Evaluation of a Telehealth Case Management Intervention to Prevent Suicide Among Soldiers Discharged From Psychiatric Hospitalization

SAFEGUARD Phase 2 Pathfinding Study

This study evaluates the effectiveness of Pathfinding, a 6-month, remotely-delivered case management intervention designed to decrease suicidal behavior among active-duty Regular Army soldiers recently discharged from inpatient psychiatric treatment. Soldiers discharged from military treatment facilities across the U.S. will be identified and recruited to participate. Those who consent will be randomly assigned to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus Pathfinding. Participants will complete a baseline assessment and follow-up assessments 6 months and 12 months later. The 6- and 12-month follow-up periods will also include examination of participants' electronic healthcare data and Army administrative data. The overall goals of the study are: (1) to evaluate whether Pathfinding decreases suicidal behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) to determine which discharged soldiers are most likely to benefit from the Pathfinding intervention versus TAU alone.

Study Overview

Detailed Description

Discharge from psychiatric hospitalization is the highest risk period for death by suicide. Intensive case management programs have been effective in reducing post-discharge suicidal behavior, but such programs are too resource-intensive to implement for all psychiatric inpatients. It would be more scalable to target the intervention to those most likely to benefit and implement it remotely with centralized training & management. This study evaluates the effectiveness of Pathfinding, a 6-month, adjunctive, telehealth case management intervention, in decreasing suicide-related behaviors among active-duty Regular Army soldiers over the 12 months following discharge from inpatient psychiatric treatment. The Pathfinding intervention combines elements from two case management programs that have been found to reduce suicidal behavior and other negative outcomes among individuals transitioning out of the hospital and back to the community-Coping with Long-Term Active Suicide Program (CLASP) and Critical Time Intervention (CTI)-and adapts them for the unique needs of an active-duty military population. The intervention is delivered remotely by "Guides," masters-level mental health professionals who are centrally trained and supervised.

Soldiers hospitalized for inpatient psychiatric care at military treatment facilities (MTFs) across the U.S. will be identified in the electronic health record (EHR) as soon as possible after being discharged. A previously developed machine learning model based on EHR and Army administrative data will be used to stratify discharged soldiers based on their predicted probability of suicidal behavior. Soldiers will be recruited from across the distribution of predicted risk via emails, text messages, and phone calls. Consenting soldiers will complete a baseline assessment of their health, experiences, and characteristics. They will then be randomized to receive either Treatment As Usual (TAU), which is the Army's standard post-discharge care, or TAU plus the 6-month Pathfinding case management intervention. All participants will be administered follow-up assessments 6 and 12 months after baseline to identify self-reported suicide-related events and other outcomes. Outcomes will also be tracked through EHR data.

The study will examine: (1) whether Pathfinding decreases suicide-related behaviors among soldiers transitioning from psychiatric hospitalization back to the community; and (2) whether certain soldiers are more likely than others to benefit from the Pathfinding intervention versus TAU alone.

Study Type

Interventional

Enrollment (Estimated)

1500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Recruiting
        • Uniformed Services University of the Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Active duty Regular Army soldiers recently discharged from inpatient psychiatric care at a military treatment facility in the US
  • Access to telephone and computer (including smartphone)

Exclusion Criteria:

  • Impaired ability to provide informed consent
  • Terminal illness
  • Failure to complete baseline survey within 30 days of discharge
  • Positive screen for post-discharge suicide-related behaviors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pathfinding intervention plus Treatment As Usual (TAU)
Pathfinding is a 6-month, adjunctive, telehealth intervention that integrates 2 evidence-based case management programs and adapts them for active duty soldiers: Coping Long Term with Active Suicide Program (CLASP), a case management intervention for suicidal patients transitioning out of psychiatric hospitals; and Critical Time Intervention (CTI), a more general case management intervention for high-risk transitions out restrictive environments. Administered remotely by a centrally trained & supervised team of "Guides." Focuses on key suicide risk factors (e.g., treatment engagement, social connection, problem-solving) and unmet needs across life domains (e.g., legal, financial, housing, and relationships). Participants receive Pathfinding in addition to standard post-discharge care (see TAU intervention description for details).
The Pathfinding intervention consists of remote (videoconference or phone) interactions between participants and masters-level Guides over the 6 months following study enrollment. Participants have the option of involving a support person (SP) in the intervention (e.g., family member, friend). First 4 sessions (45 min. each) occur as soon as possible following hospital discharge and focus on orientation to Pathfinding, identifying a SP, and identifying and prioritizing values/needs, values-consistent goals, corresponding actions, and relevant resources. Participants subsequently receive up to 10 brief (15-30 min. each) contacts to monitor risk and progress. Frequency of contacts is front-loaded and diminishes over time as participants take more control over managing their transition. SPs are contacted for up to 5 sessions (10-15 min. each) to help with monitoring and support. Sessions, risk assessments, and any crisis response actions are documented in the electronic health record.
Active Comparator: Treatment As Usual (TAU)
Treatment As Usual (TAU) is the Army's standard care for soldiers discharged from inpatient psychiatric treatment. It involves discharge planning, risk assessment, and referrals (as detailed in the TAU intervention description).
TAU is standard post-discharge care based on Defense Health Agency policy (DHA Administrative Instruction 6025.06): Discharge plans must consist of referral with plans for outpatient or partial hospitalization follow-up within 7 days (optimally within 72 hours). Discharged patients are placed on a High-Risk (HR) list for at least 30 days. During this period, patients are seen weekly for follow-up appointments or attendance of the HR group if individual psychotherapy is not available. If, after 4 weeks, the patient is assessed as no longer acutely suicidal, they are removed from the HR list. After removal from the HR list, patients are seen either weekly or every other week, depending on clinical need. Initial care coordination is handled by the discharge nurse. Ongoing care coordination is managed by the outpatient mental health team. Safety planning is conducted at discharge and every few sessions thereafter using the DHA safety plan. Safety assessments are conducted at each visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suicide-related behaviors
Time Frame: Within the 12 months following completion of the baseline assessment
Suicide-related behaviors are defined as: suicide death (administratively documented or informant reported), nonfatal suicide attempt (self-reported or administratively documented), and interrupted suicide attempt, aborted suicide attempt, and preparatory behaviors for suicide (the latter 3 are all self-reported).
Within the 12 months following completion of the baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of suicide attempts
Time Frame: Within the 12 months following completion of the baseline assessment
A count of nonfatal suicide attempts (self-reported or administratively documented) that occurred during the follow-up period.
Within the 12 months following completion of the baseline assessment
Rehospitalization
Time Frame: Within the 12 months following completion of the baseline assessment
Psychiatric hospitalization (self-reported, informant reported, or administratively documented) during the follow-up period.
Within the 12 months following completion of the baseline assessment
Non-suicide death
Time Frame: Within the 12 months following completion of the baseline assessment
Any manner of death other than suicide (informant reported or administratively documented) during the follow-up period.
Within the 12 months following completion of the baseline assessment
Risky behaviors
Time Frame: Within the 12 months following completion of the baseline assessment
Risky behaviors (self-reported) related to driving or riding in a vehicle, sexual encounters, and aggression (bullying, sexual harassment, intimate partner violence) during the follow-up period.
Within the 12 months following completion of the baseline assessment
Suicide ideation
Time Frame: Within the 12 months following completion of the baseline assessment
Worst-week frequency, severity, and controllability of suicide ideation during the follow-up period.
Within the 12 months following completion of the baseline assessment
Low psychological resilience
Time Frame: Within the 12 months following completion of the baseline assessment
Perceived increase or decrease in ability to manage stressful experiences (self-reported) during the follow-up period.
Within the 12 months following completion of the baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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