The "AIM Study": Investigating Whether Actigraphy and Ideation Measures Can Promote Patient Safety

NCT03080168 | Completed DMC

• 2 other identifiers: MHBA-017-15S1I01CX001424-01
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research project looking at whether measuring movements or responses to certain questions can help predict suicidal thoughts or actions. This project has two parts: The first part will occur while the participant is receiving hospitalized at the Bedford VA Hospital. It involves wearing a watch-like device on his/her wrist and answering questions or doing tasks to measure mood and other mental health symptoms, and suicidal thoughts. In the second phase, the investigators will call the participant around 12 months after s/he has left the hospital. The investigators will discuss how s/he is doing and if s/he has had suicidal thoughts or made suicidal acts.

Conditions

Suicidal Ideation; Suicidal Behavior; Mental Health Symptoms; Mental Health Hospitalizations

Keywords

suicidal ideation; suicidal behavior; Veterans; inpatients; Actigraphy; implicit associations; risk factors

Outcome Measures

Primary Outcomes (2)

• POST DISCHARGE FOLLOW-UP (COMPOSITE): CSSRS Suicidal Behaviors (self-report), Rehospitalization with Suicidal Ideation (self-report), combined with chart data re Suicidal Behavior and Rehospitalization with Suicidal Ideation

  The investigators will call some participants who are not undergoing alcohol detoxification and administer the Columbia-Suicide Severity Rating Scale to determine occurrence of all suicidal behavior (actual, interrupted, aborted, and preparatory), ask them to also self-report rehospitalization with suicidal ideation (SI), and use VA chart data as another source of information about suicidal behavior and rehospitalization. For those patients who we reach by phone we will use both their self-report and the information from chart review to inform this outcome, and from those patients not undergoing analysis who we don't reach, or those who are in participant groups not receiving phone calls (the participants undergoing alcohol detoxification). The data will then be reconciled and combined into a measure of Suicidal Behavior or rehospitalization with suicidal ideation over the 12 months since discharge.

  12 months since discharge from index hospitalization

• INPATIENT: Sheehan STS scale

  Association of Actigraph measurements with Sheehan STS Scale

  Last 24 hours up to assessment

Secondary Outcomes (10)

• INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis]

  Duration of Inpatient Stay (Daily Measures, up to 365 days)

• POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]

  12 months (12 months since discharge from index hospitalization)

• POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary]

  12 months since Discharge

• INPATIENT: Severity of Suicidal Ideation

  Duration of Inpatient Stay (Daily Measures, up to 365 days [It is anticipated most subjects will provide from 2-7 days of data)

• INPATIENT: Duration of Suicidal Ideation (Thinking Diary)

  Duration of Inpatient Stay (Daily Measures, up to 365 days)

Other Outcomes (30)

• POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors (without Rehospitalization)

  12 months post Discharge

• POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation involves Plan and Intent

  12 months post discharge

• POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation includes Method, Intent, or Plan

  12 months post discharge

Study Arms (1)

Actigraph

All participants will wear an Actigraph (monitoring device) for the duration of their inpatient stay. NOTE: In clarification, for both this section and Section 4, this devices is an FDA-regulated monitoring device, but NOT an Intervention in this study.

Device: Actigraph

Interventions

Actigraph DEVICE

This is NOT an intervention but a monitoring device. All participants will wear an Actigraph for the duration of their inpatient stay, as well as complete paper and computer assessments.

Actigraph

Eligibility Criteria

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

Study Population

US Veteran inpatients hospitalized for suicidal ideation, suicidal behavior, or alcohol detoxification

You may qualify if:

• age 18 years or older and endorsing either suicidal ideation upon admission or within the last 7 days, or endorsing (or otherwise documented) suicidal behavior within the past 14 days before admission; OR
• age 18 years or older and undergoing alcohol detoxification (including patients who qualify under #1 and are undergoing alcohol detoxification).

You may not qualify if:

• presence of a primary psychotic disorder \[schizophrenia, schizoaffective disorder, psychosis not otherwise specified, and other psychoses\] diagnosis on admission; or major depressive disorder with psychosis, or current hallucinations or ideas of reference, endorsing current psychotic thinking on the Psychosis Screen measure
• presence of a flag specifying a history of disruptive or violent behavior, or, if found during review of elements of the patient's chart prior to study enrollment, indication of a history of violent behavior towards staff, caregivers, or other patients in the patient's record, or if discussion with hospital staff indicates the potential participant's mental status is unstable enough or hostile enough to raise concerns about assaultive behavior
• Prisoner (of federal, state, or local authorities)
• Currently admitted to 78G under an involuntary commitment (e.g., "Section 12"). Specifically, no patients will be enrolled as participants who were committed to the inpatient unit involuntarily who has not chosen voluntarily to change their status to that of a voluntarily admitted patient (ie., signed a "Conditional Voluntary" form)
• Interviewer or Hospital staff-suspected or chart-documented presence of mental retardation (IQ \<70) or other DSM-IV organic mental disorder (e.g., including Alzheimer's dementia)
• acute alcohol or drug intoxication or any delirium
• receiving alcohol detoxification treatment \[for Primary Analysis\]
• women who are pregnant
• patients undergoing detoxification for opiates

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Eric G. Smith, MD PhD MPH

  Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: March 15, 2017
• Study Start: February 21, 2017
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)