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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03072875
Other study ID # 1R43MH108222-01A1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 18, 2015
Est. completion date December 17, 2017

Study information

Verified date July 2018
Source Evidence-Based Practice Institute, Seattle, WA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 17, 2017
Est. primary completion date December 17, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
CAMS-RAS


Locations

Country Name City State
United States Evidence-Based Practice Institute Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
Evidence-Based Practice Institute, Seattle, WA The Catholic University of America, University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. up to one day
Primary 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". 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.
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