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
- PMID: 40481660
- DOI: 10.1161/CIRCULATIONAHA.125.075403
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
Abstract
Background: Many individuals with chronic kidney disease (CKD) face a considerable but modifiable risk of cardiovascular and renal outcomes because of suboptimal implementation of guideline-directed medical therapy (GDMT). We investigated whether electronic letter-based nudges delivered to individuals with CKD and their general practices could increase GDMT uptake.
Methods: This was a nationwide 2×2 factorial implementation trial with randomization at the patient and general practice level and analyzed at the patient level. All Danish adults with a hospital diagnosis of CKD and access to the official Danish electronic letter system were individually randomized at a 1:1 ratio to usual care (no letter) or to receive an electronic letter-based nudge on GDMT for CKD; general practitioners of individuals with CKD were independently randomized (1:1) to receive no letter or an electronic informational letter on GDMT. Intervention letters were delivered on August 19, 2024. Data were collected through the Danish administrative health registries. The primary end point was a filled prescription of a renin-angiotensin system inhibitor or a sodium-glucose cotransporter 2 inhibitor within 6 months of intervention delivery.
Results: A total of 22 617 patients with CKD were randomized to the patient-level intervention, with 11 223 allocated to receive the electronic nudge letter and 11 394 to usual care. Separately, 1540 general practices caring for 28 069 patients with CKD were randomized to the provider-level intervention, with 774 practices (13 959 patients) allocated to the intervention and 766 practices (14 110 patients) to usual care. During follow-up, 7303 (65.1%) allocated to the patient-directed nudge had filled a prescription for a renin-angiotensin system inhibitor or sodium-glucose cotransporter 2 inhibitor compared with 7505 (65.9%) in usual care (difference, -0.79 percentage points [95% CI, -2.03 to 0.45]; P=0.21). Among patients of practices receiving the provider-directed letter, 8921 (63.9%) filled a prescription for a renin-angiotensin system inhibitor or sodium-glucose cotransporter 2 inhibitor compared with 9086 (64.4%) in the usual care group (difference, -0.49 percentage points [95% CI, -1.64 to 0.66]; P=0.41). No interaction was observed between the two interventions (Pinteraction=0.85).
Conclusions: In this nationwide pragmatic, 2×2 factorial implementation trial, electronic letter-based nudges on GDMT delivered to patients with CKD or their general practice did not increase the uptake of a renin-angiotensin system inhibitor or sodium-glucose cotransporter 2 inhibitor as compared with usual care.
Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06300086.
Keywords: chronic kidney disease; guideline-directed medical therapy; patient-facing nudging; provider-facing nudging; randomized implementation trial.
Conflict of interest statement
Dr Skaarup served on an advisory board for Sanofi and received financial support for congress participation from AstraZeneca outside the submitted work. Dr Claggett reported receiving consulting fees from Alnylam, Cardurion, Corvia, Cytokinetics, Intellia, Rocket, CVRX, BMS, and Eli Lilly outside the submitted work. Dr Vaduganathan reported receiving research grant support from American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, BMS, Boehringer Ingelheim, Chiesi, Cytokinetics, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health and serving on advisory boards and clinical trial committees or having speaker engagements and receiving grants from AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics outside the submitted work. Dr Bhatt reported receiving speaker engagement fees from Sanofi, Merck, AstraZeneca, and Novo Nordisk outside the submitted work. Dr Van Spall received