Clinical Decision Support to Prevent Suicide

NCT ID: NCT05312437

Last Updated: 2023-03-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2023-02-16

Brief Summary

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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).

Detailed Description

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The investigators seek to study if identifying patients at high predicted risk of suicide in clinical settings where suicide risk screening only happens sporadically, if at all, will improve face-to-face screening rates and documentation of suicide risk assessment in their EHRs.

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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Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
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.

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.

Group Type EXPERIMENTAL

Interruptive Alert, CDS

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Passive Prompt, CDS

Intervention Type 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.

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)

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. \> 18 years of age
2. A visit in Neurology (first phase) or other non-mental health specialty setting at VUMC (second phase)

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Colin G. Walsh

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 33710291 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39752160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38562678 (View on PubMed)

Other Identifiers

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210865

Identifier Type: -

Identifier Source: org_study_id

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