CAMS-RAS: for Suicide Prevention (CAMS-RAS)
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAMS-RAS
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicidality, Collaborative Assessment and Management of Suicidality, Technology, Suicide Prevention, Suicide Intervention
Eligibility 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)
Sites / Locations
- Evidence-Based Practice Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAMS-RAS
Arm Description
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.
Outcomes
Primary Outcome Measures
Usability Satisfaction and Acceptability Questionnaire (USAQ)
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.
Number of ED Patient Participants Who Completed Semi-Structured Interview
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".
Secondary Outcome Measures
Full Information
NCT ID
NCT03072875
First Posted
February 23, 2017
Last Updated
July 2, 2018
Sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
The Catholic University of America, University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT03072875
Brief Title
CAMS-RAS: for Suicide Prevention
Acronym
CAMS-RAS
Official Title
CAMS Relational Agent System for Suicide Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 18, 2015 (Actual)
Primary Completion Date
December 17, 2017 (Actual)
Study Completion Date
December 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evidence-Based Practice Institute, Seattle, WA
Collaborators
The Catholic University of America, University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicidality, Collaborative Assessment and Management of Suicidality, Technology, Suicide Prevention, Suicide Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAMS-RAS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CAMS-RAS
Primary Outcome Measure Information:
Title
Usability Satisfaction and Acceptability Questionnaire (USAQ)
Description
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.
Time Frame
up to one day
Title
Number of ED Patient Participants Who Completed Semi-Structured Interview
Description
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".
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Dimeff, PhD
Organizational Affiliation
Evidence-Based Practice Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evidence-Based Practice Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
CAMS-RAS: for Suicide Prevention
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