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Men and Providers Preventing Suicide (MAPS)

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ClinicalTrials.gov Identifier: NCT02986113
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Suicidal Intention Suicidal Ideation Suicide, Attempted Behavioral: MAPS tailored multimedia patient activation program Behavioral: Sleep hygiene video Behavioral: Telephone evidence-based follow-up care Behavioral: Commitment to Living for Primary Care Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Men and Providers Preventing Suicide (MAPS): A Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: MAPS tailored multimedia patient activation program
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
Other Name: TEBFC

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

Active Comparator: Sleep hygiene video
A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.
Behavioral: Sleep hygiene video
3 minute video on sleep hygiene produced by HealthiNation

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
Other Name: TEBFC

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




Primary Outcome Measures :
  1. Patient: Beck Scale for Suicide Ideation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986113


Contacts
Contact: Camille Cipri 916-734-2672 cscipri@ucdavis.edu
Contact: Peach Dounias 916-703-5642 prdounias@ucdavis.edu

Locations
United States, California
Palo Alto Medical Foundation Research Institute Terminated
Palo Alto, California, United States, 94301
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Contact: Camille Cipri    916-734-2672    cscipri@ucdavis.edu   
Contact: Peach Dounias    916-703-5642    prdounias@ucdavis.edu   
Principal Investigator: Anthony Jerant, MD         
Sub-Investigator: Richard L Kravitz, MD, MSPH         
Sponsors and Collaborators
University of California, Davis
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Anthony Jerant, MD University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02986113     History of Changes
Other Study ID Numbers: 922468
U01CE002664 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Suicide
Suicidal Ideation
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms