Assessment of Digital Consultations on Clinical Impact and Efficiency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial

Conditions
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Heart Failure

Intervention / Treatment
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* Combination Product: Digital consult


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HFrEF Severe secondary mitral valve insufficiency with complaints Exclusion Criteria: Patients not in possession of any attributes to perform the consults digitally

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving digital consultations<br>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<br>* Consultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams.<br>|
| No Intervention: Standard care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. For patients with periodic screening for iron deficiency a score of 1 is allocated. Other patients will receive a score of 0. Significant differences between groups will be assessed at both timepoints. | 12 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | At baseline and 12 weeks after the baseline recording | 
| Time spend on healthcare | The amount of time the patient spends on healthcare. | 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 | 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). | 12 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital consultations, GDMT optimization, HFrEF