Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300086
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-02-16
Brief Title:
Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
Sponsor:
Tor Biering-Sørensen
Organization:
Herlev and Gentofte Hospital
Study Overview
Official Title:
Nationwide Utilization of Danish Government Electronic Letter System for Increasing Guideline-directed Medical Therapy in Chronic Kidney Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUDGE-CKD
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
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 11 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 11 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
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 11 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None