Men and Providers Preventing Suicide (MAPS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial

Conditions
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Suicidal Intention, Suicidal Ideation, Suicide, Attempted

Intervention / Treatment
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* Behavioral: MAPS tailored multimedia patient activation program
* Behavioral: Sleep hygiene video
* Behavioral: Telephone evidence-based follow-up care
* Behavioral: Commitment to Living for Primary Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men and Providers Preventing Suicide<br>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 | Behavioral: MAPS tailored multimedia patient activation program<br> <br> Behavioral: Telephone evidence-based follow-up care<br>* 3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider<br>* Other names: TEBFC;Behavioral: Commitment to Living for Primary Care<br>* Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention<br>|
| Active Comparator: Sleep hygiene video<br>A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk. | Behavioral: Sleep hygiene video<br>* 3 minute video on sleep hygiene produced by HealthiNation<br>Behavioral: Telephone evidence-based follow-up care<br>* 3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider<br>* Other names: TEBFC;Behavioral: Commitment to Living for Primary Care<br>* Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient: Beck Scale for Suicide Ideation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient: Reported discussion of suicide during study visits |  | Immediately post-study visit | 
| Patient: suicidal intent scale |  | 3 months | 
| Patient: enrollment in telephone evidence-based follow-up care |  | Immediately post-study visit, 1 month, 2 months, 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: Interpersonal Needs Questionnaire | Perceived burdensomeness and belongingness to others | 1 month, 2 months, 3 months | 
| Patient: augmented Patient Health Questionnaire (PHQ-9) | PHQ-9 plus six male depression items | 1 month, 2 months, 3 months | 
| Patient: Short Form-12 health survey (SF-12) Mental Component Summary score | Mental health status | 1 month, 2 months, 3 months | 
| Patient: SF-12 Physical Component Summary score | Physical health status | 1 month, 2 months, 3 months | 
| Patient: Toughness scale | Gender-linked views regarding health-related help-seeking | 1 month, 2 months, 3 months | 
| Patient: perceptions of the study interventions and trial participation questionnaire |  | 3 months | 
| PCP: perceptions of baseline training videos questionnaire | Measured by 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 | 
| PCP: attitudes toward caring for suicidal patients questionnaire |  | At study completion, up to 3 years | 
| PCP: perceptions of study participation questionnaire |  | At study completion, up to 3 years |