Clinical trial NCT06300086: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
Official title: Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Kidney Diseases
Behavior and Behavior Mechanisms
Keywords: Chronic Kidney Disease
Nudging
Behavioral Science
Guideline-directed medical therapy
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 28388
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2x2 factorial design
Primary purpose: OTHER

Brief 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.

Detailed 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 (a digital nudge letter). 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.

Eligibility criteria: 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 within ≤ 5 years: N18- N19, I12, E102, E112, E132, E142.

Exclusion criteria

For patient-level intervention comparisons:

1) Exemption from the official, mandatory Danish electronic mailbox system.

For general practice-level intervention comparisons:

1. Individuals on a patient list of general practice clinics run by Danish administrative Regions.
2. Individuals not on a patient list of a general practice.

Primary outcomes:
measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
Secondary outcomes:
measure: Number of participants with any prescription of renin-angiotensin system inhibition
timeFrame: within 6 months
measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
measure: Number of participants with a new prescription of renin-angiotensin system inhibition
timeFrame: within 6 months
measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
measure: Time from intervention delivery to a new prescription of renin-angiotensin system inhibition
timeFrame: within 6 months
measure: Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
Other outcomes:
measure: Number of participants with an increase in baseline daily RASi dosage
timeFrame: within 6 months
measure: Number of participants with any prescription of mineralocorticoid receptor antagonists
timeFrame: within 6 months
measure: Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists
timeFrame: within 6 months
measure: Number of participants with any prescription of cholesterol-lowering medication
timeFrame: within 6 months
measure: Number of participants with any prescription of glucagon-like peptide-1 analogue
timeFrame: within 6 months
measure: Number of participants with any prescription of antidiabetic medication besides SGLT2i
timeFrame: within 6 months
measure: Number of participants with any prescription of antidiabetic medication
timeFrame: within 6 months
measure: Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition
timeFrame: within 6 months
measure: Number of participants with any prescription of antihypertensive medication
timeFrame: within 6 months
measure: Number of participants with a new prescription of mineralocorticoid receptor antagonists
timeFrame: within 6 months
measure: Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists
timeFrame: within 6 months
measure: Number of participants with a new prescription of cholesterol-lowering medication
timeFrame: within 6 months
measure: Number of participants with a new prescription of glucagon-like peptide-1 analogue
timeFrame: within 6 months
measure: Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors
timeFrame: within 6 months
measure: Number of participants with a new prescription of antidiabetic medication
timeFrame: within 6 months
measure: Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition
timeFrame: within 6 months
measure: Number of participants with a new prescription of antihypertensive medication
timeFrame: within 6 months
measure: Change in number of antihypertensive medications
timeFrame: within 6 months
measure: Number of participants referred to nephrology outpatient clinics
timeFrame: within 6 months
measure: Number of participants with an assessment of urine albumine to creatine ratio
timeFrame: within 6 months
measure: Number of participants with an assessment of plasma-creatinine.
timeFrame: within 6 months
measure: Number of participants with an assessment of estimated glomerular filtration rate by creatinine
timeFrame: within 6 months
measure: Number of participants with an assessment of hemoglobin A1c
timeFrame: within 6 months
measure: Number of participants with an assessment of lipids
timeFrame: within 6 months
measure: Number of participants recipient of influenza vaccination
timeFrame: within 6 months
measure: Number of participants recipient of COVID-19 vaccination
timeFrame: within 6 months
measure: Total number of visits to general practitioners
timeFrame: within 6 months
measure: Time to first phone contact to a general practice
timeFrame: within 6 months
measure: Time to first visit with a general practitioner
timeFrame: within 6 months
measure: Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with any prescription of renin-angiotensin system inhibition
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with a new prescription of renin-angiotensin system inhibition
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Time from intervention delivery to prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Time from randomization to prescription of renin-angiotensin system inhibition
timeFrame: Within 1, 2, 5 and 10 years
measure: Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants who have discontinued renin-angiotensin system inhibition treatment.
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment.
timeFrame: Within 1, 2, 5 and 10 years
measure: Rate of change in estimated glomerular filtration rate
timeFrame: Within 1, 2, 5 and 10 years
measure: Rate of change in urine albumine to creatinine ratio
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with any hospitalization
timeFrame: Within 1, 2, 5 and 10 years
measure: Total number of all-cause hospitalizations
timeFrame: Within 1, 2, 5 and 10 years
measure: All-cause mortality
timeFrame: Within 1, 2, 5 and 10 years
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
timeFrame: Within 1, 2, 5 and 10 years
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
timeFrame: Within 1, 2, 5 and 10 years
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.
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with acute dialysis
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with acute kidney insufficiency
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with major adverse cardiovascular events defined as a composite of myocardial infarction, stroke, and cardiovascular death.
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with major adverse cardiovascular events (alternative definition) defined as a composite of myocardial infarction, revascularization, stroke, and cardiovascular death.
timeFrame: Within 1, 2, 5 and 10 years
measure: Number of participants with individual components of the renal/cardiovascular composite outcomes
timeFrame: Within 1, 2, 5 and 10 years
Locations:
city: Hellerup
country: Denmark
facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
state: Hovedstaden
Study officials:
affiliation: Study Principal Investigator Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Tor Biering-Sørensen, MD, MSc, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: