Men and Providers Preventing Suicide (MAPS)

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986113
• Other study ID #: 922468
• Secondary ID: U01CE002664
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 2019

Study information

• Verified date: October 2019
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicidal Intention
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• MAPS tailored multimedia patient activation program

• Sleep hygiene video
3 minute video on sleep hygiene produced by HealthiNation
• 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
• 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

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation Research Institute	Palo Alto	California
United States	University of California Davis Health System	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient: suicide attempts from electronic medical record and insurance claims database review		Up to 3 years follow-up
Other	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		Through study completion, up to 3 years
Primary	Patient: Beck Scale for Suicide Ideation		3 months
Secondary	Patient: Reported discussion of suicide during study visits		Immediately post-study visit
Secondary	Patient: suicidal intent scale		3 months
Secondary	Patient: enrollment in telephone evidence-based follow-up care		Immediately post-study visit, 1 month, 2 months, 3 months
Secondary	Patient adherence to telephone evidence-based follow-up care, ascertained from care manager patient contact logs		1 month, 2 months, 3 months
Secondary	Patient: Interpersonal Needs Questionnaire	Perceived burdensomeness and belongingness to others	1 month, 2 months, 3 months
Secondary	Patient: augmented Patient Health Questionnaire (PHQ-9)	PHQ-9 plus six "male depression" items	1 month, 2 months, 3 months
Secondary	Patient: Short Form-12 health survey (SF-12) Mental Component Summary score	Mental health status	1 month, 2 months, 3 months
Secondary	Patient: SF-12 Physical Component Summary score	Physical health status	1 month, 2 months, 3 months
Secondary	Patient: Toughness scale	Gender-linked views regarding health-related help-seeking	1 month, 2 months, 3 months
Secondary	Patient: perceptions of the study interventions and trial participation questionnaire		3 months
Secondary	PCP: perceptions of baseline training videos questionnaire	Measured by questionnaire	Immediately after completing the video training
Secondary	PCP: reported discussion of suicide during study visits		Immediately post-study visit
Secondary	PCP: The number of times that PCPs refer study patients to TEBFC, ascertained from study care manager logs		Through study completion, up to 3 years
Secondary	PCP: attitudes toward caring for suicidal patients questionnaire		At study completion, up to 3 years
Secondary	PCP: perceptions of study participation questionnaire		At study completion, up to 3 years