Clinical trial NCT03724370: Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide
Official title: Using Telehealth to Improve Outcomes in Veterans at Risk for Suicide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Lead sponsor: VA Pittsburgh Healthcare System
Sponsor class: FED
Collaborators: name: American Foundation for Suicide Prevention
First posted: 2018-10-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: A subject will be considered enrolled after they sign the consent form, but prior to the initiation of study procedures. After enrollment, subjects will undergo baseline assessments and will be randomized prior to discharge from index hospitalization. The study aims to randomize 120 Veterans in 3-sites over 16-20 months.

Once a Veteran has been identified and referred, a member of the study team will meet with the Veteran on the inpatient unit to obtain consent. The baseline visit may take place all at once or on different days while patients are on the inpatient service. The investigators will attempt to perform baseline assessments as close to discharge as possible in order to obtain a true baseline assessment. However, the investigators may not be able to be certain regarding time of discharge and if this is the case or if discharge is extended, the baseline will be repeated one or more times to ensure that we have baseline data close to the time of discharge.

To assess eligibility, the following will be administered:

1. Folstein Mini Mental Status Exam to assess cognitive impairment.
2. The Beck Scale for Suicidal Ideation (SSI) to assess suicidal ideation.
3. The 17 item Hamilton Depression Rating Scale (HAM-17) to rate depressive symptoms.
4. The Mini International Neuropsychiatric Interview (MINI) to determine diagnoses.

Also administered will be the Sociodemographics Form, Columbia Scale for Suicidality (C-SSRS), Beck Hopelessness Scale©, Brief Addiction Monitor (BAM), Brief Emotional Closeness Questionnaire (ECQ), Brief Medication Questionnaire (BMQ), Hamilton Depression Rating Scale (HAM-D17), Clinical Global Impressions (CGI), and the Medical Outcomes Studies Social Support Survey (MOS-36). Participants that have a diagnosis of Schizophrenia(SZ) or Schizoaffective(SZA) disorder will additionally receive the Scales for the Assessment of Positive and Negative Symptoms (SAPS and SANS). These may be completed any time during the inpatient hospitalization.

In order to obtain a true baseline, these assessments may be administered more than once to obtain the measure as close to the participant's discharge as possible.

Eligible Veterans who complete the assessments will be randomized close to the time of discharge in blocks and stratified by site. When a participant is ready to be randomized, a non-blinded study staff member will access the randomization scheme database/spreadsheet. Staff will click a button to "randomize" and to determine which group they are in. The slot with the group will be provided to the staff member and documented in the database/spreadsheet with the subject identifier (ID) and the date of randomization. At least one of the assessors will be masked, or "blinded," to treatment. The control condition will consist of Veterans randomized to VHA suicide risk management (VHA-SRM). The experimental condition will be the telehealth + VHA suicide risk management (TES+VHA-SRM) intervention.

The intervention is an Interactive Voice Response system, provided by vendor AMC Health. See Appendices 3 and 4. Using the scripts in the protocol, the system will call the patient at the time of day requested by the patient, and ask the questions on the schizophrenia script(for Veterans with schizophrenia or schizoaffective disorder) or the questions on the depression script for all other patients. The patient will answer each question numerically, by either pressing a number or stating the number to the system. The responses will be accessed through a secure web portal maintained by AMC Health, and reviewed Q4 hours by the VAPHS nurses.

The study team will aim to keep an assessor blinded to treatment. This assessor will administer the assessments over follow up.

Veterans randomized to TES+VHA-SRM will receive the IVR system in addition to VHA-SRM and will receive training on how to use the TES from non-blinded research staff, including instructions to contact their providers for any clinical concerns, as well as the research team, or the Veterans Crisis Line. Veterans can use IVR as telephonic device accessed by a local or toll-free number and can use a Plain Old Telephone System (POTS) device connected to their landline or Cellular phone or Internet Protocol phone connected to their phone service provider. Participants will be instructed to interact daily with the TES system daily. Patients will receive the dialogue specific for depression unless they have a diagnosis of SZ/SZA, in which case they will receive the SZ/SZA dialogue. 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 VAPHS nurses every 4 hours, during regular daytime work hours, 9-5. VAPHS will serve as the central site retrieving downloads for all sites. The website will include responses with color-coded risk triage level designations and staff will receive guidance regarding next steps based on these color codes. The protocol for assessing suicidal patients will follow standard VA procedures, outlined in each medical center's safety plan for suicidal patients.

Veterans randomized to TES+VHA-SRM will be asked to use the IVR system once within a 24 hour period. If an IVR session is not completed within this time frame, the system will automatically call the participant the next morning at a phone number provided by the participant. If the IVR session is not successfully completed after the automatic session is sent, the VAPHS nursing staff will be alerted to this at 12 pm, noon on the website. They will contact the participant's clinician or study staff at that particular site to alert them they have not completed an IVR session. Study staff will track adherence rates to the IVR system.

Veterans randomized to TES+VHA-SRM will have adherence to the telehealth system tracked daily. All subjects will have appointment adherence tracked for 12 weeks post discharge from index hospitalization and psychiatric hospitalizations will be tracked for 12 months post-randomization.

The study team may call the patient's psychiatrist, other clinician, or a significant other (i.e. a family member), or another significant other in the community who the subject has identified and has provided consent for the study team to contact. The team will only contact someone other than the subject's psychiatrist or other clinician if the team has not been able to reach the subject for 48 hours.

All subjects will come in at weeks 2, 4, 8 and 12 following discharge either at the VAPHS outpatient clinics, the VA community based outpatient clinics, Vet centers. They may come in within a 2-week window before or after the expected assessment date.

The following assessments will be administered at follow up: SSI, CSS, HAM-D17, Beck Hopeless Scale, National Institute of Drug Abuse (NIDA) Brief Substance Use Questionnaire, BMQ, and CGI. Participants that have a diagnosis of Schizophrenia or Schizoaffective disorder will additionally receive SAPS and SANS.

In addition to the assessments listed above, week 12 will also administer MOS-36 for all participants and the After Scenario questionnaire for those randomized to TES+VHA-SRM.

During the course of the study, appointment adherence will be tracked for the 12 week of active participation and psychiatric hospitalizations will be tracked for 12 months post-randomization.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Beck Scale for Suicidal Ideation (BSS). Aaron T. Beck, copyright 1991.
timeFrame: At every visit: screen, baseline(s), week 2,4,6,8,12; timeframe is the past week, including today.
Secondary outcomes:
measure: 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.
timeFrame: At every visit: screen, baseline(s), week 2,4,6,8,12; time frame includes lifetime and since last visit.
Other outcomes:
Locations:
city: Bronx
country: United States
facility: James J. Peters Medical Center
state: New York
city: New York
country: United States
facility: VA NY Harbor Healthcare System, Manhattan Campus
state: New York
Study officials:
affiliation: VA Pittsburgh Healthcare System
name: Gretchen L Haas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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