Clinical Decision Support to Prevent Suicide

NCT05312437 | Completed

• 1 other identifier: 210865
• Study Type: interventional
• Target: 596
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide kills 132 Americans every day. The first step of suicide prevention is risk identification and prognostication. Researchers like this study team have developed and validated predictive models that use routinely collected Electronic Health Record (EHR) data like past diagnoses and medications to predict future suicide attempt risk. The study team's model based in machine learning is known as the Vanderbilt Suicide Attempt and Ideation Likelihood (VSAIL). VSAIL has been validated prospectively and externally to predict suicide attempt risk with a number needed to screen (NNS) of 271 for suicide attempt and 23 for suicidal ideation. NNS is the number of people who need to receive a test result to prevent one outcome - lower NNS is better. 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).

Conditions

Suicide, Attempted; Suicidal Ideation

Outcome Measures

Primary Outcomes (1)

• Face-to-face screening by clinician

  Documentation of the validated, brief-version of the Columbia Suicide Severity Rating Scale (https://www.cms.gov/files/document/cssrs-screen-version-instrument.pdf) or recording a binary response "Will screen with alternative method" input by providers into the intervention Best Practice Advisory using a button in the Acknowledge Reason section of the BPA.

  Up to 24 hours

Secondary Outcomes (3)

• Subsequent encounter for suicidal ideation within sixty days

  Sixty days after study encounter

• Subsequent encounter for suicide attempt within sixty days

  Sixty days after study encounter

• Emergency Department Utilization

  Sixty days after study encounter

Study Arms (2)

Interruptive Best Practice Advisory - CDS Intervention

EXPERIMENTAL

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.

Other: Interruptive Alert, CDS

Passive Storyboard Prompt - CDS Intervention

ACTIVE COMPARATOR

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.

Other: Passive Prompt, CDS

Interventions

Interruptive Alert, CDS OTHER

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)

Interruptive Best Practice Advisory - CDS Intervention

Passive Prompt, CDS OTHER

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 Storyboard Prompt - CDS Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years of age
• A visit in Neurology (first phase) or other non-mental health specialty setting at VUMC (second phase)

You may not qualify if:

• \) A CSSRS conducted within one week of the visit in another care setting at VUMC (recent screening)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

• 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.

  PMID: 33710291 BACKGROUND

• 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.

  PMID: 39752160 DERIVED

• 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.

  PMID: 38562678 DERIVED

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Colin G Walsh, MD, MA

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Those randomized to intervention arm will have the intervention BPA prompt. Those randomized to the control arm will not have an associated BPA prompt. Risk predictions for all participants in study settings will be visible in eStar flowsheets for equipoise.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 5, 2022
• Study Start: August 16, 2022
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)