CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention (V-CAMS)
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|ClinicalTrials.gov Identifier: NCT03584386|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Suicide||Device: V-CAMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAMS Relational Agent System (CAMS-RAS) for Suicide Prevention|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
In Phase I (formative), all enrolled participants are asked to provide feedback on the V-CAMS prototype as it is being refined. Feedback will be gathered via survey measure and interview.
In Phase II (summative), enrolled patient participants will be randomly assigned to this arm and will be given access to the V-CAMS tools as part of their treatment in the ED. Baseline assessment surveys will be administered in the ED, and three follow up assessments after discharge at 7 days, 30 days, and 90 days.
V-CAMS is an integrated software system for use on any device by suicidal patients in the ED.
No Intervention: Care As Usual
In Phase II (summative), enrolled patient participants will be randomly assigned to this arm so there is an even number of participants in the experimental condition and this condition. Those assigned to this condition will be treated as usual in the ED. Same as the experimental condition, those in the Care As Usual condition will be asked to complete baseline assessment surveys while they are waiting in the ED, and then three subsequent assessments after discharge at 7 days, 30 days, and 90 days).
- Change in Columbia-Suicide Severity Rating Scale (CSSRS) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]The Columbia-Suicide Severity Rating Scale (CSSRS) is an interviewer-administered FDA-recommended tool to assess suicidal ideation and behaviors in healthcare systems. The scale has two subscales: Severity of Ideation and Suicidal Behavior. For the first subscale, answers are summed for a total ranging from 2 to 25, with higher scores indicating more intense ideation and greater risk. The Suicidal Behavior subscale consists of Yes or No questions that inquire about level of actual or potential medical damage, with greater number of "yes" answers indicating increased risk. It is administered to patient participants at four time-points during Phase II (summative) to assess change across time.
- Change in Suicide Cognitions Scale (SCS) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]An 18-item psychometrically sound self-report measure, the Suicide Cognitions Scale (SCS) assesses suicidal schemas. The score is found by summing the items for a total ranging from 18 to 90 with higher scores indicating worse outcomes. The scale is administered to patient participants at four time-points during Phase II (summative) to assess change over time.
- Change in Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]A nine-item self-report measure that assesses recent depressive symptoms and has excellent sensitivity (.77 to .86) and specificity (.78 to .95) in detecting major depression. The Patient Health Questionnaire-9 (PHQ-9) total score is found by summing the answers and ranges from 0 to 27. Higher scores indicate more severe symptoms. It is administered to patient participants at four time-points during Phase II (summative).
- Change in Coping Skills Use [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]A face-valid self-report measure developed by Dr. Dimeff and used in other clinical trials to assess frequency of skills use, perceived helpfulness of skill, and self-efficacy in using them. It is administered to patient participants at four time-points during Phase II (summative).
- Change in Client Satisfaction Questionnaire (CSQ) [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]An eight-item measure frequently used in clinical trials, modified for this study to focus on patient participants' emergency department experience. The Client Satisfaction Questionnaire (CSQ) is scored by summing the individual items to produce a range of 8 to 32, with higher scores indicating greater satisfaction. It is administered to patient participants at four time-points during Phase II (summative):
- 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). Open-ended questions are included to better understand what was most and least helpful with respect to each category and also measures users' acceptance. This scale is only administered during Phase I, formative usability and acceptability testing. It is administered directly after participants complete their interaction with the technology during their one-time participation.
- Change in Provider Ratings Questionnaire [ Time Frame: Baseline, 7 days, 30 days, and 90 days. ]A face-valid self-report measure that will be adapted by the Principal Investigators to assess patient preparedness for clinical interview, patient distress, provider confidence in suicide risk assessment and helpfulness of clinical support tool. Expected date of development: February, 2019. It is administered to provider participants at four time-points during Phase II (summative).
- Semi-Structured Interview [ Time Frame: Up to one day ]A semi-structured interview to ask about and understand the user's likes, dislikes, and preferences. The semi-structured interview will be conducted for purposes of evaluating the usability of the technology rather than collecting any quantitative data for data analyses. It is administered in Phase I, formative usability and acceptability testing. Participants are asked to complete the semi-structured interview conducted by the research assistant after interacting with the technology.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584386
|Contact: Research Team||206-455-7934 ext firstname.lastname@example.org|
|United States, Washington|
|Evidence-Based Practice Institute||Recruiting|
|Seattle, Washington, United States, 98144|
|Contact: Julie Chung 206-455-7934 email@example.com|
|Contact: Nadia Kako 206-455-7934 firstname.lastname@example.org|
|Principal Investigator:||Linda Dimeff, PhD||Evidence-Based Practice Institute|
|Principal Investigator:||David A Jobes, PhD||The Catholic University of America|