SuicideCAMS-RASNCT03072875
CAMS-RAS: for Suicide Prevention
A study testing CAMS-RAS in people with Suicide, run by Evidence-Based Practice Institute, Seattle, WA at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- CAMS-RAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2015to 17 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Evidence-Based Practice Institute
Seattle, Washington, 98144
About this study
Official title: 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.
- Conditions
- Suicide
- Being tested
- CAMS-RAS
- Keywords
- Suicidality, Collaborative Assessment and Management of Suicidality, Technology, Suicide Prevention, Suicide Intervention
- Medical subject headings
- Suicide, Suicidal Ideation, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAMS-RASDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: CAMS-RAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start18 Dec 2015
- Primary completion17 Dec 2017
- Study completion17 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evidence-Based Practice Institute, Seattle, WA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Catholic University of America, University of Florida
- Responsible party
- Sponsor
- Investigators
- Linda Dimeff, PhD, Principal investigator, Evidence-Based Practice Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072875
- Sponsor's protocol ID
- 1R43MH108222-01A1
- Acronym
- CAMS-RAS
- Status last verified
- Jul 2018
- First submitted
- 23 Feb 2017
- Last updated
- 31 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAMS Relational Agent System for Suicide Prevention
- ClinicalTrials.gov ID
- NCT03072875
- Acronym / sponsor ID
- CAMS-RAS / 1R43MH108222-01A1
- Conditions
- Suicide
- Keywords
- Suicidality, Collaborative Assessment and Management of Suicidality, Technology, Suicide Prevention, Suicide Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Evidence-Based Practice Institute, Seattle, WAIndustry (pharma, biotech, devices)
- Collaborators
- The Catholic University of America, University of Florida
- Study start
- 18 Dec 2015 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 17 Dec 2017 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Posted 31 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAMS-RAS | Experimental | Device: CAMS-RASIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAMS-RAS | Device | CAMS-RAS |
Primary outcome
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.
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".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Requests for use of data will be considered on a case-by-case basis. Interested researchers may send data requests to research@ebpi.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Dimeff, PhD principal investigator
Evidence-Based Practice Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAMS-RAS in people with Suicide, run by Evidence-Based Practice Institute, Seattle, WA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability Satisfaction and Acceptability Questionnaire (USAQ) (time frame: up to one day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.