Digital consults in heart failure care: a randomized controlled trial

Abstract

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 .

Fig. 1. CONSORT flowchart.

Patient flow diagram.

Fig. 2. DCs resulted in a greater use of ΔGDMT.

The increase in the median GDMT score is shown (along with error bars displaying the 95% CIs). The asterisk indicates a significant difference according to the two-sided Mann–Whitney U-test (difference = 0.75, 95% CI (0.21, 1.12), P < 0.01).

Fig. 3. Time-until-event analysis on the DC group versus usual care revealed a shorter time until OMT for the DC group compared to usual care.

The red cumulative incidence curve represents the time until OMT in the treatment group, and the blue curve represents the time until OMT in the usual care group. Estimates are shown along with error bars displaying the 95% CIs.

Fig. 4. The pre-specified exploratory analysis shows that the DC group effect of the difference in ΔGDMT is observed across eGFR groups, NYHA classes, new-onset or existing HF, ischemic or non-ischemic etiologies, age groups, the use of nurse support and non-academic hospitals or tertiary academic referral centers.

The median, along with error bars indicating the 95% CI, is shown, as well as the P values of the two-sided Mann–Whitney U-test for the effect in each subgroup.