Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Prescription rate of betablockers according to the guidelines
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Masking the clinicians of the control group assignment is done to optimally capture local practice. Masking of the intervention group is not feasable as patients and healthcare workers will know whether they are receiving normal care or digital care. Outcome measures are determined beforehand.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients not in possession of any attributes to perform the consults digitally
结局指标
主要结局
Prescription rate of betablockers according to the guidelines
时间窗: 12 weeks after baseline
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.
Prescription rate of MRA according to the guidelines
时间窗: 12 weeks after baseline
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.
Prescription rate of periodic screening of iron insufficiency
时间窗: 12 weeks after baseline
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.
Prescription rate of ACE/ARNI according to the guidelines
时间窗: 12 weeks after baseline
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.
Prescription rate of SGLT2i according to the guidelines
时间窗: 12 weeks after baseline
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.
次要结局
- Patient satisfaction(At baseline and 12 weeks after the baseline recording)
- Amount of hospitalizations per patient(Hospitalization are recorded from baseline until 12 weeks after baseline)
- Healthcare satisfaction(12 weeks after baseline)
- Time spend on healthcare(12 weeks after baseline)
- Difference in summary score of Kansas city cardiomyopathy questionnaire(At baseline and 12 weeks after the baseline recording)
研究者
Mark Schuuring
Principle investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)