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| Name | Class |
|---|---|
| Arizona State University | OTHER |
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This study addresses a critical gap of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving recommended SGLT2 and MRA therapies that save lives and prevents HF hospitalizations. The investigators will compare the effect of clinician directed nudges as strategies to improve the health of Veterans with HF.
This study addresses a critical gap in quality of care for Veterans with heart failure (HF). Only 1/3 or fewer eligible Veterans are receiving SGLT2 inhibitors and mineralocorticoid receptor antagonists, both medications that save lives and prevents HF hospitalizations. The investigators will combine insights from behavioral science and quality improvement science to create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will create two types of 'nudges' - informational alerts and peer comparison feedback - to increase prescribing of these medications. The investigators will compare the effect of these two nudge strategies alone and in combination compared to usual care. This project will develop simple, scalable, and low-cost strategies to improve the health of Veterans with HF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Comparison Report | Active Comparator | Clinicians assigned to peer comparison, will receive messages by secure email every two weeks regarding their SGLT2i and MRA prescribing performance. |
|
| Alert | Active Comparator | Clinicians in the alert arm will receive an alert two business days prior to a patient's upcoming appointment. Clinicians will receive approximately two alerts per week. |
|
| Alert and Peer Comparison | Active Comparator | The combined alert and peer comparison arm will receive both interventions. |
|
| Control | No Intervention | No alert or peer comparison |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alert | Behavioral | Interruptive alert. The prototype alert is in the form of a chart note with evidence-based practice guidelines that will actively display in the clinician's list of daily alerts (like an inbox) that must be cleared daily. It is interruptive because can only be dismissed from the clinician's inbox list after signing the note |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness (MRA Prescriptions) | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled. | 30 days |
| Effectiveness (SGLT2 Prescriptions) | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Reach-Clinician | Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison report. The control group did not receive any alert. | 6 months |
| Incidence of Treatment Emergent Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandesh Dev, MD | Southern Arizona VA Health Care System, Tucson, AZ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Arizona VA Health Care System, Tucson, AZ | Tucson | Arizona | 85723-0001 | United States |
There is a plan to make IPD and related data dictionaries available.
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.
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The leadership of both units agreed that all providers would participate.
The 81 participants (providers) were randomly assigned to one of four study arms (control, Alert [EHR note], Pier Comparison Report [Email notification], or Both [EHR and Email]. The providers were numbered and blindly randomize by department, education, and employment site.
All employed providers within Cardiology and Primary Care units were enrolled into this study per agreement with management.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Participants within this arm will not receive any intervention. |
| FG001 | Alert | Participants in this arm would be notified 2 days prior of any upcoming appointment with an eligible patient who would benefit from the guideline approved medication via Electronic Health Record Note. |
| FG002 | Peer Comparison Report | Participants within this arm received an email alert every 15 days regarding their ranking among their piers in providing the guideline medication administration. |
| FG003 | Alert & Peer Comparison Report | Participants within this arm would receive the EHR note 2 days prior to an eligible patient and an Email alert every 15 days regarding their ranking concerning the guideline directed medication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristic data was not collected for participants of this study
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Participants within this arm will not receive any intervention. |
| BG001 | Alert | Participants in this arm would be notified 2 days prior of any upcoming appointment with an eligible patient who would benefit from the guideline approved medication via Electronic Health Record Note. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age was not collected as our participants are employees |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness (MRA Prescriptions) | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled. | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. The investigators' focus was on increasing the prescription rate. Participants analyzed reflect count of patients. | Posted | Number | Count of MRA prescriptions Filled | 30 days |
From enrollment through intervention completion, an average of 6 months
Should a study participant leave the VA location (Tucson VA) during the intervention, it would have been listed as an adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Participants within this arm will not receive any intervention. | 0 |
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At this point the study does not have any limitations nor caveats.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sandesh Dev | Tucson VA Medical Center | (602) 888-1257 | sandesh.dev@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2023 | Nov 12, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2023 | Jul 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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This is a type 3 hybrid (implementation focused), four group, pragmatic trial of cardiology and primary care clinicians at a single VA medical center. The trial will include a 3-month preintervention period and 3-month intervention period. Clinicians will be randomized to one of four arms: usual care, informational alert, peer comparison feedback, and combination of alert and peer comparison.
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Statistician will be blinded to treatment assignment.
