- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03072875
CAMS-RAS: for Suicide Prevention (CAMS-RAS)
July 2, 2018 updated by: Evidence-Based Practice Institute, Seattle, WA
CAMS Relational Agent System for Suicide Prevention
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98144
- Evidence-Based Practice Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to one day
|
|
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".
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Linda Dimeff, PhD, Evidence-Based Practice Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 18, 2015
Primary Completion (Actual)
December 17, 2017
Study Completion (Actual)
December 17, 2017
Study Registration Dates
First Submitted
February 23, 2017
First Submitted That Met QC Criteria
March 2, 2017
First Posted (Actual)
March 7, 2017
Study Record Updates
Last Update Posted (Actual)
July 31, 2018
Last Update Submitted That Met QC Criteria
July 2, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R43MH108222-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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VA Eastern Colorado Health Care SystemUS Department of Veterans Affairs; The Catholic University of AmericaCompleted
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Medtronic - MITGCompletedCholecystitis | Prostate Cancer | Cholelithiases | Gallbladder PolypKorea, Republic of
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Evidence-Based Practice Institute, Seattle, WAMayo Clinic; Aurora Health Care; The Catholic University of America; Harborview... and other collaboratorsCompleted
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