Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
596 participants
INTERVENTIONAL
2022-08-16
2023-02-16
Brief Summary
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This study will evaluate the effectiveness of a Clinical Decision Support System called Vanderbilt Safecourse using VSAIL to prompt a novel Best Practice Advisory (BPA) to prompt face-to-face screening with a validated suicide screening instrument like the Columbia Suicide Severity Rating Scale (CSSRS).
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Detailed Description
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The investigators will measure the VSAIL-prompted BPA's effectiveness in real-world clinical settings to increase rates of face-to-face suicide risk screening. VSAIL requires only data already collected in routine clinical encounters and is calculated in real- time (seconds) at the start of a clinical visit (inpatient or outpatient) at VUMC.
VSAIL does not replace clinical judgment in treating suicidality, but the investigators seek to measure whether VSAIL increases the rates at which the important problem of suicide is addressed and screened effectively.
The investigators seek to compare an active, Interruptive intervention, a VSAIL-prompted BPA pushed to providers, to a passive, non-interruptive visual prompt to determine if 1) CDS driven by automated risk modeling improves face-to-face screening rates and 2) whether or not that CDS needs to be interruptive or non-interruptive to be effective. In the latter case, effective non-interruptive CDS would improve care without worsening "alert fatigue." For equipoise, risk scores for all patients in the study sites would be made available in Epic flowsheets for review by providers if they choose to do so.
In the first phase, The investigators will pilot this CDS in Neurology outpatient clinics for six months. If study goals are met, The investigators will scale the CDS intervention trial across non-mental health specialty settings at VUMC over the following 18 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Interruptive Best Practice Advisory - CDS Intervention
Adults at Elevated Predicted Risk (\>=2% predicted risk, based on our study, DOI: 10.1001/jamanetworkopen.2021.1428) at visit registration (aka "check-in") will be randomized to either Interruptive Alert or Passive Prompt CDS interventions.
In the Interruptive Alert, the physician who next opens that patient's chart will be prompted to review a BPA describing the patient's risk and asking the physician to choose from the BPA options (see Interventions).
The BPA will need to be dismissed to the Epic Storyboard or completed as above to continue clinical workflow.
Interruptive Alert, CDS
Experimental: CDS Intervention Adult patients in the highest predicted risk tier (\>=2% predicted risk) at the time visit registration (aka "check-in").
The Intervention would then be described as:
Physicians review a Best Practice Advisory describing the patient's risk and choose from the following options:
1. Document face-to-face suicide risk screening with the Columbia Suicide Severity Rating Scale (CDS complete once the CSSRS is complete)
2. Agree to screen using an alternative method chosen at the clinician's discretion (CDS complete)
3. Disagree with alert and provide a rationale for disagreement (CDS complete)
4. Indicate suicide risk face-to-face screening has already occurred (CDS complete)
5. Dismiss the alert. The alert will be available in Epic "Storyboard" persistently until acted on further. The Storyboard functionality after dismissal is identical to the Passive Prompt, CDS intervention (below)
Passive Storyboard Prompt - CDS Intervention
Adult patients in the highest predicted risk tier (\>=2% predicted risk, based on our research study, DOI: 10.1001/jamanetworkopen.2021.1428) at the time of visit registration (aka "check-in") will be randomized to either the Interruptive Alert or Passive Prompt CDS intervention arms.
In the Passive Prompt arm, the physician who next opens the patients' charts after check-in (e.g., "Chart Review") will see a Storyboard icon for Elevated Suicide Risk on the left side of the screen. Hovering over this icon will bring up a window with the BPA information in a view identical to the Interruptive Alert arm. Clicking on the window will bring up the BPA with full functionality as in the Interruptive Alert arm.
Passive Prompt, CDS
Adult patients in the highest predicted risk tier (\>=2% predicted risk, based on our research study, DOI: 10.1001/jamanetworkopen.2021.1428) at the time of visit registration (aka "check-in") will be randomized to either the Interruptive Alert or Passive Prompt CDS intervention arms.
In the Passive Prompt arm, the physician who next opens the patients' charts after check-in (e.g., "Chart Review") will see a Storyboard icon for Elevated Suicide Risk on the left side of the screen. Hovering over this icon will bring up a window with the BPA information in a view identical to the Interruptive Alert arm. Clicking on the window will bring up the BPA with full functionality as in the Interruptive Alert arm.
Interventions
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Interruptive Alert, CDS
Experimental: CDS Intervention Adult patients in the highest predicted risk tier (\>=2% predicted risk) at the time visit registration (aka "check-in").
The Intervention would then be described as:
Physicians review a Best Practice Advisory describing the patient's risk and choose from the following options:
1. Document face-to-face suicide risk screening with the Columbia Suicide Severity Rating Scale (CDS complete once the CSSRS is complete)
2. Agree to screen using an alternative method chosen at the clinician's discretion (CDS complete)
3. Disagree with alert and provide a rationale for disagreement (CDS complete)
4. Indicate suicide risk face-to-face screening has already occurred (CDS complete)
5. Dismiss the alert. The alert will be available in Epic "Storyboard" persistently until acted on further. The Storyboard functionality after dismissal is identical to the Passive Prompt, CDS intervention (below)
Passive Prompt, CDS
Adult patients in the highest predicted risk tier (\>=2% predicted risk, based on our research study, DOI: 10.1001/jamanetworkopen.2021.1428) at the time of visit registration (aka "check-in") will be randomized to either the Interruptive Alert or Passive Prompt CDS intervention arms.
In the Passive Prompt arm, the physician who next opens the patients' charts after check-in (e.g., "Chart Review") will see a Storyboard icon for Elevated Suicide Risk on the left side of the screen. Hovering over this icon will bring up a window with the BPA information in a view identical to the Interruptive Alert arm. Clicking on the window will bring up the BPA with full functionality as in the Interruptive Alert arm.
Eligibility Criteria
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Inclusion Criteria
2. A visit in Neurology (first phase) or other non-mental health specialty setting at VUMC (second phase)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
Responsible Party
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Colin G. Walsh
Associate Professor
Principal Investigators
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Colin G Walsh, MD, MA
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Walsh CG, Johnson KB, Ripperger M, Sperry S, Harris J, Clark N, Fielstein E, Novak L, Robinson K, Stead WW. Prospective Validation of an Electronic Health Record-Based, Real-Time Suicide Risk Model. JAMA Netw Open. 2021 Mar 1;4(3):e211428. doi: 10.1001/jamanetworkopen.2021.1428.
Walsh CG, Ripperger MA, Novak L, Reale C, Anders S, Spann A, Kolli J, Robinson K, Chen Q, Isaacs D, Acosta LMY, Phibbs F, Fielstein E, Wilimitis D, Musacchio Schafer K, Hilton R, Albert D, Shelton J, Stroh J, Stead WW, Johnson KB. Risk Model-Guided Clinical Decision Support for Suicide Screening: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452371. doi: 10.1001/jamanetworkopen.2024.52371.
Walsh CG, Ripperger MA, Novak L, Reale C, Anders S, Spann A, Kolli J, Robinson K, Chen Q, Isaacs D, Acosta LMY, Phibbs F, Fielstein E, Wilimitis D, Musacchio Schafer K, Hilton R, Albert D, Shelton J, Stroh J, Stead WW, Johnson KB. Randomized Controlled Comparative Effectiveness Trial of Risk Model-Guided Clinical Decision Support for Suicide Screening. medRxiv [Preprint]. 2024 Mar 18:2024.03.14.24304318. doi: 10.1101/2024.03.14.24304318.
Other Identifiers
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210865
Identifier Type: -
Identifier Source: org_study_id
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