Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide

NCT03724370 | Unknown

• 1 other identifier: LSRG-0-060-15
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

Overview. The investigators will randomize 120 Veterans in this 3-site trial over 16 months. Eligible Veterans will include those to be discharged for a hospitalization for suicidal ideation. Baseline data collection and randomization will occur at discharge. The 3 month intervention will have study assessments at 2, 4, 8, and 12 weeks post-discharge. The study's primary outcome measure is suicidal ideation (measured with the Beck Scale for Suicidal Ideation\[BSS\] and secondarily with the Columbia Scale for Suicidality C-SSRS). Intervention Components. The control condition will consist of Veterans randomized to VHA-SRM (Suicide Risk Monitoring). The experimental condition will be the telehealth system (TES) + VHA-SRM (Suicide Risk Monitoring) intervention. Veterans randomized to the telehealth system will receive the Interactive Voice Response (IVR) system monitoring in addition to VHA-SRM and will receive training on how to use the TES from the research coordinator. Veterans can access the IVR as a telephonic device accessed by a local or toll-free number and can use a 'plain old telephone system' (POTS), Cellular phone or Internet phone connected to their phone service provider. Participants will be instructed to interact daily with the TES system daily. Because of safety concerns, questions pertaining to suicidal behavior will be asked daily; to avoid repetition, all other questions will be asked every 3rd day. Once participants complete the questions on the telehealth device, their responses will be automatically uploaded and checked by trained VA Pittsburgh Healthcare System (VAPHS) nurses every 4 hours, during regular daytime hours of 9-5. VAPHS will serve as the central site retrieving downloads for all sites. Color-coded risk triage level designations based on potential responses, provide guidance regarding next steps. The protocol for assessing suicidal patients will follow standard VA procedures, outlined in each medical center's safety plan for suicidal patients.

Conditions

Suicide

Outcome Measures

Primary Outcomes (1)

• Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.

  Continuous scale assessing suicidal ideation. Scores will range from 0 to 42, with lower scores indicating less suicidal ideation.

  At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today.

Secondary Outcomes (1)

• Change in Columbia Suicide Severity Rating Scale (C-SSRS). Posner, K; Brent, D; Lucas, c; Gould, M; Stanley, B; Brown, G; Fisher, P; Zelazny, J; Burke, A; Oquendo, M; Mann, J.

  At every visit: screen, baseline(s), week 2,4,6,8,12; time frame includes lifetime and since last visit.

Study Arms (2)

TES+ VHA-SRM

EXPERIMENTAL

Telehealth monitoring system (TES) will be added to the VA suicide risk management system (VHA-SRM)

Behavioral: Telehealth Monitoring System; Other: VHA-SRM

VHA-SRM

ACTIVE COMPARATOR

VHA-SRM will be active comparator

Other: VHA-SRM

Interventions

Telehealth Monitoring System BEHAVIORAL

TES will be conducted daily via Interactive Voice Response System (IVRS) during the 12 week study period.TES will be added to VHA-SRM.

TES+ VHA-SRM

VHA-SRM OTHER

Veterans Health Administration Suicide Risk Management supportive services will be provided to participant during the 12 weeks of study participation.

TES+ VHA-SRM; VHA-SRM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans \> 18 years old;
• any diagnosis as long as participants exhibit at least mild depressive symptoms, i.e., a Hamilton 17-item depression 30 score \>8; this includes patients with schizophrenia/schizoaffective disorder;
• score \>1 on items 4 or 5 on the SSI ; which assesses active or passive suicidal ideation, respectively.-

You may not qualify if:

• Cognitive problems that would interfere with Veterans' ability to manage the TES system (e.g., neurocognitive d/o, significant traumatic brain injury, or a Folstein Mini Mental Status Exam score \<22) or serious motor dexterity problems;
• Veterans without phone access.

Sponsors & Collaborators

• VA Pittsburgh Healthcare System: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (2)

VA NY Harbor Healthcare System, Manhattan Campus

New York, New York, 10010, United States

RECRUITING

James J. Peters Medical Center

The Bronx, New York, 10468, United States

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Gretchen L Haas, Ph.D.

  VA Pittsburgh Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gretchen Haas, Ph.D.

CONTACT

412-360-2662; Gretchen.Haas@va.gov

Mary McShea, M.A.

CONTACT

412-360-2300; Mary.McShea@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: October 30, 2018
• Study Start: December 14, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)