grants from the Canadian Institutes of Health Research and Heart and Stroke Foundation, education grants from Boehringer Ingelheim and Novartis, and consulting fees from the Baim Institute for Clinical Research, the Cardiovascular Research Foundation, the Colorado Prevention Center Clinical Research, Novo Nordisk, and Medtronic outside the submitted work. Dr Lindhardt received speaker fees or served on advisory boards for Novo Nordisk, AstraZeneca, Bayer, Boehringer Ingelheim, and GlaxoSmithKline and received research support from Novo Nordisk A/S, AstraZeneca, Bayer, Boehringer Ingelheim, and MSD. Dr Kristensen reports speaker fees from AstraZeneca outside the submitted work. Dr Thuesen reports speaker fees from AstraZeneca and Boehringer Ingelheim outside the submitted work. Dr Knudsen received a research grant from AstraZeneca outside the submitted work. Dr Kampman received consulting fees from Baxter and financial support for travel for congress participation from AstraZeneca outside the submitted work. Dr Hornum served on advisory boards for Novo Nordisk, Bayer, Boehringer Ingelheim, GlaxoSmithKline, CLS Vifor, and AstraZeneca and received speaker fees from Novo Nordisk, AstraZeneca, and Boehringer Ingelheim and research grants from Boehringer Ingelheim, AstraZeneca, Novo Nordisk, Novartis, and Dimerix Bioscience Inc outside the submitted work. Dr Zannad received consulting fees from 89bio, Applied Therapeutics, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardior Pharmaceuticals, CellProthera, Cereno Scientific, CEVA, CVRx, Merck, Novartis, Novo Nordisk, Owkin, Pfizer and Servier; honoraria for lectures from Bayer, Boehringer Ingelheim, CEVA, CVRx, Merck and Novartis; and fees for participating on a data safety monitoring board or advisory board from Acceleron/Merck and has equity interests in G3 Pharmaceuticals, Cereno Scientific, CardioRenal, Eshmoun Clinical Research and CVCT outside the submitted work. Dr Solomon reported receiving grants from Alexion; Alnylam; Applied Therapeutics; AstraZeneca; Bellerophon; Bayer; BMS; Boston Scientific; Cytokinetics; Edgewise; Eidos/BridgeBio; Gossamer; GSK; Ionis; Lilly; the National Institutes of Health/National Heart, Lung, and Blood Institute; Novartis; NovoNordisk; Respicardia; Sanofi Pasteur; Tenaya; Theracos; and US2.AI and personal fees from Abbott, Action, Akros, Alexion, Alnylam, Amgen, Arena, AstraZeneca, Bayer, BMS, Cardior, Cardurion, Corvia, Cytokinetics, GSK, Lilly, Novartis, Roche, Theracos, Quantum Genomics, Tenaya, Sanofi Pasteur, Dinaqor, Tremeau, CellProThera, Moderna, American Regent, Sarepta, Lexicon, Anacardio, Akros, and Valo outside the submitted work. Dr Borg reports serving on research boards and/or receiving speaker fees from Novo Nordisk, AstraZeneca, Bayer, and Boehringer Ingelheim and received research grants from AstraZeneca and Boehringer Ingelheim outside the submitted work. Dr Birn reports speaker fees and/or serving on advisory boards for Novo Nordisk, AstraZeneca, Bayer, Boehringer Ingelheim, Galapagos, GlaxoSmithKline, Alexion, Otsuka Pharmaceuticals, MSD, and Vifor Pharma; received research grants from Novo Nordisk, GlaxoSmithKline and Vifor Pharma; and serves as chairman of the Danish Society of Nephrology and the Society’s working group on the Danish CKD guidelines. Dr Hansen reports research grants from Vifor Pharma and Gedeon Richter and received consultancy fees and speaker fees from UCB Nordic, GlaxoSmithKline, and AstraZeneca. Dr Biering-Sørensen has received research grants from Novartis, Pfizer, Sanofi Pasteur, GSK, Novo Nordisk, AstraZeneca, Boston Scientific, and GE Healthcare; consulting fees from Novo Nordisk, IQVIA, Parexel, Amgen, CSL Seqirus, GSK, and Sanofi Pasteur, and lecture fees from AstraZeneca, Bayer, Novartis, Sanofi Pasteur, GE Healthcare, and GSK. Dr Van Spall has received trial-related or consulting fees from Bayer, Medtronic, and Novo Nordisk and grants from Boehringer Ingelheim and Novartis.
