Assessment of Digital Consultations on Clinical Impact and Efficiency

NCT05413447 | Completed

• 1 other identifier: 123456567
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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.

Conditions

Heart Failure

Keywords

Digital consultations, GDMT optimization, HFrEF

Outcome Measures

Primary Outcomes (5)

• 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. 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.

  12 weeks after baseline

Secondary Outcomes (5)

• Patient satisfaction

  At baseline and 12 weeks after the baseline recording

• Difference in summary score of Kansas city cardiomyopathy questionnaire

  At baseline and 12 weeks after the baseline recording

• Time spend on healthcare

  12 weeks after baseline

• Amount of hospitalizations per patient

  Hospitalization are recorded from baseline until 12 weeks after baseline

• Healthcare satisfaction

  12 weeks after baseline

Study Arms (2)

Patients receiving digital consultations

EXPERIMENTAL

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

Standard care

NO INTERVENTION

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.

Interventions

Digital consult COMBINATION_PRODUCT

Consultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams.

Patients receiving digital consultations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HFrEF

You may not qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (5)

Amsterdam UMC, location AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Cardiology Centers of the Netherlands

Amsterdam, North Holland, 1105 BJ, Netherlands

Location

Amsterdam UMC, location VUmc

Amsterdam, Netherlands

Location

Red Cross Hospital

Beverwijk, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (1)

• Man JP, Koole MAC, Meregalli PG, Handoko ML, Stienen S, de Lange FJ, Winter MM, Schijven MP, Kok WEM, Kuipers DI, van der Harst P, Asselbergs FW, Zwinderman AH, Dijkgraaf MGW, Chamuleau SAJ, Schuuring MJ. Digital consults in heart failure care: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.

  PMID: 39217271 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 10, 2022
• Study Start: September 1, 2022
• Primary Completion: June 6, 2024
• Study Completion: June 6, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

NL (5)