Clinical trial NCT02986113: Men and Providers Preventing Suicide (MAPS)
Official title: Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal Intention
Suicidal Ideation
Suicide, Attempted
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2016-12-08
Enrollment: 93
Sex: MALE
Minimum age (years): 35
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Patient: Beck Scale for Suicide Ideation
timeFrame: 3 months
Secondary outcomes:
measure: Patient: Reported discussion of suicide during study visits
timeFrame: Immediately post-study visit
measure: Patient: suicidal intent scale
timeFrame: 3 months
measure: Patient: enrollment in telephone evidence-based follow-up care
timeFrame: Immediately post-study visit, 1 month, 2 months, 3 months
measure: Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
timeFrame: 1 month, 2 months, 3 months
measure: Patient: Interpersonal Needs Questionnaire
timeFrame: 1 month, 2 months, 3 months
measure: Patient: augmented Patient Health Questionnaire (PHQ-9)
timeFrame: 1 month, 2 months, 3 months
measure: Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
timeFrame: 1 month, 2 months, 3 months
measure: Patient: SF-12 Physical Component Summary score
timeFrame: 1 month, 2 months, 3 months
measure: Patient: Toughness scale
timeFrame: 1 month, 2 months, 3 months
measure: Patient: perceptions of the study interventions and trial participation questionnaire
timeFrame: 3 months
measure: PCP: perceptions of baseline training videos questionnaire
timeFrame: Immediately after completing the video training
measure: PCP: reported discussion of suicide during study visits
timeFrame: Immediately post-study visit
measure: PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs
timeFrame: Through study completion, up to 3 years
measure: PCP: attitudes toward caring for suicidal patients questionnaire
timeFrame: At study completion, up to 3 years
measure: PCP: perceptions of study participation questionnaire
timeFrame: At study completion, up to 3 years
Other outcomes:
measure: Patient: suicide attempts from electronic medical record and insurance claims database review
timeFrame: Up to 3 years follow-up
measure: 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
timeFrame: Through study completion, up to 3 years
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation Research Institute
state: California
city: Sacramento
country: United States
facility: University of California Davis Health System
state: California
Study officials:
affiliation: University of California, Davis
name: Anthony Jerant, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.