Asthma and Chronic Obstructive Pulmonary Disease (COPD) represent two of the most common respiratory diseases. Together, over 40 million Americans suffer from asthma or COPD. While asthma affects all ages, COPD impacts mostly adults; however, each of these conditions is associated with exacerbations that are debilitating, require healthcare utilization, and greatly reduce quality of life. In the United States, the annual healthcare costs related to these complex diseases exceed $100 billion, largely due to repeated hospitalizations and emergency department (ED) visits from exacerbations.
Insufficient management of asthma or COPD has profound economic, clinical, and societal impacts, both at the personal level and across the healthcare system. These chronic disease conditions are not curable. Therefore, an integrated care approach that encourages self-management and self-actualization for managing symptoms is necessary to identify exacerbation triggers and onset, and ultimately, optimize clinical outcomes, reduce costs, and improve quality of life.
Scalable virtual care programs have been successful for improving outcomes and costs associated with other chronic conditions, such as diabetes. Thus, leveraging similar virtual care models for guiding individuals with respiratory disease to achieve self-management offers great promise. It appears that Health Care Originals has developed such a model with its Nightingale Virtual Respiratory Care Program, described herein.
The two most common respiratory diseases worldwide are asthma and Chronic Obstructive Pulmonary Disease (COPD). Characteristics shared by these two complex conditions include: cough, wheeze, and difficulty breathing, and each condition is associated with clinical exacerbations, or the acute worsening of respiratory symptoms that results in additional therapy (Fabbri et al., 2017). Clinical exacerbations are not only disruptive and debilitating, but also, these flare-ups greatly reduce quality of life (QoL) and are expensive.
Depending on disease severity, people with asthma or COPD may experience fatigue regularly and find self-care, such as getting dressed and hygiene overwhelming. As chronic respiratory conditions progress, breathing can become increasingly compromised, further diminishing QoL and rendering daily tasks even more challenging. Additionally, it is not uncommon for asthma and COPD to exist in the presence of comorbid conditions (Cavailles et al., 2013; Kaplan et al., 2020). Compared to people without an asthma or COPD diagnosis, comorbidities are significantly higher among people with one of these two respiratory conditions and the impacts on physical capacity and daily life are substantial (Santos et al., 2022; Su et al., 2016). Impairments from chronic respiratory (and coexisting) conditions negatively influence one’s ability to comply with medication regimens, engage in pulmonary rehabilitation exercises, and implement lifestyle changes to optimize clinical outcomes. Non-adherence to asthma or COPD treatment plans remains a primary driver of increased exacerbations and ultimately, healthcare costs (Davis et al., 2017; Mäkelä et al., 2013).
Asthma and COPD are relatively widespread and are associated with high morbidity and mortality, healthcare utilization, and costs. Management of this population is evolving, with home-based and virtual care companies striving to offer care solutions that “meet the patient where they are,” in the comfort of their living environment. However, the best practice methodologies for effective remote and virtual care continue to evolve. This report will examine the asthma and COPD population, established and evidence-based disease management practices, and highlight the findings from a virtual care company that offers great promise for those with chronic respiratory disease.
Population Health Pulse
Statistics surrounding the prevalence, mortality, care utilization, and costs for a given population – in this case, COPD and asthma patients – can be very helpful. However, there are often disparities between the data, based on how they were collected. The data herein were derived from a number of different studies, each with different methodologies (target populations, years reviewed, data sets, etc.). As a result, different values were identified for the some of the same parameters across the scientific literature. To gain a better perspective, several studies have been considered in some instances.
An estimated 7.8% of Americans are afflicted with asthma (8.4% of adults) (Center for Disease Control and Prevention, 2020) and COPD affects between 5% and 6.6% of American adults (10.8% of those older than 65 years old) (American Lung Association, 2023). Over 26 million Americans suffer from asthma and over 15 million Americans suffer from COPD. Of note, other sources suggest that up to 24 million (or even 30 million) Americans have COPD (Mosher et al., 2022; C. M. Riley & Sciurba, 2019), perhaps because COPD may be underdiagnosed, as more than twice the number of individuals diagnosed with COPD exhibit impaired lung function (American Lung Association, 2023). These complex and chronic disease conditions not only represent the fourth-leading cause of death in the United States (Zeller et al., 2023), but also, they are associated with high rates of morbidity and reduced quality of life (QoL).
Morbidity and Mortality
Worldwide, COPD constitutes the third-leading cause of death, with over 3.3 million deaths in 2019 (Safiri et al., 2022; World Health Organization, 2023). In 2020, COPD was linked to 10.3% of deaths among ever-employed individuals in the United States, equaling roughly 316,023 deaths (Syamlal et al., 2022). Asthma mortality rates are not insignificant, either; on average, ten people in the United States die each day due to asthma. In 2020, 4,145 people were reported to have died from asthma in the United States, with an average adult death rate of 15.4 per million (Centers for Disease Control and Prevention, 2022).
Clinical exacerbations (acute flare-ups) resulting from asthma or COPD are disruptive, often devolve into an emergency situation, and significantly reduce QoL. Approximately 40% of adults with asthma (and up to over 50% of children) reported experiencing one or more asthma attacks in the prior year (Asthma and Allergy Foundation of America, 2023). Exacerbations among those with COPD are more frequent with increased severity of disease and for roughly 20% individuals with COPD, nearly three exacerbations per year is normal (Donaldson & Wedzicha, 2006). Exacerbations are the root-cause for most ED visits and hospitalizations for populations with respiratory disease.
Compared to the general population, people with asthma or COPD record more physician office visits each year. While asthma accounted for approximately 9.8 million outpatient visits annually in the United States (Centers for Disease Control and Prevention, 2022; Song et al., 2020), COPD constituted roughly 3.2% of all physician office visits annually (C. M. Riley & Sciurba, 2019). The actual number of outpatient visits for those with a COPD diagnosis was not readily available at the time this report was written, but a report from 2002 determined that COPD resulted in 15.4 million physician visits (Mannino et al., 2002).
Asthma and COPD exacerbations have each been linked to increased hospitalizations, ED utilization, and 30-day hospital readmission rates (AL-Jahdali et al., 2012; Bollmeier & Hartmann, 2020), and as a result, account for the high direct healthcare costs associated with these respiratory diseases. In 2019, ED visits per 10,000 individuals with asthma were 108.4 and 41.8 for children (< 18 years old) and adults (>18 years old), respectively (Center for Disease Control and Prevention, 2020), while ED visits for COPD represented 40.2 per 10,000 (more than 1.3 million) in 2019 (American Lung Association, 2023). The National Hospital Ambulatory Medical Care Survey reported that asthma and COPD constituted 9.7% and 6.3% of ED visits in the United States in 2020 (National Center for Health Statistics, 2020).
Reported average hospitalization rates per 10,000 with asthma or COPD were 5.2 and 16.3, respectively (American Lung Association, 2023; Center for Disease Control and Prevention, 2020). The Centers for Disease Control and Prevention reported 169,330 hospital inpatient stays (and over 1.8 million ED visits) for those with asthma as a primary diagnosis in 2019 (Centers for Disease Control and Prevention, 2022).
Readmission rates are of great interest, as these are expensive, and often deemed avoidable. In 2014, the Centers for Medicare and Medicaid Services (CMS) identified COPD as a top healthcare priority and added it to a select list of conditions impacted by the Hospital Readmissions Reduction Program (HRRP), a program dedicated to reducing 30-readmission rates in common, high-impact diseases (Press et al., 2021). The 30-day readmission rates for those with COPD and asthma are relatively high, reported at 22.6% and 11.9% (dataset from 2013), respectively (N. Patel et al., 2022; Shah et al., 2015). These findings align with a different source, which noted that 30-day readmission rates for COPD were roughly 20% (Press et al., 2021).
Economics – Direct and Indirect Costs
Ranked in the top five most costly medical conditions in the United States, more than $100 billion is spent annually to care for approximately 40 million Americans who suffer from asthma or COPD (Barnett & Nurmagambetov, 2011; Centers for Disease Control and Prevention, 2018a; Zeller et al., 2023). Healthcare costs for these two respiratory diseases are projected to increase and hospitalizations due to exacerbations are the main cost driver for related healthcare expenses. Asthma and COPD are considered separately in this section, though, at the end there is a table (Table 1) with overall estimated values for the two conditions. Worth noting is that healthcare costs are particularly challenging statistics to nail down, as methodology and factors vary considerably from study to study.
In 2018, and based on longitudinal data from 2008 to 2013, the American Thoracic Society reported overall annual asthma costs (direct and indirect) in the United States were more than $80 billion (in 2015 USD) (American Thoracic Society, 2018). These data came from a study published in the Annals of the American Thoracic Society journal using the Medical Expenditure Panel Survey (MEPS) (Nurmagambetov et al., 2018). Of the 213,994 included in the pooled sample, 4.8% had treated asthma, which was defined as the presence of at least one medical or pharmaceutical encounter or claim associated with asthma. The estimated overall direct medical costs came to over $50 billion. For people with treated asthma, the annual per-person medical costs were $3,266 (in 2015 USD). Prescriptions accounted for $1,830, while $640 was for office visits, $529 for hospitalizations, $176 for hospital-based outpatient visits, and $105 for ED care (all in 2015 USD). Of note, this study did not include those with untreated (or undiagnosed) asthma; therefore, actual costs may likely have been higher.
A different study, which also leveraged MEPS data (from 2011 – 2015), examined medical costs for United States workers (>18 years old), and reported that the total annual prescription drug expenditures for asthma were over $5 billion (Syamlal et al., 2020).
Using a cross-sectional analysis of the MEPS database (2010-2017), another group of researchers investigated healthcare utilization, direct medical costs, and indirect costs from productivity loss due to asthma by severity of disease (Song et al., 2020). Compared to individuals (12 years of age or older) without an asthma diagnosis, the additional annual direct medical costs per patient were significantly higher, and ranged from $3,305 in mild cases to $9,175 in severe cases. The total direct costs associated with an asthma diagnosis were between 78.3% and 88.5% higher than for those without asthma.
The additional indirect costs incurred by a patient with asthma compared to one without an asthma diagnosis revealed a similar pattern, increasing with disease severity, from $106 to $1,000 annually.
The study by Nurmagambetov and colleagues showed that compared to those without asthma, those with an asthma diagnosis missed roughly 2.3 more school days and 1.8 more work days (Nurmagambetov et al., 2018). In the United States, total absenteeism costs for asthma have been estimated to be $42 million (Chan, 2019).
Chronic Obstructive Pulmonary Disease
The Center for Disease Control and Prevention (CDC) calculated a 52% increase in COPD-related costs between 2010 and 2020 and the global costs for this patient population has been projected to increase to $4.8 trillion by 2030 (Bloom et al., 2011).
A systematic review of studies reported that the mean cost of treatment for a COPD exacerbation requiring hospitalization ranged from $7,000 to $39,200 (Bollmeier & Hartmann, 2020). A different study with 5,701 participants demonstrated that frequent COPD exacerbators (≥ 2 per year) and infrequent exacerbators (1 per year) demonstrated significantly higher direct costs ($17,651 per year and $14,501 per year, respectively) than “non-exacerbators” with a COPD diagnosis ($11,395) (J. Patel et al., 2018).
In yet another systematic review, Rehman and researchers found that direct annual medical costs per-patient were $10,367 in the United States, while per-patient hospitalization costs were $6,852 (Anees Ur Rehman et al., 2020). Together, it’s clear that although exact per-patient medical cost values ranged across studies, that the per-patient impact was not insignificant.
The aforementioned study by Syamlal et al. (2020) that assessed medical expenditures in the United States for workers (>18 years old) using MEPS data (2011-2015) concluded that total annual prescription drug expenditures for COPD exceeded $1.6 billion. This same report indicated that the annual cost of inpatient visits for COPD in the United States was $2 billion, while the annualized per-patient expenditures for inpatient visits were $27,597 (Syamlal et al., 2022).
Like asthma, the cost of COPD extends far beyond direct economics; indeed, the indirect social and emotional costs are extraordinarily burdensome. For example, those with COPD experience productivity loss due to absence from work, with an average of five more days per year than those without a COPD diagnosis (J. Patel et al., 2018).
In 2010, an estimated 16.4 million days of work were lost due to COPD, accounting for $3.9 billion of the $36 billion overall estimated costs for COPD (Ford et al., 2015). The incremental indirect costs from short-term disability for a person with COPD were $641 annually (J. Patel et al., 2018).
A 2021 population-based study from Spain also demonstrated the high loss of productivity due to asthma and/or COPD (Dierick et al., 2021). The study population (n=14,383) with asthma and/or COPD experienced significantly more work absence (15.2%) compared to the general population (8.9%). While those with asthma had more frequent periods of work absence compared to those with COPD (16.0% versus 12.8%), the number of days absent were higher among individuals with COPD, with a median of 39 days compared to 15 days for those with asthma.
A summary table (Table 1) delineates the estimated overall values for a variety of parameters pertaining to asthma and COPD and is based on the data referenced in this section.
These chronic and complex disease conditions are not curable. Consequently, an integrated care approach for managing symptoms, and particularly for achieving effective self-management, is necessary to optimize clinical outcomes, reduce costs, and improve quality of life.
Chronic Respiratory Disease Management
With the correct treatment and care, asthma and COPD exacerbations (and deaths), as well as related hospitalizations and ED visits, could be avoided and QoL could be improved. In turn, disease-related costs – both direct and indirect – could be significantly reduced.
Scientific research has identified several key aspects for managing each of these respiratory conditions, some of which have demonstrated to be more promising than others. It is generally accepted in the literature that interventions maximizing bronchodilation using the appropriate maintenance therapy, in conjunction with a multifaceted approach to disease management and patient education facilitates reduced exacerbations, hospitalizations, and readmissions (Bollmeier & Hartmann, 2020; Maltby et al., 2020; McClatchey et al., 2023; McDonald et al., 2022; Pinnock et al., 2017). Another main objective of disease management is to identify exacerbations early on and ideally, to predict the onset of these acute flare-ups. Due to the chronic nature of these respiratory conditions, the ability of the afflicted individual to notice symptoms and to care for oneself is integral to the clinical trajectory of disease. Several guidelines have been established to optimize care management for these respiratory conditions.
The CDC has recognized asthma as one of six particularly costly health conditions with proven interventions and thus, it is included in the CDC’s 6 18 initiative (Centers for Disease Control and Prevention, 2018b). Specifically, the CDC identified four evidence-based interventions for asthma management including: promoting management practices described in the National Asthma Education and Prevention Program (NEAPP) Guidelines; employing strategies that improve access to and continued use of asthma medications and devices; enhancing access to intensive self-management education, particularly for those who have poorly controlled asthma; and expanding access to home visits with licensed professionals when asthma is not controlled with medication and education. The CDC reported that following NAEPP Guidelines reduced asthma-related ED visits by 45%, hospitalization by 56%, outpatient visits by 19%, and symptom days by 59% (Centers for Disease Control and Prevention, 2020a). The CDC also referenced a study that reported a return on investment of $2.40 to $4.00 return on each $1.00 spent (Cloutier et al., 2009).
For COPD diagnosis, management, and prevention, the Global Initiative for COPD has established evidence-based guidelines (Global Initiative for Chronic Obstructive Lung Disease, 2020). These guidelines highlight both pharmacologic and non-pharmacologic interventions, pulmonary rehabilitation, and education and self-management. Research has expanded on best practices for COPD self-management, noting it should be structured, but personalized, and multifaceted, such that individuals are motivated, engaged, and supported in a way that nurtures individuals to adopt positive behaviors and develop skills to better manage disease (Cravo et al., 2022; Howcroft et al., 2016; Lenferink et al., 2017; Schrijver et al., 2022). The CDC has reinforced the value of self-management education (SME) programs (Centers for Disease Control and Prevention, 2018c). Moreover, it’s been ascertained that participation in pulmonary rehabilitation programs following hospitalization is particularly helpful for those with COPD; however, enrollment in this type of program has been “extremely low” (Spitzer et al., 2019).
Despite the development of guidelines and efforts to mitigate disease exacerbation, management of asthma and COPD remains challenging for several reasons. Oftentimes, barriers can limit the implementation of evidence-based practices for management. For example, research has revealed that individuals with asthma lack confidence about self-management and/or feel that monitoring seems insufficient because of the unpredictability of severe asthma and related asthma attacks (Apps et al., 2019; Bidad et al., 2018). Studies with COPD participants have documented similar findings, as well as additional hindrances with regard to self-management: lack of awareness of COPD; physical inability or a feeling of being overwhelmed by daily tasks; and memory loss associated with COPD, which further compromises one’s ability to execute self-care tasks, such as taking medications in a timely manner (Greenlund et al., 2016; Mannino et al., 2000; Vachon et al., 2022). Moreover, and importantly, it is not uncommon for those with asthma or COPD to present with co-morbidities, ranging from rhinitis, vocal cord dysfunction, and gastro-esophageal reflux disease (GERD) for those with asthma, to diabetes, GERD, and cardiovascular disease for those with COPD (Cavailles et al., 2013; Kaplan et al., 2020), which makes self-care, treatment, and daily tasks, such as meal preparation, and household chores even more challenging.
Other factors, such as social determinants of health (SDOH), which are the conditions in the environment where people are born, live, learn, work, play, worship, and age (Office of Disease Prevention and Health Promotion, 2022), also impact effective asthma and COPD management (Grant et al., 2022; Kearney et al., 2022).
To address these obstacles, home-based management programs and virtual care programs have sought to optimize care and treatment mechanisms for asthma and COPD management. To this end, patients are often offered educational resources about their condition, monitoring devices and apps for data transmission, and access – in some capacity – to clinicians.
Studies evaluating home-based care support programs have yielded variable clinical and economic results, likely due to the multitude of approaches and methodologies employed. Some research has suggested that home monitoring programs can offer favorable results for those with asthma or COPD, reducing condition-related admissions, ED visits, and hospitalization (Shany et al., 2017); yet others have exhibited limited success and scientists have proposed that better methods are necessary for predicting which patients are at higher risk of experiencing readmission (Jacobs et al., 2018).
Similarly, the authors of a systematic review including 17 randomized controlled trials determined that not all remote care monitoring programs are equal and that program methodology should be carefully evaluated (Nagase et al., 2022). These researchers and others have proposed that the current devices, such as spirometers and pulse-oximeters, may be insufficient to accurately identify acute exacerbations in COPD patients (Nagase et al., 2022; Pépin et al., 2022). Nagase and co-authors suggested that inclusion of regular feedback from providers may reduce COPD-related hospital admissions and other studies have found this to help. For example, home management programs led by respiratory therapists reduced 30-, 60-, and 90-day readmission rates for those with COPD (Truumees et al., 2022) and decreased hospitalizations, in-patient days, and costs for those prone to asthma exacerbations (Shelledy et al., 2009). Indeed, human-to-human and patient-provider partnership is of great value for achieving perhaps the most critical piece of respiratory disease management: self-management. What exactly is self-management and how is it achieved?
Realizing complete self-management of chronic respiratory disease including asthma and COPD is instrumental for achieving optimal clinical, quality, and economic outcomes (Centers for Disease Control and Prevention, 2020b; Global Initiative for Chronic Obstructive Lung Disease, 2020). Additionally, programs that offer supported self-management for asthma and COPD have yielded favorable clinical outcomes (Kinley et al., 2022; Schrijver et al., 2022).
Self-management interventions encourage individuals to “develop the skills and behaviors they need to successfully manage their disease, and the emotional and practical issues that may go along with it” (Schrijver et al., 2022). Some critically important aspects of self-management for individuals with asthma or COPD, include: recognizing and responding to symptoms (self-actualization), avoiding exacerbation triggers, and understanding and adhering to treatment plans (Crooks et al., 2020; I. L. Riley et al., 2021; Watson & Wilkinson, 2022). Several strategies have been determined for optimizing self-management.
Cravo and colleagues examined methods for optimizing self-management in the context of symptom monitoring and the presence of educational support (Cravo et al., 2022). From their findings, the authors outlined six recommendations for implementing self-management, including: pertinent education for care professionals on disease management and consultation skills, a focus on patient outcomes, identification of barriers and gaps to self-management, dissemination of best practice standards with key care professionals, strong initial consultations for establishing optimal self-management from the start, and negotiation and sharing of self-management expectations upon diagnosis. Cravo et al. (2022) depicted proposed self-management strategies, which are shared in Figure 1.
Figure 1. Self-management strategies, with (A) factors that influence effectiveness of programs and (B) components of educational programs (image adapted from Cravo et al., 2022).
As described, self-management education and coaching by healthcare professionals is integral to attaining self-management. Patient education that establishes the importance of and fosters self-management and can improve medication adherence, reduce exacerbation-related hospital utilization (including emergency department visits and inpatient), and decrease indirect and direct social and economic costs (Centers for Disease Control and Prevention, 2020b; Worsnop & McDonald, 2020). Nonetheless, patient education alone is insufficient and patient monitoring and regular assessment of disease status and progress is critical (Jordan et al., 2015).
As noted earlier in this report, to attain patient readings, home-based self-management programs offer devices and related mobile interfaces, such that patient data is at the minimum, recorded. A number of wearables and digital programs have been developed for improving the self-management of asthma and COPD. The marketplace has a variety of options, ranging from smartphones and associated applications (referred to as “apps” herein), to small devices that record and transmit different types of data. An effective device and related program must be adaptable to the patient’s understanding of technology, monitor deep lung symptoms, and educate patients and their caregivers to learn and recognize signs and symptoms that may be indicative of exacerbation. Ideally, the device, together with virtual care program would use the data to predict imminent exacerbations, rather than simply monitor respiratory status.
Virtual Care Programs
In recent years, companies in the healthcare industry have sought to offer mechanisms for improving asthma and COPD self-care and self-management through virtual care programs. To this end, many virtual care programs provide their patients with monitoring device(s) and mobile apps, and some also offer self-serve education and health coaching. To encourage behavioral change, virtual care companies may employ automated, algorithmic communication with users, as this intervention is relatively inexpensive and scalable, particularly if the method is not customized to a particular chronic condition. While each of these interventions may be necessary for improving self-management for chronic diseases, it has been demonstrated that they are not sufficient when standing alone or in the absence of other considerations (Omada Health, 2022). In many instances, engagement with devices and apps can be enhanced when used in conjunction with guidance from a trusted healthcare professional or coach. To achieve full behavioral change, specific human-to-human interaction is necessary
Worth noting are several industry leaders in the virtual care of diabetes: Omada Health and Virta Health. In recent years, companies such as Omada and Virta have identified critically important aspects of what makes an effective virtual care management program for those with chronic disease conditions. These companies have well-established programs that have been built on science and are scalable. For example, Omada has proposed that apps and devices are insufficient for chronic condition management, and has highlighted the value of developing trusted relationships with healthcare coaches and professionals, particularly at the beginning of a program for bolstering engagement and sustained outcomes. Many virtual care companies focus on “self-serve” education and reactive health coaching, but the literature has demonstrated that while information is necessary, it is not sufficient for behavior change and that individuals with chronic disease benefit from assistance with nurturing intrinsic motivation to act on what they learn.
Health Care Originals (HCO) has pioneered a similar successful virtual care approach for respiratory diseases with its Nightingale Virtual Respiratory Care Program.
The evidence-based, multi-faceted approach offered by Health Care Original’s Nightingale Virtual Respiratory Care Program (“Nightingale Program” or “Nightingale”) is uniquely different in that the ultimate goal is for patients to achieve “self” management at the most basic level of the meaning of the word, being completely self-sufficient (without devices and a constant need for clinical interface) in their ability to manage their own disease. The three-pronged approach (device, digitization of data, and clinician interface) represents the heart and true value of the Nightingale program.
Perhaps one of the more prominent features of HCO’s Nightingale Program is the integrated use of its ADAMM-RSM device, a small, soft and pliable, light-weight wearable device that monitors respiratory auscultations and patterns. Like select other devices in the industry, ADAMM-RSM tracks frequency, type (productive vs dry; rhonchi, crackles, etc.), and severity of cough; however, an advantage to HCO’s ADAMM-RSM wearable is that it also detects “chronic cough.” This is a critically important capability, as chronic cough is a crucial parameter for guiding asthma and COPD treatment (Calverley, 2013). When an individual with asthma or COPD tries to stifle coughs, a different sound is produced, which may preclude detection by some devices. The ADAMM-RSM wearable also tabulates body motion resultant from coughing, as well as body positioning, and each cough is associated with a time-stamp; each of these parameters serve to inform and guide care. Like other monitoring devices, ADAMM-RSM also measures respiration, heart rate, temperature and activity. However, rather than measuring average heart rate over a given period of time, ADAMM-RSM measures and records actual, quantitative heart rate data.
Some of the unique technical capabilities of the ADAMM-RSM also differentiate it from others in the marketplace. For example, ADAMM-RSM offers dual-modality remote monitoring, together with real-time telemedicine telemetry. This means an individual can monitor daily respiratory patterns, as well as have the opportunity to connect with his or her respiratory therapist over a video call, for example, such that the provider can visualize the data in real-time, just a would be the case during an office visit. Adding Telemetry to TelemedicineTM allows for synchronously monitoring cardiopulmonary auscultations – just as would be accomplished during an office visit – while engaging with a participant, who instead, is in the comfort of their own environment.
Another way in which ADAMM-RSM differs from similar devices on the market lies in its ability to store data from an extensive period of time. While some devices record and store data, which is then transmitted during the charging process, ADAMM-RSM data processing is founded on “edge-computing,” which means the device selectively detects and identifies the data to be transmitted, allowing for up to six weeks of data to be stored on the device. In the event internet access is scarce, such as when on vacation or in some geographical areas, this is a very useful feature.
Data are transmitted from the device while it is being charged; though importantly, only in the presence of a recognized and trusted internet source. Using powerful algorithms, ADAMM-RSM leverages leading indicators that are capable of detecting an exacerbation up to three months in advance (Rhee et al., 2015).
The “bed-side” monitoring mode feature on ADAMM-RSM allows for cough data collection even when the device is not being worn. When it is being worn, and auscultations are determined to deviate from baseline, the wearable device vibrates, notifying the individual of the aberration. A text alert noting the detected change may also be sent to designated numbers.
While HCO’s ADAMM-RSM device is at the frontier of the marketplace for offering objective monitoring of cardiopulmonary parameters, it is HCO’s Nightingale Program that elevates self-management to a new and superior model. Indeed, the three-pronged approach achieved by the Nightingale Program – simple digital interface, comprehensive monitoring device, and human interaction for personalized education and guidance – offers patients a multifaceted solution for self-management of asthma or COPD.
Companion to the ADAMM-RSM device, HCO’s Nightingale Program has a user-friendly back-end and web interface, app that serves as one “space” for members and healthcare providers to access information and communicate. The patient-facing mobile app dashboard does not bombard the user with unnecessary information, but focuses on key parameters, including cough frequency, heart rate, and symptom triggers. Nightingale participants may also use the app to proactively create their own medication reminders, identify any symptom triggers, and assess overall self-management, as well as maintain personal journaling notes and review treatment plans. Health Care Originals designed the app to solicit medication tracking and reminders, as well as journaling, rather than to have members become dependent on app-generated reminders.
Nightingale Program respiratory therapists leverage the app to 1) share disease condition-specific information; 2) connect and obtain a status check-up; 3) offer words of encouragement for favorable progression; and 4) respond to event-driven incidents, such as a lack of adherence for raising awareness. The texts are customized as individualized texts. However, the app is not the only platform through which HCO’s respiratory therapists and wellness coaches connect with their members. Emails, phone calls and video calls, as well as messaging on social media platforms are each used to reach members, as determined by the individual’s preference and ability.
Health Care Originals has recognized that although apps, connective devices, and education are each necessary for optimizing the self-management of respiratory conditions, these aspects of a virtual care program are not sufficient for effectively developing and nurturing self-management for chronic disease.
From day one, the Nightingale program fosters trusted relationships between its members and healthcare professionals and coaches. To this end, HCO members with asthma or COPD first engage with a respiratory therapist and when it seems the individual is ready to work with a life coach, one-on-one meetings are scheduled either via phone or video, as preferred by the member. In essence, although encouragement is offered by the healthcare professional, delivery of additional services is customized according to member readiness.
For quantitatively measuring progress, Nightingale participants provide symptom feedback using clinically validated assessments. To evaluate asthma and COPD impairment, the St. Georges Respiratory Questionnaire (SGRQ) is administered, while the Health-Related Quality of Life (HRQoL) tool is used to better understand a member’s perspective on his or her QoL. Finally, the COPD and Asthma Sleep Impact Scale (CASIS) captures sleep quality for Nightingale members. Together, these scientifically validated assessments provide critically important information for informing care and treatment plans.
Health Care Original’s Nightingale program is highly customized to accommodate for various social determinants of health (SDOH) and to optimize care delivery for those who face numerous challenges or barriers to care. For example, in areas where the air quality is poor and wi-fi is unavailable, HCO provides HEPA filtration and Wi-Fi services, respectively. Additionally, because of the inherent nature of the ADAMM-RSM device, which stores key audio clips, a variety of human resources can be leveraged. For example, in an area where there is a paucity of specialists, a less-experienced clinician could obtain the readings and forward them onto the appropriate healthcare professional for further analysis.
The Nightingale program “meets patients where they are” and offers a “bite-size” approach for members with asthma or COPD to encourage and prime for the adoption of novel behavioral changes. For example, the integration of sessions with a wellness coach occurs only after an individual has demonstrated a capacity for behavioral change as determined by time with the respiratory therapist. Moreover, members develop and maintain a relationship with the same respiratory therapist and life coach; they are not regularly interfacing with different healthcare professionals. This facilitates a long-term and trusted relationship, which is crucial for engagement, the identification of intrinsic motivation, and sustained outcomes. The patient-facing mobile app dashboard does not bombard the user with unnecessary information, but focuses on key parameters, including cough frequency,
The Nightingale program is accessible and scalable. In addition to addressing many barriers that create real-life challenges for those with asthma or COPD, the Nightingale program offers an online community support network that allows individuals to engage with others in the population who are also afflicted with asthma or COPD. While programs at the community-level have sought to develop such opportunities for asthma and COPD sub-populations, they have fallen short because the local nature of these groups is not scalable. Through its established online community support networks, HCO’s Nightingale members interface regularly with others encountering similar challenges and self-management care. The virtual community methodology is founded on evidence and creates opportunity for rapid scaling and dissemination, reaching individuals who may not otherwise be connected to people with the same real-world struggles.
As is the case with any clinical program, it is imperative to assess clinical efficacy. To this end, HCO has captured patient-reported health outcome parameters. To better understand the results, a brief explanation of the program enrollment methodology will be considered first. Individuals enrolled in the Program were either from one of two local unions or from advertising via the internet and were invited to enroll if they “self-identified as having asthma or COPD and needed help” (email correspondence, Sharon Samjitsignh, July 17, 2023). Each enrollee was offered a spacer and an ADAMM device; those with asthma chose or paid for peak flow meters and those with COPD chose or paid for OPEP devices. Enrollees were invited to receive tips on self-management in “bite-sized” pieces via text (or email, if preferred) and it was reported that only about 5% of enrollees opted out of this opportunity. As described earlier in this document, Program enrollees were offered access to respiratory therapists and health coaching. The mean age of the individuals enrolled in the Program was 53.6 years old (range 22-90 years old), and 66.2% identified as female. The percent enrolled with asthma and COPD were 63.5%, 36.5%, respectively, though 2.7% of those classified as “COPD” also indicated having asthma.
The results presented herein represent data from validated assessment tools obtained upon enrollment (baseline) and at three-, six-, nine-, and 12- months following the baseline reading. According to HCO, the median number of members for this analysis set was 74.
To measure disease-related impairment, HCO used the SGRQ, a clinically validated tool. From baseline to three months, members in the Nightingale Program experienced significant improvements in the health-related quality of life (HRQoL) section of the SGRQ, with baseline scores for respondents at 44 (scale 0-100, with higher scores indicating more limitations) and the three- month scores dropping to 24, (Figure 2), a favorable change deemed clinically effective (P. Jones, 1994; P. W. Jones, 2002; Welling et al., 2015). The six- and nine- month HRQoL scores were 26 and 40, respectively, which corresponded to 31% and 25% of respondents showing clinically efficacious improvements (see blue arrows, Figure 2). For those enrolled 12-months, HRQoL scores dropped favorably, to 21, which aligned with 60% of respondents demonstrating clinically effective score reductions (at least a 12-point reduction) (Figure 2).
Figure 2. Average health-related quality of life (HRQoL) scores (SGRQ) reported by participants at baseline and over time enrolled in the Nightingale Program (data provided by Health Care Originals, 2023).
Compared to baseline, the average participant-reported HRQoL score improved at all the times this measure was assessed following enrollment (three-, six-, nine-, and twelve- months) (Figure 2). Of note, compared to measurements taken at three-, six-, and 12-months, there was a slightly less substantial response in the HRQoL category reported at nine months. It is possible this finding reflects the time of year at which most participants completed the nine-month survey and this will be discussed further in the Discussion. Importantly, despite the less substantial decline in this category after enrollment for nine months, 25% of the respondents maintained at least a 12-point reduction in the HRQoL category, which has been identified as clinically efficacious in the literature.
Health Care Originals also reported that the Nightingale Program was associated with symptom improvement following enrollment. Scores in the SGRQ category evaluating symptoms (on a scale of 0-100, with higher scores indicating more limitations) were 64 at baseline and on average, were reduced 18 points to 46 after six months of engagement and reduced by 28 points to 36 for those enrolled 12 months (Figure 3). Sixty-three percent of the respondents enrolled in the Nightingale Program for six months reported clinically efficacious reductions in symptoms, and this favorable reduction in symptoms was maintained, with 50% of respondents in the Program for 12 months also having at least a 12-point reduction (blue arrows). Compared to baseline scores, the average symptom score improved at all times measured (three-, six-, nine-, and twelve- months).
Figure 3. Average symptom scores (SGRQ) reported by participants at baseline and over time enrolled in the Nightingale Program (data provided by Health Care Originals, 2023).
The total average scores of respondents enrolled in the Nightingale Program also reflected clinical improvements (Figure 4). On the scale of 0-100, with higher scores representing more adverse clinical outcomes.
Figure 4. Average total scores reported by respondents (SGRQ) at baseline and over time enrolled in the Nightingale Program (Health Care Originals, 2023).
The improvements in SGRQ scores from baseline to subsequent measurements demonstrated Nightingale’s efficacy in limiting disease impairment and improving symptoms (Figures 2-4).
As indicated earlier in this document, sleep quality is an issue of great importance for those with chronic respiratory conditions. Thus, using the clinically validated CASIS assessment, HCO monitored patient-reported sleep outcomes for those enrolled in its Nightingale Program upon enrollment (baseline) and at three-, six-, nine-, and 12- months following enrollment.
The sleep problem parameters from CASIS are presented in Figure 5, with green, yellow, and red bars depicting sleep problems as “never/rarely,” “sometimes,” or “often/very often,” respectively. While roughly a quarter of individuals reported having “a bad night’s sleep” often or very often at baseline, only 15% reported this at three months, and by six months, 0% of members reported having a bad night’s sleep often or very often. In fact, after six months of being enrolled in the Nightingale Program, 62% of individuals indicated they “never or rarely” had a bad night’s sleep (Figure 5a). After three months, none (0%) of the respondents reported “waking up at night with breathing problems,” “having problems staying awake during the day,” or “having trouble falling asleep” (Figure 5b-d). Importantly, by 12 months, a mere minority of respondents enrolled in the Program reported having sleep problems (as measured by CASIS) “often” or “very often,” and in most cases, a majority of the Program respondents reported “never” or “rarely” having sleep problems 12-months following enrollment (Figure 5a-e).
Figure 5. Frequency of sleep problems at different times for those enrolled in HCO’s Nightingale Program (data from CASIS).
It is worth noting that there was an increase in the number of respondents experiencing sleep problems nine months following enrollment. This patient-reported decline in sleep quality (compared to three- and six- month measurements) aligned with the slight decline in outcomes observed in the SGRQ data, which further reinforces the idea that another factor, such as the time of year at which most participants completed the nine-month survey, may be affecting the results.
Overall, these results demonstrate that the majority of responding members experienced a decline in sleep problems following enrollment in HCO’s Nightingale Program.
The CASIS measures asking about the frequency of good, or quality, sleep also reflected improvements following enrollment in the Nightingale Program (Figure 6a and b). At the time of enrollment, 30% and 38% reported “never” or “rarely” having “a good night’s sleep” or waking up “feeling rested,” respectively. However, three- and six- months following enrollment, only 15% and 8% of respondents in the Nightingale Program reported “never” or “rarely” having a good night’s sleep, respectively. Accordingly, fewer than 20% of respondents indicated “never” or “rarely” having a good night’s sleep or waking up feeling rested, a great reduction compared to baseline.
Similarly, after three- and six- months in the Program, only 8% of respondents reported “never” or “rarely” waking up feeling rested, suggesting that sleep quality improved within months following enrollment.
Eighty-five percent of program respondents indicated having a good night’s sleep “often” or “very often” six months following enrollment, while 69% reported waking up feeling rested “often” or “very often” at this same time (Figure 6).
Health Care Original’s Virtual Respiratory Nightingale Program offers a remarkable three-pronged care strategy that is similar to virtual care management programs for different chronic conditions, such as diabetes, which have proven clinically and economically successful. Through apps, a small connective device, coaching, and education, the Nightingale Program offers a comprehensive care management program for those struggling with chronic respiratory disease(s).
It is clear from the patient-reported results presented in this report that individuals enrolled in HCO’s Nightingale Program experienced improved health-related quality of life, disease-related symptoms, and sleep quality. Based on the data obtained from using the SGRQ tool, participants in the Nightingale Program reported clinically meaningful improvements across each category assessed (average HRQoL score, symptoms score, and total scores) at the various measurement periods following enrollment. Likewise, Nightingale members reported significantly meaningful improvements in symptoms and sleep, which ultimately, can enhance one’s quality of life perception and reduce depressive symptoms (Kennair et al., 2022; Scott et al., 2021).
As noted earlier, the SGRQ scores reported at nine months suggested slightly less clinical improvement than the scores reported for each SGRQ category at other measurement times following enrollment in the Nightingale Program. Similarly, more Program respondents indicated sleep problems (and reduced quality of sleep) at nine months. There are several possible reasons for these observations. For example, HCO noted that most (86%) of the nine-month patient-reported data was obtained between January and March and the remainder was submitted during April. It is during this time of year (winter and spring) that viruses, other maladies, and allergies tend to be more prevalent due to seasonal and environmental impacts. Several individuals in the Program were particularly ill during that timeframe, with some individuals reporting symptoms scores over 75 on the SGRQ assessment (email correspondence with Sharon Samjitsingh, July 17, 2023), which may have skewed the data. Oftentimes, it is during the winter and spring that respiratory illness and related allergies can be particularly challenging. Nonetheless, other reasons may exist for data changes after nine months of program engagement. For example, perhaps after experiencing clinical improvements during the first few months in the Program, individuals became more complacent and less engaged around nine months, another possible reason for slightly less substantial improvement in symptoms, QoL, or sleep. If program- or device- fatigue played a role, perhaps the more favorable outcomes were again observed around 12 months, when individuals realized the value of the program and reinstated engagement practices. Regardless of the underlying reasons for a slight disruption in the clinical improvement trend, by 12 months, a majority of respondents reported robust improvements in symptoms, QoL, and sleep quality. These findings substantiate the idea that a seasonal factor could have been influencing the nine-month data.
This study was limited by a small sample size and a lack of certain parameter calculations, such as device days and healthcare utilization measurements. Going forward, HCO intends to capture additional data for fully demonstrating the clinical and economic efficacy of its Nightingale Program. The Nightingale Program has already started to capture additional patient-reported data, including: medication usage (mined from the App), healthcare utilization prior to enrollment (provided by payer claims data); and out-of-pocket spending and co-pays for medications and healthcare utilization.
The preliminary data findings reported by individuals enrolled in HCO’s Nightingale Program appear promising and the Nightingale model aligns with successful virtual care models that have been developed for other chronic conditions. Additional information could further bolster, support, and promote the use of the HCO’s ADAMM-RSM and Nightingale Program, establishing it as an exemplar forerunner in virtual care management for respiratory diseases.
Poorly managed chronic respiratory conditions have profound economic, clinical, and societal impacts, both at the personal level and across the healthcare system. Individuals with COPD and/or asthma also experience a significantly reduced QoL. Accordingly, proper disease management can greatly improve clinical outcomes, reduce hospital utilization, and result in substantial savings for both the individual and the healthcare system.
The evidence-based, customized, and scalable Nightingale program establishes Health Care Originals (HCO) as the forerunner in the virtual respiratory care industry. The Nightingale Virtual Care Program has demonstrated meaningful clinical outcomes for its members through individualized self-management education, unparalleled insights from ADAMM-RSM and its companion mobile app, and regular connection with dedicated respiratory therapists and wellness coaches. The model is accessible, considers real-life context and circumstances, is whole-person-focused, and scalable.
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