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CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention (V-CAMS)

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ClinicalTrials.gov Identifier: NCT03584386
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
University of Florida
Mayo Clinic
Allina Health
Aurora Health Care
Harborview Injury Prevention and Research Center
The Catholic University of America
Information provided by (Responsible Party):
Evidence-Based Practice Institute, Seattle, WA

Tracking Information
First Submitted Date  ICMJE June 11, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date February 26, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Change in Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    The Columbia-Suicide Severity Rating Scale (CSSRS) is an interviewer-administered FDA-recommended tool to assess suicidal ideation and behaviors in healthcare systems. The scale has two subscales: Severity of Ideation and Suicidal Behavior. For the first subscale, answers are summed for a total ranging from 2 to 25, with higher scores indicating more intense ideation and greater risk. The Suicidal Behavior subscale consists of Yes or No questions that inquire about level of actual or potential medical damage, with greater number of "yes" answers indicating increased risk. It is administered to patient participants at four time-points during Phase II (summative) to assess change across time.
  • Change in Suicide Cognitions Scale (SCS) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    An 18-item psychometrically sound self-report measure, the Suicide Cognitions Scale (SCS) assesses suicidal schemas. The score is found by summing the items for a total ranging from 18 to 90 with higher scores indicating worse outcomes. The scale is administered to patient participants at four time-points during Phase II (summative) to assess change over time.
  • Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    A nine-item self-report measure that assesses recent depressive symptoms and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. The Patient Health Questionnaire-9 (PHQ-9) total score is found by summing the answers and ranges from 0 to 27. Higher scores indicate more severe symptoms. It is administered to patient participants at four time-points during Phase II (summative).
  • Change in Coping Skills Use [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    A face-valid self-report measure developed by Dr. Dimeff and used in other clinical trials to assess frequency of skills use, perceived helpfulness of skill, and self-efficacy in using them. It is administered to patient participants at four time-points during Phase II (summative).
  • Change in Client Satisfaction Questionnaire (CSQ) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    An eight-item measure frequently used in clinical trials, modified for this study to focus on patient participants' emergency department experience. The Client Satisfaction Questionnaire (CSQ) is scored by summing the individual items to produce a range of 8 to 32, with higher scores indicating greater satisfaction. It is administered to patient participants at four time-points during Phase II (summative):
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584386 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Usability Satisfaction and Acceptability Questionnaire (USAQ) [ Time Frame: Up to one day ]
    A brief face-valid, self-report measure that the PI derived from the System Usability Scale and has been successfully used in previous studies. Items are rated on a 5-point Likert Scale (1=poor; 3=good; 5=excellent). Open-ended questions are included to better understand what was most and least helpful with respect to each category and also measures users' acceptance. This scale is only administered during Phase I, formative usability and acceptability testing. It is administered directly after participants complete their interaction with the technology during their one-time participation.
  • Change in Provider Ratings Questionnaire [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]
    A face-valid self-report measure that will be adapted by the Principal Investigators to assess patient preparedness for clinical interview, patient distress, provider confidence in suicide risk assessment and helpfulness of clinical support tool. Expected date of development: February, 2019. It is administered to provider participants at four time-points during Phase II (summative).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2018)
Semi-Structured Interview [ Time Frame: Up to one day ]
A semi-structured interview to ask about and understand the user's likes, dislikes, and preferences. The semi-structured interview will be conducted for purposes of evaluating the usability of the technology rather than collecting any quantitative data for data analyses. It is administered in Phase I, formative usability and acceptability testing. Participants are asked to complete the semi-structured interview conducted by the research assistant after interacting with the technology.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention
Official Title  ICMJE CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention
Brief Summary This Phase II study is a continuation of the Phase I feasibility study where the investigators fully met and exceeded project aims to design, build, and test the usability and acceptability of an avatar-based system, the Virtual-CAMS (V-CAMS, formerly called CAMS-RAS), for use by suicidal ED patients and medical personnel responsible for their care. Phase II includes a formative phase, during which the investigators will continue conducting usability and acceptability tests of new features, and a summative phase to conduct a clinical trial. SBIR Phase II project aims include: (1) Complete development of V-CAMS, including readiness for electronic health record integration; (2) Cultivate and utilize the advisory board so that V-CAMS is positioned to meet the needs of diverse healthcare systems and successful conduct of the proposed research; (3) Conduct usability/acceptability tests of new features with target end-users (suicidal patients, including those in the ED, medical providers) and key stakeholders (i.e., administrators); and (4) Conduct a randomized controlled trial (RCT; N=90) of suicidal ED patients comparing V-CAMS (n=45) to Care-As-Usual (CAU; n=45). Participants will be assessed at baseline while in the ED, and again at 7, 30, and 90 days. The investigators predict that V-CAMS participants will report a significantly greater decrease in suicidal behaviors and ED/hospital admissions, as well as significantly greater increases in use of behavioral coping skills, self-efficacy in coping with distress, and perceived helpfulness of patients' ED experience.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Suicide
Intervention  ICMJE Device: V-CAMS
V-CAMS is an integrated software system for use on any device by suicidal patients in the ED.
Study Arms  ICMJE
  • Experimental: V-CAMS

    In Phase I (formative), all enrolled participants are asked to provide feedback on the V-CAMS prototype as it is being refined. Feedback will be gathered via survey measure and interview.

    In Phase II (summative), enrolled patient participants will be randomly assigned to this arm and will be given access to the V-CAMS tools as part of their treatment in the ED. Baseline assessment surveys will be administered in the ED, and three follow up assessments after discharge at 7 days, 30 days, and 90 days.

    Intervention: Device: V-CAMS
  • No Intervention: Care As Usual
    In Phase II (summative), enrolled patient participants will be randomly assigned to this arm so there is an even number of participants in the experimental condition and this condition. Those assigned to this condition will be treated as usual in the ED. Same as the experimental condition, those in the Care As Usual condition will be asked to complete baseline assessment surveys while they are waiting in the ED, and then three subsequent assessments after discharge at 7 days, 30 days, and 90 days).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2018)
303
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years or older
  • English speaker
  • Clinically stable Suicidal Patient* currently admitted to the ED, psychiatric inpatient unit, and medical floors of the participating sites; Suicidal Patients currently receiving outpatient mental health services
  • Hospital medical personnel who treat suicidal patients, hospital administrators, hospital-based peer advocates, and outpatient mental health clinicians and administrators

"Suicidal Patient" is defined as those patients who:

  1. Have explicitly indicated to their treatment provider that they are suicidal and/or are seeking treatment in part because they want to kill themselves or
  2. Have made a suicide attempt in the last six months or
  3. Engaged in non-suicidal self-injurious behaviors with high suicidal ideation (defined as 4 to 5 on a 0-5 point Likert scale) in the past three months.

"Clinically Stable"and not in clear and imminent danger is defined as:

  1. Patients who are oriented to time, place, person and are no longer in acute phase of distress that led to their ED admission (for those in the ED)
  2. For those in outpatient context, patient is not in imminent risk for suicide as deemed by their treatment provider
  3. In all cases, patient is able to follow instructions for mood improvement/distress tolerance protocol to help stabilize their mood; current status is unlikely to worsen as a result of engagement with research staff in study activities as deemed by their treatment provider.

The Site Contact or Coordinators and/or designated medical staff will determine if suicidal patients fit these criteria before referring them to the research team.

Exclusion Criteria:

  • Acutely psychotic and thus unable to provide informed consent
  • Severely agitated (as deemed by physician, nurse, or outpatient therapist)
  • Not fluent in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Research Team 206-455-7934 ext 83 research@ebpi.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584386
Other Study ID Numbers  ICMJE 2R44MH108222-02A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org
Responsible Party Evidence-Based Practice Institute, Seattle, WA
Study Sponsor  ICMJE Evidence-Based Practice Institute, Seattle, WA
Collaborators  ICMJE
  • University of Florida
  • Mayo Clinic
  • Allina Health
  • Aurora Health Care
  • Harborview Injury Prevention and Research Center
  • The Catholic University of America
Investigators  ICMJE
Principal Investigator: Linda Dimeff, PhD Evidence-Based Practice Institute
Principal Investigator: David A Jobes, PhD The Catholic University of America
PRS Account Evidence-Based Practice Institute, Seattle, WA
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP