TY - JOUR
T1 - Digital consults to optimize guideline-directed therapy
T2 - design of a pragmatic multicenter randomized controlled trial
AU - Man, Jelle P
AU - Dijkgraaf, Marcel G W
AU - Handoko, M Louis
AU - de Lange, Frederik J
AU - Winter, Michiel M
AU - Schijven, Marlies P
AU - Stienen, Susan
AU - Meregalli, Paola
AU - Kok, Wouter E M
AU - Kuipers, Dorianne I
AU - van der Harst, Pim
AU - Koole, Maarten A C
AU - Chamuleau, Steven A J
AU - Schuuring, Mark J
N1 - Publisher Copyright:
© 2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2024/2
Y1 - 2024/2
N2 - 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.
AB - 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.
KW - Heart Failure/drug therapy
KW - Humans
KW - Morbidity
KW - Multicenter Studies as Topic
KW - Pragmatic Clinical Trials as Topic
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
UR - http://www.scopus.com/inward/record.url?scp=85180692642&partnerID=8YFLogxK
U2 - 10.1002/ehf2.14634
DO - 10.1002/ehf2.14634
M3 - Article
C2 - 38146630
SN - 2055-5822
VL - 11
SP - 560
EP - 569
JO - ESC heart failure
JF - ESC heart failure
IS - 1
ER -