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

Official title

SAFEGUARD Phase 2 Pathfinding Study

Overview

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

• Behavioral Pathfinding
  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-consi
• Behavioral Treatment 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

Primary outcome measures

• Suicide-related behaviors [Time frame: Within the 12 months following completion of the baseline assessment]

Secondary outcome measures (6)

• Number of suicide attempts [Time frame: Within the 12 months following completion of the baseline assessment]
• Rehospitalization [Time frame: 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]
• Risky behaviors [Time frame: Within the 12 months following completion of the baseline assessment]
• Suicide ideation [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Uniformed Services University of the Health Sciences — Bethesda

Publications

• Herman, D. B., Susser, E. S., & Conover, S. (2024). Critical Time Intervention: Mobilizing Supports for People During Perilous Transitions. Oxford University Press.
• Miller, I., Gaudiano, B., & Weinstock, L. (2022). The Coping Long Term with Active Suicide Program (CLASP): A multi-modal intervention for suicide prevention. Oxford University Press.
• Miller IW, Gaudiano BA, Weinstock LM. The Coping Long Term with Active Suicide Program: Description and Pilot Data. Suicide Life Threat Behav. 2016 Dec;46(6):752-761. doi: 10.1111/sltb.12247. Epub 2016 Apr 2. PMID 27038050
• Weinstock LM, Bishop TM, Bauer MS, Benware J, Bossarte RM, Bradley J, Dobscha SK, Gibbs J, Gildea SM, Graves H, Haas G, House S, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Marx BP, Miller A, Nock MK, Owen RR, Pigeon WR, Sampson NA, Santiago-Colon A, Shivakumar G, Urosevic S, Kessler RC. Design of a multicenter randomized controlled trial of a post-discharge suicide prevention intervention for high-r PMID 39352173
• Kessler RC, Warner CH, Ivany C, Petukhova MV, Rose S, Bromet EJ, Brown M 3rd, Cai T, Colpe LJ, Cox KL, Fullerton CS, Gilman SE, Gruber MJ, Heeringa SG, Lewandowski-Romps L, Li J, Millikan-Bell AM, Naifeh JA, Nock MK, Rosellini AJ, Sampson NA, Schoenbaum M, Stein MB, Wessely S, Zaslavsky AM, Ursano RJ; Army STARRS Collaborators. Predicting suicides after psychiatric hospitalization in US Army soldi PMID 25390793
• Kessler RC, Bauer MS, Bishop TM, Bossarte RM, Castro VM, Demler OV, Gildea SM, Goulet JL, King AJ, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Mair P, Marx BP, Nock MK, Petukhova MV, Pigeon WR, Sampson NA, Smoller JW, Miller A, Haas G, Benware J, Bradley J, Owen RR, House S, Urosevic S, Weinstock LM. Evaluation of a Model to Target High-risk Psychiatric Inpatients for an Intensive Postdischarge Suici PMID 36652267

Identifiers

NCT: NCT07404787 · USUHS.2025-156 · Federal Award # HU00012520025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