Integrating participatory design and health literacy to improve research and interventions

3.1.Definitions

An early definition of health literacy from the World Health Organization [127] is “The cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand, and use information in ways which promote and maintain good health.” The American Medical Association [1] defined it as “The constellation of skills, including the ability to perform basic reading and numerical tasks required to function in the healthcare environment.” In 2004, the US Institute of Medicine (IOM) – now the National Academies of Science, Engineering and Medicine – advocated for a definition that has become the most standard one in the US: “the degree to which individuals have the capacity to obtain, process, and understand basic health information needed to make appropriate health decisions” [44]. Nutbeam [82] proposed three levels of competencies related to health literacy. In the lowest basic or “functional” level, an individual has a fundamental understanding of a health problem and the ability to comply with prescribed actions to remedy the problem. At an “interactive” level, a person has more advanced knowledge and skills to function in everyday society and the ability to seek out information in order to respond to changing needs. At the highest or “critical” level, a person has a significant level of knowledge, personal skills and confidence to manage their health, and the ability to take action to change the determinants of health in the environment.

Although early definitions focused on individual skills, the importance of contextual factors has been increasingly emphasized. For example, in its 2003 action plan objectives for Healthy People 2010, the U.S. Department of Health and Human Services emphasized that the concept of health literacy not only involves patients, but also providers, and organizations [113]. Although the IOM/NAM report proposed the above definition focused on individual skills, the report also acknowledged that health literacy is an interaction between the skills of individuals and the demands of health systems, and that there is a notable mismatch between them. The trend toward more contextual definitions highlights the multiple dimensions of health literacy, including the skills of healthcare providers to present information to individuals in a way that is understandable and actionable. The Calgary Charter [15] defined health literacy as:

In addition to increasing emphasis on interpersonal interactions between individuals and health educators and other providers, health literacy definitions are also highlighting the importance of healthcare and other community contexts. Kickbush and colleagues [46] proposed this definition: “The ability to make sound health decision(s) in the context of everyday life – at home, in the community, at the workplace, the healthcare system, the market place and the political arena. It is a critical empowerment strategy to increase people’s control over their health, their ability to seek out information and their ability to take responsibility.” This definition situates the phenomenon of health literacy within the public health social-ecological model, specifying the important associations of social and structural determinants of health. A new focus is to identify attributes of “health literate” healthcare institutions based on the degree to which they provide equal, easy, and shame-free access to and delivery of health care and health information [10,98]. Further, Freedman and colleagues [34] developed a definition for “public health literacy”: “the degree to which individuals and groups can obtain process, understand, evaluate, and act upon information needed to make public health decisions that benefit the community.”

In a systematic literature review, Sorensen and colleagues [107] identified 17 health literacy definitions. In their content analysis, they condensed definitions to six cluster areas: (1) competence, skills, abilities (cognitive, social, personal and communication skills, motivation, etc.); (2) actions (accessing, understanding, processing and making decisions about health information, etc.); (3) information and resources (including kinds of health information in multiple formats, and health-related services, etc.); (4) objective (promoting/maintaining health, becoming empowered, making health decisions, interacting with healthcare environments, etc.); (5) context (healthcare, home, community, workplace and political settings, etc.); and (6) time (across the life course). In a 2016 National Academy of Medicine report, Pleasant and colleagues [90] commented on the multidisciplinary and multidimensional nature of health literacy. They advocated for the development of a new definition of health literacy that provides “a description of this multidimensionality; an explanation of a variety of settings and modes and media; and the unique psychological impact of health literacy on empowerment and health decisions.”

3.2.Health literacy models, dimensions and new directions

The evolution of health literacy definitions is linked to expanding conceptual health literacy models. In their 2012 systematic review, Sorensen and colleagues [107] identified 12 models and their dimensions and analyzed their similarities and differences. Models included many core health literacy factors: individual capacities related to knowledge, information access, reading, listening, speaking, numeracy, memory, healthcare navigation, and critical health decision-making. Some models incorporated behavioral factors such as health risk behaviors, use of healthcare, and medication adherence. These factors are considered important within the “medical health literacy” models that focus on individuals’ abilities for self-care and interacting effectively within healthcare systems. Other “public health literacy” models take a broader view and incorporate factors that go beyond personal health literacy factors to encompass determinants of health in a variety of societal situations [88]. These models have stronger emphasis on empowerment, advocacy, and group and community factors.

The models posit a wide range of antecedents and consequences of health literacy [107]. In addition to the above-mentioned capacities, antecedents include wide range of demographic, psychosocial, cultural, media use, past health experience/knowledge, social support, and social capital factors that influence a person or groups’ health literacy status. The models conceptualize that higher health literacy can result in more positive attitudes, higher motivation and self-efficacy, improved health status, improved health behaviors, lower healthcare costs, less frequent use of healthcare services, improved healthcare systems, etc. Consequences range from those at the individual level to community and societal levels, such as positive effects on social capital, intergenerational community empowerment, on (other) determinants of health, and on health equity.

The evolving definitions, conceptual models and dimensions are an impressive achievement for the relatively new field of health literacy, but important gaps remain. Sorensen and colleagues [107] suggest that these models can be improved to: 1) include more comprehensive factors related to existing knowledge about health literacy; 2) better integrate factors in “medical” and “public health” perspectives; 3) acknowledge that health literacy is not static, but rather changes over the life course; and 4) develop stronger causal pathways between antecedents and consequences [84]. They propose a new model (see their Fig. 1) that conceptualizes social, environmental, situational and personal determinants of health as antecedents, and health literacy as competencies to access, understand, appraise and apply health information as a patient in healthcare, disease prevention and health promotion domains. Their model includes individual, health system and societal consequences, with additional emphasis on empowerment, and notes that consequences reflect a process over the life course, and affect health sustainability and equity.

Just as Pleasant and colleagues [90] called for a new definition of health literacy that includes its unique psychological impact on empowerment and health decisions, conceptual frameworks should also illustrate how health literacy and other determinants of health promote or hinder motivation, empowerment, self-efficacy and behavior change. Although some health literacy conceptual frameworks include these factors either as an antecedent, a health literacy “capacity,” or a consequence of health literacy, the pathways are still vague, and many are still focused on cognitive, skills-based factors. Because some research shows that “patient activation” can compensate for low health literacy as an independent predictor of improved health behaviors, Hibbard [42] proposes that this factor be included in models. McCormack and colleagues [65] likewise call for expanding models to include various patient engagement factors.

As noted earlier, substantial research from the public health field of epidemiology shows that sense of control/empowerment is one of the strongest predictors of people’s health [64,103,122]. Therefore, epidemiological research and models can greatly contribute to building out health literacy models, as can research from other disciplines, like psychology [119] and behavioral sciences. Taking an even broader view, Logan [59] cites the need for an expanded, multidimensional conceptual framework that integrates health literacy and multiple other determinants of health to posit how they overlap and how they affect health disparities and health inequities. Because health literacy is a powerful determinant of health and mediates of determinants of health, a new model could identify unique health literacy pathways for interventions that could reduce health disparities.

4.1.Results of health literacy interventions research

Although results are uneven, many studies of health information using health literacy principles show improvements in patients’ comprehension and/or behavioral outcomes [3,9,39,45,70,78,100,101,110,124,129]. Taggert and colleagues [112] found overall positive outcomes in health literacy and behavioral risk factor reduction among a wide variety of healthcare and community interventions. Another promising intervention area is applying health literacy strategies to improve medication adherence and medical device use. Some studies are showing that interventions that simplify medication labeling and instructions, combined with improved patient engagement are associated with better medication adherence and proper device use [4,9,91,100,104,105,124,128]. The US Food and Drug Administration and pharmaceutical companies are becoming increasingly active in health literacy research and interventions [33,77,104,126].

Although research about healthcare provider interactions with patients (“oral health literacy”) is at an early stage, a recommended technique is “teach back” (or, “teach to goal”) in which providers assess patient’s comprehension of important information and clarify it as needed, is showing some positive results [6,100]. Research about “health literate” systems and is nascent, but growing [97,98]. Likewise, community-level (“public health”) health literacy efforts are at an early stage, but are showing positive results [39,70,87–89]. Community-level interventions show promise to move health literacy efforts “upstream” to prevent disease and promote health.

The AHRQ [9] review assessed health literacy interventions among 42 interventions that met study design criteria. Among this relatively small pool of intervention studies, the review found uneven, and as yet “low” or “insufficient” evidence for efforts intended to redesign information for better comprehension. There was moderate evidence for positive effects of mixed interventions on healthcare use, intensive self-management interventions on behavior, and disease management interventions on disease prevalence/severity. Evidence was mixed and “insufficient” about the effects of health literacy interventions on knowledge, self-efficacy, and quality of life, and costs. The report suggested these priorities to advance the design features of interventions: testing novel approaches to increase motivation, techniques for delivering information orally or numerically, “work around” interventions such as patient advocates; determining the effective components of already-tested interventions; determining the cost-effectiveness of programs; and determining the effect of policy and practice interventions.

4.2.Gaps and new directions for health literacy interventions research

Overall, health literacy intervention research shows positive, but uneven results and an updated systematic review is needed to encompass more recent efforts. Examination of basic research and interventions research in health literacy indicates important gaps. Conceptual models need to be built out to incorporate more determinants of health and their relationship to health literacy factors, including identification of mediating and moderating variables that affect health outcomes and disparities. More examination is needed of non-cognitive variables, such as motivation and self-efficacy and their relationship to health behaviors and health/quality of life outcomes. For example, it has been frustrating to learn that even with all the important health literacy principles applied to health communications, not all “health literate” information has been shown to improve people’s comprehension, and evidence is still sparse about whether it significantly increases positive health behaviors. Health literacy design principles do not include all the factors that affect people’s interest in, comprehension of, motivation, and ability to use health information to make changes [77,78]. Similarly, “oral health literacy” interventions to improve patient-provider communication, do not always show significant outcomes in desired behaviors. This may be related to many factors, such as the patient’s anxiety in an examining room, non-verbal behavior of healthcare providers, lack of visual tools to accompany the oral communication, or lack of social support from a family member. Likewise, in these situations, a person’s health concerns may be secondary to other important issues they are dealing with in their lives.

Currently, important work is underway to define attributes of “health literate” healthcare settings engage and support patients [10]. These factors include recommendations from health literacy research such as improving the design of information resources, patient-provider communication, signage, etc. However, it will be challenging to identify many other factors that are not yet clear in the literature: What exactly is a “shame-free environment?” What colors, sounds, spaces and designs in the setting calm and engage people? How can information be presented in the setting that intrigues people to interact with it, search out their own questions, and become more “activated” to make and carry out health decisions? A deeper question is: How do researchers and practitioners even know what questions to ask? In my view, the lack of intensive participation of the users has been a major impediment to designing, implementing and evaluating more powerful health literacy interventions. The AHRQ report [9] recommends that investigators pilot test new interventions, but this is quite different from engaging users from the start as co-designers. Although health literacy models and principles offer helpful guidance and tools, researchers themselves cannot specifically define what helps or hinders people from making healthy changes within their multiple contexts and what actions would further health equity [60]. Fortunately, there is a growing body of research about the value of participatory design to improve health communication interventions, and some early guidance about applying these strategies to health literacy initiatives.

5.1.Origin and scientific foundation of participatory design in social sciences

Theories and methods of participatory design have emerged over the past 60 years from multiple disciplinary roots. In the field of health promotion, participatory design is typically traced to its social science origins. Beginning in the middle of the last century, social scientists began to critique definitions and models of health as overly focused on clinical risk factors and medical treatment, rather than on broader health promotion within socio-ecological models, such as sociologist Aaron Antonovsky’s model of “salutogenesis” [2]. Scholars were also concerned about the tension between investigators’ agendas vs. people’s needs, such as researchers’ motivation to create constructs and publish papers rather than collaboratively engage in transformational actions to benefit groups. They thought the investigator-directed approach limited the theoretical understanding of conceptual models of health as well as empirical methods develop effective interventions. For example, Antonovsky criticized researcher-created health models as too focused on individual comprehension of health knowledge, rather motivational factors with social contexts.

Sociologist Kurt Lewin created the concept of “action research” in 1946 [56]. He described it as “a comparative research on the conditions and effects of various forms of social action and research leading to social action” that uses “a spiral of steps, each of which is composed of a circle of planning, action and fact-finding about the result of the action.” Reason and Bradbury [93] described action research as “an interactive inquiry process that balances problem solving actions implemented in a collaborative context with data-driven collaborative analysis or research to understand underlying causes enabling future predictions about personal and organizational change.” Related models that integrate highly collaborative research and action models include participatory action research and community-based participatory research [16,66,94]. These models emphasize “research for action” and “action for research, and engage researchers and community members as co-collaborators. They highlight the importance of using multiple qualitative methods in specific contexts, rather than quantitative methods to generalize research across contexts, as does traditional research. Action research, especially community-based participatory action research, generally involves long-term processes of community-researcher engagement, problem identification, reflection and intervention development, implementation and revision [66].

5.2.Origin and scientific foundation of participatory design in design sciences

Although researchers and practitioners in health communication/health literacy fields are more familiar with models and methods of participatory design derived from social sciences, participatory design also emerged in parallel through socio-technical sciences and offers important theoretical and methodological guidance. Architect and designer Buckminster Fuller introduced the term “design science” (the study of design) in 1963 [35]. Design science is considered one of three major categories of the systematic study of knowledge (epistemology); the others are the natural sciences and the human sciences [36]. In the natural sciences (e.g., physics, chemistry), researchers seek law-based explanations about phenomena in the natural world and assume that this knowledge can be generalized to multiple settings. This was the dominant scientific paradigm until the mid-20th century. At that time, the human, or interpretive, sciences emerged and are considered the second epistemological paradigm [28]. This research perspective includes social sciences and humanities, and acknowledges that because human phenomena are not as predictable or generalizable as are natural science laws, they should be studied using multiple methods in many settings [19].

Design sciences, or “sciences of the artificial” are concerned “not with how things are, but with how they might be” [102]. In design sciences, researchers study human-created (artificial) objects and phenomena intended to solve problems and meet goals. These artifacts can be symbols, material objects, activities, services, and learning or living environments [13] – such as health care and health literacy interventions. Design science fields include engineering, information systems, architecture, computer science and other primarily “socio-technical” fields. Because design sciences focus on things that do “not yet exist,” they specifically address the so-called “wicked” nature of problems [13]. In this situation, problem understanding and problem solving should happen concurrently, and there is no end to identifying problems and refining designs. Therefore, researchers should not predict solutions or hypothesize outcomes too early, but rather conduct iterative, problem identification-problem solution processes. Because of their complexity across social-ecological contexts, most health problems, such as those related to health literacy, can be considered “wicked.”

The epistemological differences between design sciences, and natural and human sciences are reflected in differences in research goals, overall research design and methods [61]. Because the goal of design science inquiry is on inductive problem solving, research is focused on studying processes to arrive at a solution. In contrast, research in both the natural and human sciences is traditionally focused on predicting and testing theories. This is an important distinction because design science research is not aligned with the traditional requirements that researchers define theories, hypotheses, interventions and analysis plans before a project is funded. Human and design sciences overlap in the area of participatory action research in which health and social interventions are collaboratively developed and studied iteratively [66,75]. From the design science perspective, participatory (or user-centered) design has been defined as “an approach to the assessment, design and development of technological and organizational systems that places a premium on the active involvement of… potential or current users of the system in design and decision-making processes” [18].

