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This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.
PROMPT-CKD is a single-system, cluster-randomized clinical trial to evaluate the effectiveness of a tailored, user-centered, clinical decision support (CDS) tool for the prescription of guideline-directed medical therapy (GDMT) in patients with Chronic Kidney Disease (CKD). Consented providers (physicians, DOs, PA, APRNs, and PharmDs within internal medicine, family medicine and nephrology departments) will be randomized to either an intervention group that will be exposed to the CDS tool, or to a control (usual care) group that will not be exposed to the CDS tool. Upon opening of the order entry screen in the patient's medical record, the CDS tool will automatically and immediately evaluate inclusion and exclusion criteria for the patient, and if all criteria are met, the patient will be automatically enrolled into the study under the randomization group of the provider who opened the chart.
The CDS tool is a best practice alert that appears for each eligible patient with CKD at the level of the order entry screen in the patient's medical record. The alert informs the provider of the presence of CKD, details the patient's most current relevant lab values, and lists current GDMT prescribed. Additionally, the alert lists GDMT which is indicated for the patient but which is not currently prescribed. The alert will also contain an order set containing the indicated medications. Providers may choose to dismiss the alert and indicate the reason. Those in the control arm of the trial will not see alerts, however a "silent alert" will be generated that registers the patient into the study. These patients will receive care as usual.
The primary outcome will assess the proportion of patients with one or more new eligible GDMT prescriptions within 90 days of randomization. Secondary outcomes include time to Major Adverse Kidney Events (MAKE), time to all-cause mortality, time to greater than 40% reduction in eGFR, time to end stage kidney disease (ESKD), time to all-cause hospitalization, and time to worsening of CKD stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure to clinical decision support tool | Experimental | Providers will see a best practice alert with an attached order set upon opening the order entry screen in an eligible patient's medical record. |
|
| Usual Care | No Intervention | Providers will not be exposed to the clinical decision support tool when in the medical record of an eligible patient. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best practice alert and order set for CKD | Other | Providers are exposed to a best practice alert upon opening of the order entry screen in a patient's medical record. The alert informs the provider of the presence of CKD, details the patient's current relevant labs and medications, and provides a list of recommended indicated GDMT for CKD which the patient is currently not prescribed. The alert includes an order set with all indicated medications with additional prescribing information. The alerts additionally includes a link to updated guidelines for GDMT prescription for CKD. Providers will be given the option to dismiss the alert and to indicate reasons for dismissing. |
| Measure | Description | Time Frame |
|---|---|---|
| New GDMT prescription within 90 days | Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization. | Up to 90 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Major Adverse Kidney Events (MAKE) | Measure of the statistical difference between study arms in the time to develop any Major Adverse Kidney Events within one year-post randomization, to include:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francis P Wilson, MD MSCE | Contact | 203-737-1704 | francis.p.wilson@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Francis P Wilson, MD MSCE | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Health | New Haven | Connecticut | 06520 | United States |
De-identified data for the primary and secondary outcomes will be made available.
Upon publication; indefinitely.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Patient participants will be blinded to randomization group, however provider participants will not be blinded as they are receiving alerts in the electronic medical record as part of the intervention.
|
| Up to 365 days post-randomization |
| Time to all-cause mortality | Measure of the statistical difference between study arms in the time to death from any cause within one year-post randomization. | Up to 365 days post-randomization |
| Time to reduction in estimated glomerular filtration rate (eGFR) | Measure of the statistical difference between study arms in the time to achieve reduction of eGFR by greater than 40% within one year-post randomization. | Up to 365 days post-randomization |
| Time to end-stage kidney disease (ESKD) | Measure of the statistical difference between study arms in the time to develop ESKD within one year-post randomization. | Up to 365 days post-randomization |
| Time to all-cause hospitalization | Measure of the statistical difference between study arms in the time to hospitalization from any cause within one year-post randomization. | Up to 365 days post-randomization |
| Time to CKD progression | Measure of the statistical difference between study arms in the time to worsening of CKD stage, either by eGFR criteria, or by albuminuria criteria within one year-post randomization:
| Up to 365 days post-randomization |
| Time to new GDMT prescription | Measure of the statistical difference between study arms in the time to at least one new GDMT prescription for CKD within 90 days post-randomization. | Up to 90 days post-randomization |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |