Clinical trial NCT05413447: Assessment of Digital Consultations on Clinical Impact and Efficiency
Official title: Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Digital consultations, GDMT optimization, HFrEF
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. It is and will in the future be challenging to deliver optimal HF care because of personnel shortages, the high costs of healthcare, intensive GDMT uptitration schedules, and an epidemic rise in HF patients.This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.

A randomized controlled trial on multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. Included patients will be randomly (1:1) assigned to the intervention group or standard care.

The ADMINISTER trial is expected to offer the first robust randomized controlled multicenter data of GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, patient satisfaction and quality of life of digital consults in GDMT optimization.

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

Methods: Patients (n = 150) diagnosed with HF with a reduced ejection fraction (HFrEF) will be randomized to DC or standard care (1:1). The intervention group receive multifaceted digital consults including 1) digital data sharing (e.g. exchange of pharmacotherapy use, home measured vital signs, etc), 2) patient education via an eLearning, and 3) digital guideline recommendations to treating physicians. The consultations are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, 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.

Conclusion: 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.

Eligibility criteria: Inclusion Criteria:

* HFrEF

Exclusion Criteria:

* Patients not in possession of any attributes to perform the consults digitally

Primary outcomes:
measure: Prescription rate of ACE/ARNI according to the guidelines
timeFrame: 12 weeks after baseline
measure: Prescription rate of betablockers according to the guidelines
timeFrame: 12 weeks after baseline
measure: Prescription rate of MRA according to the guidelines
timeFrame: 12 weeks after baseline
measure: Prescription rate of SGLT2i according to the guidelines
timeFrame: 12 weeks after baseline
measure: Prescription rate of periodic screening of iron insufficiency
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: Patient satisfaction
timeFrame: At baseline and 12 weeks after the baseline recording
measure: Difference in summary score of Kansas city cardiomyopathy questionnaire
timeFrame: At baseline and 12 weeks after the baseline recording
measure: Time spend on healthcare
timeFrame: 12 weeks after baseline
measure: Amount of hospitalizations per patient
timeFrame: Hospitalization are recorded from baseline until 12 weeks after baseline
measure: Healthcare satisfaction
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location AMC
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Cardiology Centers of the Netherlands
state: Noord Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
References: