Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 28, 2020
Date Accepted: Aug 2, 2020
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Impact of Remote Titration Combined with Telemonitoring on the Optimization of Guideline Directed Medical Therapy for Patients with Heart Failure: Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Guideline directed medical therapy (GDMT), optimized to maximal tolerated doses, has been shown to improve clinical outcomes in HF patients. However, studies indicate that GDMT remains substantially underutilized, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support and facilitate remote titration of medication.
Objective:
The primary objective of this study is to evaluate the impact of remote titration facilitated by telemonitoring on patient health outcomes, with a primary outcome measure of the proportion of patients achieving target doses. The secondary objective is to identify barriers and facilitators that can impact the implementation and effectiveness of the intervention.
Methods:
A mixed-methods study of a smartphone-based telemonitoring system is being conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, in Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside assessment of clinical outcomes. The effectiveness research component is assessed via a 2-arm randomized controlled trial (RCT), aiming to enroll 108 patients. The RCT compares a remote titration strategy which utilizes data from a smartphone-based telemonitoring system, with a standard titration program consisting of in-office visits. The implementation research component consists of a qualitative study based on semi-structured interviews with a purposive sample of clinicians and patients.
Results:
Patient recruitment began in January 2019 at the Peter Munk Cardiac Centre, with a total of 76 participants recruited by February 24, 2020 (39 in the intervention group and 37 in the control group). The final analysis is expected to occur in the winter of 2021.
Conclusions:
This study will be among the first to provide evidence on the implementation of remote titration facilitated by telemonitoring, and its impact on patient health outcomes. Successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and provide evidence for the development of a care delivery model that combines clinic visits with virtual follow-ups. Clinical Trial: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513
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