Rapid Personalization of Safety Plans for Psychiatrically Hospitalized Veterans at High-Risk for Suicide

Overview

Veterans psychiatrically hospitalized face significantly elevated suicide risk, particularly in the three months post-discharge. While Safety Planning is a required component of discharge planning, many safety plans lack personalization thereby reducing their effectiveness. The proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined and finalized in a case series (N = 15) then evaluated in a pilot randomized controlled trial (N = 96) comparing PSP to Safety Plans as Usual among psychiatrically hospitalized Veterans. Overall, the study aims to: 1) iteratively refine PSP; 2) examine PSP's preliminary effectiveness in reducing suicide ideation and increasing adaptive coping; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring.

Detailed description

Veterans hospitalized in inpatient psychiatry units are eight times more likely to die by suicide than all Veterans who use VA services, with the highest risk period being the first three months post-discharge. Safety Planning is a required component of discharge planning for psychiatrically hospitalized Veterans, yet many safety plans (SPs) are often poorly personalized which significantly limits their effectiveness. Clinicians need better training to personalize SPs and Veterans prefer a personalized intervention that identifies their specific suicide warning signs and adaptive coping skills. Improvements in SP application are critically needed. To address this gap, the proposed intervention, Personalized Safety Plans (PSP), will be developed for rapid delivery on acute inpatient psychiatry units. PSP is a single-session intervention followed by twice monthly brief, personalized coaching sessions during the three-month high-risk discharge period. PSP will be iteratively refined in a case series (N = 15) and then, consistent with a hybrid I effectiveness-implementation design, evaluated in a pilot randomized controlled trial (RCT; N = 96) comparing PSP to SP as Usual among psychiatrically hospitalized Veterans. In the case series, Veterans will complete assessments at baseline, post-treatment, and at 1 month post-discharge. In the pilot RCT, Veterans will complete assessments at baseline, post-treatment, and at 1, 3, and 6 months post-discharge. The primary goal is to determine PSP's preliminary effectiveness; the secondary goal is to understand the implementation context through feedback from Veterans, clinicians, and stakeholders. The proposed study will provide a foundation for a larger RCT through four aims: 1) iteratively refine PSP, guided by Veteran, clinician, and stakeholder feedback; 2) examine PSP's preliminary effectiveness in reducing suicide ideation, increasing adaptive coping, and increasing SP personalization compared to SP as Usual; 3) identify barriers and facilitators to implementation; and 4) develop a fidelity measure to support future personalization monitoring. The proposed study will be conducted in the Behavioral Science Division of the National Center for PTSD at the VA Boston Healthcare System with support from a collaborative and expert mentorship team. The candidate will pursue five training aims: 1) obtain expertise in treatment adaptation and conducting RCTs with psychiatrically hospitalized Veterans; 2) gain analytic skills to evaluate RCTs; 3) refine clinical expertise in treating suicidal Veterans; 4) acquire fundamentals of implementation science; and 5) engage in professional development to support the transition to an independently funded VA investigator. The proposed study and training directly aligns with the candidate's career goal of becoming a VA clinical trialists who develops, adapts, and tests personalized and implementable interventions to reduce Veteran suicide.

Interventions

• Behavioral Personalized Safety Plans
  Personalized Safety Plans is a single-session (up to 90min) inpatient intervention followed by twice-monthly coaching sessions (up to 30min each) over the three-month high-risk discharge period. The inpatient session uses chain and solution analyses from Dialectical Behavior Therapy to build a shared understanding of the suicide crisis, including vulnerability factors, prompting events, behavioral links, consequences, and solutions. Veterans also identify distal patterns of suicide risk, support
• Behavioral Safety Plans as Usual + Calls
  The comparator condition is Safety Plan as Usual plus attentional control phone calls. Safety Plan as Usual reflect standard clinical practice on the inpatient psychiatry. Per VHA Directives and clinical requirements, all at-risk patients must collaboratively develop a SP and receive a copy prior to discharge. Providers use the suicide narrative alongside questions from the Safety Planning Intervention Manual. Attentional control phone calls are twice-monthly supportive check-ins, matched in fre

Primary outcome measures

• Columbia-Suicide Severity Rating Scale - Suicide Ideation Duration [Time frame: Baseline and 1, 3, and 6-month follow-up, an average of 6 months]
• Columbia-Suicide Severity Rating Scale - Suicide Ideation Frequency [Time frame: Baseline and 1, 3, and 6-month follow-up, an average of 6 months]
• Feasibility of PSP Intervention [Time frame: Throughout Part 1 of study completion, an average of 1 month]
• Acceptability of PSP Intervention - Patient Satisfaction [Time frame: Throughout Part 1 of study completion, an average of 1 month]
• Acceptability of PSP Intervention [Time frame: Throughout Part 1 of study completion, an average of 1 month]
• Beck Scale for Suicide Ideation [Time frame: Baseline and 1, 3, and 6-month follow-up]

Secondary outcome measures (3)

• Suicide-Related Coping Scale [Time frame: Baseline and 1, 3, and 6-month follow-up]
• Safety Plan Rating Scale [Time frame: Baseline and 1, 3, and 6-month follow-up]
• Safety Plan Use Scale [Time frame: Baseline and 1, 3, and 6-month follow-up]

Eligibility criteria

Inclusion criteria

Participants will be Veterans who are:

• admitted to VABHS inpatient psychiatry for suicide risk
• display sufficient English comprehension and cognitive capacity to understand the study and provide informed consent
• have been medically cleared by attending physician

Exclusion criteria

The exclusion criteria for Veterans in this study are:

• current psychosis
• current mania
• dementia or other significant cognitive impairment
• being inaccessible and discharged from the unit less than 48 hours after being identified by study staff
• prisoner status

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

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston

Identifiers

NCT: NCT07507786 · MHBC-012-25S · IK2RD001575-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