CAMS-RAS: for Suicide Prevention

NCT03072875 | Completed Results DMC

• 1 other identifier: 1R43MH108222-01A1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide

Keywords

Suicidality; Collaborative Assessment and Management of Suicidality; Technology; Suicide Prevention; Suicide Intervention

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

Study Arms (1)

CAMS-RAS

EXPERIMENTAL

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

Interventions

CAMS-RAS DEVICE

CAMS-RAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English fluency
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Evidence-Based Practice Institute, Seattle, WA: lead
• The Catholic University of America: collaborator
• University of Florida: collaborator

Study Sites (1)

Evidence-Based Practice Institute

Seattle, Washington, 98144, United States

Location

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

This SBIR Phase I Feasibility Study endeavored to create a prototype of a tool to determine its feasibility with suicidal patients in emergency departments. This is not a clinical trial.

Results Point of Contact

• Title: Linda Dimeff, PhD
• Organization: Evidence-Based Practice Institute

research@ebpi.org

206-455-7934

Study Officials

• Linda Dimeff, PhD

  Evidence-Based Practice Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: March 7, 2017
• Study Start: December 18, 2015
• Primary Completion: December 17, 2017
• Study Completion: December 17, 2017
• Last Updated: July 31, 2018
• Results First Posted: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)