Men and Providers Preventing Suicide (MAPS)

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

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicidal Intention
• Intervention / Treatment: Behavioral: MAPS tailored multimedia patient activation program; Behavioral: Telephone evidence-based follow-up care; Behavioral: Commitment to Living for Primary Care; Behavioral: Sleep hygiene video

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation Research Institute
    • Sacramento, California, United States, 95817
      • University of California Davis Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: MAPS tailored multimedia patient activation program; Behavioral: Telephone evidence-based follow-up care; 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; Other Names: TEBFC; Behavioral: Commitment to Living for Primary Care; Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention
Active Comparator: Sleep hygiene video; A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.	Behavioral: Telephone evidence-based follow-up care; 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; Other Names: TEBFC; Behavioral: Commitment to Living for Primary Care; Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention; Behavioral: Sleep hygiene video; 3 minute video on sleep hygiene produced by HealthiNation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Patient: suicide attempts from electronic medical record and insurance claims database review	Up to 3 years follow-up
The number of times that the trial standardized and proactive safety protocols for patients found to be at heightened acute risk of suicide are invoked, ascertained from patient contact tracking sheets	Through study completion, up to 3 years

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Anthony Jerant, MD, University of California, Davis

Publications and helpful links

General Publications

• Jerant A, Duberstein PR, Kravitz RL, Kleiman EM, Rizvi SL, Cipri C, Liu D, Scher L, Freitas M, Jones-Hill M, Oravetz A, Van Orden KA, Franks P. Ethical and methodological challenges slowing progress in primary care-based suicide prevention: Illustrations from a randomized controlled trial and guidance for future research. J Psychiatr Res. 2022 Oct;154:242-251. doi: 10.1016/j.jpsychires.2022.07.038. Epub 2022 Aug 6.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 922468; U01CE002664 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO