Key result
A randomized controlled trial is currently underway to evaluate whether remote titration facilitated by telemonitoring increases the proportion of heart failure patients achieving target medication doses compared to standard in-office visits.
Why the study?
Guideline-directed medical therapy remains underused in heart failure, with under 25% of patients achieving target doses, but telemonitoring could facilitate remote titration.
Does a remote titration strategy facilitated by telemonitoring improve the proportion of patients achieving target doses of guideline-directed medical therapy in patients with heart failure?
RCT (n=108)
Open-label
Block randomization in blocks of 4
No
Does a remote titration strategy facilitated by telemonitoring improve the proportion of patients achieving target doses of guideline-directed medical therapy in patients with heart failure?
This protocol outlines a randomized controlled trial to determine if remote medication titration via telemonitoring can increase the proportion of heart failure patients achieving target doses of guideline-directed medical therapy compared to standard in-office titration.
BACKGROUND: Guideline-directed medical therapy (GDMT), optimized to maximum tolerated doses, has been shown to improve clinical outcomes in patients with heart failure (HF). Timely use and optimization of GDMT can improve HF symptoms, reduce the burden of hospitalization, and increase survival rates, whereas GDMT deferral may worsen the progression of HF, decrease survival rates, and predispose patients to poor outcomes. However, studies indicate that GDMT remains underused, 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 health care outcomes, with a primary outcome measure being the proportion of patients achieving target doses. The secondary objective is to identify the barriers and facilitators that can affect 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, Toronto. The study is based on an effectiveness-implementation hybrid design and incorporates process evaluations alongside the assessment of clinical outcomes. The effectiveness research component is assessed by a two-arm randomized controlled trial (RCT) aiming to enroll 108 patients. The RCT compares a remote titration strategy that uses 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 semistructured interviews with a purposive sample of clinicians and patients. RESULTS: Patient recruitment began in January 2019 at PMCC, 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 be completed by 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. The successful use of telemonitoring for this purpose has the potential to alter the existing approach to titration of HF medication and support the development of a care delivery model that combines clinic visits with virtual follow-ups. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19705.
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Artanian et al. (2020) conducted an RCT in Heart failure (n=108). Remote titration facilitated by telemonitoring (Medly) vs. Standard titration management strategy (in-office visits) was evaluated on Proportion of patients achieving target doses. A randomized controlled trial is currently underway to evaluate whether remote titration facilitated by telemonitoring increases the proportion of heart failure patients achieving target medication doses compared to standard in-office visits.
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