Men and Providers Preventing Suicide (MAPS)

NCT ID: NCT02986113

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2019-09-30

Brief Summary

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

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).

Conditions

Suicidal Intention; Suicidal Ideation; Suicide, Attempted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

MAPS tailored multimedia patient activation program

Intervention Type: BEHAVIORAL

Telephone evidence-based follow-up care

Intervention Type: BEHAVIORAL

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

Commitment to Living for Primary Care

Intervention Type: BEHAVIORAL

Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention

Sleep hygiene video

A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.

Group Type: ACTIVE_COMPARATOR

Sleep hygiene video

Intervention Type: BEHAVIORAL

3 minute video on sleep hygiene produced by HealthiNation

Telephone evidence-based follow-up care

Intervention Type: BEHAVIORAL

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

Commitment to Living for Primary Care

Intervention Type: BEHAVIORAL

Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention

Interventions

MAPS tailored multimedia patient activation program

Intervention Type: BEHAVIORAL

Sleep hygiene video

3 minute video on sleep hygiene produced by HealthiNation

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

TEBFC

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Jerant, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Palo Alto Medical Foundation Research Institute

Palo Alto, California, United States

University of California Davis Health System

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35961180 (View on PubMed)

Other Identifiers

U01CE002664

Identifier Type: NIH

Identifier Source: secondary_id

View Link

922468

Identifier Type: -

Identifier Source: org_study_id