protocolSection identificationModule nctId: NCT06300086, orgStudyIdInfo id: NUDGE-CKD, briefTitle: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease, acronym: NUDGE-CKD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-10-01, completionDateStruct date: 2034-10-01, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Tor Biering-Sørensen, class: OTHER, descriptionModule briefSummary: Kidney Disease Improving Global Outcomes (KDIGO) has recently updated the Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (CKD). This update follows large placebo-controlled randomized trials, which established sodium-glucose cotransporter 2 inhibitors (SGLT2i) as an additional treatment option to reduce the risk of progression to kidney failure and cardiovascular disease in patients with CKD, both with and without diabetes or albuminuria. As a result, SGLT2i is now recommended to a broad range of CKD patients by KDIGO, along with established medical therapies such as renin-angiotensin system inhibition (RASi). Despite the significant adverse consequences of CKD and substantial evidence supporting guideline-directed medical therapy (GDMT) to improve patient outcomes, awareness of CKD among patients and providers remains disproportionately low. Innovative solutions are needed to increase awareness of CKD. Such a solution could potentially be the use of electronic nudge letters delivered to patients with CKD and their general practitioners (GPs) that highlight the importance of GDMT and inform them of updated guidelines.This study will investigate whether digital nudge letters delivered via the official Danish electronic letter system directly to patients with CKD and their associated GPs will improve GDMT in patients with CKD when compared to no letters., conditionsModule conditions: Chronic Kidney Diseases, conditions: Behavior and Behavior Mechanisms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: FACTORIAL, interventionModelDescription: 2x2 factorial design, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 35000, type: ESTIMATED, armsInterventionsModule interventions name: Electronically delivered nudging letters to patients with CKD, interventions name: Electronically delivered nudging letter to associated GPs of patients with CKD, outcomesModule primaryOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, secondaryOutcomes measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition, secondaryOutcomes measure: Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with an increase in baseline daily RASi dosage, otherOutcomes measure: Number of participants with any prescription of mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with any prescription of cholesterol-lowering medication, otherOutcomes measure: Number of participants with any prescription of glucagon-like peptide-1 analogue, otherOutcomes measure: Number of participants with any prescription of antidiabetic medication besides SGLT2i, otherOutcomes measure: Number of participants with any prescription of antidiabetic medication, otherOutcomes measure: Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with any prescription of antihypertensive medication, otherOutcomes measure: Number of participants with a new prescription of mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists, otherOutcomes measure: Number of participants with a new prescription of cholesterol-lowering medication, otherOutcomes measure: Number of participants with a new prescription of glucagon-like peptide-1 analogue, otherOutcomes measure: Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of antidiabetic medication, otherOutcomes measure: Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with a new prescription of antihypertensive medication, otherOutcomes measure: Change in number of antihypertensive medications, otherOutcomes measure: Number of participants referred to nephrology outpatient clinics, otherOutcomes measure: Number of participants with an assessment of urine albumine to creatine ratio, otherOutcomes measure: Number of participants with an assessment of plasma-creatinine., otherOutcomes measure: Number of participants with an assessment of estimated glomerular filtration rate by creatinine, otherOutcomes measure: Number of participants with an assessment of hemoglobin A1c, otherOutcomes measure: Number of participants with an assessment of lipids, otherOutcomes measure: Number of participants recipient of influenza vaccination, otherOutcomes measure: Number of participants recipient of COVID-19 vaccination, otherOutcomes measure: Total number of visits to general practitioners, otherOutcomes measure: Time to first phone contact to a general practice, otherOutcomes measure: Time to first visit with a general practitioner, otherOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with any prescription of renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants with a new prescription of renin-angiotensin system inhibition, otherOutcomes measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Time from randomization to prescription of renin-angiotensin system inhibition, otherOutcomes measure: Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors, otherOutcomes measure: Number of participants who have discontinued renin-angiotensin system inhibition treatment., otherOutcomes measure: Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment., otherOutcomes measure: Rate of change in estimated glomerular filtration rate, otherOutcomes measure: Rate of change in urine albumine to creatinine ratio, otherOutcomes measure: Number of participants with any hospitalization, otherOutcomes measure: Total number of all-cause hospitalizations, otherOutcomes measure: All-cause mortality, otherOutcomes measure: Number of participants with kidney failure defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence and kidney transplantation, otherOutcomes measure: Number of participants with kidney failure (alternative definition #1) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation and renal death, otherOutcomes measure: Number of participants with kidney failure (alternative definition #2) defined as a composite of sustained estimated glomerular filtration rate <15ml/min/1.73m2, dialysis dependence, kidney transplantation, renal death, and cardiovascular death., otherOutcomes measure: Number of participants with acute dialysis, otherOutcomes measure: Number of participants with acute kidney insufficiency, otherOutcomes measure: Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death, otherOutcomes measure: Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death., otherOutcomes measure: Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death., otherOutcomes measure: Number of participants with individual components of the renal/cardiovascular composite outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, city: Hellerup, state: Hovedstaden, zip: 2900, country: Denmark, geoPoint lat: 55.73204, lon: 12.57093, hasResults: False