NCT03724370

Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide

Status unknown NA Last updated 6 May 2022

What this trial tests

NA trial testing Telehealth Monitoring System in Suicide in 180 participants. Status unknown.

Timeline

14 December 2018

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	VA Pittsburgh Healthcare System
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	180
Start date	14 December 2018
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	2 locations across United States

Drugs / interventions tested

• Telehealth Monitoring System
• VHA-SRM

Conditions studied

• Suicide — all drugs for Suicide →

Sponsor

VA Pittsburgh Healthcare System

Who can join

18 and older, any sex, with Suicide. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Open Clinical Trials for Veterans With Suicidal Ideation.
   · 2019 · PMID 31772493