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

Completed

• Conditions: Mental Health Symptoms; Mental Health Hospitalizations; Suicidal Ideation; Suicidal Behavior
• Interventions: Device: Actigraph

• Registration Number: NCT03080168
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

As a consequence of the COVID-19 pandemic, and after consultation with the appropriate research oversight, regulatory and monitoring entities, screening and enrollment was been placed on temporary administrative hold as of 3 17 2020. As the pandemic has continued, we have reviewed our data and decided to close the study to enrollment and proceed to our analyses of findings.

RESEARCH DESIGN: A prospective cohort study of Veterans will be conducted to determine if the previously-identified specific actigraphy-based measurements highly associated with suicidal ideation in non-Veterans will predict suicidal ideation, suicidal behavior, and/or rehospitalization in Veterans.

METHODS: An analysis of Veterans admitted to the Bedford, Massachusetts VAMC acute psychiatry unit will be conducted. The primary analysis will focus upon Veterans with current suicidal ideation or recent suicidal behavior (SI/SB) who do not have a primary psychotic disorder, Alzheimer's, or Parkinson's disease, and who are not undergoing alcohol detoxification. A separate analysis will be conducted of patients undergoing alcohol detoxification, half with SI/SB and half without SI/SB. Participants will wear a small, unobtrusive, wristwatch-like actigraph on their nondominant wrist, and complete self-rated and clinician-rated assessments of suicidal ideation, as well as self-rated assessments of the severity of other psychiatric symptoms. A Resiliency Index (RI) will be calculated using nonlinear dynamic analysis of the amplitude of movements over time frames from 6 minutes - 2 hours. These time frames are the periods for which a clear structure to the movement data is evident, with patients with suicidal ideation showing less variation in amplitude than patients without suicidal ideation. If medications given for alcohol detoxification are determined to not interfere with the RI, then a secondary analysis will examine the entire sample of Veterans. One Aim will focus upon determining whether the original Resiliency Index or alternative movement data indices, such as one based on the change in the movement data over the hospitalization, predicts the presence and severity of suicidal ideation among Veteran inpatients. This aim will also examine the sensitivity and specificity of the RI for detecting the presence of any suicidal ideation, and of substantial suicidal ideation. (In non-Veterans, the RI showed a sensitivity of 72% and a specificity of 100% for detecting any suicidal ideation, and 86% and 88%, respectively, for detecting substantial ideation). In addition, the investigators may determine whether the RI predicts subsequent suicidal behavior or rehospitalization over different time periods within the original 12 month followup period, alone or combined with data about symptom severity, past history, and the present hospitalization.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-15
• Status Verified: 2021-04
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Last Update Submitted: 2021-04-02
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. 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
2. age 18 years or older and undergoing alcohol detoxification (including patients who qualify under #1 and are undergoing alcohol detoxification).

Read More

Exclusion Criteria

• 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Actigraph	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.

Primary Outcome Measures

Name	Time	Method
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	12 months since discharge from index hospitalization	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.
INPATIENT: Sheehan STS scale	Last 24 hours up to assessment	Association of Actigraph measurements with Sheehan STS Scale

Secondary Outcome Measures

Name	Time	Method
POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary]	12 months (12 months since discharge from index hospitalization)	The investigators will use the data gathered from the CSSRS from phone interviews and chart review to determine the occurrence of Actual Suicidal Behavior in the 12 months since discharge. We will use both sources of information to assess those patients who are reached by phone and the chart review alone for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).
INPATIENT: Duration of Suicidal Ideation (Thinking Diary)	Duration of Inpatient Stay (Daily Measures, up to 365 days)	Daily rankings of Duration of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.
INPATIENT: Duration of Suicidal Ideation (Hours/minutes)	Duration of Inpatient Stay (Daily Measures, up to 365 days)	Daily rankings of Duration of Suicidal Ideation, from the Sheehan Tracking Scale, in hours and minutes.
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	The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI, as well as determine information from the chart about the occurrence of these outcomes, both for patients who are reached by phone and those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls).
INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day	Duration of Inpatient Stay (Daily Measures, up to 365 days)	Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan).
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)	Participants rank the Severity and Duration of their suicidal thinking on 0-10 scales each day, This outcome will look at the distribution of the interaction between the scores (e.g., multiplicative/multiplication of scores) and determine whether that simple interaction/combination will be used, log or otherwise transformed, and/or more weighting given to duration than severity, etc. This determination will be made on the spread of this data, not any information about how it correlates with actigraphy or other data gathered. This is being designated a secondary outcome simply because how the measure will be determined is not yet specified, but it is expected that this composite measure will likely have a stronger association with actigraphy and other RFs (risk factors)/predictors than simply the severity of suicidal ideation, one of the co-primary outcomes.
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)	Daily rankings of Severity of Suicidal Ideation, from the Suicidal Thinking Diary, on a scale of 0-10.
INPATIENT: Wish to be Dead	Duration of Inpatient Stay (Daily Measures, up to 365 days)	Daily rankings of Wish to be Dead, from the Thinking Diary, on a 0-10 scale. \[This was the outcome used in the previous actigraphy study\].
INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items	Duration of Inpatient Stay (Daily Measures, up to 365 days)	Maximum Level of Suicidal Ideation per CSSRS 5 Level scale (ranging from Wish to be Dead to Active Ideation with Intent and Plan) combined with the items/scores in the 2nd half of the suicidal ideation assessment (frequency, controllability). Investigators will use chart and interview information for patients who can be reached by phone and interview information for those who cannot or are in the groups undergoing alcohol detoxification (who are not in the group who receive phone calls). Exact procedure for combining (e.g. simple addition) to be determined, possibly in consultation with Columbia scale staff.
Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale)	12 months post-discharge	We have created our own 0-10 scale of the highest intensity of suicidal thinking a participant experienced in the 12 months post-discharge. This will be used for some of the secondary analyses of outcomes 12 months after discharge. While it is not validated, it has the advantage that, as opposed to any Yes/No events (rehospitalization, experiencing of a certain severity of suicidal thinking), that every study participant will have a value on this particular scale.

Trial Locations

Locations (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA; 🇺🇸 Bedford, Massachusetts, United States