An interventional study of Digital consult in Heart Failure, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Supportive care
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.
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.
5,801 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.
This study's enrollment of 150 is above the median of 72 across 3,790 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
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.
Combination Product: Digital consult
If the patient is drawn into the control group the patient will receive standard care. Clinicians are free to use all standard modes of communication, and are not specifically encouraged to use remote types of communication. The clinicians are not informed about the assignment of a patient to the control group to optimally capture remote practice.
Consultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams.
Prescription rate of ACE/ARNI according to the guidelines
The treatment with ACE/ARNI in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Time frame: 12 weeks after baseline
Prescription rate of betablockers according to the guidelines
The treatment with betablockers in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Time frame: 12 weeks after baseline
Prescription rate of MRA according to the guidelines
The treatment with MRA in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Time frame: 12 weeks after baseline
Prescription rate of SGLT2i according to the guidelines
The treatment with SGLT2i in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.
Time frame: 12 weeks after baseline
Prescription rate of periodic screening of iron insufficiency
It is checked whether periodic (once a year) screening of iron deficiency is performed. And if the patient had iron insufficiency; it is checked whether the patient is receiving intravenous iron administration. Iron insufficiency is defined as ferritin \<100 ng/ml or ferritin \< 300 ng/ml with transferrin saturation (TSAT) \< 20%. For patients with periodic screening for iron deficiency and if appropriate supplementation, a score of 1 was assigned. Other patients will receive a score of 0. Significant differences between groups will be assessed at both timepoints.
Time frame: 12 weeks after baseline
Patient satisfaction
Patient satisfaction measured with the Net Promotor Score. This is a score in which the patient is asked to give a value between 1 and 10 indicating the likelihood that he/she will recommend the care given at the AUMC to other patients (1 equals unlikely and 10 likely).
Time frame: At baseline and 12 weeks after the baseline recording
Difference in summary score of Kansas city cardiomyopathy questionnaire
Worsening of experienced HF, assessed with the "Kansas city cardiomyopathy questionnaire". This will lead to a summary score indicating the severity of the experienced heart failure. This score will range from 0 indicating a bad outcome of the questionnaire to 100 indicating a good outcome.
Time frame: At baseline and 12 weeks after the baseline recording
Time spend on healthcare
The amount of time the patient spends on healthcare.
Time frame: 12 weeks after baseline
Amount of hospitalizations per patient
Amount of hospitalizations is recorded for each patient and group differences between the treatment and control group are determined
Time frame: Hospitalization are recorded from baseline until 12 weeks after baseline
Healthcare satisfaction
Clinicians will be asked to rate their satisfaction using the Net Promotor Score. This is a score in which the clinician is asked to give a value between 1 and 10 indicating the likelihood that he/she will recommend the remote care with digital consultations to other collegues (1 equals unlikely and 10 likely).
Time frame: 12 weeks after baseline
Ran from Sep 2022 to primary completion in Jun 2024, 21 months.
Of 1,018 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's 21 months is below that.
Counting every sponsor, half of 1,220 studies reached it within 31 months; a quarter within 16 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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