Behavior and Behavior Mechanisms, Chronic Kidney Diseases
Conditions
Keywords
Chronic Kidney Disease, Nudging, Behavioral Science, Guideline-directed medical therapy
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.
Interventions
BEHAVIORALElectronically delivered nudging letters to patients with CKD
Patients in the active arm will receive a digital nudge letter as part of the study. The nudge letter will be delivered at baseline. 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).
BEHAVIORALElectronically 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).
Sponsors
Tor Biering-Sørensen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
2x2 factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors | within 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with any prescription of renin-angiotensin system inhibition | within 6 months |
| Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Number of participants with a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Time from intervention delivery to a new prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Time from intervention delivery to a new prescription of renin-angiotensin system inhibition | within 6 months |
| Time from intervention delivery to a new prescription of sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Number of participants with a new prescription of renin-angiotensin system inhibition | within 6 months |
Other
| Measure | Time frame |
|---|---|
| Number of participants with any prescription of antihypertensive medication | within 6 months |
| Number of participants with a new prescription of mineralocorticoid receptor antagonists | within 6 months |
| Number of participants with a new prescription of non-steroid mineralocorticoid receptor antagonists | within 6 months |
| Number of participants with a new prescription of cholesterol-lowering medication | within 6 months |
| Number of participants with a new prescription of glucagon-like peptide-1 analogue | within 6 months |
| Number of participants with a new prescription of antidiabetic medication besides sodium-glucose cotransporter 2 inhibitors | within 6 months |
| Number of participants with a new prescription of antidiabetic medication | within 6 months |
| Number of participants with a new prescription of antihypertensive medication besides renin-angiotensin system inhibition | within 6 months |
| Number of participants with a new prescription of antihypertensive medication | within 6 months |
| Change in number of antihypertensive medications | within 6 months |
| Number of participants referred to nephrology outpatient clinics | within 6 months |
| Number of participants with an assessment of urine albumine to creatine ratio | within 6 months |
| Number of participants with an assessment of plasma-creatinine. | within 6 months |
| Number of participants with an assessment of estimated glomerular filtration rate by creatinine | within 6 months |
| Number of participants with an assessment of hemoglobin A1c | within 6 months |
| Number of participants with an assessment of lipids | within 6 months |
| Number of participants recipient of influenza vaccination | within 6 months |
| Number of participants recipient of COVID-19 vaccination | within 6 months |
| Total number of visits to general practitioners | within 6 months |
| Time to first phone contact to a general practice | within 6 months |
| Time to first visit with a general practitioner | within 6 months |
| 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 |
| Number of participants with any prescription of renin-angiotensin system inhibition | Within 1, 2, 5 and 10 years |
| Number of participants with any prescription of sodium-glucose cotransporter 2 inhibitors | Within 1, 2, 5 and 10 years |
| 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 |
| Number of participants with a new prescription of renin-angiotensin system inhibition | Within 1, 2, 5 and 10 years |
| Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors | Within 1, 2, 5 and 10 years |
| 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 |
| Time from randomization to prescription of renin-angiotensin system inhibition | Within 1, 2, 5 and 10 years |
| Number of participants with any prescription of glucagon-like peptide-1 analogue | within 6 months |
| Number of participants who have discontinued renin-angiotensin system inhibition treatment. | Within 1, 2, 5 and 10 years |
| Number of participants who have discontinued sodium-glucose cotransporter 2 inhibition treatment. | Within 1, 2, 5 and 10 years |
| Rate of change in estimated glomerular filtration rate | Within 1, 2, 5 and 10 years |
| Rate of change in urine albumine to creatinine ratio | Within 1, 2, 5 and 10 years |
| Number of participants with any hospitalization | Within 1, 2, 5 and 10 years |
| Total number of all-cause hospitalizations | Within 1, 2, 5 and 10 years |
| All-cause mortality | Within 1, 2, 5 and 10 years |
| 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 |
| 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 |
| 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 |
| Number of participants with acute dialysis | Within 1, 2, 5 and 10 years |
| Number of participants with incident heart failure, heart failure hospitalization, or cardiovascular death | Within 1, 2, 5 and 10 years |
| 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 |
| 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 |
| Number of participants with individual components of the renal/cardiovascular composite outcomes | Within 1, 2, 5 and 10 years |
| Time from randomization to prescription of sodium-glucose cotransporter 2 inhibitors | Within 1, 2, 5 and 10 years |
| Number of participants with any prescription of antidiabetic medication besides SGLT2i | within 6 months |
| Number of participants with any prescription of antidiabetic medication | within 6 months |
| Number of participants with acute kidney insufficiency | Within 1, 2, 5 and 10 years |
| Number of participants with any prescription of cholesterol-lowering medication | within 6 months |
| Number of participants with an increase in baseline daily RASi dosage | within 6 months |
| Number of participants with any prescription of mineralocorticoid receptor antagonists | within 6 months |
| Number of participants with any prescription of non-steroid mineralocorticoid receptor antagonists | within 6 months |
| Number of participants with any prescription of antihypertensive medication besides renin-angiotensin system inhibition | within 6 months |
Countries
Denmark
Outcome results
None listed