The Intervention

The Medly program features a clinically validated algorithm [23] to provide patients with personalized self-care messages and to alert members of their core HF care team when clinical intervention may be required. By outsourcing much of the self-care support to the algorithm, clinician resources are freed to manage more urgent cases within minutes of receiving patient data. This, according to the US Food and Drug Administration, is a form of active monitoring [24]. In contrast, passive TM is when patient data get transmitted but a clinician is not expected to take immediate clinical action [24], as is the case if a TM system cannot contextualize data based on urgency or if the telehealth clinician does not have rapid access to the patient’s most responsible physician (MRP) to make a necessary change to the patient’s care plan. The Medly program is hypothesized to improve patient self-care and enable early clinical intervention at the onset of symptom exacerbations. This, in turn, is expected to reduce avoidable health service utilization and improve HF clinical outcomes as well as patients’ QoL.

The Medly system includes a patient-facing app, which can be downloaded into an iOS or Android smartphone. The app enables patients to record weight, blood pressure, and heart rate using peripheral weight scales and blood pressure monitors. These data can be transmitted automatically to the Medly app via Bluetooth or entered manually. In addition, patients manually report symptoms by answering yes or no to a short series of questions (as seen in Figure 1). Once entered, these measures are processed by the algorithm embedded within the app that classifies a patient’s current health status into 1 of 9 states based on whether a value (or a clinically meaningful combination of multiple values) is above or below target thresholds, which have been set by the clinical team. The states (ie, algorithm outputs) determine which self-care messages are displayed to patients within the app. Examples of the self-care feedback messages include confirming with patients when everything is normal, instructing patients to take their prescribed diuretic medication when the change in weight is above the set threshold (ie, evidence of fluid retention), and suggesting when to contact their care providers or go to the emergency department (ED). The details of the algorithm’s development and its clinical validation have been published [23]. Other features of the Medly app include the ability to view graphical trends of each reading’s values and, to assist with adherence, an automated phone call to remind patients if they have not yet taken morning readings by 10 AM.

Pages of the Medly app showing the incomplete morning card with required readings, the symptoms questionnaire, and personalized self-care feedback after all 4 readings were taken and processed by the algorithm.

The algorithm also triggers alerts destined to clinical members of the patients’ care team, which can be delivered via email or viewed in the Web-based Medly dashboard, which currently stands apart from the hospital electronic medical record (EMR). Email alerts are contextualized by indicating which parameter or parameters triggered the alert, which is presented alongside the patient’s current medication list, latest HF-related laboratory results, and patient contact information. Similarly, this contextual information is also available on the Medly dashboard in addition to longitudinal graphs of each parameter measured and laboratory results. As such, the Medly dashboard is primarily used to actively manage periods of HF instability, but it can also be used when the patient is stable (eg, during follow-up visits), as it provides a holistic and longitudinal snapshot of the patient’s health. The Medly system was developed at the UHN, and all data collected resides in secure UHN servers. An example of the patient profile in the Medly dashboard has been illustrated in Figure 2

Patient profile in the Web-based Medly clinician dashboard and an example of an email alert message.

The Medly program is intended to complement and not replace existing services. As such, the treating cardiologist presents the Medly program to a patient as a therapeutic option, and a decision regarding enrollment is made jointly between both parties. After a patient agrees to enter the program, they meet with a technical support staff member to begin the onboarding process, which includes an assessment of the patient’s equipment needs. Patients who require all pieces of equipment are provided with a Medly kit that includes a smartphone, which has been paired with an A&D Bluetooth–enabled weight scale and blood pressure cuff. For patients using their own smartphone, the technical support staff helps them download the Medly app from the Apple or Google Play store. If patients are missing one or both peripheral devices, they can borrow the missing device from the clinic for the duration of enrollment. Rationale and details of the bring your own device (BYOD) model have been published [25]. After setting up the equipment, the staff member then trains the patient on how to use the system and sets the target thresholds (based on the MRP’s instructions) to customize the algorithm. The entire onboarding process (ie, account creation, training, study consent, and equipment management) takes approximately 30 min. If technical issues are experienced, patients are instructed to contact the technical support staff member who helps them troubleshoot the problem and replace the equipment if necessary.

Unlike many other HF TM programs and trials, the Medly program does not have a defined end date. Rather, patients can stay in the program indefinitely or until there is no longer a clinical need (eg, patient receives a heart transplant). Regardless of duration, patients are expected to take their readings every day, first thing in the morning. The clinical response to TM alerts follows a triage structure during business hours with a frontline clinician (typically a registered nurse [RN] or nurse practitioner [NP] embedded within the care team in the outpatient clinic) who reviews alerts in the Medly dashboard and coordinates with the wider circle of care. Assuming a caseload of roughly 300 patients, a single frontline coordinator will typically receive and manage between 45 and 60 alerts per day. If required, more serious alerts or issues outside the frontline clinician’s scope of practice are escalated to the MRP. When adapting this program to fit clinic workflows, the MRPs opted to receive all email alerts so that when issues were escalated, they could easily retrieve all the relevant information from their email without having to log in to the dashboard. To ensure 7-day per week coverage, MRPs know that there is no frontline clinician working; therefore, it is up to them to manage all the alerts received in their email on weekends. Previous studies on the implementation of the program confirm that the intervention was being used by patients and clinicians as intended and that satisfaction was high among patients and clinicians [26,27].

A qualitative study identified program components that can be adapted to ensure sustainability and fit within a site’s existing workflows, culture, and resources while maintaining the key ingredients needed to deliver the program’s intended outcomes [25]. First, the types of peripheral devices used are adaptable (ie, it does not matter if patients use their own device or borrow standardized equipment nor does it matter if data are transferred automatically via Bluetooth). Second, the professional qualifications of the frontline clinical staff members are adaptable, provided they have some experience in cardiology. These findings informed moving toward a BYOD model for those who already have the necessary equipment. Another change is that when the program started, the frontline clinical and technical support roles were played by NPs and a telehealth analyst, respectively. However, since May 2018, both roles are being performed by a single RN who is still embedded within the outpatient clinic but who actively monitors all patients enrolled in the Medly program.