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| Peer comparison report | Behavioral | Clinicians will receive an email describing their recent SGLT2 and MRA prescribing performance relative to their peers. |
|
The investigators will measure safety as the number of patients who were deemed by the participant (clinician) to discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions. |
| 30 days |
| Implementation-Acceptability | Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. The REDCap survey was on the Likert Scale: minimum 1 and maximum 5. With 5 being the highest. Acceptability was determine by the number of participants who were neutral or positive with their responses according the the Likert Scale. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | 6 months |
| Reach-Patient | At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts | 6 months |
| Reach-Comparison of Strategies | The investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy. | 6 months |
| Implementation-Appropriateness | Appropriateness will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The number of respondents who were neutral and positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | 6 months |
| Implementation-Feasibility | Feasibility will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The survey participants responded used the Likert scale to determine if the intervention would be feasible. All responses neutral or positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | 6 months |
| BG002 | Peer Comparison Report | Participants within this arm received an email alert every 15 days regarding their ranking among their piers in providing the guideline medication administration. |
| BG003 | Alert & Peer Comparison Report | Participants within this arm would receive the EHR note 2 days prior to an eligible patient and an Email alert every 15 days regarding their ranking concerning the guideline directed medication. |
| BG004 | Total | Total of all reporting groups |
| Sex/Gender, Customized | Sex/Gender were not collected from any participant. |
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Participants |
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Control | Participants within this arm will not receive any intervention. |
| OG001 | Alert | Participants in this arm would be notified 2 days prior of any upcoming appointment with an eligible patient who would benefit from the guideline approved medication via Electronic Health Record Note (Alert). |
| OG002 | Peer Comparison Report | Participants within this arm received an email alert every 15 days regarding their ranking among their piers in providing the guideline medication administration. |
| OG003 | Both Alert and Peer Comparison Report | Participants within this arm would receive the Alert (EHR note) 2 days prior to an eligible patient and an Peer Comparison Report (Email alert) every 15 days regarding their ranking concerning the guideline directed medication. |
|
|
| Secondary | Reach-Clinician | Reach will be measured at the clinician level as the number of unique clinicians who received an informational alert or peer comparison report. The control group did not receive any alert. | This is the number of clinicians within Primary Care and Cardiology who were participants. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Incidence of Treatment Emergent Adverse Events | The investigators will measure safety as the number of patients who were deemed by the participant (clinician) to discontinued prescribed medicine due to suspected adverse effects within 30 days of the nudge interventions. | The deprescribed medicine rate was determined by patient and not associated directly with the participants (clinicians) nor Arms/Groups, being that a patient may be seen by multiple providers. | Posted | Number | Deprescribed patients | 30 days |
|
|
|
| Secondary | Implementation-Acceptability | Implementation will be assessed by clinician-directed survey of Acceptability of intervention Measure. The REDCap survey was on the Likert Scale: minimum 1 and maximum 5. With 5 being the highest. Acceptability was determine by the number of participants who were neutral or positive with their responses according the the Likert Scale. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | Surveys were anonymous and no identifying information was collected, therefore, investigators are unable to determine which Arm/Group participants with survey responses were assigned. Rows represent responses from the surveys and do not correspond to a specific Arm/Group. The survey was voluntary and only 14 of the 81 clinicians participated. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Reach-Patient | At the patient level, Reach will be measured as the number of unique patients for whom the participants received informational alerts | The number of patients were not broken down by each participant nor Arm/Group. | Posted | Number | Total unique patients | 6 months |
|
|
|
| Secondary | Reach-Comparison of Strategies | The investigators will measure the proportion of alerts relative to the total number of eligible patients with HF; this denominator will allow for comparisons of representativeness of the alert strategy. | Posted | Number | alerts sent | 6 months |
|
|
|
| Secondary | Implementation-Appropriateness | Appropriateness will be assessed by clinician direct survey of Intervention Appropriateness Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The number of respondents who were neutral and positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | Surveys were anonymous and no identifying information was collected, therefore, investigators are unable to determine which Arm/Group participants with survey responses were assigned. Rows represent responses from the surveys and do not correspond to a specific Arm/Group. The survey was voluntary and only 10 of the 81 clinicians participated. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Implementation-Feasibility | Feasibility will be assessed by clinician direct survey of Feasibility of Intervention Measure. Likert scale: minimum 1 and maximum 5. With 5 being the highest. The survey participants responded used the Likert scale to determine if the intervention would be feasible. All responses neutral or positive were counted. The anonymous surveys were sent to all in the three groups and did not collect any identifying information. | Surveys were anonymous and no identifying information was collected, therefore, investigators are unable to determine which Arm/Group participants with survey responses were assigned. Rows represent responses from the surveys and do not correspond to a specific Arm/Group. The survey was voluntary and only 10 of the 81 clinicians participated. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Effectiveness (SGLT2 Prescriptions) | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. Thirty days is a common time interval for HF outcomes assessment and allows for chart documentation, care coordination, laboratory testing, and medication prescribing that may occur days after a patient encounter. The investigators will record all SGLT2 or MRA prescriptions, including those from non-targeted clinicians, given that nudge interventions, especially the informational alert, may impact other clinicians directly (e.g., view alert in EHR) or indirectly (e.g., referral from targeted clinician). Data represent a cumulative number of prescriptions filled. | The primary effectiveness outcome is the amount of SGLT2 or MRA prescriptions in eligible HF patients in the three intervention groups compared with the control group within 30 days of appointment. The investigators' focus was on increasing the prescription rate. Participants analyzed reflect count of patients. | Posted | Number | Count of SGLT2 Prescriptions Filled | 30 days |
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|
|
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Alert | Participants in this arm would be notified 2 days prior of any upcoming appointment with an eligible patient who would benefit from the guideline approved medication via Electronic Health Record Note. | 0 | 19 | 0 | 19 | 0 | 19 |
| EG002 | Peer Comparison Report | Participants within this arm received an email alert every 15 days regarding their ranking among their piers in providing the guideline medication administration. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG003 | Alert & Peer Comparison Report | Participants within this arm would receive the EHR note 2 days prior to an eligible patient and an Email alert every 15 days regarding their ranking concerning the guideline directed medication. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |