Chronic Kidney Diseases
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERBest practice alert and order set for CKD
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.
Sponsors
Yale University
Boehringer Ingelheim International GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged ≥18 years 2. Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL/min/1.73m2 with an uACR ≥30 mg/g or eGFR \>90 mL/min/1.73m2 with an uACR ≥30 mg/g. 3. Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria. 4. To receive an ACEi/ARB: eGFR ≥15 ml/min/1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg/g). 5. To receive an SGLT2i: have heart failure (defined by ICD10 code); or T2D; or uACR ≥200 mg/g; or eGFR ≥20 ml/min/1.732. 6. To receive an MRA: ns-MRA: have an eGFR ≥25 ml/min/1.732, diagnosis of T2D, normal serum potassium (≤4.8 mmol/L) and albuminuria (\>30 mg/g). s-MRA: have an eGFR ≥45 ml/min/1.732 and heart failure, hyperaldosteronism, or refractory hypertension. 7. To receive a GLP-1 RA: have T2D. 8. Ability to take oral medication.
Exclusion criteria
1. Allergy to the GDMT for which the patient is eligible 2. End-stage kidney disease 3. CKD stage 5 (eGFR \<15 ml/min/1.73m2) 4. Glomerulonephritis (by ICD-10 code) 5. Polycystic kidney disease (by ICD-10 code) 6. History of kidney transplant 7. End-stage heart failure 8. Eligible to receive ACEi/ARB but having blood pressure \<110/70 mmHg or have known renal artery stenosis 9. Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code. 10. Eligible to receive MRA but serum potassium ≥5 mmol/L, have office SBP \<100 mmHg, adrenal insufficiency based on ICD10 code or concomitant treatment with CYP3A4 inhibitors (Strong: grapefruit, grapefruit juice, itraconazole. Moderate: erythromycin. Weak: amiodarone). 11. Eligible to receive GLP-1 RA but pregnant; or found to have personal history of pancreatitis; or personal or family history of medullary thyroid cancer or MEN type 2 based on ICD10 code or gastroparesis based on ICD10 code. 12. Opted out of EHR-based research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New GDMT prescription within 90 days | Up to 90 days of randomization | Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Major Adverse Kidney Events (MAKE) | Up to 365 days post-randomization | 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: 1. Death OR 2. 40% reduction in eGFR as defined by 2 measurements at least 30 days apart OR 3. Development of end-stage kidney disease (ESKD) defined by ICD10 code n18.6 OR 4. Receipt of dialysis OR 5. Receipt of kidney transplant |
| Time to all-cause mortality | Up to 365 days post-randomization | Measure of the statistical difference between study arms in the time to death from any cause within one year-post randomization. |
| Time to reduction in estimated glomerular filtration rate (eGFR) | Up to 365 days post-randomization | 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. |
| Time to end-stage kidney disease (ESKD) | Up to 365 days post-randomization | Measure of the statistical difference between study arms in the time to develop ESKD within one year-post randomization. |
| Time to all-cause hospitalization | Up to 365 days post-randomization | Measure of the statistical difference between study arms in the time to hospitalization from any cause within one year-post randomization. |
| Time to CKD progression | Up to 365 days post-randomization | 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: * eGFR criteria (with a higher stage indicating worsening disease): Stage 1: eGFR of 90 or higher Stage 2: eGFR of 60-89 Stage 3: eGFR of 30-59 Stage 4: eGFR of 15-29 Stage 5: eGFR of less than 15 * Albuminuria criteria (based on urine protein levels), with higher stages indicating worsening disease: A1: \<30 mg/g or \<3mg/mmol; A2: 30-300 mg/g or 3-30 mg/mmol; A3: \>300 mg/g or \>30 mg/mmol. |
| Time to new GDMT prescription | Up to 90 days post-randomization | 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. |
Countries
United States
Contacts
CONTACTFrancis P Wilson, MD MSCE
PRINCIPAL_INVESTIGATORFrancis P Wilson, MD MSCE
Yale University
Outcome results
None listed