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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-02-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Diseases Behavior and Behavior Mechanisms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2x2 factorial design

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient letters + no GP letter.

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.

Group Type EXPERIMENTAL

Electronically delivered nudging letters to patients with CKD

Intervention Type 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).

Patient letters + GP letter.

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.

Group Type EXPERIMENTAL

Electronically delivered nudging letters to patients with CKD

Intervention Type 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).

Electronically delivered nudging letter to associated GPs of patients with CKD

Intervention Type 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).

No patient letters + GP letter

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.

Group Type EXPERIMENTAL

Electronically delivered nudging letter to associated GPs of patients with CKD

Intervention Type 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).

No patient letters + no GP letter

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Electronically 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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Other Intervention Names

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Patient letters GP letter

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Tor Biering-Sørensen

Professor, MD, MSc, MPH, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

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