Assessment of Digital Consultations on Clinical Impact and Efficiency (ADMINISTER)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Heart Failure

Treatments: Combination Product: Digital consult

Study type: Interventional

Funder types: Other

Identifiers

NCT05413447

123456567

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HFrEF

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Patients receiving digital consultations

Experimental group

Description:

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.

Treatment:

Combination Product: Digital consult

Standard care

No Intervention group

Description:

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.