5.3.Design science methods

There are also methodological differences among the three research paradigms. Methods in natural sciences are primarily observational and quantitative, whereas those in human science are more mixed, qualitative and researcher-participative. Design science methods are mostly qualitative, user-intensive, and emphasize “problem and solution” and “build and evaluate” loops [62], as shown in Fig. 1 [95].

Fig. 1.

The general design process (Roschuni, 2012). Celeste Nicole Roschuni. Reproduced by permission of Celeste Nicole Roschuni. Permission to reuse must be obtained from the rights holder.

In the problem development cycle in Fig. 1, data are gathered from users and other sources, analyzed, and used to define problems and needs. In the solution development cycle, ideas are generated to build and test prototypes with users. Iterative feedback loops are used within and between the cycles. Although there is no theoretical end to problem identification and solution, there is a point where researchers and developers finalize and deploy a solution when it reaches the users’ key specifications. For example, for a health literacy materials-based intervention, user criteria might include content and format that are attractive, navigable, comprehensible, motivating, culturally appropriate, and actionable. In addition to involving users intensively, communication with other stakeholders is also important. A health literacy intervention might require that researchers, healthcare providers, members of community organizations, policymakers or others collaborate with users on the identification of specifications, barriers to implementation, and evaluation design. Evaluation and later revisions of the “solution” (prototype) continue over time using this process. Because design methods focus equally on building and evaluating solutions, evaluation is a continuous detailed process that starts at project initiation – in contrast with traditional “before” and “after” research designs. Although this conceptual model is intricate, it can guide rapid development of viable, user-designed solutions in a more pragmatic way than traditional approaches.

Design science as a form of scientific inquiry also subsumes the area known as “human factors research” which takes into consideration the interaction between the intended users and the products, systems or processes that are being designed – such as in engineering or medical informatics. Design science approaches are frequently referred to as “user-centered,” “human-centered,” or “human factors” design and include many techniques from multiple fields. “Usability testing” and “design thinking” are two commonly used methods. As mentioned earlier, even though participatory action research and community-based participatory research are traditionally considered under the human sciences branch of scientific inquiry, their methods often overlap, or are synergistic with, those in the design sciences. A positive trend is that researchers and practitioners from both human and design sciences are increasingly drawing on methods – outside their traditional disciplines – that share the commonality of engaging intended users in design and implementation. The Institute of Design at the University of California, Berkeley, is developing a repository of design methods called The Design Exchange (http://www.thedesignexchange.org) that will include many design methods and cases.

Design thinking methods originated at the Stanford University Institute of Design (http://dschool.stanford.edu) and include five stages: empathize with users, define issues, generate ideas, and prototype and test solutions. Note that the requirement to reach a deep level of empathy with users before moving on to other steps differs from traditional research strategies that begin with identifying problems. In early design thinking exercises, users and stakeholders engage in rapid problem and solution identification. These exercises are especially effective because both experts and end users participate as equals and processes are highly visual and interactive (i.e. teams draw solutions), rather than primarily cognitive and data-oriented, as in traditional health “program planning.” User-centered design is effective at individual, organizational, community and societal levels. Vechakul and colleagues [117] used these methods in a community-based project with new mothers.

Usability testing refers to a broad range of structured methods to engage users in designing communication materials [79,96]. Usability tests are often one-on-one situations that involve a tester asking a user to interact with a prototype, accomplish specific tasks related to it, and to recommend changes to it (such as to text, format, and graphics for a health communication resource). The prototype is then revised with participant input. Usability testing should continue until additional tests no longer elicit major new issues or recommendations. As participatory design becomes more widespread in health and social sciences, methods are being drawn from both the human and design sciences. One difference is that user-centered design processes are typically rapid cycles of problem identification and solution creation, whereas participatory action research emphasizes longer-term community engagement. Decisions about which approach to use and/or how to combine these approaches should be made collaboratively with participants in the specific context of a project.

8.1.Participatory development of mass communication for Medicaid beneficiaries

The problem: in the US, highly vulnerable populations like seniors and people with disabilities participating in Medicaid (a US program for low-income beneficiaries) are required to make complex choices to select a health plan. In California in 2008, only 25% of these beneficiaries made active choices, given the major communication barriers they faced related to literacy, language, culture and disabilities and the overly complex document about health plans that they were expected to comprehend [38]. The State of California engaged our HRA staff to work closely with Medicaid beneficiaries and stakeholders to create a guidebook that would meet their needs.

We followed all the above steps to: identify and engage user subgroups and stakeholders; establish an Advisory Group; set health literacy and cultural competency standards and iteratively test and refine prototypes of the What Are My Medi-Cal Choices guide; adapt the final version into 13 languages; disseminate it to hundreds of thousands of beneficiaries; and evaluate the processes and outcomes. See Neuhauser & Rothschild et al. [78] for details including the use multiple participatory methods (in-depth interviews, Advisory Group feedback, usability testing, health literacy assessments, and quantitative evaluation). The integration of health literacy principles and continuous participatory design transformed the initial ineffective state resource into a successful guide that met highly nuanced needs and preferences of intended users. In addition, the project integrated qualitative methods with a randomized-controlled trial to examine efficacy [54]. The model has now been adapted to multiple health communication interventions for people on Medicaid. Among many lessons learned, we noted that even when a prototype guide adhered to all currently accepted health literacy principles, users proposed making further changes to about one-third to one-half of the document to suit their needs and preferences.

8.2.Participatory design of a community wellness project with Chinese factory workers

The problem: China has an estimated over 250 million “migrant workers” who are moving from rural areas into industrial zones. Most of the migrants are young, have low education levels (average 7th grade) and struggle to adjust to factory jobs in urban areas. These workers one of the most vulnerable groups in China, and have little knowledge about health issues or how to access health and social services. They suffer from high rates of depression, infectious diseases and unplanned pregnancies and abortions. Taking a broader view of “health,” the workers also have little knowledge about their rights at work and as non-residents of their new city, and they struggle to handle life issues (education, housing, social life, etc.). They feel they have few opportunities to change work or city policies.

Although supporting these workers is a key objective of the Chinese government, their “top down” efforts to engage workers have shown disappointing results. One reason is that the concept of health has been mostly focused on physical health and service access, rather than the broader social, structural and environmental determinants of health – especially worker empowerment. In 2011, HRA staff were invited by national and local government officials to apply our participatory design process to co-develop a project to support factory workers in Changzhou, a large industrial city with 1.5 million migrant workers. We were invited based on the success of our participatory efforts to work with Chinese Americans in California. That project created the Chinese Wellness Guide using the above steps.

We adapted the above six steps to the Changzhou context. Our first step was get “buy-in” about the participatory approach from key national and local government officials, health and social service providers, researchers from a local university, factory managers and others. To do that, our team conducted three participatory workshops over a one-year period to introduce the concepts of multiple determinants of health and the power of participatory design. Participants examined baseline research about workers’ health and social issues and then mapped out >50 determinants of health. Surprisingly, these determinants included low health literacy – not a common concept as yet in China. After securing buy-in and enthusiasm from these decision-makers, teams of workers from two factories joined the project. Several advisory committees were established including all worker and stakeholder groups who then identified problems and solutions. Though these processes, participants defined three novel interventions: creation of an easy-to-use Changzhou Wellness Guide covering a broad range of health and social issues, service access, tips for managing life issues; a “Wellness House” in each factory where workers could socialize, solve problems, and attend trainings; and a buddy system in which established workers help new workers.

