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. 2024 Feb;11(1):560-569.
doi: 10.1002/ehf2.14634. Epub 2023 Dec 26.

Digital consults to optimize guideline-directed therapy: design of a pragmatic multicenter randomized controlled trial

Jelle P Man  1   2   3   4 , Marcel G W Dijkgraaf  5   6 , M Louis Handoko  2   4 , Frederik J de Lange  1   4 , Michiel M Winter  1   4   7 , Marlies P Schijven  8 , Susan Stienen  1   4 , Paola Meregalli  1   4 , Wouter E M Kok  1   4 , Dorianne I Kuipers  1   4 , Pim van der Harst  9 , Maarten A C Koole  1   7   10 , Steven A J Chamuleau  1   2   3   4 , Mark J Schuuring  2   3   4   9
Affiliations

Digital consults to optimize guideline-directed therapy: design of a pragmatic multicenter randomized controlled trial

Jelle P Man et al. ESC Heart Fail. 2024 Feb.

Abstract

Aims: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consults (DCs) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. The investigator-initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled open-label trial to evaluate efficacy and safety of DC in patients on HF treatment.

Methods and results: Patients (n = 150) diagnosed with HF with a reduced ejection fraction will be randomized to DC or standard care (1:1). The intervention group receives multifaceted DCs including (i) digital data sharing (e.g. exchange of pharmacotherapy use and home-measured vital signs), (ii) patient education via an e-learning, and (iii) digital guideline recommendations to treating clinicians. The consults are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, and secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy Questionnaire. Results will be reported in accordance to the CONSORT statement.

Conclusions: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient- and clinician-targeted DC for GDMT optimization.

Keywords: Clinical trial; Digital health; Guideline adherence; Heart failure.

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Conflict of interest statement

Dr M.L.H. is supported by the Dutch Heart Foundation (Dr E. Dekker Senior Clinical Scientist Grant 2020T058) and CVON (2020B008 RECONNEXT). Dr M.L.H. has received an investigator‐initiated research grant from Vifor Pharma, an educational grant from Boehringer Ingelheim and Novartis, and speaker/consultancy fees from Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, MSD, Novartis, Sankyo, Daiichi, Quin, and Vifor Pharma.

Figures

Figure 1
Figure 1
Flowchart of study procedures and outcomes of the ADMINISTER trial. GDMT, guideline‐directed medical therapy; HFrEF, heart failure with reduced ejection fraction.
Figure 2
Figure 2
Information flow of digital consults in the ADMINISTER trial.
See this image and copyright information in PMC

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