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. 2022 Aug 25;11(8):e36741.
doi: 10.2196/36741.

Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study

Courtney Reamer  1 , Wei Ning Chi  2 , Robert Gordon  1 , Nitasha Sarswat  1   3 , Charu Gupta  1 , Safwan Gaznabi  1 , Emily White VanGompel  4 , Izabella Szum  5 , Melissa Morton-Jost  5 , Jorma Vaughn  6 , Karen Larimer  6 , David Victorson  7 , John Erwin  1   3 , Lakshmi Halasyamani  1   3 , Anthony Solomonides  2 , Rema Padman  8 , Nirav S Shah  1   3
Affiliations

Continuous Remote Patient Monitoring in Patients With Heart Failure (Cascade Study): Protocol for a Mixed Methods Feasibility Study

Courtney Reamer et al. JMIR Res Protoc. .

Abstract

Background: Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM).

Objective: The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution in patients with HF at NorthShore University HealthSystem.

Methods: This study is a feasibility study and uses a wearable biosensor to continuously remotely monitor patients with HF for 30 days after discharge. Eligible patients admitted with an HF exacerbation at NorthShore University HealthSystem are being recruited, and the wearable biosensor is placed before discharge. The biosensor collects physiological ambulatory data, which are analyzed for signs of patient deterioration. Participants are also completing a daily survey through a dedicated study smartphone. If prespecified criteria from the physiological data and survey results are met, a notification is triggered, and a predetermined electronic health record-based pathway of telephonic management is completed. In phase 1, which has already been completed, 5 patients were enrolled and monitored for 30 days after discharge. The results of phase 1 were analyzed, and modifications to the program were made to optimize it. After analysis of the phase 1 results, 15 patients are being enrolled for phase 2, which is a calibration and testing period to enable further adjustments to be made. After phase 2, we will enroll 45 patients for phase 3. The combined results of phases 1, 2, and 3 will be analyzed to determine the feasibility of a CRPM program in patients with HF. Semistructured interviews are being conducted with key stakeholders, including patients, and these results will be analyzed using the affective adaptation of the technology acceptance model.

Results: During phase 1, of the 5 patients, 2 (40%) were readmitted during the study period. The study completion rate for phase 1 was 80% (4/5), and the study attrition rate was 20% (1/5). There were 57 protocol deviations out of 150 patient days in phase 1 of the study. The results of phase 1 were analyzed, and the study protocol was adjusted to optimize it for phases 2 and 3. Phase 2 and phase 3 results will be available by the end of 2022.

Conclusions: A CRPM program may offer a low-risk solution to improve care of patients with HF after hospital discharge and may help to decrease readmission of patients with HF to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other groups of patients considered to be at high risk.

International registered report identifier (irrid): DERR1-10.2196/36741.

Keywords: continuous remote patient monitoring; feasibility; heart failure; mobile phone; preliminary efficacy; remote patient monitoring; wearable biosensor.

PubMed Disclaimer

Conflict of interest statement

Conflicts of Interest: The study devices, monitoring platform, and technical support are nonfinancial support by physIQ. KL and JV own shares in, and are engaged in paid employment at physIQ. NSS reports nonfinancial support from physIQ during the conduct of the study. JE reports to, and serves on, the American College of Cardiology MedAxiom Board of Trustees. This is the for-profit arm of the American College of Cardiology Foundation. Although JE has no direct relationships with vendors, the Board approves partnerships with vendors.

Figures

Figure 1
Figure 1
Overview of the clinician portal showing the portal, possible clinician-defined events, and a notification. HR: heart rate; MCI: multivariate change index; RR: respiratory rate; RVR: rapid ventricular response.
Figure 2
Figure 2
The clinician portal showing an alert and clinical events, where green dots represent events that have been seen already, and red dots represent new events.
Figure 3
Figure 3
The daily symptom survey on the mobile app.
Figure 4
Figure 4
Mobile app alerts.
Figure 5
Figure 5
Data transmission pathway. ECG: electrocardiogram; HR: heart rate; RR: respiratory rate.
Figure 6
Figure 6
Workflow process map. AF: atrial fibrillation; APP: advanced practice provider; BMP: basic metabolic panel; CBC: complete blood count; CMP: comprehensive metabolic panel; ED: emergency department; HF: heart failure; IV: intravenous; LE: lower extremity; MCI: multivariate change index; NT-proBNP: N-terminal pro–B-type natriuretic peptide; SOB: shortness of breath.
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