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临床试验/NCT03444935
NCT03444935已完成不适用

Phone Call Follow-up After Crisis Centre Presentation With Suicidal Ideation and Behaviours.

Winnipeg Regional Health Authority2 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2018年5月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
83
试验地点
2
主要终点
Suicidal ideation (frequency)

研究概览

简要总结

This goal of this research is to examine the efficacy and feasibility of starting a phone call follow-up program for individuals discharged to the community after presenting to the Crisis Response Centre (CRC), a standalone mental health facility in Winnipeg, with suicidal ideation or behaviours. Currently there is no worldwide gold standard for how best to follow-up with individuals following presentations to health services with suicidal ideation or behaviours, despite the period immediately after discharge from mental health services being identified as a period of increased risk for death by suicide (Chung et al., 2017; Steeg et al., 2012). This risk is higher still for individuals who specifically had suicidal ideation or behaviours as a component of their reason for presenting to mental health services (Chung et al., 2017). One strategy that has been employed to mitigate this risk is brief contact interventions (BCI), which involves following up with people through text, phone calls, or written messages. Research has shown that this type of follow-up is well-received by individuals and although some studies have found this strategy reduces the rates of suicidal behaviours during this high-risk period, the overall literature shows mixed results (Miller et al., 2017; Exbrayat et al., 2017; Cebria et al., 2016; Milner et al., 2015; Morthorst et al., 2012; Fleischmann et al., 2008; Cedereke et al., 2002).

Because the research on phone call follow up programs has been mixed, we will be conducting a brief trial to study the efficacy and feasibility of a phone call follow-up system in Winnipeg to inform whether or not this type of program would be of benefit to the community. In order to best study this, we will be conducting a randomized control trial for individuals who are discharged to the community after presenting to the CRC with a recent history of suicidal thoughts or behaviours. Participants will be randomized into either an intervention group or a control group. All participants will receive at least one and no more than five phone calls during the five-week period immediately following discharge from the CRC, and the content and timing of these phone calls will be different depending on which group a participant is randomized to. We will rely on both self-reported data, which will be collected in a formalized fashion, and data in the electronic medical records of participants to analyze this intervention. Our hypothesis is that the specific protocol we have designed to follow up with the intervention group will result in decreased suicidal thoughts and behaviours in the period immediately following discharge.

详细描述

The proposed randomized control trial will occur over a three-month period at the Crisis Response Centre (CRC) in Winnipeg. The CRC serves as a standalone facility that offers 24/7 walk in assessment and treatment for adults with mental health crises, as well as referrals to mental health services. All individuals who present to the CRC and report any suicidal ideation or behaviour within the one week prior to their presentation will be considered eligible for the study. Further inclusion and exclusion criteria are outlined in the "Eligibility" section. A variety of employees at the CRC will be involved in different roles to assist with this research.

In current practice, all individuals are able to connect with Crisis Clinicians working at the CRC both in person and through the use of a telephone call to the Mobile Crisis Unit, which provides the capacity for Crisis Clinicians to both talk on the phone to individuals or leave the CRC and assess individuals offsite to support them. All individuals who connect with Crisis Clinicians in any of these capacities have a Mental Health Assessment (MHA) completed by Crisis Clinicians. All Crisis Clinicians are trained specifically in how to assess and assist individuals with suicidal thoughts or behaviours, therefore making them optimal individuals to assist in this research given their experience to support the safety of individuals in crisis.

Participants who present to the CRC, are deemed appropriate for participation in the study based on inclusion and exclusion criteria, and who are otherwise ready for discharge back into the community will be consented by the same Crisis Clinician who completed their MHA. Participants will be informed that they will receive no less than one and no more than five phone calls over the five weeks immediately following the date of their discharge from the CRC as part of this study, without informing them of the specific differences between the intervention and control groups. Individuals will decide prior to discharge whether they would like to participate, and those who choose to participate will provide a phone number that they can be contacted at and that messages can be left on.

Individuals who choose to participate will be randomized to either a control or intervention group based on a coin flip done by the Attendants (Front Desk Staff at the CRC). The Crisis Clinician will not be involved in the randomization process to prevent allocation bias. Once participants are randomized, they will be informed by the Attendants of the exact dates on which they should expect phone calls without revealing to the participant what group they have been randomized to, thereby blinding the participants. This blinding is possible because we have concealed the exact number and nature of phone calls that will occur for the two groups. Attendants will update a schedule after randomizing each participant with appointment times for all phone calls required for the study.

On each day, Team Leads will be responsible for reviewing the schedule and allocating all required phone calls between themselves and the Crisis Clinicians working that day. Crisis Clinicians will attempt to call participants a maximum of three times on the assigned day between 0800 and 2200. All Crisis Clinicians are provided with scripts to follow for phone calls based on which group they are calling and at what time. If Crisis Clinicians are unsuccessful at contacting the participant by the third attempt, they will leave a scripted voicemail offering support and encouraging the participant to call back. If at any point during phone conversations the Crisis Clinician has concerns about a participant's safety or suicide risk, this will be approached in the same way the Clinician would approach anyone who calls in to the Mobile Crisis Unit with suicidal ideation or behaviours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Crisis Clinicians who consent individuals for participation will be masked from randomization. The randomization process will be completed by a different staff member separate from the Crisis Clinician to prevent allocation bias.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being discharged to the community from the Crisis Centre
  • At least 18 years old
  • Suicidal ideation or behaviour within one week of presentation to the CRC
  • Suicidal ideation = thoughts of suicide or death, ranging from passive thoughts to organized plans
  • Suicidal behaviour = suicide attempt, interrupted suicide attempt, aborted suicide attempt, suicide preparatory actions (eg. writing a suicide note, selling off/giving away all possessions)

排除标准

  • Medically or cognitively unable to participate
  • Having an insurmountable language barrier
  • Psychiatrist deems that this type of follow-up could be harmful for the patient
  • Living in an institutional setting
  • Patient being admitted to hospital/treatment facility as a result of their presentation to the Crisis Response Centre
  • Being enrolled in outreach/follow up program that would directly overlap with involvement in this study
  • No reliable access to phone

结局指标

主要结局

Suicidal ideation (frequency)

时间窗: Self-report; outcome pertains to frequency over the entire five weeks.

Self-report of any thoughts of ending own life, from passive thoughts to formal plans.

Suicidal behaviours (frequency)

时间窗: Self-report; outcome pertains to frequency over the entire five weeks.

Self-report that includes a gradation of behaviour: suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory act (eg. writing suicide note, selling off possessions). Note that death by suicide is also included in this category (but will only be available if family/friends of participant reports).

次要结局

  • Satisfaction with and perceived helpfulness of phone calls in reducing suicidal thoughts and behaviours.(Self-report; outcome pertains to frequency over the entire five weeks.)
  • Non-suicidal self harm (frequency)(Self-report; outcome pertains to frequency over the entire five weeks.)
  • Perceived improvement in mental health(Self-report; outcome pertains to perceived improvement since the date of enrollment.)
  • Health care utilization (frequency)(Self-report; outcome pertains to frequency over the entire five weeks.)
  • Perceived mental health(Self-report; outcome pertains to frequency over the entire five weeks.)

研究者

发起方
Winnipeg Regional Health Authority
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laura Sutherland

PGY1 Psychiatry (University of Manitoba)

Winnipeg Regional Health Authority

研究点 (2)

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