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

• 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: Evidence-Based Practice Institute, Seattle, WA
• Collaborators: The Catholic University of America; University of Florida
• Information provided by (Responsible Party): Evidence-Based Practice Institute, Seattle, WA

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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".

Eligibility Criteria

• 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)

Contacts and Locations

Locations

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

• Principal Investigator: Linda Dimeff, PhD; Evidence-Based Practice Institute

  Study Documents (Full-Text)

Documents provided by Evidence-Based Practice Institute, Seattle, WA:

Study Protocol and Statistical Analysis Plan  [PDF] December 10, 2015

More Information

• 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
• 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.

• 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:

Suicide; Self-Injurious Behavior; Behavioral Symptoms