Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

— NUDGE-CKD  

Official title:

Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300086
• Other study ID #: NUDGE-CKD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 15, 2034

Study information

• Verified date: May 2024
• Source: Herlev and Gentofte Hospital
• Contact: Kristoffer Grundtvig Skaarup, MD
• Phone: +4542451250
• Email: kristoffer.grundtvig.skaarup[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study is a prospective, 2x2 factorial, registry-based, randomized, open-label implementation trial. The study population will consist of Danish adults diagnosed with CKD. Participants will be identified through Danish nationwide health registries using codes from the International Classification of Diseases, 10th revision (ICD-10). The primary objective of this study is to investigate the effects of electronically sent nudging letters delivered directly to (1) patients with CKD and, separately, (2) electronically sent nudge letters delivered to GPs of the included CKD patients on the primary outcome of use of GDMT defined as at least one prescription of RASi or SGLT2i 6 months after intervention delivery in patients with CKD. Patients with CKD will be randomized (1:1) to either a control arm (no digital nudge letters sent to the patient) or an intervention arm (digital nudge letters). GPs of the enrolled patients with CKD will be randomized (1:1) to a control arm (no digital nudge letters sent to the GP) or an intervention arm (a digital nudge letter). The letters will inform the recipients about the importance of GDMT in CKD and that updated Danish guidelines for treating CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines. The interventions will be delivered through the official, mandatory Danish electronic letter system. All subject data will be retrieved from the Danish nationwide registries except for information on intervention allocation. Endpoints will be retrieved at prespecified dates using prespecified search algorithms. This study will coincide with the release of the updated clinical guidelines on the treatment of CKD by the Danish Society of Nephrology.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35000
• Est. completion date: December 15, 2034
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age =18 years

2. Diagnosis of CKD defined as at least one hospital encounter with the following ICD-10 codes in the primary diagnostic positions = 5 years before intervention delivery: N18- N19, I12, E102, E112, E132, E142

3. Access to the official, mandatory Danish electronic mailbox system

4. Assigned to a general practice patient list (only for general practice-level intervention comparisons) Exclusion Criteria: None

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Electronically delivered nudging letters to patients with CKD
Patients in the active arm will receive two digital nudge letters as part of the study. The first nudge letter will be delivered at baseline, and a nearly identical second nudge letter will be delivered one month after the first. The letters will be delivered through the official, mandatory Danish electronic letter system. The control arm will consist of patients with CKD randomized to not receive digital nudge letters (usual care).
• Electronically delivered nudging letter to associated GPs of patients with CKD
The associated GPs of the patients in the active arm will receive one digital nudge letter as part of the study. The nudge letter will be delivered at baseline. The letters will be delivered through the official, mandatory Danish electronic letter system. The control arm will consist of patients with CKD whose associated GP was randomized to not receive a digital nudge letter (usual care).

Locations

Country	Name	City	State
Denmark	Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte	Hellerup	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Tor Biering-Sørensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with an increase in baseline daily RASi dosage		within 6 months
Other	Number of participants with any prescription of mineralocorticoid receptor antagonists		within 6 months
Other	Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists		within 6 months
Other	Number of participants with any prescription of cholesterol-lowering medication		within 6 months
Other	Number of participants with any prescription of glucagon-like peptide-1 analogue		within 6 months
Other	Number of participants with any prescription of antidiabetic medication besides SGLT2i		within 6 months
Other	Number of participants with any prescription of antidiabetic medication		within 6 months
Other	Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition		within 6 months
Other	Number of participants with any prescription of antihypertensive medication		within 6 months
Other	Number of participants with a new prescription of mineralocorticoid receptor antagonists		within 6 months
Other	Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists		within 6 months
Other	Number of participants with a new prescription of cholesterol-lowering medication		within 6 months
Other	Number of participants with a new prescription of glucagon-like peptide-1 analogue		within 6 months
Other	Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors		within 6 months
Other	Number of participants with a new prescription of antidiabetic medication		within 6 months
Other	Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition		within 6 months
Other	Number of participants with a new prescription of antihypertensive medication		within 6 months
Other	Change in number of antihypertensive medications		within 6 months
Other	Number of participants referred to nephrology outpatient clinics		within 6 months
Other	Number of participants with an assessment of urine albumine to creatine ratio		within 6 months
Other	Number of participants with an assessment of plasma-creatinine.		within 6 months
Other	Number of participants with an assessment of estimated glomerular filtration rate by creatinine		within 6 months
Other	Number of participants with an assessment of hemoglobin A1c		within 6 months
Other	Number of participants with an assessment of lipids		within 6 months
Other	Number of participants recipient of influenza vaccination		within 6 months
Other	Number of participants recipient of COVID-19 vaccination		within 6 months
Other	Total number of visits to general practitioners		within 6 months
Other	Time to first phone contact to a general practice		within 6 months
Other	Time to first visit with a general practitioner		within 6 months
Other	Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Number of participants with any prescription of renin-angiotensin system inhibition		Within 1, 2, 5 and 10 years
Other	Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Number of participants with a new prescription of renin-angiotensin system inhibition		Within 1, 2, 5 and 10 years
Other	Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Time from randomization to prescription of renin-angiotensin system inhibition		Within 1, 2, 5 and 10 years
Other	Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors		Within 1, 2, 5 and 10 years
Other	Number of participants who have discontinued renin-angiotensin system inhibition treatment.		Within 1, 2, 5 and 10 years
Other	Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment.		Within 1, 2, 5 and 10 years
Other	Rate of change in estimated glomerular filtration rate		Within 1, 2, 5 and 10 years
Other	Rate of change in urine albumine to creatinine ratio		Within 1, 2, 5 and 10 years
Other	Number of participants with any hospitalization		Within 1, 2, 5 and 10 years
Other	Total number of all-cause hospitalizations		Within 1, 2, 5 and 10 years
Other	All-cause mortality		Within 1, 2, 5 and 10 years
Other	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		Within 1, 2, 5 and 10 years
Other	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		Within 1, 2, 5 and 10 years
Other	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.		Within 1, 2, 5 and 10 years
Other	Number of participants with acute dialysis		Within 1, 2, 5 and 10 years
Other	Number of participants with acute kidney insufficiency		Within 1, 2, 5 and 10 years
Other	Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death		Within 1, 2, 5 and 10 years
Other	Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death.		Within 1, 2, 5 and 10 years
Other	Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death.		Within 1, 2, 5 and 10 years
Other	Number of participants with individual components of the renal/cardiovascular composite outcomes		Within 1, 2, 5 and 10 years
Primary	Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		within 6 months
Secondary	Number of participants with any prescription of renin-angiotensin system inhibition		within 6 months
Secondary	Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors		within 6 months
Secondary	Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		within 6 months
Secondary	Number of participants with a new prescription of renin-angiotensin system inhibition		within 6 months
Secondary	Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors		within 6 months
Secondary	Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors		within 6 months
Secondary	Time from intervention delivery to a new prescription of renin-angiotensin system inhibition		within 6 months
Secondary	Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors		within 6 months