Suicide PreventionNCT06506344
Syncing Screening and Services for Suicide Prevention Across Health and Jail Systems
A study testing 5S Trial in people with Suicide Prevention, run by Henry Ford Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- 5S Trial
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,250 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
HealthPartners Institute
Bloomington, Minnesota, 55425
Caitlin Borgert-Spaniol, MA, 952-883-5421, Caitlin.M.BorgertSpaniol@HealthPartners.com
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Diane Wisnieski, MSW, 313-319-6084, dwisnie2@hfhs.org
About this study
Official title: Project 1 (Signature): Syncing Screening and Services for Suicide Prevention Across Health and Jail Systems
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.
Read the detailed description
This study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. There are 3 primary aims of this study: (1) Examine the effectiveness of the intervention on suicide attempt outcomes. (2) Evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) Evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.
- Conditions
- Suicide Prevention
- Being tested
- 5S Trial
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5S TrialBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 5S Trial | Experimental | Participants will receive an intervention aimed at suicide prevention in this group. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-months from jail release date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start24 Jun 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan State University, HealthPartners Institute, Brown University
- Responsible party
- Principal investigator, Brian Ahmedani, Henry Ford Health System
- Investigators
- Brian Ahmedani, PhD, MSW, Principal investigator, Henry Ford HealthLauren Weinstock, PhD, Principal investigator, Brown UniversityRebecca Rossom, MD, MS, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506344
- Sponsor's protocol ID
- 5P50MH127512-02
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41407099
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1 (Signature): Syncing Screening and Services for Suicide Prevention Across Health and Jail Systems
- ClinicalTrials.gov ID
- NCT06506344
- Acronym / sponsor ID
- 5P50MH127512-02
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,250 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Michigan State University, HealthPartners Institute, Brown University
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. There are 3 primary aims of this study: (1) Examine the effectiveness of the intervention on suicide attempt outcomes. (2) Evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) Evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5S Trial | Experimental | Behavioral: 5S TrialParticipants will receive an intervention aimed at suicide prevention in this group. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5S TrialParticipants 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. | Behavioural | 5S Trial |
Primary outcome
Composite measures of suicide attempt and death
Time frame: 6-months from jail release date
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Derived from this study: PubMed 41407099Wisnieski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Ahmedani, PhD, MSW principal investigator
Henry Ford Health
Lauren Weinstock, PhD principal investigator
Brown University
Rebecca Rossom, MD, MS principal investigator
HealthPartners Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5S Trial in people with Suicide Prevention, run by Henry Ford Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Wisnieski, MSW (313-319-6084, dwisnie2@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite measures of suicide attempt and death (time frame: 6-months from jail release date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.