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Trial record 12 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Patient Safety"

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

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ClinicalTrials.gov Identifier: NCT03080168
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Suicidal Ideation Suicidal Behavior Mental Health Symptoms Mental Health Hospitalizations Device: Actigraph

Detailed Description:

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 Type : Observational
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Actigraphy-Determined Movement Variability as a Novel Objective Marker
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months since discharge from index hospitalization ]
    The investigators will call clients 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. 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.

  2. INPATIENT: Severity of Suicidal Ideation [ Time Frame: 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.

  3. INPATIENT: Duration of Suicidal Ideation (Thinking Diary) [ Time Frame: 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.


Secondary Outcome Measures :
  1. INPATIENT: Self-report response to Suicidal thinking diary questions re Combined Severity and Duration of suicidal thinking [Main Secondary Analysis] [ Time Frame: 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.

  2. POST DISCHARGE FOLLOW-UP: Actual Suicidal Behavior (self-report and chart informed) [Main Secondary] [ Time Frame: 12 months (12 months since discharge from index hospitalization) ]
    The investigators will use the data gathered from the CSSRS and chart review to determine the occurrence of Actual Suicidal Behavior in the 12 months since discharge.

  3. POST-DISCHARGE FOLLOW-UP: All Suicidal Behavior plus Rehospitalization plus Severity of Worst Suicidal Ideation (Some Intent or Some Intent or Plan) [Main Secondary] [ Time Frame: 12 months since Discharge ]
    The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI.

  4. INPATIENT: Duration of Suicidal Ideation (Hours/minutes) [ Time Frame: 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.

  5. INPATIENT: Maximum Level of Suicidal Ideation per CSSRS each day [ Time Frame: 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).

  6. INPATIENT: Wish to be Dead [ Time Frame: 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].

  7. INPATIENT: Combination of Maximum Level of Suicidal Ideation per CSSRS each day plus Frequency, Controllability, etc. items [ Time Frame: 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). Exact procedure for combining (e.g. simple addition) to be determined, possibly in consultation with Columbia scale staff.

  8. Maximum severity of suicidal ideation in 12 months post-discharge (self-report, 0-10 scale) [ Time Frame: 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.


Other Outcome Measures:
  1. POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors (without Rehospitalization) [ Time Frame: 12 months post Discharge ]
    The investigators will call patients and administer CSSRS to determine.

  2. POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation involves Plan and Intent [ Time Frame: 12 months post discharge ]
    The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI.

  3. POST-DISCHARGE FOLLOW-UP: All Suicidal Behaviors, Rehospitalization with SI, and Severity of Worst Ideation includes Method, Intent, or Plan [ Time Frame: 12 months post discharge ]
    The investigators will call patients and administer CSSRS to determine, and ask about rehospitalization with SI.

  4. INPATIENT: Nonsuicide Symptom Diary Items [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    11 items concerning psychiatric symptoms and movement/activity, on a 0-10 scale. Each will be examined individually.

  5. INPATIENT: Combination of Sheehan Measures [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    The investigators will use Sheehan scale as an index, either: A) Weighting reach response on questions 2-6, and 8 with each question being worth 5X the previous question, and responses worth 0-4 points, depending on frequency (this will result in a scale from 0 - 4096), and/or B) a simple unweighted version which gives a score from 0 - 24 based on how frequently client endorses highest numbered item, based on specific thresholds ( a little, moderately, etc.) .

  6. INPATIENT: Individual Sheehan Items [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    The investigators will examine the association of each Sheehan item, questions 2-6 and 8 with the actigraph and other predictors.

  7. INPATIENT: CSSRS Duration Item [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    Suicidal Ideation Item on CSSRS.

  8. INPATIENT: CSSRS Frequency Item [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    Suicidal Ideation Item on CSSRS.

  9. INPATIENT: CSSRS Frequency/Duration Item combination [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    The investigators will use some combination of the Frequency and Duration item (either simple addition or multiplication, or some other combination, taking into account as frequency increases the maximum duration must at some point decrease).

  10. INPATIENT: CSSRS Controllability Item [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    Suicidal Ideation Item on CSSRS.

  11. INPATIENT: CSSRS Deterrents Item [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.

  12. INPATIENT: CSSRS Reasons Item [ Time Frame: Duration of Inpatient Stay (Daily Measures, up to 365 days) ]
    Although this will be analyzed, it is not expected this will correlate as much with actigraphy or other predictors than other CSSRS items.

  13. POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality of 1+ on CSSRS [ Time Frame: 12 months post-discharge ]
    Suicidal behavior, only counting behaviors of a certain level of lethality.

  14. INPATIENT: Change in Severity or Duration of Suicidal Thinking or the Composite Measure [ Time Frame: Inpatient (Daily Measures, Days 1 and 2 combined versus last 1, 2, or 3 days [longest period up to 3 days that does not overlap with days 1&2) ]
    For analyses examining CHANGE in the Actigraph index, or CHANGE in the Actigraph index plus change in some of the other predictors, the investigators will examine an outcome involving Change in Suicidal Thinking (probably the measure most predictive in the earlier analyses of the level of the index/predictors and the severity/duration of suicidal thinking).

  15. POST-DISCHARGE FOLLOW-UP: Actual Suicidal Behavior with Lethality 2+ on CSSRS [ Time Frame: 12 months (post-discharge ]
    Suicidal behavior, only counting behaviors of a certain level of lethality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
US Veteran inpatients hospitalized for suicidal ideation, suicidal behavior, or alcohol detoxification
Criteria

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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03080168


Contacts
Contact: Eric G Smith, MD PhD MPH (781) 687-2766 eric.smith5@va.gov

Locations
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Recruiting
Bedford, Massachusetts, United States, 01730
Contact: Eric G Smith, MD PhD MPH    781-687-2766    eric.smith5@va.gov   
Principal Investigator: Eric G. Smith, MD PhD MPH         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Eric G. Smith, MD PhD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03080168     History of Changes
Other Study ID Numbers: MHBA-017-15S
1I01CX001424-01 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
suicidal ideation
suicidal behavior
Veterans
inpatients
Actigraphy
implicit associations
risk factors

Additional relevant MeSH terms:
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms