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CAMS-RAS: for Suicide Prevention (CAMS-RAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072875
Recruitment Status : Completed
First Posted : March 7, 2017
Results First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Collaborators:
The Catholic University of America
University of Florida
Information provided by (Responsible Party):
Evidence-Based Practice Institute, Seattle, WA

Brief Summary:
This Phase I feasibility study endeavors to create a prototype of a tool to determine its feasibility with suicidal patients in emergency departments (EDs). This is not a clinical trial. The overarching goal of this research is to create a tool that could reduce suicide rates, increase delivery of efficacious suicide interventions, and decrease overall costs associated with suicidal behaviors. SBIR Phase I project aims include: (1) creating an advisory board to guide the development of CAMS-RAS; (2) iteratively design and develop relational agent ("Dr. Dave") modeled after the gestures, expressions, and mannerisms of CAMS treatment developer, David Jobes, PhD; and (3) conduct feasibility tests to determine whether CAMS-RAS is acceptable, easy to use, and liked by target end-users: acutely suicidal patients admitted to hospital EDs, psychiatric inpatient units, and medical floors for treatment of injuries sustained during a suicide attempt; hospital medical personnel, administrators, and other stakeholders including peer advocates; and outpatient suicidal patients, clinicians and administrators.

Condition or disease Intervention/treatment Phase
Suicide Device: CAMS-RAS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CAMS Relational Agent System for Suicide Prevention
Actual Study Start Date : December 18, 2015
Actual Primary Completion Date : December 17, 2017
Actual Study Completion Date : December 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: CAMS-RAS
In this single-arm study design, all enrolled patient participants are asked to provide feedback on the CAMS-RAS prototype as it is developed for this study. Feedback will be gathered via survey measure and interview.
Device: CAMS-RAS



Primary Outcome Measures :
  1. 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). Includes open-ended questions to better understand what was most and least helpful with respect to each category and also measures users' acceptance.

  2. Number of ED Patient Participants Who Completed Semi-Structured Interview [ Time Frame: After interacting with the technology (length: approximately 1 hour), subjects were then asked to complete the semi-structured interview conducted by the research assistant. On average, the interview lasted approximately 15 minutes. ]
    A semi-structured interview was conducted following use of the CAMS-RAS tool to assess users' likes, dislikes, and other preferences. Questions included: "What were your experiences in using 'Dr. Dave' and the CAMS-RAS system?" and "What suggestions would you have for improvement?" All subjects indicated that they found the tool helpful to them. They described the tool using adjectives similar to those used to describe "Nurse Louise" - a "discharge nurse" avatar on which the investigator's avatar was based: "He's kind and asks me really practical, helpful questions"; "He speaks to me directly in a compassionate way"; and "He is kind and invested".



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
Criteria

Patient Inclusion Criteria:

  • English fluency
  • 18 years or older
  • receiving clinical care in a hospital or outpatient clinic for suicidality
  • Suicidal patients currently admitted to EDs, psychiatric inpatient units, and medical floors, or patient with past (last 6 months) suicidality receiving outpatient treatment

Patient Exclusion Criteria:

  • Acutely psychotic
  • severely agitated (as determined by care team)

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): NCT03072875


Locations
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United States, Washington
Evidence-Based Practice Institute
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Evidence-Based Practice Institute, Seattle, WA
The Catholic University of America
University of Florida
Investigators
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Principal Investigator: Linda Dimeff, PhD Evidence-Based Practice Institute
  Study Documents (Full-Text)

Documents provided by Evidence-Based Practice Institute, Seattle, WA:
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Responsible Party: Evidence-Based Practice Institute, Seattle, WA
ClinicalTrials.gov Identifier: NCT03072875    
Other Study ID Numbers: 1R43MH108222-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2017    Key Record Dates
Results First Posted: July 31, 2018
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Evidence-Based Practice Institute, Seattle, WA:
Suicidality
Collaborative Assessment and Management of Suicidality
Technology
Suicide Prevention
Suicide Intervention
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms