Original Article

POPULATION HEALTH MANAGEMENT Volume 0, Number 0, 2014 ª Mary Ann Liebert, Inc. DOI: 10.1089/pop.2014.0073

Are Telehealth Technologies for Hypertension Care and Self-management Effective or Simply Risky and Costly? June McKoy, MD, MPH/JD, MBA,1 Karen Fitzner, PhD,2 Miranda Margetts, LLB, LLM,3 Elizabeth Heckinger, MAT, CP, CFom,4 James Specker, MBA, MIS,5 Laura Roth, BA,3 Maxwell Izenberg, MSc,3 Molly Siegel, MS,3 Shannon McKinney,3 and Gail Moss, MA 3

Abstract

Hypertension is a prevalent chronic disease that requires ongoing management and self-care. The disease affects 31% of American adults and contributed to or caused the deaths of 348,000 Americans in 2008, fewer than 50% of whom effectively self-managed the disease. However, self-management is complex, with patients requiring ongoing support and easy access to care. Telehealth may help foster the knowledge and skills necessary for those with hypertension to engage in successful self-management. This paper considers the applicability, efficacy, associated risks, and cost-effectiveness of telehealth for individuals and populations with hypertension. Telehealth is a broad term, encompassing telemedicine and mobile health that is used for physician-patient interactions, diagnostics, care delivery, education, information sharing, monitoring, and reminders. Telemedicine may have considerable utility for people diagnosed with hypertension who have poor access or social barriers that constrain access, but potential risks exist. Telehealth technology is evolving rapidly, even in the absence of fully proven cost-effectiveness and efficacy. Considering the cost of inpatient and emergency department care for patients with hypertension, telehealth is a highly attractive alternative, but there are risks to consider. Incorporating telehealth, which is increasingly characterized by mobile health, can increase both the capacity of health care providers and the reach of patient support, clinical management, and self-care. Telehealth studies need improvement; long-term outcome data on cardiovascular events must be obtained, and robust risk analyses and economic studies are needed to prospectively evaluate the safety and cost savings for hypertension selfmanagement. (Population Health Management 2014;xx:xxx–xxx)

number of hypertension self-care instruments are available, and evidence-based medicine is increasingly stressing the importance of patient self-care.4,5 Kvedar et al recently examined connected health, noting that telehealth strategies can increase patient access and may afford some level of value to health care professionals and patients.6 Telehealth is generally perceived as a means to achieve high-quality care at reduced costs, which has attracted attention from key stakeholders.6,7,8 Telehealth capabilities were available at 42% of US hospitals in 2012.8 However, rates of telehealth adoption vary by state and are dependent on state policies, particularly those relating to reimbursement.7

Introduction

H

ypertension is a prevalent chronic disease that requires ongoing management and self-care. The disease, which is often referred to as high blood pressure (BP), has contributed to or caused the deaths of 348,000 Americans in 2008, and affects 31% (67 million) of American adults.1,2 Fewer than 50% of these individuals effectively self-manage or have the disease under control.3 However, self-management is complex, with patients requiring ongoing support and easy access to care. Telehealth provides a means with which to foster the knowledge and skills necessary for those with hypertension to engage in successful self-management. A 1

Northwestern University Feinberg School of Medicine, Chicago, Illinois. DePaul University, Chicago, Illinois. 3 FH Consultants, Chicago, Illinois. 4 UC Scout from University of California, Santa Cruz, California. 5 American Association of Diabetes Educators, Chicago, Illinois. 2

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This paper considers telehealth for individual patients and populations with hypertension—its applicability, efficacy, risks, and cost-effectiveness. It also addresses economic incentives and disincentives and highlights association views and international experiences with telehealth delivery and self-management interventions. Background

Telehealth is increasingly transforming health care by moving diagnostics, education, and patient monitoring out of physicians’ offices and into patients’ homes and other nontraditional care settings. Telephonic general packet radio service or satellite connectivity, computer interface, and mobile health (m-health; provided via mobile medical apps) are used to facilitate remote diagnostics, care delivery, and monitoring. Today, medical apps allow smartphones to become electrocardiography machines to diagnose abnormal heart rhythms. Telehealth apps now also serve as mobile ultrasound devices or interconnected glucose meters for people with insulin-dependent diabetes and comorbid hypertension. Additionally, connectivity helps patients better manage their own health by enabling access to useful information (and reminders) that is at the patients’ fingertips whenever and wherever they wish to find it. The director of the Centers for Disease Control and Prevention, Tom Frieden, MD, MPH, recently declared better BP control to be a national priority, raising the importance of tools that can help achieve it.4 Clinical guidelines state that systolic BP level should be the major factor for detection, evaluation, and treatment of hypertension.9 Two or more BP lowering agents are often required to meet BP goals. BP and weight are to at least some extent amenable to behavior modification, which can be affected by educationrelated behavior change and self-management. Effective and efficient ways to improve clinical and economic outcomes for those with hypertension and related chronic diseases are of considerable interest to key stakeholders (employers, health plans, physicians, and policy makers). Direct medical expense costs of hypertension in the United States are notable at $47.5 billion; productivity losses add another $3.5 billion.10 Hence, affordable approaches to care delivery are being sought. Several recent telehealth offerings provide a means with which to foster the knowledge and skills necessary for those with hypertension to engage in successful self-management. Self-management, however, is complex and patients require ongoing support. Care management and patient support addressing this complexity are increasingly available via telehealth for those with hypertension. Telephonic, home telehealth, and remote BP monitoring devices as well as mobile applications (apps) for hypertension have proven promising in recent studies.11,12,13 This is possibly because telehealth has proven to be both an individualizable tool for care management as well as a population-based approach that offers the potential to optimize resources and increase access to self-management education and support.14,15 The literature on telehealth and chronic illnesses such as diabetes includes several studies showing the approach to be efficacious, cost-effective, and scalable; it also can increase access to care for individuals with chronic illnesses in underserved areas.16,17

MCKOY ET AL.

Remotely delivered health care has had only limited oversight and regulation even though a variety of risks are associated with it. It was only in October 2013 that the US Food and Drug Administration (FDA) released final guidance for mobile medical apps, outlining a tailored approach to these software programs that run on mobile communication devices and can perform the same functions as traditional medical devices.18 Methods

In this paper, telehealth is broadly defined as telecommunication technologies, which include but are not limited to mobile phones, computers, Web, supporting software, and emergent offerings. Telehealth is a broad term, encompassing telemedicine and m-health that is used for physician-patient interactions, diagnostics, care delivery, education, information sharing, monitoring, and reminders. Table 1 presents telehealth definitions and terminology. Information derives from association and government Web sites, policy experts and practitioners working in the field in the United States and abroad, and the published literature. In November 2013 the study team searched PubMed using the terms ‘‘telehealth’’ and ‘‘hypertension’’ and identified 253 papers. Subsequent searches using the terms ‘‘mobile health’’ and ‘‘hypertension’’ yielded 50 papers, while ‘‘apps’’ and ‘‘hypertension’’ yielded 5. The study also includes more recently published literature in the following discussion. A preliminary scan of this literature indicated that telephonic, home telehealth, and remote BP monitoring devices as well as mobile apps for hypertension have proven promising but the literature was not yet sufficiently robust to merit a more formal systematic review. Results and Discussion Telehealth supply and demand

Technology improvements in the last 10 years parallel the practitioner’s ability to deliver remote patient education and support and the demand for participation in telehealth programs. Concurrently, the development of new services also has increased. Evidence supports increased demand for telehealth, especially in regard to chronic disease management and education. The uptake of mobile devices is apparent in all ages and socioeconomic groups.19,20 This growing demand is rapidly being met on the supply side. IBIS World reports that the telehealth services industry has expanded rapidly over the past 5 years, and it will continue to do so in the next 5 years to 2019.21 BCC Research analyzed the global telemedicine market finding that it grew from $9.8 billion in 2010 to $11.6 billion in 2011 and is likely to almost triple to $27.3 billion in 2016, offering a compound annual growth rate of 18.6% over the next 5 years.22 Moreover, the market for apps on mobile devices also is expanding rapidly—more than 40,000 are available and being used in the United States. The rapid expansion may be partly because there are few barriers to entry and a low level of capital is necessary for start-up. Third-party payers also impact telehealth take-up. Medicare has begun reimbursing some telehealth services for chronic illness and some commercial payers are following this lead.23,24,25 As coverage expands, both the demand for and supply of telehealth opportunities are anticipated to grow. Some practitioners find that the technology is beneficial for patient

TELEHEALTH TECHNOLOGIES FOR HYPERTENSION CARE

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Table 1. Definitions and Terminology Term Telehealth

M-health

Short Message Service (SMS)

Apps on smartphone and Android devices

Remote monitoring

Definition Telehealth is a broad term that encompasses telemedicine, telecommunication, and m-health. Other terminology includes telediabetes care, telehome care, and teleconsultation. Telehealth may be provided via computers or wireless or handheld phones/devices that have Internet access.1 Telehealth is the use of electronic information and telecommunications technology to support long-distance clinical health care, patient and professional health-related education, public health, and health administration. It may include a way to view still images, monitor vital signs, and provide continuous improvement in medical education, and includes transmitting test results through phone lines and using videoconferencing for long-distance consultations or education. The American Telemedicine Association defines telehealth as a way of obtaining medical information from one site in order to improve patient’s health status. M-health is a shortened version of ‘‘mobile health’’ or ‘‘mobile health care.’’ It is the use of mobile and wireless devices to improve health outcomes, health care service, and health research. M-health technologies include health text messaging, mobile phone apps, remote monitoring, and portable sensors.2 Such services can be used for monitoring services and transmitting real-time clinical or stored and forwarded data, such as blood pressure (BP) and weight changes.3 This can assist providers in monitoring and establishing treatment plans for people with chronic illnesses. SMS is more commonly referred to as ‘‘text messaging’’ and consists of alphanumeric data that are transmitted from a mobile telephone or Internet site to another mobile telephone or Internet site.4 Multimedia message service (MMS) is a method of transmitting graphics, video clips, or sound files in addition to text. Mobile tools such as smartphones are devices that are a combination of both a cell phone and a handheld computer. They typically have Internet access, data storage, e-mail capability, and even calendars with reminders; almost all have cameras that enable the user to take videos and pictures.4 An app is a software application running on an Android, iOS, or another smartphone platform. Some apps are made available by developers through their Web sites; most apps are uploaded and published on the Android, Apple, or other smartphone market (ie, online store offering these applications).5 A smartphone is a cellular telephone with built-in applications and Internet access. Smartphones provide digital voice service as well as text messaging, e-mail, Web browsing, still and video cameras, MP3 players, video viewing, and video calling. In addition to their built-in functions, smartphones can run myriad applications, turning the cell phone into a mobile computer. Remote monitoring, which can be done by diabetes patients/caregivers, is sometimes referred to as homecare telehealth. Smartphone and Android technology, Internet connectivity, and monitoring devices (eg, BP or wireless weight scales that interface with the Internet via a computer or wirelessly) facilitate daily monitoring for patients with diabetes. Data can be stored and/or sent to an educator or physician.6

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American Telehealth Association. What is Telemedicine? http://www.americantelemed.org. Accessed August 22, 2014. US Department of Health and Human Services. mHealth Initiative. http://www.hhs.gov/open/initiatives/mhealth/. Accessed August 22, 2014. 3 Kyriacou E, Pavlopouopos S, Berlier A, et al. Multi-purpose HealthCare Telemedicine Systems with mobile communication link support. Biomed Eng Online. 2003;2:7. 4 TechTerms.com. SMS. www.techterms.com/definition/sms. Accessed August 22, 2014. 5 What is a mobile application? http://mobiledevices.about.com/od/glossary/g/What-Is-A-Mobile-Application.htm. Accessed August 22, 2014. 6 Agency for Healthcare Research and Quality. Technology Assessment. Remote cardiac monitoring. 2007. http://www.cms.gov/ Medicare/Coverage/DeterminationProcess/downloads/id51TA.pdf. Accessed August 22, 2014. 2

scheduling, communication, monitoring, and management. In addition, patients recognize the benefits (time saved, increased access to quality care, and connectivity) of telehealth. According to Becker’s Hospital Review of a recent report by InMedica, there are currently 4 main drivers of demand for telehealth.26 These are: 1. Federal-driven demand. In the United States, readmission penalties introduced by the Centers for Medicare & Medicaid Services are driving providers to adopt telehealth as a means to reduce readmission penalties. Worldwide, health care providers are look-

ing to reduce health care expenditure through telehealth programs. 2. Provider-driven demand. Health care providers want to use telehealth to maintain ties with patients and improve quality of care. 3. Payer-driven demand. Insurance providers also are using telehealth to increase competitiveness and reduce inpatient payouts. 4. Patient-driven demand. For now, patient-driven demand is limited to mostly rural areas where there is poor availability of clinics and physicians. However, patients in metropolitan areas are expected to in-

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MCKOY ET AL.

creasingly seek professional devices to remotely track their health, according to the report.26 Not surprisingly, the American Telemedicine Association recently reported that organizational and individual memberships have reached a new peak, with 132 private companies, 134 health care institutions, and more than 7000 professionals.27 This represents an increase of 10% in organizations and more than 25% in individual members. Risks associated with telehealth/risk management— the legal viewpoint

In contrast to the provision of traditional face-to-face health care services, telemedicine presents a range of scenarios, each with its own inherent risks, which do not necessarily fit neatly into the legal framework established for face-to-face services. As such, risk identification and mitigation in the telehealth space are important factors to consider. It has been recognized that technology enables health care organizations to deliver new ways of providing health care, which can blur the boundaries of health care settings and also the traditional roles of health care professionals.28 It is this ‘‘blurring’’ of settings and professional roles that may give rise to new risks and questions surrounding the increased liability of physicians who adopt and implement telehealth. Although the following scenarios are not exhaustive, telehealth legal risks can arise in relation to privacy and security requirements, jurisdictional boundaries, and informed consent. It has been recognized that legal or ethical guidance for health practitioners to safely navigate these circumstances is lacking. Given the actual or perceived level of risks associated with telehealth, this lack of guidance for physicians and other participants in telehealth is a concern, particularly when considering the adoption and uptake of telehealth services. Further, the FDA’s recently published approach to the regulation of mobile medical applications lends support to the continuing ambiguous legal circumstances in which physicians who engage in telehealth may find themselves.18 Telehealth, which functioned with little oversight or regulation until fall 2013, when the FDA increased its oversight but stated that it ‘‘intends to exercise enforcement discretion for the majority of mobile apps as they pose minimal risk to consumers’’18 (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act). Regulatory oversight will focus on those mobile medical apps that are likely to present a risk to patients if they do not work as intended. Although the FDA has taken steps to clarify the regulatory framework applying to mobile health applications (ie, by stipulating which medical applications they will focus their attention on), a gap may still exist in relation to the multitude of applications that do not fall within those criteria. Applicability and efficacy of telehealth to hypertension

The literature suggests the usefulness of telehealth for patients with hypertension. As Table 2 shows, some studies examine telehealth for hypertension specifically; many other studies address the technology for chronic illnesses in gen-

eral. Eakin found that regular, ongoing telephone contact helps to motivate patients with chronic illnesses to increase physical activity and improve their diets.29 Delivery of care via telehealth boosts adherence to hypertension treatment according a Brazilian study of 502 patients with the condition who attended Web conferences over a period of 6 months.30 That study concluded that adherence to antihypertensive drugs and a low salt diet improved after the telehealth intervention. Studies by Pare´ and others showed that successful outcomes may be achieved by combining telehealth with usual care or incorporating multiple telehealth approaches.31 Bove randomized 241 urban, underserved patients with systolic BP ‡ 140 mm Hg to a telemedicine intervention or usual care, concluding that the intervention may be a useful tool for managing hypertension, particularly among nondiabetic subjects.32 Carter reported success with home-based use of wireless scales, BP cuffs, and glucometers for patients with diabetes and comorbid conditions.33 Wakefield’s randomized controlled study (RCT) of home telehealth in comorbid hypertension and diabetes found that ‘‘although older patients may not be accustomed to using technology, it doesn’t mean they aren’t willing to learn.’’12 That 6-month telehealth study focused on heart disease in Iowa and reported improved A1c and systolic BP among those with hypertension. Conversely, Takahashi, who assessed differences in hospitalizations and emergency department visits among older adults (> 60 years) with chronic conditions, reported that using telemonitoring vs. usual care did not result in lower utilization (fewer hospitalizations or emergency visits).34 It is concerning that in that study mortality was higher in the telemonitoring group; there were no significant differences between the telemonitoring group and the usual care group for other measures. Takahashi’s findings may be the reason some hospitals are expanding on the typical telehealth communication capabilities to enhance safety and better manage clinical data via wireless sensor networks for care monitoring systems. Telephonic and Web-based interventions have been found to be effective for specific groups such as veterans and the underserved. A 2001–2006 Veterans Administration study examined a nurse telephone intervention, finding that 85% of patients completed all 12 calls and had notable improvement in BP.35 Bove’s RCT, which evaluated an Internet- and telephone-based telemedicine system for reducing BP in underserved patients diagnosed with hypertension, showed that engaged patients had significantly lower BP with or without telemedicine.32 Further, as compared to the controls, the telemedicine intervention resulted in a greater reduction in systolic BP for patients with hypertension who did not have diabetes as a comorbid condition. Clearly, there is considerable interest in using technology-assisted interventions but the results for selfmanagement for hypertension control, while very promising, are inconsistent, as Table 2 indicates. Automated patient-focused Web sites have been designed with the aim of empowering and engaging patients and providers; empowerment and engagement are essential to effective behavior change and self-management. Thiboutot’s 2013 RCT addressed empowerment by tailoring messages for patients, suggesting questions they might ask their physician to improve their BP control.36 That study found high patient

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Home BP monitoring, secure electronic messaging, and medication intensification for improving hypertension control: a mediation analysis

Home-based telemedicine intervention for patients with uncontrolled hypertension: a real life–non-randomized study

Organizational factors associated with readiness to implement and translate a primary care-based telemedicine behavioral program to improve BP control: the HTN-IMPROVE study

Bernocchi P, Scalvini S, Bertacchini F, Rivadossi F, Muiesan ML. BMC Med Inform Decis Mak. 2014;14:52.

Shaw RJ, Kaufman MA, Weiner BJ, et al. Implemt Sci. 2013;8:106.

Results

Organizational readiness-to-change facilitators for telemedicine include stakeholder buy-in and a clear goal of improving hypertension. The Weiner Organizational Theory of Implementation Effectiveness identified key facilitators and barriers, showing that readiness to implement the telemedicine program was primarily positive. Key facilitators and barriers identified from this study may inform programs for other types of chronic disease.

The addition of a structured physician-nurse approach supported by remote telemonitoring of BP is likely to improve outcomes in patients with uncontrolled hypertension.

The effect of Web-based pharmacist care on improved BP was explained in part through a combination of home BP monitoring, secure messaging, and antihypertensive medication intensification.

An interactive Web site designed to overcome clinical inertia for hypertension care did not lead to improvement in BP control even though participant adherence to the intervention was high. Patients did use individually tailored questions to discuss BP with PCP but these discussions did not lead to improvement.

Authors’ Conclusion

(continued)

Studies of Telehealth Technology for Chronic Conditions Ekeland AG, Bowes A, Effectiveness of telemedicine: a Systematic review of published reviews on 21 systematic reviews met the inclusion criteria and Interventions that are effective in reducing health Flottorp S systematic review of reviews impact and costs of telemedicine to answer: concluded that telemedicine is effective; 18 found service use include home monitoring. There is International J Med Informatics. (1) how are telemedicine services defined and that evidence is promising but incomplete; others a continuing need for larger studies of 2010;79:736–771. described; (2) what are the reported effects of that evidence is limited and inconsistent. Costtelemedicine as controlled interventions, and telemedicine; (3) what are the knowledge gaps effectiveness of home telecare for older people more focus on patient’s perspectives, and what methodologies can be recommended with chronic conditions is uncertain; consistent economic analyses and on telemedicine for future research? Timeframe studied: 2005– results regarding costs of synchronous telehealth innovations as complex processes and 2010. in primary care and cost-effectiveness of IT is ongoing collaborative achievements. lacking. Concerns exist about the nature of economic analyses of telemedicine and the benefits of the intervention for patients.

More than one third of study participants logged into and used the Web site all 12 months of their enrollment; 82% used the intervention during at least 6 months and asked questions directly from the Web-based tool. Controls were more likely to report having tetanus and pneumonia vaccinations. There was no significant difference in use of the intervention between the study groups or for prevention (eg, creatinine or urine protein tests). Two-arm study conducted from 6/05–12/07 At 12 months follow-up, participants in the Web-based compared a Web-based intervention using pharmacist arm were significantly more likely to pharmacists to home BP monitoring alone for have BP < 140/90 mmHg than those in the home people with hypertension. Intervention monitoring arm. The intervention’s effectiveness included home monitoring, communication was largely (30%) attributable to home BP with pharmacists; outcomes evaluated were monitoring. Fidelity to the chronic care model, medication use and adherence, lifestyle measured via the Patient Assessment of Chronic factors, and BP control. Care (PACIC) score, accounted for another 22% of the intervention’s effect. There was no difference in medication adherence, weight, or self-reported intake of fruits/vegetables across the 2 groups. Non-randomized study (N = 168; 370 scheduled telephone contacts were initiated by Intervention = 74; Controls = 94) of homethe nurse and 30 unscheduled calls were initiated based telemedicine service effectiveness in by patients. Those receiving telephone contact patients with uncontrolled hypertension in and using the telemonitoring device had a mean Italy for 80 ( – 25) days. Patients received a systolic BP decrease from 153 – 19mmHg to BP monitoring device that transmitted 130 – 15mmHg during the study and diastolic BP decreased from 89 – 10mmHg to 76 – 11mmHg. readings, were followed by a physician or Both were significant at the 99% level. Controls nurse, and had unscheduled telephone also experienced BP improvements, which were appointments. significant at the 95% level. The mixed-methods study aimed to identify Positive organizational characteristics include facilitators, barriers, and contextual factors availability of other similar programs, adequate that affect organizational readiness to change. staff, and alignment with existing environment. Nurses, physicians, administrators, and About two thirds of responders felt they had information technology professionals sufficient resources to implement the program but provided input for a nurse-delivered selfstaffing was a concern. The primary barrier was management phone intervention, which was unclear long-term commitment of nursing staff. A conducted through 3 Veterans Integrated key finding is that buy-in is temporary until Service Networks representing 21 geographic evidence shows improved clinical outcomes. regions between 2010 and 2011.

Ralston JD, Cook AJ, Anderson ML, et al. Appl Clin Inform. 2014; 5(1):232–248.

Summary

Effects of a Web-based patient Two-arm randomized comparison (N = 500; activation intervention to interventions = 282; controls = 218) of an overcome clinical inertia on intervention designed to help patients ask BP control: cluster questions at the point of care so as to randomized controlled trial encourage primary care physicians to appropriately intensify BP treatment.

Title

Thiboutot J, Sciamanna CN, Falkner B, et al. J MedInternet Res. 2013;15(9):e158.

Authors & Journal

Table 2. Studies of Telehealth for Hypertension Self-Management

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Behavior change interventions delivered by mobile telephone short-message service

Title

Randomized controlled trial of telemonitoring in older adults with multiple health issues to prevent hospitalizations and emergency department visits

Table 2. (Continued) Results

Authors’ Conclusion

Assessment of telephone short message service Of 14 studies of SMS interventions, 13 demonstrated SMS-delivered interventions have positive short(SMS) for delivering behavior change positive behavior changes although some lacked term behavioral outcomes. Further research is interventions. Focused on behavior change. sufficient power to provide significant findings. required to evaluate interventions for Costs were not examined. Timeframe studied: Significant positive behavioral changes were preventive health behaviors that incorporate Jan 1990–March 2008. observed in 8 studies; 1 study showed no change. features found to affect behavioral outcomes and participant acceptance. The quality of studies in this emerging field of research needs to improve to allow the full potential of this medium to be explored. The aim was to understand the clinical effects 13 papers out of 64 selected for the review addressed The findings of empirical studies are encouraging associated with home telemonitoring hypertension, including 5 RCTs with automated for hypertension. It is not clear whether programs in the context of chronic diseases telephone contact and counseling or remote improvement in the clinical condition was the (diabetes, asthma, heart failure, and monitoring. The non-randomized studies result of the technology itself or of other hypertension). Costs were not included. examined the clinical outcomes of home mechanisms. Larger trials are needed to Timeframe studied: 1966–2008. telemonitoring. All 13 studies indicated that the confirm the benefits of home telemonitoring intervention appears to be beneficial based on for heart failure patients. findings from measures of clinical effects. One study found BP treatment based on telemonitoring to be as effective as that based on office monitoring. Case study of software-based telehealth remote The study tracked impact, consequences and Use of telehealth for monitoring of patients with monitoring systems and corresponding health acceptability, and sustainability of the chronic conditions results in increased patient indicator measure devices for uninsured or intervention. Stakeholders emphasized: (1) the engagement and self-management, and underinsured individuals with diabetes, importance of introducing telehealth technology improvements in decision making and the cardiovascular disease, or hypertension to both patients and providers through a trusted delivery of quality care for predominately attending a federally qualified health center in source, (2) the potential for telehealth to be cost rural minority populations. It is important to North Carolina. Phase 1 began 2006–2009; saving, and (3) that health IT can improve customize technology and program it to meet currently in Phases 2 and 3. communication. the needs of providers and their patients. Systematic review of literature on cost22 studies (RCTs, case control, and a pre-post study) Telehealth has the potential to reduce costs but effectiveness of home telehealth for chronic met the study criteria. Diverse patient populations impact from the societal perspective remains diseases. Also aimed to develop a framework participate in home telehealth programs. All but 2 uncertain. Studies may underestimate the costfor such evaluation. Direct and indirect costs of the studies indicated that telehealth is cost effectiveness of the intervention because were considered in the analysis, as were saving from the health system and insurer telehealth costs have decreased over time. A outcomes such as quality of life and perspectives. However, the quality of most of the standardized approach to the evaluation of effectiveness. Study timeframe: 1998–2008. studies was low. There are limitations to home telehealth should be developed to economic evaluation because of the shortage of increase the quality of studies and amount of data on health care resources, patient costs, evidence available. quality of life, and clinical outcomes. 2-arm RCT trial of 205 older adults with a high Mortality rates between the group that used Among older patients, telemonitoring did not risk of rehospitalizations for heart, lung, and telemonitoring services and the control group result in lower utilization (fewer kidney disease and diabetes assessed were 14.7% and 3.9%, respectively. No difference hospitalizations or emergency visits). differences in hospitalizations and emergency was found in hospitalization rates, ED visits, and Mortality was higher in the telemonitoring department (ED) visits among older adults hospital day rates between the groups. group; there were no significant differences ( > 60 years) using telemonitoring vs. usual between the telemonitoring group and the care. usual care group for other measures.

Summary

BP, blood pressure; IT, information technology; PCP, primary care physician; RCT, randomized controlled trial.

Takahashi PY, Pecina JL, Upatising B, et al. Arch Intern Med. 2012;172:773–779.

Polisena J, Coyle D, Coyle K, Home telehealth for chronic McGill S. disease management: a International J Tech Assessment systematic review and an in Health Care. analysis of economic evaluations 2009;25:339–349.

*NORC at the University of Health IT and health disparities Chicago patient-provider telehealth http://www.healthit.gov/sites/ network. Using telehealth to default/files/pdf/ improve chronic disease RCCHCandPHS_CaseStudy management .pdf.

Pare´ G, Moqadem K, Pineau G, Clinical effects of home St-Hilaire C. telemonitoring in the context J Med Internet Res. of diabetes, asthma, heart 2010;12(2):e21. failure and hypertension: a systematic review

Fjeldsoe BS, Marshall AL, Miller YD Am J Prev Med. 2009; 36:165–173.

Authors & Journal

TELEHEALTH TECHNOLOGIES FOR HYPERTENSION CARE

adherence but no improvements in BP control, indicating that providers’ behavior is not easily altered by telehealth interventions. On the other hand, there are promising assessments of the effect of telehealth on patient engagement for those with chronic disease. Findings from the case study report, Patient Provider Telehealth Network—Using Telehealth to Manage Chronic Disease, indicate that remote monitoring can increase patient engagement, improve self-management, yield better outcomes, and reduce hospital-related costs.37 Population-based strategies for telehealth

Population health is integral to chronic disease management, which is of particular importance to low-income and minority communities. Several population health management programs (also known as disease management programs) utilize short messaging service (SMS) or telephonic contact; both clinical and economic improvements have been reported from these interventions. The usefulness of such outreach by care managers to populations with hypertension and other chronic illnesses has been demonstrated in the United States and abroad.37,38,39,40 Fjeldsoe et al assessed SMS for delivering behavior change interventions in 2009, finding positive behavior change outcomes in 13 out of 14 studies, 4 of which reported on targeted health behaviors and 10 on clinical care (eg, disease management).38 These authors concluded that SMS-delivered interventions have positive short-term behavioral outcomes but noted the need for improvement in the quality of related studies. These enhanced behavioral outcomes suggest that interventions using SMS are promising for population health management. Piette’s 2013 study of disease management in Honduras, Mexico, and the United States assessed whether interactive voice response support calls for Spanish-speaking patients influenced their engagement level. In all, 86% of patients reported that the calls helped them manage their health problems; call completion rates were significantly lower among patients who reported fair or poor health status upon enrollment.39 Patients with informal caregivers had significantly greater odds of completing their calls than did those who participated alone. Apps are designed for health management of chronically ill populations and according to Harris survey data reported by Silow-Carroll, one third of patients using online capabilities want mobile health apps that increase engagement with their clinicians, allowing them to ask questions, make appointments, or obtain results of clinical tests.40 Likewise, they desire clinical management apps that facilitate chronic care management, and enable patients and providers to work to control BP by helping patients monitor and record their BP and access their electronic health records. Because these attributes may be especially useful to members of underserved, low-income, and minority communities, identification of best practices for program implementation and engagement will be helpful. Economic analyses of telehealth

Telehealth economic analyses over the past several years have yielded inconsistent findings and conflicting evidence. Systematic reviews on the cost-effectiveness of telehealth

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interventions conducted prior to 2009 generally tend to demonstrate its cost-effectiveness. But in 2002, Whitten et al concluded that there is no good evidence that telemedicine is or is not a cost-effective means to deliver health care in general.41 Polisena conducted a systematic review of 22 evaluations on home telehealth in 2009, reporting that the quality of most of the studies was low and that those earlier studies may underestimate the cost-effectiveness of the intervention because telehealth costs have decreased over time.42 Ekeland examined 80 systematic reviews on the effectiveness of telemedicine; 21 of these concluded that telemedicine is effective and that home monitoring of diabetes is among the interventions that are effective in reducing health services use; however, 41 studies concluded that evidence is limited and inconsistent.43 Although not specifically on hypertension, Stellefson’s systematic review of Web 2.0 for older adults articulates a need to better understand the costs and benefits associated with patient-centered technologies for chronic disease self-management.44 One problem with many current studies is that benefits may be undervalued because little research exists about additional benefits, such as travel/time costs avoided by patients in rural areas. In the context of economic evaluations, the practitioners’ perspective cannot be overlooked. In addition to being convinced of the efficacy, safety, reliability, and cost-effectiveness of telehealth interventions, physicians also must be assured that their economic incentives are properly aligned. Currently, disincentives exist for practitioners and their practices—telehealth monitoring, for example, increases the amount of information that a practice captures and incorporates into the patient care plan; this adds to clinician workload and requires sophisticated Health Insurance Portability and Accountability Act (HIPAA)compliant data management capabilities. Increased workload and other barriers have limited uptake of high-tech telehealth by physician practices; solutions for overcoming these barriers may include financial incentives that recognize the increased demands on practitioners. As a case in point, a pilot project in England offered a creative solution. After discovering that only 350 of 2000 telehealth home monitoring units were in use by patients with long-term conditions, a primary care trust in North Yorkshire, England, offered a 1-time payment of £200 per physician practice and additional payments of £50 for equipment installation and another 50 for each patient who clinically required telehealth for 6 months or longer.45 Policy perspective—issues/benefits

Public and private payers are increasingly interested in investing in cost-effective programs. These payers are currently exploring policies that support the use of telehealth (including mobile applications) for chronic disease management. However, for policy to be effective, there will need to be more research on best practices and ways for payers (such as the government) to mitigate risk. In addition, Medicaid policy makers specifically struggle to ensure access for patients in rural areas, and telehealth offers potential opportunities to improve access. If more widely available at a lower cost, both self-management and telehealth/m-health will help with the concurrent issue of resource distribution. Policy also needs to be respectful of physicians’ workload and ensure their engagement. As a matter of policy, payers

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are not interested in cutting programming but rather making spending more efficient. Policy makers struggle to establish policies focused on prevention so that more cost-effective disease management, specifically self-care and less reliance on institutionalized care, is increasingly appealing. Telehealth safety is also being addressed at the state level. Joseph C. Kvedar, MD, director, Partners Center for Connected Health, has called upon states to adopt telehealth policies that embrace 4 key principles relating to patient safety. These are: (1) patient evaluation and treatment should be held to the same standard of practice that applies in traditional settings; (2) the online physician-patient relationship should ensure the usual standard of care is met; (3) prescribing in a telehealth encounter should be at the discretion of the physician; and (4) telehealth encounters should be HIPAA compliant, include informed consent, the generation of a medical record, and support continuity of care. To achieve these concepts, states can look to the model policy adopted by the Federation of State Medical Boards.46 State-level initiatives in the United States

Many states are beginning to define telehealth and look at possible reimbursement models for it. Some states have created pilot programs to show the feasibility, economic justification, and/or the health outcomes of telehealth for hypertenison.23,24 As of October 2012, 13 states required private insurers to pay for medically necessary telehealth services that otherwise would be covered when provided face-to-face. These states are Maryland, California, Colorado, Georgia, Hawaii, Kentucky, Louisiana, Maine, New Hampshire, Oklahoma, Oregon, Texas, and Virginia.25 An example of payer interest can be found in the state of Maine, where a number of barriers to access to care have been noted. Designed to help persons with diabetes, cardiovascular disease, hypertension, and/or high cholesterol overcome barriers to access by using telephone-based intervention, the Telephonic Diabetes Education & Support program (TDES), has partnered with organizations such as Aetna Health, Blue Cross and Blue Shield of Maine, and the Maine Municipal Employees Health Trust to address the needs of chronically ill patients.47 The overarching goal of TDES is to help increase the number of patients involved in their own self-management and to improve health outcomes. Since implementation of the pilot program in 2004, participants have seen overall clinical improvements in A1c, BP, total cholesterol, and low-density lipoprotein cholesterol as well as improvements in HEDIS measures. The 2008 return on investment showed a cost savings of $1300 per participant per year as well as a significantly higher medication adherence and use of preventive care, which can be associated with a higher quality of care. The success of this program has led to the second offering (TDES2), wherein participants who have completed the first phase receive advanced training in selfmanagement. Telehealth beyond US borders

Telehealth is being implemented and accepted by practitioners and patients worldwide.48,49,50,51 There is substantial potential for telehealth as a tool to improve reach and to reduce geographic disparities in developing nations. For ex-

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ample, in India the market is significantly greater for traditional forms of telehealth for hypertension management vs. open-source self-management apps (which are limited to Android users with data packages). India’s objectives and implementation strategy are very much parallel with telehealth in the United States; however, it faces many additional implementation and financing setbacks, some unique to the context and other challenges generalizable. India’s telehealth has been spearheaded largely by government initiatives or large, private, super-specialty hospitals that foster partnerships with rural hospital units, with the exception of a few nongovernmental organization-run programs.50,51,52,53,54,55,56 As a result, most telehealth programs in India are narrow in terms of scope, although they still improve access to specialty care that otherwise would have been unattainable. Globally, the burden of hypertension has been growing rapidly, particularly in populations in developing nations. In India its prevalence is rising at much faster rates in some states than in others. In Tamil Nadu, a study published in 2012 estimated that rural population prevalence of hypertension is 21.4%, with 75% of those hypertensive individuals unaware of their status.54 Hence, BP may be addressed as a comorbid condition of diabetes. The Madras Diabetes Research Foundation (MDRF) founded a satellite-connected rural telemedicine facility via a rural mobile care center.55 The aims of the Sai Rural Diabetes Specialties Centre project include implementing prevention by initial screening and screening for complications. Although designed for diabetes, there is considerable overlap with hypertension and self-management. In addition to the limited literature on evidence of telehealth in developing nations, where uptake is low and limited in scale, telehealth has many additional challenges globally. Mobile apps, however, offer promise worldwide and are being adopted for disease management and technologybased health behavior change interventions. Free’s 2012 systematic review of 26 international trials, which were mostly from high-income countries, suggested benefits from app interventions for chronic conditions and found pooled positive effects of text messaging on smoking cessation. There was inconsistency in results for hypertension; 2 of the 26 trials reported BP outcomes and only 1 showed a statistically significant BP reduction.56 Implementation challenges in developing nations include resource constraints, administrative capacity, donor interest, logistics and transportation, and technological setbacks, all of which can prove to be significant barriers to scale. The future of telehealth for hypertension control and self-management

The literature reviewed for this paper suggests that telehealth is accepted by patients and is growing in its reach. Telehealth care delivery and interventions have a positive effect on patients’ engagement, activation, motivation to undertake healthy behaviors, ability to self-manage, adherence to treatment plans, and satisfaction. The majority of studies reviewed found evidence of acceptability, clinical effectiveness, and improved behavioral outcomes for those with chronic illnesses. Findings are mixed on other key outcomes, such as BP control, and mortality. International and state-level projects suggest that telehealth interventions

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can lead to better medication compliance, thereby suggesting a positive impact on health.28,30,40,48 Fjeldsoe, Eakin, and Free have demonstrated that telehealth can achieve at least some level of behavior change success, but the findings for BP control are mixed.29,38,56,57 The addition of a structured physician-nurse approach supported by remote telemonitoring of BP is likely to improve outcomes in patients with uncontrolled hypertension.58 Additionally, the use of mobile technologies for health-related computations and communication is a rapidly expanding area of research and practice, particularly with younger and ‘‘connected’’ patients. Although underrepresented in the peer-reviewed literature, m-health communication tools also can be used to deliver preventive and educational services. Organizational factors can impede or facilitate adoption of the technology; attentiveness to readiness-to-change facilitators for telemedicine, which include stakeholder buy-in and articulating a clear goal of improving hypertension, is helpful.59 Although recent economic analyses tend to be promising, a large proportion of earlier economic evaluations of telehealth and chronic conditions were inconclusive, and many studies showing positive results are not robust.60 A handful of highquality economic evaluations suggest that telehealth interventions can save money, which is of prime importance to payers who are interested in advancing cost-effective care management programs that align with evidence-based medicine. Payers, who can very much effect demand, are beginning to recognize the need to better align economic incentives with provider reimbursement, but more needs to be done in this direction. Mobile phone apps facilitate simple and fast communication about key health information between patients and care providers, reduce barriers, and augment care management. These apps now need to prove that they can help achieve optimal clinical and better economic outcomes for people with hypertension and other chronic diseases. Worldwide, telehealth demand and supply are expected to continue to grow. The challenges will be making the case for reimbursement for telehealth and mobile applications and continuing to demonstrate the applicability of the technology for population-based disease management. At the US state level, telehealth is increasingly being embraced. Model policies have been developed to assist policy makers in encouraging the adoption of affordable, safe, high-quality care that is provided in the right setting at the right time. However, legal or ethical guidance is needed for health practitioners to safely navigate the legal risks that may arise in relation to privacy and security requirements, jurisdictional boundaries, and informed consent. Summary

Making better BP control a national priority raises the importance of tools that can help achieve it. The potential for ongoing growth of telehealth for hypertension is high; nearly 60% of adults in the United States use laptops and smartphones to connect to the Internet by wireless means, and 1 in 4 smartphone owners eschew desktops or laptop computers for accessing the Internet.61 At the same time, the published literature indicates that telehealth is acceptable to hypertension patients because of its convenience and the way it increases access to care at low cost to the end user. Recent manuscripts

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further demonstrate the feasibility of virtual environments for educating adults with chronic illness.62,63,64 Additionally, studies of telehealth programs show at least short-term clinical improvements for BP outcomes; such findings may be explained in part because home BP readings may be more reliable than those obtained in a physician’s office because of ‘‘white coat syndrome’’ in which a patient’s BP is elevated in the clinical setting, but not in other settings. As more robust studies emerge, it will be helpful to have a systematic review and/or meta-analysis conducted to show positive and negative impact of BP studies by type of intervention. Readers are cautioned to evaluate telehealth studies critically because few long-term studies have been conducted and some published studies have flawed methodologies or lack objectivity. Additional analyses are needed to clarify provider perceptions, engagement, and satisfaction with telehealth as a care delivery technology. Future economic analyses need to be of the highest quality to ensure they produce robust findings. Conclusion

Telemedicine for people diagnosed with hypertension may have considerable utility but findings regarding its effect on behavior change, medication compliance, reduction of hypertension, provider engagement, and cost-effectiveness are mixed; there are also considerable risks. Adoption of telehealth technology is rapidly evolving, even in the absence of fully proven cost-effectiveness and efficacy. For patients with poor access or social barriers that constrain their access, telemedicine can be a particularly effective tool. Considering the cost of inpatient and emergency department care for patients with hypertension, telehealth may be a highly attractive alternative, but there are trade-offs to consider. Incorporating telehealth into care delivery has the potential to increase both the capacity of health care providers and the reach of patient support, clinical management, and self-care. However, long-term outcome data on cardiovascular events need to be obtained and future telehealth studies must be improved so that they are valid, reliable, and generalizable. Future risk analyses and economic studies are needed to prospectively evaluate the safety and cost savings for hypertension self-management. Author Disclosure Statement

Drs. McCoy and Fitzner, Ms. Margetts, Ms. Heckinger, Mr. Specker, Ms. Roth, Mr. Izenberg, Ms. Siegel, Ms. McKinney, and Ms. Moss declared no conflicts of interest with respect to the research, authorship, and/or publication of this article. The authors received no financial support for the research, authorship, and/or publication of this article. References

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Address correspondence to: Dr. Karen Fitzner DePaul University 2. E Jackson St Chicago, IL 60604 E-mail: [email protected]