Recruiting

Telehealth

Sponsor:

VA Pittsburgh Healthcare System

Code:

NCT03724370

Conditions

Suicide

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Telehealth Monitoring System

VHA-SRM

Study Details

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

Study ID

NCT03724370

Start date

Dec 14, 2018

Status verified date

May, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Veterans > 18 years old;
2. 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;
3. score >1 on items 4 or 5 on the SSI ; which assesses active or passive suicidal ideation, respectively.-

Exclusion Criteria:

1. 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;
2. Veterans without phone access.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: TES+ VHA-SRM

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

active comparator: VHA-SRM

VHA-SRM will be active comparator

Interventions

Telehealth Monitoring System

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

VHA-SRM

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

Primary outcome measure

  • Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991. [ Time Frame: At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today. ]

Central Contacts and Locations

Central contacts

Locations

James J. Peters Medical Center

Recruiting

Bronx, New York, United States, 10468

Contacts

Principal Investigator:

Marianne Goodman, MD

VA NY Harbor Healthcare System, Manhattan Campus

Recruiting

New York, New York, United States, 10010

Contacts

More Information

Sponsor

VA Pittsburgh Healthcare System

Last update posted

May 6, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Pittsburgh Healthcare System on 2022-05-06.