Health care is moving into the home increasingly often and involving a mixture of people, a variety of tasks, and a broad diversity of devices and technologies; it is also occurring in a range of residential environments. The factors driving this migration include the rising costs of providing health care; the growing numbers of older adults; the increasing prevalence of chronic disease; improved survival rates of various diseases, injuries, and other conditions (including those of fragile newborns); large numbers of veterans returning from war with serious injuries; and a wide range of technological innovations. The health care that results varies considerably in its safety, effectiveness, and efficiency, as well as its quality and cost.
The committee was charged with examining this major trend in health care delivery and resulting challenges from only one of many perspectives: the study of human factors. From the outset it was clear that the dramatic and evolving change in health care practice and policies presents a broad array of opportunities and problems. Consequently the committee endeavored to maintain focus specifically on how using the human factors approach can provide solutions that support maximizing the safety and quality of health care delivered in the home while empowering both care recipients and caregivers in the effort.
The conclusions and recommendations presented below reflect the most critical steps that the committee thinks should be taken to improve the state of health care in the home, based on the literature reviewed in this report examined through a human factors lens. They are organized into four areas: (1) health care technologies, including medical devices and health information technologies involved in health care in the home; (2)
caregivers and care recipients; (3) residential environments for health care; and (4) knowledge gaps that require additional research and development. Although many issues related to home health care could not be addressed, applications of human factors principles, knowledge, and research methods in these areas could make home health care safer and more effective and also contribute to reducing costs. The committee chose not to prioritize the recommendations, as they focus on various aspects of health care in the home and are of comparable importance to the different constituencies affected.
HEALTH CARE TECHNOLOGIES
Health care technologies include medical devices that are used in the home as well as information technologies related to home-based health care. The four recommendations in this area concern (1) regulating technologies for health care consumers, (2) developing guidance on the structure and usability of health information technologies, (3) developing guidance and standards for medical device labeling, and (4) improving adverse event reporting systems for medical devices. The adoption of these recommendations would improve the usability and effectiveness of technology systems and devices, support users in understanding and learning to use them, and improve feedback to government and industry that could be used to further improve technology for home care.
Ensuring the safety of emerging technologies is a challenge, in part because it is not always clear which federal agency has regulatory authority and what regulations must be met. Currently, the U.S. Food and Drug Administration (FDA) has responsibility for devices, and the Office of the National Coordinator for Health Information Technology (ONC) has similar authority with respect to health information technology. However, the dividing line between medical devices and health information technology is blurring, and many new systems and applications are being developed that are a combination of the two, although regulatory oversight has remained divided. Because regulatory responsibility for them is unclear, these products may fall into the gap.
The committee did not find a preponderance of evidence that knowledge is lacking for the design of safe and effective devices and technologies for use in the home. Rather than discovering an inadequate evidence base, we were troubled by the insufficient attention directed at the development of devices that account, necessarily and properly, for users who are inadequately trained or not trained at all. Yet these new users often must
rely on equipment without ready knowledge about limitations, maintenance requirements, and problems with adaptation to their particular home settings.
The increased prominence of the use of technology in the health care arena poses predictable challenges for many lay users, especially people with low health literacy, cognitive impairment, or limited technology experience. For example, remote health care management may be more effective when it is supported by technology, and various electronic health care (“e-health”) applications have been developed for this purpose. With the spectrum of caregivers ranging from individuals caring for themselves or other family members to highly experienced professional caregivers, computer-based care management systems could offer varying levels of guidance, reminding, and alerting, depending on the sophistication of the operator and the criticality of the message. However, if these technologies or applications are difficult to understand or use, they may be ignored or misused, with potentially deleterious effects on care recipient health and safety. Applying existing accessibility and usability guidelines and employing user-centered design and validation methods in the development of health technology products designed for use in the home would help ensure that they are safe and effective for their targeted user populations. In this effort, it is important to recognize how the line between medical devices and health information technologies has become blurred while regulatory oversight has remained distinct, and it is not always clear into which domain a product falls.
Recommendation 1. The U.S. Food and Drug Administration and the Office of the National Coordinator for Health Information Technology should collaborate to regulate, certify, and monitor health care applications and systems that integrate medical devices and health information technologies. As part of the certification process, the agencies should require evidence that manufacturers have followed existing accessibility and usability guidelines and have applied user-centered design and validation methods during development of the product.
Guidance and Standards
Developers of information technologies related to home-based health care, as yet, have inadequate or incomplete guidance regarding product content, structure, accessibility, and usability to inform innovation or evolution of personal health records or of care recipient access to information in electronic health records.
The ONC, in the initial announcement of its health information technology certification program, stated that requirements would be forthcom-
ing with respect both to personal health records and to care recipient access to information in electronic health records (e.g., patient portals). Despite the importance of these requirements, there is still no guidance on the content of information that should be provided to patients or minimum standards for accessibility, functionality, and usability of that information in electronic or nonelectronic formats.
Consequently, some portals have been constructed based on the continuity of care record. However, recent research has shown that records and portals based on this model are neither understandable nor interpretable by laypersons, even by those with a college education. The lack of guidance in this area makes it difficult for developers of personal health records and patient portals to design systems that fully address the needs of consumers.
Recommendation 2. The Office of the National Coordinator for Health Information Technology, in collaboration with the National Institute of Standards and Technology and the Agency for Healthcare Research and Quality, should establish design guidelines and standards, based on existing accessibility and usability guidelines, for content, accessibility, functionality, and usability of consumer health information technologies related to home-based health care.
The committee found a serious lack of adequate standards and guidance for the labeling of medical devices. Furthermore, we found that the approval processes of the FDA for changing these materials are burdensome and inflexible.
Just as many medical devices currently in use by laypersons in the home were originally designed and approved for use only by professionals in formal health care facilities, the instructions for use and training materials were not designed for lay users, either. The committee recognizes that lack of instructional materials for lay users adds to the level of risk involved when devices are used by populations for whom they were not intended.
Ironically, the FDA’s current premarket review and approval processes inadvertently discourage manufacturers from selectively revising or developing supplemental instructional and training materials, when they become aware that instructional and training materials need to be developed or revised for lay users of devices already approved and marketed. Changing the instructions for use (which were approved with the device) requires manufacturers to submit the device along with revised instructions to the FDA for another 510(k) premarket notification review. Since manufacturers can find these reviews complicated, time-consuming, and expensive, this requirement serves as a disincentive to appropriate revisions of instructional or training materials.
Furthermore, little guidance is currently available on design of user
training methods and materials for medical devices. Even the recently released human factors standard on medical device design (Association for the Advancement of Medical Instrumentation, 2009), while reasonably comprehensive, does not cover the topic of training or training materials. Both FDA guidance and existing standards that do specifically address the design of labeling and ensuing instructions for use fail to account for up-to-date findings from research on instructional systems design. In addition, despite recognition that requirements for user training, training materials, and instructions for use are different for lay and professional users of medical equipment, these differences are not reflected in current standards.
Recommendation 3. The U.S. Food and Drug Administration (FDA) should promote development (by standards development organizations, such as the International Electrotechnical Commission, the International Organization for Standardization, the American National Standards Institute, and the Association for the Advancement of Medical Instrumentation) of new standards based on the most recent human factors research for the labeling of and ensuing instructional materials for medical devices designed for home use by lay users. The FDA should also tailor and streamline its approval processes to facilitate and encourage regular improvements of these materials by manufacturers.
Adverse Event Reporting Systems
The committee notes that the FDA’s adverse event reporting systems, used to report problems with medical devices, are not user-friendly, especially for lay users, who generally are not aware of the systems, unaware that they can use them to report problems, and uneducated about how to do so. In order to promote safe use of medical devices in the home and rectify design problems that put care recipients at risk, it is necessary that the FDA conduct more effective postmarket surveillance of medical devices to complement its premarket approval process. The most important elements of their primarily passive surveillance system are the current adverse event reporting mechanisms, including Maude and MedSun. Entry of incident data by health care providers and consumers is not straightforward, and the system does not elicit data that could be useful to designers as they develop updated versions of products or new ones that are similar to existing devices. The reporting systems and their importance need to be widely promoted to a broad range of users, especially lay users.
Recommendation 4. The U.S. Food and Drug Administration should improve its adverse event reporting systems to be easier to use, to collect data that are more useful for identifying the root causes of events
related to interactions with the device operator, and to develop and promote a more convenient way for lay users as well as professionals to report problems with medical devices.
CAREGIVERS IN THE HOME
Health care is provided in the home by formal caregivers (health care professionals), informal caregivers (family and friends), and individuals who self-administer care; each type of caregiver faces unique issues. Properly preparing individuals to provide care at home depends on targeting efforts appropriately to the background, experience, and knowledge of the caregivers. To date, however, home health care services suffer from being organized primarily around regulations and payments designed for inpatient or outpatient acute care settings. Little attention has been given to how different the roles are for formal caregivers when delivering services in the home or to the specific types of training necessary for appropriate, high-quality practice in this environment.
Health care administration in the home commonly involves interaction among formal caregivers and informal caregivers who share daily responsibility for a person receiving care. But few formal caregivers are given adequate training on how to work with informal caregivers and involve them effectively in health decision making, use of medical or adaptive technologies, or best practices to be used for evaluating and supporting the needs of caregivers.
It is also important to recognize that the majority of long-term care provided to older adults and individuals with disabilities relies on family members, friends, or the individual alone. Many informal caregivers take on these responsibilities without necessary education or support. These individuals may be poorly prepared and emotionally overwhelmed and, as a result, experience stress and burden that can lead to their own morbidity. The committee is aware that informational and training materials and tested programs already exist to assist informal caregivers in understanding the many details of providing health care in the home and to ease their burden and enhance the quality of life of both caregiver and care recipient. However, tested materials and education, support, and skill enhancement programs have not been adequately disseminated or integrated into standard care practices.
Recommendation 5. Relevant professional practice and advocacy groups should develop appropriate certification, credentialing, and/or training standards that will prepare formal caregivers to provide care in the home, develop appropriate informational and training materials
for informal caregivers, and provide guidance for all caregivers to work effectively with other people involved.
RESIDENTIAL ENVIRONMENTS FOR HEALTH CARE
Health care is administered in a variety of nonclinical environments, but the most common one, particularly for individuals who need the greatest level and intensity of health care services, is the home. The two recommendations in this area encourage (1) modifications to existing housing and (2) accessible and universal design of new housing. The implementation of these recommendations would be a good start on an effort to improve the safety and ease of practicing health care in the home. It could improve the health and safety of many care recipients and their caregivers and could facilitate adherence to good health maintenance and treatment practices. Ideally, improvements to housing design would take place in the context of communities that provide transportation, social networking and exercise opportunities, and access to health care and other services.
Safety and Modification of Existing Housing
The committee found poor appreciation of the importance of modifying homes to remove health hazards and barriers to self-management and health care practice and, furthermore, that financial support from federal assistance agencies for home modifications is very limited. The general connection between housing characteristics and health is well established. For example, improving housing conditions to enhance basic sanitation has long been part of a public health response to acute illness. But the characteristics of the home can present significant barriers to autonomy or self-care management and present risk factors for poor health, injury, compromised well-being, and greater dependence on others. Conversely, physical characteristics of homes can enhance resident safety and ability to participate in daily self-care and to utilize effectively health care technologies that are designed to enhance health and well-being.
Home modifications based on professional home assessments can increase functioning, contribute to reducing accidents such as falls, assist caregivers, and enable chronically ill persons and people with disabilities to stay in the community. Such changes are also associated with facilitating hospital discharges, decreasing readmissions, reducing hazards in the home, and improving care coordination. Familiar modifications include installation of such items as grab bars, handrails, stair lifts, increased lighting, and health monitoring equipment as well as reduction of such hazards as broken fixtures and others caused by insufficient home maintenance.
Deciding on which home modifications have highest priority in a given
setting depends on an appropriate assessment of circumstances and the environment. A number of home assessment instruments and programs have been validated and proven to be effective to meet this need. But even if needed modifications are properly identified and prioritized, inadequate funding, gaps in services, and lack of coordination between the health and housing service sectors have resulted in a poorly integrated system that is difficult to access. Even when accessed, progress in making home modifications available has been hampered by this lack of coordination and inadequate reimbursement or financial mechanisms, especially for those who cannot afford them.
Recommendation 6. Federal agencies, including the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services, along with the U.S. Department of Housing and Urban Development and the U.S. Department of Energy, should collaborate to facilitate adequate and appropriate access to health- and safety-related home modifications, especially for those who cannot afford them. The goal should be to enable persons whose homes contain obstacles, hazards, or features that pose a home safety concern, limit self-care management, or hinder the delivery of needed services to obtain home assessments, home modifications, and training in their use.
Accessibility and Universal Design of New Housing
Almost all existing housing in the United States presents problems for conducting health-related activities because physical features limit independent functioning, impede caregiving, and contribute to such accidents as falls. In spite of the fact that a large and growing number of persons, including children, adults, veterans, and older adults, have disabilities and chronic conditions, new housing continues to be built that does not account for their needs (current or future). Although existing homes can be modified to some extent to address some of the limitations, a proactive, preventive, and effective approach would be to plan to address potential problems in the design phase of new and renovated housing, before construction.
Some housing is already required to be built with basic accessibility features that facilitate practice of health care in the home as a result of the Fair Housing Act Amendments of 1998. And 17 states and 30 cities have passed what are called “visitability” codes, which currently apply to 30,000 homes. Some localities offer tax credits, such as Pittsburgh through an ordinance, to encourage installing visitability features in new and renovated housing. The policy in Pittsburgh was impetus for the Pennsylvania Residential VisitAbility Design Tax Credit Act signed into law on October 28, 2006, which offers property owners a tax credit for new construction
and rehabilitation. The Act paves the way for municipalities to provide tax credits to citizens by requiring that such governing bodies administer the tax credit (Self-Determination Housing Project of Pennsylvania, Inc., n.d.).
Visitability, rather than full accessibility, is characterized by such limited features as an accessible entry into the home, appropriately wide doorways and one accessible bathroom. Both the International Code Council, which focuses on building codes, and the American National Standards Institute, which establishes technical standards, including ones associated with accessibility, have endorsed voluntary accessibility standards. These standards facilitate more jurisdictions to pass such visitability codes and encourage legislative consistency throughout the country. To date, however, the federal government has not taken leadership to promote compliance with such standards in housing construction, even for housing for which it provides financial support.
Universal design, a broader and more comprehensive approach than visitability, is intended to suit the needs of persons of all ages, sizes, and abilities, including individuals with a wide range of health conditions and activity limitations. Steps toward universal design in renovation could include such features as anti-scald faucet valve devices, nonslip flooring, lever handles on doors, and a bedroom on the main floor. Such features can help persons and their caregivers carry out everyday tasks and reduce the incidence of serious and costly accidents (e.g., falls, burns). In the long run, implementing universal design in more homes will result in housing that suits the long-term needs of more residents, provides more housing choices for persons with chronic conditions and disabilities, and causes less forced relocation of residents to more costly settings, such as nursing homes.
Issues related to housing accessibility have been acknowledged at the federal level. For example, visitability and universal design are in accord with the objectives of the Safety of Seniors Act (Public Law No. 110-202, passed in 2008). In addition, implementation of the Olmstead decision (in which the U.S. Supreme Court ruled that the Americans with Disabilities Act may require states to provide community-based services rather than institutional placements for individuals with disabilities) requires affordable and accessible housing in the community.
Visitability, accessibility, and universal design of housing all are important to support the practice of health care in the home, but they are not broadly implemented and incentives for doing so are few.
Recommendation 7. Federal agencies, such as the U.S. Department of Housing and Urban Development, the U.S. Department of Veterans Affairs, and the Federal Housing Administration, should take a lead role, along with states and local municipalities, to develop strategies that promote and facilitate increased housing visitability, accessibil-
ity, and universal design in all segments of the market. This might include tax and other financial incentives, local zoning ordinances, model building codes, new products and designs, and related policies that are developed as appropriate with standards-setting organizations (e.g., the International Code Council, the International Electrotechnical Commission, the International Organization for Standardization, and the American National Standards Institute).
RESEARCH AND DEVELOPMENT
In our review of the research literature, the committee learned that there is ample foundational knowledge to apply a human factors lens to home health care, particularly as improvements are considered to make health care safe and effective in the home. However, much of what is known is not being translated effectively into practice, neither in design of equipment and information technology or in the effective targeting and provision of services to all those in need. Consequently, the four recommendations that follow support research and development to address knowledge and communication gaps and facilitate provision of high-quality health care in the home. Specifically, the committee recommends (1) research to enhance coordination among all the people who play a role in health care practice in the home, (2) development of a database of medical devices in order to facilitate device prescription, (3) improved surveys of the people involved in health care in the home and their residential environments, and (4) development of tools for assessing the tasks associated with home-based health care.
Health Care Teamwork and Coordination
Frail elders, adults with disabilities, disabled veterans, and children with special health care needs all require coordination of the care services that they receive in the home. Home-based health care often involves a large number of elements, including multiple care providers, support services, agencies, and complex and dynamic benefit regulations, which are rarely coordinated. However, coordinating those elements has a positive effect on care recipient outcomes and costs of care. When successful, care coordination connects caregivers, improves communication among caregivers and care recipients and ensures that receivers of care obtain appropriate services and resources.
To ensure safe, effective, and efficient care, everyone involved must collaborate as a team with shared objectives. Well-trained primary health care teams that execute customized plans of care are a key element of coordinated care; teamwork and communication among all actors are also
essential to successful care coordination and the delivery of high-quality care. Key factors that influence the smooth functioning of a team include a shared understanding of goals, common information (such as a shared medication list), knowledge of available resources, and allocation and coordination of tasks conducted by each team member.
Barriers to coordination include insufficient resources available to (a) help people who need health care at home to identify and establish connections to appropriate sources of care, (b) facilitate communication and coordination among caregivers involved in home-based health care, and (c) facilitate communication among the people receiving and the people providing health care in the home.
The application of systems analysis techniques, such as task analysis, can help identify problems in care coordination systems and identify potential intervention strategies. Human factors research in the areas of communication, cognitive aiding and decision support, high-fidelity simulation training techniques, and the integration of telehealth technologies could also inform improvements in care coordination.
Recommendation 8. The Agency for Healthcare Research and Quality should support human factors–based research on the identified barriers to coordination of health care services delivered in the home and support user-centered development and evaluation of programs that may overcome these barriers.
Medical Device Database
It is the responsibility of physicians to prescribe medical devices, but in many cases little information is readily available to guide them in determining the best match between the devices available and a particular care recipient. No resource exists for medical devices, in contrast to the analogous situation in the area of assistive and rehabilitation technologies, for which annotated databases (such as AbleData) are available to assist the provider in determining the most appropriate one of several candidate devices for a given care recipient. Although specialists are apt to receive information about devices specific to the area of their practice, this is much less likely in the case of family and general practitioners, who often are responsible for selecting, recommending, or prescribing the most appropriate device for use at home.
Recommendation 9. The U.S. Food and Drug Administration, in collaboration with device manufacturers, should establish a medical device database for physicians and other providers, including pharmacists, to use when selecting appropriate devices to prescribe or recommend
for people receiving or self-administering health care in the home. Using task analysis and other human factors approaches to populate the medical device database will ensure that it contains information on characteristics of the devices and implications for appropriate care recipient and device operator populations.
Characterizing Caregivers, Care Recipients, and Home Environments
As delivery of health care in the home becomes more common, more coherent strategies and effective policies are needed to support the workforce of individuals who provide this care. Developing these will require a comprehensive understanding of the number and attributes of individuals engaged in health care in the home as well as the context in which care is delivered. Data and data analysis are lacking to accomplish this objective.
National data regarding the numbers of individuals engaged in health care delivery in the home—that is, both formal and informal caregivers—are sparse, and the estimates that do exist vary widely. Although the Bureau of Labor Statistics publishes estimates of the number of workers employed in the home setting for some health care classifications, they do not include all relevant health care workers. For example, data on workers employed directly by care recipients and their families are notably absent. Likewise, national estimates of the number of informal caregivers are obtained from surveys that use different methodological approaches and return significantly different results.
Although numerous national surveys have been designed to answer a broad range of questions regarding health care delivery in the home, with rare exceptions such surveys reflect the relatively limited perspective of the sponsoring agency. For example,
- The Medicare Current Beneficiary Survey (administered by the Centers for Medicare & Medicaid Services) and the Health and Retirement Survey (administered by the National Institute on Aging) are primarily geared toward understanding the health, health services use, and/or economic well-being of older adults and provide no information regarding working-age adults or children or information about home or neighborhood environments.
- The Behavioral Risk Factors Surveillance Survey (administered by the Centers for Disease Control and Prevention, CDC), the National Health Interview Survey (administered by the CDC), and the National Children’s Study (administered by the U.S. Department of Health and Human Services and the U.S. Environmental Protection Agency) all collect information on health characteristics, with limited or no information about the housing context.
- The American Housing Survey (administered by the U.S. Department of Housing and Urban Development) collects detailed information regarding housing, but it does not include questions regarding the health status of residents and does not collect adequate information about home modifications and features on an ongoing basis.
Consequently, although multiple federal agencies collect data on the sociodemographic and health characteristics of populations and on the nation’s housing stock, none of these surveys collects data necessary to link the home, its residents, and the presence of any caregivers, thus limiting understanding of health care delivered in the home. Furthermore, information is altogether lacking about health and functioning of populations linked to the physical, social, and cultural environments in which they live. Finally, in regard to individuals providing care, information is lacking regarding their education, training, competencies, and credentialing, as well as appropriate knowledge about their working conditions in the home.
Better coordination across government agencies that sponsor such surveys and more attention to information about health care that occurs in the home could greatly improve the utility of survey findings for understanding the prevalence and nature of health care delivery in the home.
Recommendation 10. Federal health agencies should coordinate data collection efforts to capture comprehensive information on elements relevant to health care in the home, either in a single survey or through effective use of common elements across surveys. The surveys should collect data on the sociodemographic and health characteristics of individuals receiving care in the home, the sociodemographic attributes of formal and informal caregivers and the nature of the caregiving they provide, and the attributes of the residential settings in which the care recipients live.
Tools for Assessing Home Health Care Tasks and Operators
Persons caring for themselves or others at home as well as formal caregivers vary considerably in their skills, abilities, attitudes, experience, and other characteristics, such as age, culture/ethnicity, and health literacy. In turn, designers of health-related devices and technology systems used in the home are often naïve about the diversity of the user population. They need high-quality information and guidance to better understand user capabilities relative to the task demands of the health-related device or technology that they are developing.
In this environment, valid and reliable tools are needed to match users with tasks and technologies. At this time, health care providers lack the
tools needed to assess whether particular individuals would be able to perform specific health care tasks at home, and medical device and system designers lack information on the demands associated with health-related tasks performed at home and the human capabilities needed to perform them successfully.
Whether used to assess the characteristics of formal or informal caregivers or persons engaged in self-care, task analysis can be used to develop point-of-care tools for use by consumers and caregivers alike in locations where such tasks are encouraged or prescribed. The tools could facilitate identification of potential mismatches between the characteristics, abilities, experiences, and attitudes that an individual brings to a task and the demands associated with the task. Used in ambulatory care settings, at hospital discharge or other transitions of care, and in the home by caregivers or individuals and family members themselves, these tools could enable assessment of prospective task performer’s capabilities in relation to the demands of the task. The tools might range in complexity from brief screening checklists for clinicians to comprehensive assessment batteries that permit nuanced study and tracking of home-based health care tasks by administrators and researchers. The results are likely to help identify types of needed interventions and support aids that would enhance the abilities of individuals to perform health care tasks in home settings safely, effectively, and efficiently.
Recommendation 11. The Agency for Healthcare Research and Quality should collaborate, as necessary, with the National Institute for Disability and Rehabilitation Research, the National Institutes of Health, the U.S. Department of Veterans Affairs, the National Science Foundation, the U.S. Department of Defense, and the Centers for Medicare & Medicaid Services to support development of assessment tools customized for home-based health care, designed to analyze the demands of tasks associated with home-based health care, the operator capabilities required to carry them out, and the relevant capabilities of specific individuals.
Association for the Advancement of Medical Instrumentation. (2009). ANSI/AAMI HE75:2009: Human factors engineering: Design of medical devices. Available: http://www.aami.org/publications/standards/HE75_Ch16_Access_Board.pdf [April 2011].
Self-Determination Housing Project of Pennsylvania, Inc. (n.d.) Promoting visitability in Pennsylvania. Available: http://www.sdhp.org/promoting_visitability_in_pennsy.htm [March 30, 2011].