Change in ratings between baseline, 6 months and 12 months prospectively.)
- Ability to cope effectively with life stress(Change in ratings between baseline, 6 months and 12 months prospectively.)
- Global psychiatric symptoms(Change in ratings between baseline, 6 months and 12 months prospectively.)
- Ability to regulate emotions(Change in ratings between baseline, 6 months and 12 months prospectively.)
- Satisfaction with health care(Change in ratings between baseline, 6 months and 12 months prospectively.)