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.
Looking for future studies?
Notify MeKey information
Conditions
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
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
Sleep hygiene video
Behavioral3 minute video on sleep hygiene produced by HealthiNation
Telephone evidence-based follow-up care
Behavioral3 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
BehavioralBrief (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
-
Patient: Beck Scale for Suicide Ideation
Time frame: 3 months
Secondary outcomes
-
Patient: Reported discussion of suicide during study visits
Time frame: Immediately post-study visit
-
Patient: suicidal intent scale
Time frame: 3 months
-
Patient: enrollment in telephone evidence-based follow-up care
Time frame: 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
Time frame: 1 month, 2 months, 3 months
-
Patient: Interpersonal Needs Questionnaire
Time frame: 1 month, 2 months, 3 months
Perceived burdensomeness and belongingness to others
-
Patient: augmented Patient Health Questionnaire (PHQ-9)
Time frame: 1 month, 2 months, 3 months
PHQ-9 plus six "male depression" items
-
Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
Time frame: 1 month, 2 months, 3 months
Mental health status
-
Patient: SF-12 Physical Component Summary score
Time frame: 1 month, 2 months, 3 months
Physical health status
-
Patient: Toughness scale
Time frame: 1 month, 2 months, 3 months
Gender-linked views regarding health-related help-seeking
-
Patient: perceptions of the study interventions and trial participation questionnaire
Time frame: 3 months
-
PCP: perceptions of baseline training videos questionnaire
Time frame: Immediately after completing the video training
Measured by questionnaire
-
PCP: reported discussion of suicide during study visits
Time frame: Immediately post-study visit
-
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
-
PCP: attitudes toward caring for suicidal patients questionnaire
Time frame: At study completion, up to 3 years
-
PCP: perceptions of study participation questionnaire
Time frame: At study completion, up to 3 years
Other outcomes
-
Patient: suicide attempts from electronic medical record and insurance claims database review
Time frame: 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
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Biomarkers as Predictors of Suicidal Risk in Adolescents
NCT03014518
Behavior, Behavioral Symptoms
Cleveland, Ohio, United States
View Trial DetailsZero Suicide Plus KICKS
NCT03924037
Behavior, Behavioral Symptoms
Albuquerque, New Mexico, United States
View Trial DetailsTMS for Suicidal Crisis in Active Duty SMs
NCT03014362
Behavior, Behavioral Symptoms
Augusta, Georgia, United States
View Trial DetailsClassification and Assessment of Mental Health Performance Using Schematics
NCT04275908
Behavior, Behavioral Symptoms
Mason, Ohio, United States
View Trial Details