Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt
2015年3月6日 更新者:Stephen O'Connor、University of Washington
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting.
40 participants will be randomized to receive the brief intervention + care as usual or only care as usual.
It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.
研究概览
详细说明
The aim of the study is to refine, elaborate, and pilot a brief intervention for adult patients following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview.
The participants will be randomized into one of two groups: those that receive the intervention and those that do not.
All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change.
The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning.
A guide to delivering the intervention has been completed and may undergo changes throughout the study.
Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide.
Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.
研究类型
介入性
注册 (实际的)
40
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Washington
-
Seattle、Washington、美国、98104
- Harborview Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- at least 15 years of age
- Inpatient on medical/surgical unit
- Admitted following a suicide attempt
- Sufficient English to benefit from psychotherapy in English
- Consents to be a research participant
Exclusion Criteria:
- Lack of sufficient English to participate in psychotherapy in English
- Prisoner/inmate at time of admission
- Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Brief Intervention
The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning
|
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
|
|
无干预:care as usual
Patients randomized to the care as usual arm will not receive the brief intervention.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Satisfaction Questionnaire
大体时间:(baseline) Assessment taking place immediately after completion of intervention
|
The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.
|
(baseline) Assessment taking place immediately after completion of intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Scale for Suicide Ideation
大体时间:One month follow-up assessment
|
The Scale for Suicide Ideation will be used to determine the severity of current suicidality in all participants at the one-month follow-up as compared to the baseline assessment.
|
One month follow-up assessment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stephen O'Connor, PhD、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2011年5月10日
首先提交符合 QC 标准的
2011年5月17日
首次发布 (估计)
2011年5月18日
研究记录更新
最后更新发布 (估计)
2015年3月10日
上次提交的符合 QC 标准的更新
2015年3月6日
最后验证
2015年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.