Suicide, AttemptedCDS_PSNCT05312437
Clinical Decision Support to Prevent Suicide
A study testing Interruptive Alert, CDS and Passive Prompt, CDS in people with Suicide, Attempted and Suicidal Ideation, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Interruptive Alert, CDS and Passive Prompt, CDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 596 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2022to 16 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- A visit in Neurology (first phase) or other non-mental health specialty setting at VUMC (second phase)
Who cannot join
- 1) A CSSRS conducted within one week of the visit in another care setting at VUMC (recent screening)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
About this study
Official title: A Pragmatic Randomized Controlled Trial of Machine Learning-driven Clinical Decision Support to Improve Suicide Risk Screening in Ambulatory Care Settings
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).
Read the detailed description
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
- Suicide, Attempted, Suicidal Ideation
- Being tested
- Interruptive Alert, CDS, Passive Prompt, CDS
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interruptive Alert, CDSOther
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:
- Document face-to-face suicide risk screening with the Columbia Suicide Severity Rating Scale (CDS complete once the CSSRS is complete)
- Agree to screen using an alternative method chosen at the clinician's discretion (CDS complete)
- Disagree with alert and provide a rationale for disagreement (CDS complete)
- Indicate suicide risk face-to-face screening has already occurred (CDS complete)
- 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, CDSOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Passive Prompt, CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 hours
Secondary outcomes (3)
Subsequent encounter for suicidal ideation within sixty days
Documented clinical encounter anywhere in health system with documented diagnostic code (ICD10CM) for suicidal ideation
The Electronic Health Record (EHR) will be queried every month and all ICD10CM codes documented for patients seen in the study sites will be analyzed for the presence of any ICD10CM codes in a reference list for suicidal ideation. In ICD10CM, a single code, R45.81, is used to document suicidal ideation. If any ICD10CM codes that match that list are found within sixty days of the encounter date in study settings, the outcome will be marked as a case of subsequent suicidal ideation.
This outcome is measured on a binary scale, 1= presence of encounter for suicidal ideation and 0 = absence
Measured: Sixty days after study encounter
Subsequent encounter for suicide attempt within sixty days
Documented clinical encounter anywhere in health system with documented diagnostic code (ICD10CM) for suicide attempt
The EHR will be queried every month and all ICD10CM codes documented for patients seen in the study sites will be analyzed for the presence of any ICD10CM codes in a reference list for suicide attempt. In ICD10CM, the National Center for Health Statistics provides a full list of acceptable codes that will be used for reference (https://www.cdc.gov/nchs/data/nhsr/nhsr108.pdf). If any ICD10CM codes that match that list are found within sixty days of the encounter date in study settings, the outcome will be marked as a case of subsequent suicidal ideation.
This outcome is measured on a binary scale, 1= presence of encounter for suicide attempt and 0 = absence
Measured: Sixty days after study encounter
Emergency Department Utilization
Any Emergency Department Encounter within sixty days of study encounter and reason for Emergency Department Encounter
The EHR will be queried every month and all clinical encounters (aka visits) will be analyzed for location, which is recorded in both Visit Type fields (type "E") in our records and by location (e.g., "Emergency Department"). The presence of a recorded visit occurring within sixty days of a clinical encounter in the study settings will be marked as a case of Emergency Department Utilization for trial purposes. The reason for visit will be analyzed as the ICD10CM codes billed for that encounter, also stored in the EHR.
This outcome is measured on a binary scale, 1= presence of Emergency Department encounter and 0 = absence. The reason for encounter will be analyzed secondarily and descriptive statistics used to count the most common reasons related to subsequent Emergency Department encounters.
Measured: Sixty days after study encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start16 Aug 2022
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colin G. Walsh, Vanderbilt University Medical Center
- Investigators
- Colin G Walsh, MD, MA, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312437
- Sponsor's protocol ID
- 210865
- Acronym
- CDS_PS
- Status last verified
- Mar 2023
- First submitted
- 7 Mar 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33710291Walsh 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.
PubMed 39752160Walsh 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.
PubMed 38562678
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Machine Learning-driven Clinical Decision Support to Improve Suicide Risk Screening in Ambulatory Care Settings
- ClinicalTrials.gov ID
- NCT05312437
- Acronym / sponsor ID
- CDS_PS / 210865
- Conditions
- Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 5 Apr 2022 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interruptive Best Practice Advisory - CDS Intervention | Experimental | Other: Interruptive Alert, CDSAdults 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. |
| Passive Storyboard Prompt - CDS Intervention | Active comparator | Other: Passive Prompt, CDSAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years of age
- A visit in Neurology (first phase) or other non-mental health specialty setting at VUMC (second phase)
Key exclusion criteria (1 listed)
- 1) A CSSRS conducted within one week of the visit in another care setting at VUMC (recent screening)
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 |
|---|---|---|
| Interruptive Alert, CDSExperimental: 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) | Other | Interruptive Best Practice Advisory - CDS Intervention |
| Passive Prompt, CDSAdult 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 Storyboard Prompt - CDS Intervention |
Primary outcome
Face-to-face screening by clinician
Time frame: Up to 24 hours
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.
3 secondary outcomes
Subsequent encounter for suicidal ideation within sixty days
Time frame: Sixty days after study encounter
Subsequent encounter for suicide attempt within sixty days
Time frame: Sixty days after study encounter
Emergency Department Utilization
Time frame: Sixty days after study encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 33710291Walsh 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.
- Derived from this study: PubMed 39752160Walsh 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.
- Derived from this study: PubMed 38562678Walsh 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.
- Individual participant dataSharing planned: No
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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.
Colin G Walsh, MD, MA principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interruptive Alert, CDS and Passive Prompt, CDS in people with Suicide, Attempted and Suicidal Ideation, run by Vanderbilt University Medical Center at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Face-to-face screening by clinician (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312437, which also lists 3 linked publications.
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 14 Mar 2023.