The Effect of Using a Remote Patient Management Platform in Optimizing Guideline-Directed Medical Therapy in Heart Failure Patients: A Randomized Controlled Trial.

BACKGROUND: Guideline-directed medical therapy (GDMT) remains underutilized in patients with heart failure with reduced ejection fraction, leading to morbidity and mortality. OBJECTIVES: The Medly Titrate (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration) study was an open-label, randomized controlled trial to determine whether remote medication titration for patients with heart failure with reduced ejection fraction was more effective than usual care (UC). METHODS: In this study, 108 patients were randomized to remote GDMT titration through the Medly heart failure program (n = 56) vs UC (n = 52). The primary outcome was the proportion of patients completing GDMT titration at 6 months. Secondary outcomes included the number of clinic visits and time required to achieve titration, patient health outcomes, and health care utilization, including urgent clinic/emergency department visits and hospitalization. RESULTS: At 6 months, GDMT titration was completed in 82.1% (95% CI: 71.2%-90.8%) of patients in the intervention arm vs 53.8% in UC (95% CI: 41.1%-67.7%; P = 0.001). Remote titration required fewer in-person (1.62 ± 1.09 vs 2.42 ± 1.65; P = 0.004) and virtual clinic visits (0.50 ± 1.08 vs 1.29 ± 1.86; P = 0.009) to complete titration. Median time to optimization was shorter with remote titration (3.42 months [Q1-Q3: 2.99-4.04 months] vs 5.47 months [Q1-Q3: 4.14-7.33 months]; P < 0.001). The number of urgent clinic/emergency department visits (incidence rate ratio of remote vs control groups: 0.90 [95% CI: 0.53-1.56]; P = 0.70) were similar between groups, with a reduction in all-cause hospitalization with remote titration (incidence rate ratio: 0.55 [95% CI: 0.31-0.97]; P = 0.042). CONCLUSIONS: Remote titration of GDMT in heart failure with reduced ejection fraction was effective, safe, feasible, and increased the proportion of patients achieving target doses, in a shorter period of time with no excess adverse events compared with UC. (Use of Telemonitoring to Facilitate Heart Failure Mediation Titration [Medly Titrate]; NCT04205513).

Experiences and Perceptions of Patients and Providers Participating in Remote Titration of Heart Failure Medication Facilitated by Telemonitoring: Qualitative Study.

BACKGROUND: Guideline-directed medical therapy (GDMT), optimized to target doses, improves health outcomes in patients with heart failure. However, GDMT remains underused, with <25% of patients receiving target doses in clinical practice. A randomized controlled trial was conducted at the Peter Munk Cardiac Centre in Toronto to compare a remote GDMT titration intervention with standard in-office titration. This randomized controlled trial found that remote titration increased the proportion of patients who achieved optimal GDMT doses, decreased the time to dose optimization, and reduced the number of essential clinic visits. This paper presents findings from the qualitative component of the mixed methods study, which evaluated the implementation of the remote titration intervention. OBJECTIVE: The objective of the qualitative component is to assess the perceptions and experiences of clinicians and patients with heart failure who participated in the remote titration intervention to identify factors that affected the implementation of the intervention. METHODS: We conducted semistructured interviews with clinicians (n=5) and patients (n=11) who participated in the remote titration intervention. Questions probed the experiences of the participants to identify factors that can serve as barriers and facilitators to its implementation. Conventional content analysis was first used to analyze the interviews and gain direct information based on the participants' unique perspectives. Subsequently, the generated themes were delineated and mapped following a multilevel framework. RESULTS: Patients and clinicians indicated that the intervention was easy to use, integrated well into their routines, and removed practical barriers to titration. Key implementation facilitators from the patients' perspective included the reduction in clinic visits and daily monitoring of their condition, whereas clinicians emphasized the benefits of rapid drug titration and efficient patient management. Key implementation barriers included the resources necessary to support the intervention and lack of physician remuneration. CONCLUSIONS: This study presents results from a real-world implementation assessment of remote titration facilitated by telemonitoring. It is among the first to provide insight into the perception of the remote titration process by clinicians and patients. Our findings indicate that the relative advantages that remote titration presents over standard care strongly appeal to both clinicians and patients. However, to ensure uptake and adherence, it is important to ensure that suitable patients are enrolled and the impact on the physicians' workload is minimized. The implementation of remote titration is now more critical than ever, as it can help provide access to care for patients during times when physical distancing is required. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19705.

Impact of Remote Titration Combined With Telemonitoring on the Optimization of Guideline-Directed Medical Therapy for Patients With Heart Failure: Internal Pilot of a Randomized Controlled Trial.

BACKGROUND: To improve health outcomes in patients with heart failure, guideline-directed medical therapy (GDMT) should be optimized to target doses. However, GDMT remains underutilized, with less than 25% of patients receiving target doses in clinical practice. Telemonitoring could provide reliable and real-time physiological data for clinical decision support to facilitate remote GDMT titration. OBJECTIVE: This paper aims to present findings from an internal pilot study regarding the effectiveness of remote titration facilitated by telemonitoring. METHODS: A 2-arm randomized controlled pilot trial comparing remote titration versus standard care in a heart function clinic was conducted. Patients were randomized to undergo remote medication titration facilitated by data from a smartphone-based telemonitoring system or standard titration performed during clinic visits. RESULTS: A total of 42 patients with new-onset (10/42, 24%) and existing (32/42, 76%) heart failure and a mean age of 55.29 (SD 11.28) years were randomized between January and June 2019. Within 6 months of enrollment, 86% (18/21) of patients in the intervention group achieved optimal doses versus 48% (10/21) of patients in the control group. The median time to dose optimization was 11.0 weeks for the intervention group versus 18.8 weeks for the control group. The number of in-person visits in the intervention group was 54.5% lower than in the control group. CONCLUSIONS: The results of this pilot study suggest that remote titration facilitated by telemonitoring has the potential to increase the proportion of patients who achieve optimal GDMT doses, decrease time to dose optimization, and reduce the number of clinic visits. Remote titration may facilitate optimal and efficient titration of patients with heart failure while reducing the burden for patients to attend in-person clinic visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/preprints.19705.

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.

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.