NCT06506344

Brief Summary

This study aims to harmonize jail release record data with electronic health record data in order to connect patients to an evidence-based suicide prevention and clinical care pathway upon jail release.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,250

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress62%
Jun 2024Jul 2027

Study Start

First participant enrolled

June 24, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

July 11, 2024

Last Update Submit

December 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite measures of suicide attempt and death

    Nonfatal medically treated suicide attempts will be identified using diagnosis and encounter codes from all inpatient, outpatient, and emergency department encounters recorded in the EHR (for services delivered by participating systems) or claims (for outside services). All suicide deaths will be identified via linkage to regularly updated state mortality data and the National Death Index (NDI). Suicide deaths will be identified using ICD-10 codes indicating definite or possible self-inflicted injury, or deaths identified as suicides in official state government mortality data (updated monthly in each site).

    6-months from jail release date

Study Arms (2)

5S Trial

EXPERIMENTAL

Participants will receive an intervention aimed at suicide prevention in this group.

Behavioral: 5S Trial

No-Contact Control Group

NO INTERVENTION

Participants will be able to engage with healthcare services as usual and will have no knowledge of their involvement in the study.

Interventions

5S TrialBEHAVIORAL

Participants will receive caring contacts/recruitment outreach, suicide risk screening, suicide safety planning, and, if indicated, connection to healthcare services, resources and the CLASP virtual outreach intervention.

5S Trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Released from jail between February 2021 and July of 2028
  • Had a prior primary care visit or behavioral health visit at a participating health system in the past 3 years

You may not qualify if:

  • Does not currently reside in the same state as the study site (i.e.- Michigan, Minnesota)
  • Would require a translator to participate in the research according to EHR data
  • Previously requested to be excluded from research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

HealthPartners Institute

Bloomington, Minnesota, 55425, United States

RECRUITING

Related Publications (1)

  • Wisnieski DM, Rossom RC, Weinstock LM, Johnson J, Miley K, Gaudiano BA, Benz MB, Borgert-Spaniol C, Graves HR, Norwood R, Kazan R, Starkey C, Kim H, Fletcher L, Kane S, Hu Y, Farrell Z, Strong S, Yeh HH, Miller T, Jones R, Morey K, Ahmedani BK. Study protocol for a type I hybrid effectiveness trial of strategies to prevent suicide attempts among adults recently released from jail. Contemp Clin Trials. 2026 Feb;161:108184. doi: 10.1016/j.cct.2025.108184. Epub 2025 Dec 15.

MeSH Terms

Conditions

Suicide Prevention

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Brian Ahmedani, PhD, MSW

    Henry Ford Health

    PRINCIPAL INVESTIGATOR
  • Lauren Weinstock, PhD

    Brown University

    PRINCIPAL INVESTIGATOR
  • Rebecca Rossom, MD, MS

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diane Wisnieski, MSW

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2024

First Posted

July 17, 2024

Study Start

June 24, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations