Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 4
- 主要终点
- Patient: Beck Scale for Suicide Ideation
研究概览
简要总结
This study will determine if suicidal middle-aged men who use a personalized computer program addressing suicide risk before a primary care visit are more likely to discuss suicide and accept treatment, reducing their suicide preparatory behaviors and thoughts.This is important because half of all men who die by suicide visit primary care within a month of death, yet few broach the topic, missing chances for prevention.
详细描述
In this study, the investigators will enroll middle-aged men with active suicide thoughts in a randomized controlled trial (RCT) to examine whether their use of the Men and Providers Preventing Suicide (MAPS) tailored interactive multimedia patient activation program immediately before a primary care provider (PCP) visit, linked with integrated telephone evidence-based follow-up care (TEBFC) (vs. attention control exposure linked with TEBFC), reduces suicide preparatory behaviors and ideation over 3 months. About half of all middle-aged men who die by suicide are seen by a PCP within a month of dying, suggesting the value of primary care-based suicide prevention efforts, to complement strategies in other settings. Current impediments to primary care-based prevention are that many suicidal middle-aged men do not visit a PCP, and among those who do the topic of suicide is rarely broached, due to societal gender-linked norms (e.g., toughness); stigma; spurious concerns that talking about suicide increases risk; competing time demands; and lack of resources to cope with positive responses. PCP-targeted educational interventions have increased detection of suicidal men, but have inconsistently affected suicide behaviors, and still many suicidal men went undetected. Suicide behaviors are more likely to be reduced by evidence-based follow-up care - supportive follow-up contact and collaborative mental health care. However, such care can only be effective if at-risk men visit a PCP who identifies suicide risk and offers the care, and the men accept it. Thus, there is a pressing need to study the use of innovative tools like MAPS to activate at risk middle-aged men to signal their receptiveness to suicide discussion and care, prompting PCP inquiry and referrals to a form of follow-up care that is feasible for most practices to implement (e.g., TEBFC).
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Self-identified male gender
- •Aged 35-74
- •Has a PCP at a primary care office in one of the two participating health systems who is actively enrolled in the RCT
- •Active suicide thoughts within past 4 weeks
- •Able to read and speak English; and self-reported adequate vision, hearing, and hand function to engage with an interactive computer program on a touchscreen electronic tablet device.
排除标准
- •Reported or apparent highly unstable medical status (e.g. acute decompensated heart failure requiring immediate care)
- •Reported or apparent highly unstable mental health status (e.g. acute uncontrolled psychosis)
- •Presence of terminal illness with death anticipated within 3 months
- •Plan to leave the current primary care office (e.g., transfer care) within 3 months
- •Incarcerated
- •Inability to understand and/or provide informed consent, following appropriate explanation
研究组 & 干预措施
Men and Providers Preventing Suicide
Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit
干预措施: MAPS tailored multimedia patient activation program (Behavioral)
Men and Providers Preventing Suicide
Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit
干预措施: Telephone evidence-based follow-up care (Behavioral)
Men and Providers Preventing Suicide
Tailored interactive multimedia intervention, aimed at activating suicidal middle-aged men to disclose and discuss their suicide thoughts with and be receptive to treatment offers from a primary care provider during a linked office visit
干预措施: Commitment to Living for Primary Care (Behavioral)
Sleep hygiene video
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
干预措施: Sleep hygiene video (Behavioral)
Sleep hygiene video
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
干预措施: Telephone evidence-based follow-up care (Behavioral)
Sleep hygiene video
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
干预措施: Commitment to Living for Primary Care (Behavioral)
结局指标
主要结局
Patient: Beck Scale for Suicide Ideation
时间窗: 3 months
次要结局
- Patient: Reported discussion of suicide during study visits(Immediately post-study visit)
- Patient: suicidal intent scale(3 months)
- Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs(1 month, 2 months, 3 months)
- Patient: enrollment in telephone evidence-based follow-up care(Immediately post-study visit, 1 month, 2 months, 3 months)
- Patient: perceptions of the study interventions and trial participation questionnaire(3 months)
- Patient: Interpersonal Needs Questionnaire(1 month, 2 months, 3 months)
- Patient: augmented Patient Health Questionnaire (PHQ-9)(1 month, 2 months, 3 months)
- Patient: Short Form-12 health survey (SF-12) Mental Component Summary score(1 month, 2 months, 3 months)
- Patient: Toughness scale(1 month, 2 months, 3 months)
- PCP: attitudes toward caring for suicidal patients questionnaire(At study completion, up to 3 years)
- Patient: SF-12 Physical Component Summary score(1 month, 2 months, 3 months)
- PCP: perceptions of study participation questionnaire(At study completion, up to 3 years)
- PCP: perceptions of baseline training videos questionnaire(Immediately after completing the video training)
- PCP: reported discussion of suicide during study visits(Immediately post-study visit)
- PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs(Through study completion, up to 3 years)
