Men and Providers Preventing Suicide (MAPS)
Primary Purpose
Suicidal Intention, Suicidal Ideation, Suicide, Attempted
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MAPS tailored multimedia patient activation program
Sleep hygiene video
Telephone evidence-based follow-up care
Commitment to Living for Primary Care
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal Intention
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
Sites / Locations
- Palo Alto Medical Foundation Research Institute
- University of California Davis Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Men and Providers Preventing Suicide
Sleep hygiene video
Arm Description
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
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
Outcomes
Primary Outcome Measures
Patient: Beck Scale for Suicide Ideation
Secondary Outcome Measures
Patient: Reported discussion of suicide during study visits
Patient: suicidal intent scale
Patient: enrollment in telephone evidence-based follow-up care
Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
Patient: Interpersonal Needs Questionnaire
Perceived burdensomeness and belongingness to others
Patient: augmented Patient Health Questionnaire (PHQ-9)
PHQ-9 plus six "male depression" items
Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
Mental health status
Patient: SF-12 Physical Component Summary score
Physical health status
Patient: Toughness scale
Gender-linked views regarding health-related help-seeking
Patient: perceptions of the study interventions and trial participation questionnaire
PCP: perceptions of baseline training videos questionnaire
Measured by questionnaire
PCP: reported discussion of suicide during study visits
PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs
PCP: attitudes toward caring for suicidal patients questionnaire
PCP: perceptions of study participation questionnaire
Full Information
NCT ID
NCT02986113
First Posted
December 2, 2016
Last Updated
October 28, 2019
Sponsor
University of California, Davis
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT02986113
Brief Title
Men and Providers Preventing Suicide (MAPS)
Official Title
Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Intention, Suicidal Ideation, Suicide, Attempted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Men and Providers Preventing Suicide
Arm Type
Experimental
Arm Description
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
Arm Title
Sleep hygiene video
Arm Type
Active Comparator
Arm Description
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
Intervention Type
Behavioral
Intervention Name(s)
MAPS tailored multimedia patient activation program
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene video
Intervention Description
3 minute video on sleep hygiene produced by HealthiNation
Intervention Type
Behavioral
Intervention Name(s)
Telephone evidence-based follow-up care
Other Intervention Name(s)
TEBFC
Intervention Description
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
Intervention Name(s)
Commitment to Living for Primary Care
Intervention Description
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 Outcome Measure Information:
Title
Patient: Beck Scale for Suicide Ideation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient: Reported discussion of suicide during study visits
Time Frame
Immediately post-study visit
Title
Patient: suicidal intent scale
Time Frame
3 months
Title
Patient: enrollment in telephone evidence-based follow-up care
Time Frame
Immediately post-study visit, 1 month, 2 months, 3 months
Title
Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs
Time Frame
1 month, 2 months, 3 months
Title
Patient: Interpersonal Needs Questionnaire
Description
Perceived burdensomeness and belongingness to others
Time Frame
1 month, 2 months, 3 months
Title
Patient: augmented Patient Health Questionnaire (PHQ-9)
Description
PHQ-9 plus six "male depression" items
Time Frame
1 month, 2 months, 3 months
Title
Patient: Short Form-12 health survey (SF-12) Mental Component Summary score
Description
Mental health status
Time Frame
1 month, 2 months, 3 months
Title
Patient: SF-12 Physical Component Summary score
Description
Physical health status
Time Frame
1 month, 2 months, 3 months
Title
Patient: Toughness scale
Description
Gender-linked views regarding health-related help-seeking
Time Frame
1 month, 2 months, 3 months
Title
Patient: perceptions of the study interventions and trial participation questionnaire
Time Frame
3 months
Title
PCP: perceptions of baseline training videos questionnaire
Description
Measured by questionnaire
Time Frame
Immediately after completing the video training
Title
PCP: reported discussion of suicide during study visits
Time Frame
Immediately post-study visit
Title
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
Title
PCP: attitudes toward caring for suicidal patients questionnaire
Time Frame
At study completion, up to 3 years
Title
PCP: perceptions of study participation questionnaire
Time Frame
At study completion, up to 3 years
Other Pre-specified Outcome Measures:
Title
Patient: suicide attempts from electronic medical record and insurance claims database review
Time Frame
Up to 3 years follow-up
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Jerant, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Palo Alto Medical Foundation Research Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
University of California Davis Health System
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35961180
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.
Results Reference
derived
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