The Changzhou Wellness Guide was created using the above steps. HRA health literacy experts trained participants on health literacy principles and iterative testing and revisions of prototypes. Workers and stakeholders created guide content and formatting and conducted multiple rounds of user testing and expert feedback. Professional stakeholders were amazed at the creativity, depth and practicality of workers’ ideas. After initial publication and use over one year, workers and stakeholders have revised the guide, using the same participatory methods and adhering to health literacy principles. In 2016, the project won the Institute for Healthcare Advancement’s International Award for Outstanding Achievement in Health Literacy. The project has expanded to 27 factories, each of which is using participatory design to contribute to the next edition of the guide and to create other interventions and catalyze city-wide policy changes. Researchers from the local university and HRA are collaborating with all participant groups (including workers) to design and conduct research about the process and effectiveness of the project. Early research findings suggest significant increases in worker knowledge, confidence, service connections and positive health behaviors.

We learned key lessons from this project. It was important to ground the project in a social-ecological model with comprehensive determinants of health, including health literacy. This project is also a good example of why health literacy factors are essential to consider in participatory projects and why participatory methods are essential to consider in health literacy projects – where health literacy issues must be explored by users in their contexts. Empowerment of workers, a core goal of this project, emerged through intensive participatory methods, and the gradual development of interventions they created. The key lesson is that if end users are engaged to create and implement interventions themselves, they will do so in a way that incorporates many highly nuanced factors that are not codified into health literacy design principles. They will also design interventions that take into consideration many social, structural and environmental determinants of health that affect them, but may not be obvious to researchers or practitioners, or included in a health literacy model.

For example, factory workers cited the lack of summer school opportunities for their children as an overarching problem that determined whether they would have to leave the factory before the summer. For many workers, this problem greatly superseded health problems. They solved the problem by advocating for and developing summer schools in the factories. Government stakeholders, disappointed by outcomes of prior projects, are eagerly embracing the participatory approach and the value of health literacy principles. Workers in the original project factories are now engaging with those in new factories to share methods and ideas. Our HRA team was able to offer guidance about health determinants, health literacy, participatory design and research through periodic visits, without “running” the project, as happens in many researcher-controlled projects. Because this is a long-term project, it is an example of integrating participatory action research and design science methods, and it spans both “medical” and “public health” health literacy models.

8.3.ChronologyMD mobile app

Crohn’s disease is a serious, incurable inflammatory bowel disease that affects over 600,000 people in the US. Good patient-provider communication about disease symptoms and severity is critical, but it is difficult for patients to keep track of multiple symptoms accurately each day and for their physicians to make life-saving treatment decisions based on that information. The ChronologyMD project used design science methods, health literacy principles and artificial intelligence components to engage patients with Crohn’s disease and their healthcare providers [75]. The project used a wide variety of participatory methods to enable patients with Crohn’s disease create a mobile application that would track their detailed “observations of daily living,” including symptoms and severity, mood, medication adherence, and behaviors (exercise, diet, etc.) to take more control over their health. Through artificial intelligence components, the app also passively collected biometric data, such as weight and sleep patterns, via connected wireless devices. With the participation of the patients’ healthcare providers, a second app was created to display these data over time to improve shared decision-making with patients.

Intensive participatory design methods were necessary to create the highly refined features that patients and providers needed for the information to be effective in managing Crohn’s disease. In addition, patients wanted and received an app that allowed them to design their own “observations of daily living” over time and assess interactions among variables such as symptoms, medication taking and behaviors. From a health literacy perspective, this highly iterative approach helped identify and address many communication barriers, such as easily inputting and understanding quantitative data (medication amounts, pain levels), and having simple displays of key information that could be understood quickly by patients and providers. Because of the iterative nature of the design, evaluation methods were also continuously revised so that interim findings could be used to constantly improve the intervention (as is done in the “build and evaluate” loops mentioned earlier). Findings from the pilot evaluation showed that the app enabled patients to greatly increase their input of symptoms and other data, better understand factors that helped or hindered their condition, and make positive changes. It also helped both patients and providers improve the quality of clinical encounters and shared decision-making. An important project lesson was that understanding of health literacy factors is at an early stage in the emerging and powerful field of artificial intelligence and health communication, and that participatory design is essential to every step of development.

8.4.Other participatory health literacy projects