The Healthy at Home study addresses a need to remove barriers to preventative and rehabilitative care for COPD patients and recognize potential indicators of COPD exacerbations. The current mainstay of COPD care is centered around acute disease management and services in post-acute settings. However, there is an unmet need for providing proactive care to avert or diffuse an acute exacerbation before hospitalization occurs. Prior studies have focused on remote patient monitoring to detect evidence of acute exacerbation, but there is a dearth of knowledge about the operational impact and implementation of these interventions. There is also limited data on whether such monitoring initiatives are cost-effective.15 This study aims to demonstrate the feasibility of conducting a larger-scale study using the novel synthetic control design to generate real-world evidence for clinical, operational, and cost outcomes related to the provision of the “Healthy at Home” program.
By employing the use of a Fitbit device, on-demand acute in-home healthcare visits, and, for full intervention participants, a pulse oximeter, spirometer, and virtual health coaching, participants will have a greater ability to view and act on their personal health metrics. In addition to monitoring their own health and being encouraged to contact the MIH program for health-related concerns, participants’ health and survey data will be used to further understand the most important factors predictive of COPD-related exacerbations. The use of integrated data steams combining participant-reported information, biometric signals, and EHR patterns will generate a rich multifaceted digital phenotype of the COPD disease process which can be used to predict future clinical outcomes and facilitate proactive intervention when deterioration is predicted.
We also expect that this important addition to the knowledge base of COPD care will come with a limited burden to participants, as the majority of the data collected is passive. It is expected that participants will spend about 10 minutes per week on study activities, with an additional hour per week of pulmonary coaching and exercises for those enrolled in the full intervention portion of the study. We predict that this consciously low physical and cognitive burden to participants will result in excellent implementation outcomes such as high retention, fidelity to the study protocol, and adoption of the interventions including use of the MIH program.
The current study is one of many programs implemented in recent years attempting to reduce COPD-related readmissions. The Centers for Medicaid and Medicare Services has listed COPD as a target condition for the Hospital Readmission Reduction Program (HRRP). This program imposes penalties on health systems in relation to their readmission rates in an effort to promote innovation and reduce 30-day readmission. Experts have raised concerns that the punitive measures associated with the HRRP could lead to efforts focused on reducing readmissions without equal consideration for improvement in the quality of patient care.28–32 Existing literature has focused on the root causes of readmissions, identifying areas in which improvement is needed.3 Evidence surrounding COPD readmissions shows that multimodal interventions that include frequent assessment, care management, and pulmonary coaching or rehabilitation have the highest efficacy for preventing readmission.9
It is expected that this study will have implications for the standard of care provided to patients at risk of admission for COPD exacerbations. If successful, increased implementation of at-home monitoring and virtual pulmonary support services may be established for patients who would benefit from this level of care. Additionally, this information can be shared with healthcare providers, such as community paramedics to assist them in providing a more proactive and robust level of care for their patients. It is also a goal of the study that these activities will help to decrease the cost acquired for patients who accumulate high levels of healthcare spending due to repeated hospitalizations and acute care needs. As a feasibility study, the current project aims to establish the impacts of study activities and expand both the population and the research partners in future analysis of this population.
By enrolling all-comers, agnostic to insurance type, residing in the towns serviced by the affiliate MIH program, it is expected that we will enroll a diverse population in reference to race, ethnicity, and socioeconomic status. However, this study is limited to those who have established health care within the system of interest and those who reside in the fairly urban areas surrounding these hospitals. Additionally, those who do not speak English are excluded from this study. Future studies should focus on a more diverse population based on geographical location and language, as there are barriers to care in those populations that will not be seen in the current study. Additionally, participants are required to have a smartphone with the ability to access the internet at home to enroll on the study app, potentially excluding a subset of the population who do not have these resources.
The Healthy at Home program’s feasibility study aims to create a foundation around which future, more expansive studies can be constructed. Independent or ancillary studies could be designed, possibly in coordination with pre-existing studies in digital medicine, to allow this novel multimodal platform to be harnessed by those aiming to better understand other disease states and populations. In the case of studying other disease states, the structure of Healthy at Home could easily be modified to work with other healthcare vendors who may be specialized to care for a specific population’s needs. Past simple expansion of study protocols, the information gathered from studies built on the foundation of Healthy at Home may be used in the long-term to grow patient care using this digital, multimodal approach. It is the hope to enhance both study protocols for future investigations and medical care for patients in a multi-phasic approach, by which optimizations are made over a period of time, building upon each other. Using biometric data gathered from participants, prognostic digital biomarkers may be able to be used to help patients understand when they may be at a heightened risk of needing acute care. This preventative care may also be used in coordination with a virtual, digital coach, enabling patients to be better notified of when they may be at risk or when their vital signs are outside a specified range and to seek interventive care early in the course of a threatened exacerbation. These optimizations, as well as others yet-to-be-articulated, may eventually aid in the elevation of the standard of care provided in both research and practice.