Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MH127512-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Michigan State University | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to test the effects of a suicide prevention intervention for individuals released from jail. The main question it aims to answer is: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? Participants will include subscribers of a managed care organization (MCO). Intervention includes sending subscribers Caring Contacts letters for 6-months following jail release to target healthcare re-engagement and suicide prevention.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caring Contact letters | Experimental | Caring Contact letters will be mailed to a randomly selected group of managed care subscribers over a 6-month period following jail release. |
|
| Control | No Intervention | Care as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Contacts letters | Behavioral | Caring Contacts involves sending individuals at risk for suicide brief, non- demanding messages of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempt | A suicide attempt is defined as "engaging in a potentially self-injurious behavior, associated with at least some intent to die as a result of the act." We will assess total number of subsequent attempts using the already-developed Mental Health Research Network (MHRN) algorithm for extracting suicide attempt information from claims data | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Injury and Poisoning | All-cause injury and poisoning data will be extracted from ICD-10 data. | 6-months |
| Outpatient Behavioral Health Service Linkage | We will extract number of outpatient behavioral health (i.e., mental health or substance use) visits during the 12 months prior to and 6 months following jail release from claims data. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Arrests | We will also extract past year and next 6 month number of arrests from the Jail-Medicaid database. | 18 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Arias | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37974126 | Derived | Arias SA, Sperber K, Jones R, Taxman FS, Miller TR, Zylberfuden S, Weinstock LM, Brown GK, Ahmedani B, Johnson JE. Managed care updates of subscriber jail release to prompt community suicide prevention: clinical trial protocol. BMC Health Serv Res. 2023 Nov 16;23(1):1265. doi: 10.1186/s12913-023-10249-5. | |
| 37841869 | Derived | Arias SA, Sperber K, Jones R, Taxman FS, Miller TR, Zylberfuden S, Weinstock LM, Brown GK, Ahmedani B, Johnson JE. Managed Care Updates of Subscriber Jail Release to Prompt Community Suicide Prevention: Clinical Trial Protocol. Res Sq [Preprint]. 2023 Sep 25:rs.3.rs-3350204. doi: 10.21203/rs.3.rs-3350204/v1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Caring Contact Letters | Caring Contacts involves sending individuals at risk for suicide brief, non-demanding messages of care. |
| FG001 | Caring Contact Control | No contact control condition for the Caring Contact letters |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Caring Contact Letters | Caring Contacts involves sending individuals at risk for suicide brief, non-demanding messages of care. |
| BG001 | Caring Contact Control | No contact control condition for the Caring Contact letters |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Suicide Attempt | A suicide attempt is defined as "engaging in a potentially self-injurious behavior, associated with at least some intent to die as a result of the act." We will assess total number of subsequent attempts using the already-developed Mental Health Research Network (MHRN) algorithm for extracting suicide attempt information from claims data | Posted | Mean | Standard Deviation | Number of suicide attempts | 6-months |
|
From enrollment until end of follow-up, up to 18 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caring Contact Letters | Caring Contacts involves sending individuals at risk for suicide brief, non-demanding messages of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medically-treated Suicide Attempt | Psychiatric disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Arias | Butler Hospital | 909-753-9444 | sarias@butler.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 17, 2023 | Sep 16, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 18 months |
| CareSource Member Services (CMS) Line Use | Caring Contact messages will list the CMS phone number (which is answered by the Care Management Team, who are trained to assess and connect callers to the appropriate services) as a way to reach out. Care Source will track calls to this line by subscribers in all study conditions. | 6-months |
| Inpatient and Emergency Department Mental Health Care Visits | Data on inpatient and emergency department mental health visits will be extracted from claims data using MHRN algorithms. | 6-months |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | All-cause Injury and Poisoning | All-cause injury and poisoning data will be extracted from ICD-10 data. | Posted | Mean | Standard Deviation | Number of all cause injury and poisoning | 6-months |
|
|
|
| Secondary | Outpatient Behavioral Health Service Linkage | We will extract number of outpatient behavioral health (i.e., mental health or substance use) visits during the 12 months prior to and 6 months following jail release from claims data. | Posted | Mean | Standard Deviation | Number of behavioral health visits | 18 months |
|
|
|
| Secondary | CareSource Member Services (CMS) Line Use | Caring Contact messages will list the CMS phone number (which is answered by the Care Management Team, who are trained to assess and connect callers to the appropriate services) as a way to reach out. Care Source will track calls to this line by subscribers in all study conditions. | Posted | Mean | Standard Deviation | Number of calls | 6-months |
|
|
|
| Secondary | Inpatient and Emergency Department Mental Health Care Visits | Data on inpatient and emergency department mental health visits will be extracted from claims data using MHRN algorithms. | Posted | Mean | Standard Deviation | Number of visits | 6-months |
|
|
|
| Other Pre-specified | Number of Arrests | We will also extract past year and next 6 month number of arrests from the Jail-Medicaid database. | Posted | Number | Number of arrests | 18 months |
|
|
|
| 0 |
| 22,380 |
| 1,177 |
| 22,380 |
| 0 |
| 22,380 |
| EG001 | Caring Contact Control | No contact control condition for the Caring Contact letters | 0 | 22,775 | 1,071 | 22,775 | 0 | 22,775 |
| Inpatient hospitalization (potentially suicide-related) | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided