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

SAFEGUARD Phase 2 Pathfinding Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07404787
Enrollment
1500
Registered
2026-02-11
Start date
2026-02-24
Completion date
2029-08-31
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide, Suicide Attempt

Keywords

suicide, suicide attempt, hospital discharge, military, intervention, case management

Brief summary

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.

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.

Interventions

BEHAVIORALPathfinding

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.

BEHAVIORALTreatment As Usual (TAU)

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.

Sponsors

Uniformed Services University of the Health Sciences
Lead SponsorFED
Harvard Medical School (HMS and HSDM)
CollaboratorOTHER
University of Michigan
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Suicide-related behaviorsWithin the 12 months following completion of the baseline assessmentSuicide-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).

Secondary

MeasureTime frameDescription
Number of suicide attemptsWithin the 12 months following completion of the baseline assessmentA count of nonfatal suicide attempts (self-reported or administratively documented) that occurred during the follow-up period.
RehospitalizationWithin the 12 months following completion of the baseline assessmentPsychiatric hospitalization (self-reported, informant reported, or administratively documented) during the follow-up period.
Non-suicide deathWithin the 12 months following completion of the baseline assessmentAny manner of death other than suicide (informant reported or administratively documented) during the follow-up period.
Risky behaviorsWithin the 12 months following completion of the baseline assessmentRisky 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.
Suicide ideationWithin the 12 months following completion of the baseline assessmentWorst-week frequency, severity, and controllability of suicide ideation during the follow-up period.
Low psychological resilienceWithin the 12 months following completion of the baseline assessmentPerceived increase or decrease in ability to manage stressful experiences (self-reported) during the follow-up period.

Countries

United States

Contacts

CONTACTPathfinding Study
pathfinding-study@usuhs.edu301-295-3409

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026