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

NCT06300086 | Completed

• 1 other identifier: NUDGE-CKD
• Study Type: interventional
• Target: 28,388
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Behavior and Behavior Mechanisms

Keywords

Chronic Kidney Disease; Nudging; Behavioral Science; Guideline-directed medical therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with any prescription of renin-angiotensin system inhibition and/or sodium-glucose cotransporter 2 inhibitors

  within 6 months

Secondary Outcomes (8)

• 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 renin-angiotensin system inhibition

  within 6 months

• Number of participants with a new prescription of sodium-glucose cotransporter 2 inhibitors

  within 6 months

Other Outcomes (54)

• 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

Study Arms (4)

Patient letters + no GP letter.

EXPERIMENTAL

Patients with CKD will receive digital nudge letters, but their associated GPs will not receive a digital nudge letter. The letters will inform patients with CKD of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available.

Behavioral: Electronically delivered nudging letters to patients with CKD

Patient letters + GP letter.

EXPERIMENTAL

Patients with CKD and their associated GPs will receive digital nudge letters. The letters will inform the recipients of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter to the GPs will also include the definition of CKD and a summary of the guidelines.

Behavioral: Electronically delivered nudging letters to patients with CKD; Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD

No patient letters + GP letter

EXPERIMENTAL

Patients with CKD will not receive digital nudge letters, but their associated GPs will receive a digital nudge letter. The letter will inform the GPs of the importance of GDMT in CKD and that updated Danish guidelines for the treatment of CKD are available. The letter will also include the definition of CKD and a summary of the guidelines.

Behavioral: Electronically delivered nudging letter to associated GPs of patients with CKD

No patient letters + no GP letter

NO INTERVENTION

Neither patients with CKD nor their associated GPs will receive digital nudge letters.

Interventions

Electronically delivered nudging letters to patients with CKD BEHAVIORAL

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).

Also known as: Patient letters

Patient letters + GP letter.; Patient letters + no GP letter.

Electronically delivered nudging letter to associated GPs of patients with CKD BEHAVIORAL

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).

Also known as: GP letter

No patient letters + GP letter; Patient letters + GP letter.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age +18 years
• 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.

You may not qualify if:

• For patient-level intervention comparisons:
• \) Exemption from the official, mandatory Danish electronic mailbox system.
• For general practice-level intervention comparisons:
• Individuals on a patient list of general practice clinics run by Danish administrative Regions.
• Individuals not on a patient list of a general practice.

Sponsors & Collaborators

• Tor Biering-Sørensen: lead

Study Sites (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Capital Region, 2900, Denmark

Location

Related Publications (2)

• Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall HGC, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. A Nationwide Factorial Randomized Trial of Electronic Nudges to Patients With Chronic Kidney Disease and Their General Practices for Increasing Guideline-Directed Medical Therapy: The NUDGE-CKD Trial. Circulation. 2025 Aug 12;152(6):369-383. doi: 10.1161/CIRCULATIONAHA.125.075403. Epub 2025 Jun 7.

  PMID: 40481660 DERIVED

• Skaarup KG, Johansen ND, Brandi L, Lindhardt MK, Bech JN, Svensson M, Kristensen T, Thuesen AD, Knudsen MG, Kampmann JD, Hornum M, Orts B, Modin D, Lassen MCH, Janstrup KH, Claggett BL, Vaduganathan M, Bhatt AS, Van Spall H, Jensen JUS, Zannad F, Solomon SD, Moller A, Borg R, Birn H, Hansen D, Biering-Sorensen T. Rationale and design of NUDGE-CKD: A nationwide randomized factorial trial of electronic nudges for increasing guideline-directed medical therapy in chronic kidney disease. Am Heart J. 2025 Sep;287:61-78. doi: 10.1016/j.ahj.2025.03.015. Epub 2025 Mar 31.

  PMID: 40174694 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Behavior

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tor Biering-Sørensen, MD, MSc, MPH, PhD

  Study Principal Investigator Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, MSc, MPH, PhD

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 8, 2024
• Study Start: August 19, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)