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| Name | Class |
|---|---|
| The Catholic University of America | OTHER |
| University of Florida | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAMS-RAS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Dimeff, PhD | Evidence-Based Practice Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evidence-Based Practice Institute | Seattle | Washington | 98144 | United States |
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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| ID | Title | Description |
|---|---|---|
| FG000 | CAMS-RAS | In this single-arm study design, all enrolled patient and non-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. CAMS-RAS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CAMS-RAS | In this single-arm study design, all enrolled patient and non-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. CAMS-RAS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age collected from 24 patient participants only (2 unknown) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Suicidal ED Patients only | Posted | Mean | Standard Deviation | units on a scale | up to one day |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CAMS-RAS | In this single-arm study design, all enrolled patient and non-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. CAMS-RAS |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Dimeff, PhD | Evidence-Based Practice Institute | 206-455-7934 | 83 | research@ebpi.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2015 | May 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Mean |
| Standard Deviation |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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". | The qualitative information from the semi-structured interviews tells us subjects' general opinions and preferences concerning the avatar. | Posted | Count of Participants | Participants | No | 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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| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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