Suicidal IdeationNCT03207217
Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
A study testing Web-based training Product in people with Suicidal Ideation, run by SIMmersion, LLC.
Trial summary
SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Web-based training Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training.
Who cannot join
- have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.
About this study
SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide in this Phase I/Phase II fast-track application. If funded, the team will develop the Risk Assessment module in Phase I and utilize a within group pre-post design to evaluate its feasibility. Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means, and Willingness to Accept a Referral modules. The efficacy of the product to positively influence patient outcomes will be tested with a Historically Controlled Trial (HCT) enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and patient outcomes will be tracked for 6 months post training. This data set will be compared to 6 months of historical data for the same provider group. Primary outcomes of this study will measure the participants' ability in obtain improved patient outcomes related to: 1) rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3) rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5) rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit; 7) and lower rates of documented suicide attempts. Ultimately, the development and successful testing of this product would provide the US health care system a novel technology to scale up a clinician's confidence and skill to better manage patients who identify as at-risk for suicide. Additionally, if effective, this product will have a direct impact on patient outcomes, a vital component to any training product that attempts to train health care professionals. The utility and scalability of the proposed product will move health care systems toward the goal of zero deaths from suicide consistent with the Zero suicide approach.
- Conditions
- Suicidal Ideation
- Being tested
- Web-based training Product
- Keywords
- Safety Planning, Access to Lethal Means, Zero Suicide
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based training ProductOther
A series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide. The modules are: Risk Assessment, Safety Planning, Access to Lethal Means, and Willingness to accept referral.
| Study group | Role | What they receive |
|---|---|---|
| Phase I Knowledge Assessment | Experimental | Not described Receives: Other: Web-based training Product |
| Phase II Efficacy | Experimental | Not described Receives: Other: Web-based training Product |
| Phase II Acceptability | Experimental | Not described Receives: Other: Web-based training Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-SSRS Screening
Higher rates of same-day C-SSRS Screening
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Suicide addition to Problem List
Higher rates of suicide being added to the problem list
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Same-day Safety Planning, if a positive screen
Higher rates of same-day Safety Planning, if a positive screen
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
C-SSRS Lifeline/Recent Completion
Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Risk Assessment
Higher rates of same-day Risk Assessment, if a positive screen
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Within-Institute referrals
Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Documented suicide attempts
Have lower rates of documented suicide attempts
Measured: Assessment will occur after a 6 month period of tracking patient records for each provider
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SIMmersion, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Institute for Family Health, Education Development Center, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207217
- Sponsor's protocol ID
- R44MH114710-01
- Status last verified
- Jun 2017
- First submitted
- 29 Jun 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Training Role-Plays to Improve Patient Suicide Outcomes in Primary Care Settings
- ClinicalTrials.gov ID
- NCT03207217
- Acronym / sponsor ID
- R44MH114710-01
- Conditions
- Suicidal Ideation
- Keywords
- Safety Planning, Access to Lethal Means, Zero Suicide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- SIMmersion, LLCIndustry (pharma, biotech, devices)
- Collaborators
- The Institute for Family Health, Education Development Center, Inc.
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 2 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SIMmersion, in collaboration with the Institute for Family Health (IFH) and the Educational Development Center (EDC) propose to develop a web-based training product, Suicide Prevention Role-plays for Interactive Training (SPiRIT), a series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide in this Phase I/Phase II fast-track application. If funded, the team will develop the Risk Assessment module in Phase I and utilize a within group pre-post design to evaluate its feasibility. Twenty practicing clinicians will be recruited to utilize the module and complete a pre-post knowledge test. In Phase II, the team will develop Safety Planning, Access to Lethal Means, and Willingness to Accept a Referral modules. The efficacy of the product to positively influence patient outcomes will be tested with a Historically Controlled Trial (HCT) enlisting 65 practicing clinicians across five IFH sites. All providers will be trained and patient outcomes will be tracked for 6 months post training. This data set will be compared to 6 months of historical data for the same provider group. Primary outcomes of this study will measure the participants' ability in obtain improved patient outcomes related to: 1) rate of same-day C-SSRS Screening; 2) rate of suicide being added to the problem list; 3) rate of same-day safety planning; 4) rate of same day C-SSRS Lifeline/Recent Completion; 5) rate of same-day Risk Assessment; 6) rate of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit; 7) and lower rates of documented suicide attempts. Ultimately, the development and successful testing of this product would provide the US health care system a novel technology to scale up a clinician's confidence and skill to better manage patients who identify as at-risk for suicide. Additionally, if effective, this product will have a direct impact on patient outcomes, a vital component to any training product that attempts to train health care professionals. The utility and scalability of the proposed product will move health care systems toward the goal of zero deaths from suicide consistent with the Zero suicide approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I Knowledge Assessment | Experimental | Other: Web-based training Product |
| Phase II Efficacy | Experimental | Other: Web-based training Product |
| Phase II Acceptability | Experimental | Other: Web-based training Product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hold an active license issued by the State of New York for their profession and be in good standing; (2) actively see patients at an IFH site; and (3) have completed IFH's mandated suicide prevention training.
Key exclusion criteria (1 listed)
- have not completed their IFH Suicide Prevention Training as outlined in the IFH's Suicide Prevention Training Policy; or (2) have uncorrected vision or hearing problems that prevent the person from using the software. Specific to Phase II an additional criteria is (3)participated in the Phase 1 feasibility testing.
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 |
|---|---|---|
| Web-based training ProductA series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide. The modules are: Risk Assessment, Safety Planning, Access to Lethal Means, and Willingness to accept referral. | Other | Phase I Knowledge Assessment, Phase II Acceptability, Phase II Efficacy |
Primary outcome
C-SSRS Screening
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of same-day C-SSRS Screening
Suicide addition to Problem List
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of suicide being added to the problem list
Same-day Safety Planning, if a positive screen
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of same-day Safety Planning, if a positive screen
C-SSRS Lifeline/Recent Completion
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of same-day C-SSRS Lifeline/Recent Completion, if a positive screen;
Risk Assessment
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of same-day Risk Assessment, if a positive screen
Within-Institute referrals
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Higher rates of acceptance and attendance to within-Institute referrals for post intervention patients who are offered the referral at the first visit
Documented suicide attempts
Time frame: Assessment will occur after a 6 month period of tracking patient records for each provider
Have lower rates of documented suicide attempts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based training Product in people with Suicidal Ideation, run by SIMmersion, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
C-SSRS Screening (time frame: Assessment will occur after a 6 month period of tracking patient records for each provider). The study lists 7 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 2 Jul 2017.