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Completed

NCT Number: NCT02986113

Men and Providers Preventing Suicide (MAPS)

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.

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Key information

Age range

35 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation Research Institute, Palo Alto, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAPS tailored multimedia patient activation program

Behavioral

Sleep hygiene video

Behavioral

3 minute video on sleep hygiene produced by HealthiNation

Telephone evidence-based follow-up care

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

Other names: TEBFC

Commitment to Living for Primary Care

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

Primary outcomes

  1. Patient: Beck Scale for Suicide Ideation

    Time frame: 3 months

Secondary outcomes

  1. Patient: Reported discussion of suicide during study visits

    Time frame: Immediately post-study visit

  2. Patient: suicidal intent scale

    Time frame: 3 months

  3. Patient: enrollment in telephone evidence-based follow-up care

    Time frame: Immediately post-study visit, 1 month, 2 months, 3 months

  4. Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs

    Time frame: 1 month, 2 months, 3 months

  5. Patient: Interpersonal Needs Questionnaire

    Time frame: 1 month, 2 months, 3 months

    Perceived burdensomeness and belongingness to others

  6. Patient: augmented Patient Health Questionnaire (PHQ-9)

    Time frame: 1 month, 2 months, 3 months

    PHQ-9 plus six "male depression" items

  7. Patient: Short Form-12 health survey (SF-12) Mental Component Summary score

    Time frame: 1 month, 2 months, 3 months

    Mental health status

  8. Patient: SF-12 Physical Component Summary score

    Time frame: 1 month, 2 months, 3 months

    Physical health status

  9. Patient: Toughness scale

    Time frame: 1 month, 2 months, 3 months

    Gender-linked views regarding health-related help-seeking

  10. Patient: perceptions of the study interventions and trial participation questionnaire

    Time frame: 3 months

  11. PCP: perceptions of baseline training videos questionnaire

    Time frame: Immediately after completing the video training

    Measured by questionnaire

  12. PCP: reported discussion of suicide during study visits

    Time frame: Immediately post-study visit

  13. PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs

    Time frame: Through study completion, up to 3 years

  14. PCP: attitudes toward caring for suicidal patients questionnaire

    Time frame: At study completion, up to 3 years

  15. PCP: perceptions of study participation questionnaire

    Time frame: At study completion, up to 3 years

Other outcomes

  1. Patient: suicide attempts from electronic medical record and insurance claims database review

    Time frame: Up to 3 years follow-up

  2. 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

    Time frame: Through study completion, up to 3 years

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2016
Registry last updated
Oct 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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