Digital consults in heart failure care: a randomized controlled trial.
Jelle Piet ManMaarten A C KoolePaola G MeregalliM Louis HandokoSusan StienenFrederik Jorrit de LangeMichiel M WinterMarlies P SchijvenWouter E M KokDorianne I KuipersPim van der HarstFolkert W. AsselbergsAeilko H ZwindermanMarcel G W DijkgraafSteven A J ChamuleauMark Johan SchuuringPublished in: Nature medicine (2024)
Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT use remains low. In the multicenter, open-label, investigator-initiated ADMINISTER trial, patients (n = 150) diagnosed with heart failure and reduced ejection fraction (HFrEF) were randomized (1:1) to receive usual care or a strategy using digital consults (DCs). DCs contained (1) digital data sharing from patient to clinician (pharmacotherapy use, home-measured vital signs and Kansas City Cardiomyopathy Questionnaires); (2) patient education via a text-based e-learning; and (3) guideline recommendations to all treating clinicians. All remotely gathered information was processed into a digital summary that was available to clinicians in the electronic health record before every consult. All patient interactions were standardly conducted remotely. The primary endpoint was change in GDMT score over 12 weeks (ΔGDMT); this GDMT score directly incorporated all non-conditional class 1 indications for HFrEF therapy with equal weights. The ADMINISTER trial met its primary outcome of achieving a higher GDMT in the DC group after a follow-up of 12 weeks (ΔGDMT score in the DC group: median 1.19, interquartile range (0.25, 2.3) arbitrary units versus 0.08 (0.00, 1.00) in usual care; P < 0.001). To our knowledge, this is the first multicenter randomized controlled trial that proves a DC strategy is effective to achieve GDMT optimization. ClinicalTrials.gov registration: NCT05413447 .
Keyphrases
- healthcare
- heart failure
- electronic health record
- palliative care
- open label
- phase iii
- study protocol
- phase ii
- randomized controlled trial
- double blind
- quality improvement
- case report
- clinical trial
- end stage renal disease
- dendritic cells
- ejection fraction
- health information
- left ventricular
- placebo controlled
- cross sectional
- chronic kidney disease
- systematic review
- smoking cessation
- atrial fibrillation
- clinical decision support
- affordable care act
- peritoneal dialysis
- pain management
- immune response
- radiation therapy
- big data
- prognostic factors
- gestational age
- adverse drug
- clinical practice
- deep learning
- phase ii study