NCT02986113

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 30, 2019

Status Verified

October 1, 2019

Enrollment Period

2.6 years

First QC Date

December 2, 2016

Last Update Submit

October 28, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient: Beck Scale for Suicide Ideation

    3 months

Secondary Outcomes (15)

  • Patient: Reported discussion of suicide during study visits

    Immediately post-study visit

  • Patient: suicidal intent scale

    3 months

  • Patient: enrollment in telephone evidence-based follow-up care

    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

    1 month, 2 months, 3 months

  • Patient: Interpersonal Needs Questionnaire

    1 month, 2 months, 3 months

  • +10 more secondary outcomes

Other Outcomes (2)

  • Patient: suicide attempts from electronic medical record and insurance claims database review

    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

    Through study completion, up to 3 years

Study Arms (2)

Men and Providers Preventing Suicide

EXPERIMENTAL

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 programBehavioral: Telephone evidence-based follow-up careBehavioral: Commitment to Living for Primary Care

Sleep hygiene video

ACTIVE COMPARATOR

A brief (3 minute) video regarding sleep hygiene, accompanied by introductory text summarizing research linking sleep problems with increased suicide risk.

Behavioral: Sleep hygiene videoBehavioral: Telephone evidence-based follow-up careBehavioral: Commitment to Living for Primary Care

Interventions

Men and Providers Preventing Suicide

3 minute video on sleep hygiene produced by HealthiNation

Sleep hygiene video

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

Also known as: TEBFC
Men and Providers Preventing SuicideSleep hygiene video

Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention

Men and Providers Preventing SuicideSleep hygiene video

Eligibility Criteria

Age35 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Palo Alto Medical Foundation Research Institute

Palo Alto, California, 94301, United States

Location

University of California Davis Health System

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicidal IdeationSuicide, Attempted

Interventions

Primary Health Care

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Anthony Jerant, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 8, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2019

Study Completion

September 1, 2019

Last Updated

October 30, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations