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Taking all recommended secondary prevention cardiac medications and fully participating in a formal cardiac rehabilitation program significantly reduces mortality and morbidity in the year following a heart attack. However, many people who have had a heart attack stop taking some or all of their recommended medications prematurely and many do not complete a formal cardiac rehabilitation program.
The objective of our study was to develop a user-centered, theory-based, scalable intervention of printed educational materials to encourage and support people who have had a heart attack to use recommended secondary prevention cardiac treatments.
Prior to the design process, we conducted theory-based interviews and surveys with patients who had had a heart attack to identify key determinants of secondary prevention behaviors. Our interdisciplinary research team then partnered with a patient advisor and design firm to undertake an iterative, theory-informed, user-centered design process to operationalize techniques to address these determinants. User-centered design requires considering users’ needs, goals, strengths, limitations, context, and intuitive processes; designing prototypes adapted to users accordingly; observing how potential users respond to the prototype; and using those data to refine the design. To accomplish these tasks, we conducted user research to develop personas (archetypes of potential users), developed a preliminary prototype using behavior change theory to map behavior change techniques to identified determinants of medication adherence, and conducted 2 design cycles, testing materials via think-aloud and semistructured interviews with a total of 11 users (10 patients who had experienced a heart attack and 1 caregiver). We recruited participants at a single cardiac clinic using purposive sampling informed by our personas. We recorded sessions with users and extracted key themes from transcripts. We held interdisciplinary team discussions to interpret findings in the context of relevant theory-based evidence and iteratively adapted the intervention accordingly.
Through our iterative development and testing, we identified 3 key tensions: (1) evidence from theory-based studies versus users’ feelings, (2) informative versus persuasive communication, and (3) logistical constraints for the intervention versus users’ desires or preferences. We addressed these by (1) identifying root causes for users’ feelings and addressing those to better incorporate theory- and evidence-based features, (2) accepting that our intervention was ethically justified in being persuasive, and (3) making changes to the intervention where possible, such as attempting to match imagery in the materials to patients’ self-images.
Theory-informed interventions must be operationalized in ways that fit with user needs. Tensions between users’ desires or preferences and health care system goals and constraints must be identified and addressed to the greatest extent possible. A cluster randomized controlled trial of the final intervention is currently underway.
A heart attack is typically a major, frightening event in a person's life. It can be difficult for people to recover and get back to their previous activities. One challenge to full recovery is that many people are not able to follow or choose not to follow all medical recommendations, including taking 4 to 5 daily secondary prevention cardiac medications and participating in cardiac rehabilitation. Without these secondary prevention treatments, approximately 10 out of every 100 people who have had a heart attack or related event will die in the year following the event [
There are a number of reasons why taking all recommended medications and participating in cardiac rehabilitation may be challenging for people. Some of these reasons occur at the system or societal level; for example, the timing and location of cardiac rehabilitation may present difficulties and social determinants of health such as income level may present barriers, even in a country with a publicly-funded health system [
This study builds upon a prior study in which we aimed to address potential knowledge gaps relevant to medications at the patient, family physician, and pharmacist levels [
In this study, we aimed to build upon these previous findings by developing mailings with targeted content at different time points over the course of a year following a heart attack, focusing on communicating key information in an understandable, emotionally acceptable, and compelling manner. Our previous, smaller-scale intervention focused primarily on providing knowledge and was not designed to address potential additional barriers to taking medication. Thus, in this intervention, we also sought to address a range of determinants of adherence beyond a potential lack of knowledge and to do so at more than a single time point. As described in detail elsewhere [
In this paper, we describe our development process and iterative design methods [
We gathered an interdisciplinary research team with experience in health behavior change, knowledge translation, cardiology, primary care, and the design and evaluation of evaluation of health communication materials. Based on our prior mixed methods work exploring psychological determinants of adherence among patients who have had a heart attack [
We used the Health Action Process Approach and Theoretical Domains Framework as a basis for identifying behavior change techniques linked to key determinants and the behavior change techniques taxonomy version 1 [
Behavior change techniques used.
Theoretical construct or domain | Behavior change techniques |
Risk perception | Information about health consequences |
Outcome expectancy | Information about health consequences |
Information about social and environmental consequences | |
Credible source | |
Comparative imagining of future outcomes | |
Self-efficacy | Verbal persuasion about capability |
Vicarious consequences | |
Instruction on how to perform the behavior | |
Social support | Social support (practical) |
Social support (unspecified) | |
Intention | Goal setting (outcome) |
Memory, attention, and decision processes | Prompts or cues |
Action planning | Action planning |
Coping planning | Problem solving |
Behavioral regulation | Self-monitoring of behavior (optional) |
Adding objects to the environment (optional) | |
Nonspecific reward (optional) |
Researcher team members partnered with a design firm to engage in an iterative design process. The design firm’s team included a person with significant lived experience as a patient who had served as a patient advisor to multiple organizations. Designers worked with the research team to develop theme boards to guide the visual design of materials. The design firm also led additional user research, that is, research to better understand the needs, contexts, and goals of people who would use the materials. This user research informed the development of personas to guide the design of the content of materials to deliver intended behavior change techniques. Personas are archetypes—not stereotypes—of potential users [
Cardiology team members (JDS, MN) identified potential participants from their cardiology practice roster in Southern Ontario that matched, to the extent possible, the various personas and recruited them to the study. A patient partner with design expertise (ENA) met with consenting study participants at Hamilton General Hospital. Patients were offered a Can $20 gift card to a common coffee shop chain in appreciation of their time and effort. This study was approved by the Hamilton Integrated Research Ethics Board (02-245).
We used a think-aloud approach in which users were asked to articulate their thoughts as they used or reviewed materials [
We transcribed interviews verbatim, and the study team reviewed transcripts for key themes that could inform design changes using data from both think-aloud and interviews to develop interpretations based on users’ verbal reactions to materials, researchers’ observations of participants’ nonverbal reactions, and participants’ responses to questions about both their cognitive and emotional responses. Following each set of user testing sessions, the design team prepared a presentation for the larger research team. The whole team met to discuss usability or other problems identified during user testing sessions, assessing the severity of problems and the feasibility of different ways of addressing such problems and grounding these discussions in the context of other available evidence and the overall study goals.
Out of the 15 eligible patients we attempted to recruit, 10 agreed to participate. The spouse of one of the patients also participated. Participants were thus 10 people who had had a heart attack within the past year (5 men, 5 women) and 1 spouse (a woman) of one of the patients. Patients’ mean age was 57 years (range 31-70 years).
The user testing revealed key tensions to be negotiated during the design process. First, in a number of instances, users expressed a desire to remove operationalizations of behavior change techniques that have previous evidence of their efficacy. Second, the ethical imperative of supporting evidence-informed decisions aligned with the preferences and goals of each patient was sometimes at odds with the overall goal of encouraging particular behaviors. Third, logistical constraints made it infeasible to enact some of the changes requested by users. The full, final set of developed mailings is available in
One significant source of tension occurred when potential users’ responses conflicted with evidence about what works to support behavior change. For example, we observed this tension around patients’ responses to embedded problem-solving (coping planning) exercises within the mailings. This behavior change technique was operationalized to be consistent with the evidence supporting the use of volitional help sheets, which present prepopulated lists of barriers to action and solution to these barriers. Completion of a volitional help sheet involved users completing tasks such as drawing lines between a prespecified barrier (eg, “If I can’t get to my pharmacy when it’s open...”) and solution that best applies to them (eg, “... then I will call about delivery options.”). Problem solving and volitional help sheets have strong theoretical grounding and empirical evidence supporting their use [
To address this tension, we analyzed and discussed user comments during testing and interviews to identify a potential root cause of the tension—users lacked a motivating reason to complete the exercise. We therefore highlighted the evidence supporting such exercises with brief explanations, “Research shows...” that connected the exercises to staying on track and thus avoiding dying due to a second heart attack (see
Final action planning and coping planning spread, patient booklet: month 1.
Final coping planning spread, patient booklet: month 5.
The appropriate method for presenting information about choices, including their risks and benefits, depends on one’s communication goals [
Our initial designs were closer to the informative end of the informative-persuasive spectrum. As our design evolved and as the research team considered users’ reactions to prototype materials, designs ultimately moved more toward persuasive communication. For example, we initially presented the choice to take medications or not to take them as somewhat visually equivalent by presenting 2 possible paths to follow (
The design team also initially attempted to convey statistics about mortality in the year following an acute coronary syndrome event using an abstract icon array with random dispersion of events (
Initial figure for path choice, patient booklet: month 1.
Final figure for path choice, patient booklet: month 1.
Initial figure (also see
Revised figure for mortality statistics, patient booklet: month 1.
The nature of the planned intervention (standardized printed materials) and the context in which it was to be implemented generated some important tensions. Some expectations and needs related to imagery and content were able to be addressed or partially addressed, but others about the timing of the materials were not.
Designing static, paper booklets that could suit all potential users was a challenge when it came to imagery and other design decisions. Many emerging methods that have been shown to optimally support comprehension of health information, informed choice, and behavior change involve digital tools [
Users also found
I think it should be more of a variety of people...you look at them and you know they’re older people...maybe...it should be parent child and grandparent...so that it shows you that it’s possible for anybody (to have a heart attack).
While constrained by the inability to tailor images to individual users, we addressed the perceived discordance between intervention imagery and participants’ self-image by changing the abstract human figures. In subsequent testing, revised figures were deemed more relatable and revised content more understandable (
User testing revealed an important missing element regarding the source of the mailings. Participants articulated their thoughts:
I’m wondering, who is this content from? One of the vital pieces of information for me, and I think probably other people, is more about who is sending me this? What’s the organization/association/ hospital/cardiologistis it the Ministry of Health?
It could be the Heart and Stroke Foundation sweepstake thing
Participants revealed that when they receive mail with the logo of the hospital, they may assume it is a fundraising campaign and may not even open the envelope. We therefore added specific imagery (
The early prototype for an introductory page (
In contrast, some user needs and expectations could unfortunately not be addressed due to contextual factors including logistical constraints. For instance, many patients suggested that the first booklet should arrive at the time of hospital discharge, stating:
You need to hit the knowledge gap. This needs to come right after or in hospital.All of this would have been maybe useful right at the beginning
This comes too late (...) I got my pills the first day. You have to have that sorted
However, such timing was not technically feasible to implement at scale.
Furthermore, iteratively developing an intervention to the extent we believed would be ideal—including conducting multiple iterative cycles with users beyond a single site—would have left insufficient time to run the cluster randomized controlled trial within the 3 years allocated to the project. We partially addressed this by planning and undertaking rapid iteration and applying design findings from 1 set of evaluations across multiple mailings, increasing efficiency. For example, following potential users’ responses to imagery in the first mailing, we adapted the images in all subsequent mailings as well.
Initial figure for opening pages of patient booklet: month 1.
Initial figure for “new normal” path, patient booklet: month 1.
Revised figure for opening pages of patient booklet: month 1.
Revised figure for “new normal” path, patient booklet: month 2.
Final version of goal setting spread, patient booklet: month 1.
Envelope for first mailing at month 1.
Signposts showing progress within series of mailings.
Relatively few quality improvement initiatives tested in trials are both theory-informed and formally user-tested [
First, we noted tension between users’ assessments and evidence of effectiveness. This finding emphasizes that what people like and what works may not always be the same. The role of designers is not to automatically add every feature that users request, nor to automatically remove any feature that users dislike. Rather, design methods require carefully observing how people respond to a prototype—verbally, nonverbally, behaviorally, emotionally, and otherwise—analyzing those observations and making adjustments to the materials accordingly.
Second, tensions between informative communication and persuasive communication need to be addressed when designing any health communication materials, but particularly in cases in which a medically preferable option exists. This element of tension occurred even within our research team, as some team members are more oriented toward informative communication and others toward persuasive communication. Related to this, we recognized an ethical tension in using design approaches to address an external goal. Treatment adherence as a measure of quality of care is a metric that matters to health care systems, researchers, and health care professionals; it may or may not matter to the individuals who are assigned the task of adhering to the plan. Design methods are well-suited to optimize users’ experiences according to their own individual goals, which may not be the same as goals externally imposed by a health care system. People may discontinue medications or not participate in cardiac rehabilitation for valid reasons. However, the demonstrated benefits of taking recommended medications and attending rehabilitation often align well with what matters to most people, namely, living longer with a higher quality of life. Therefore, we determined it was reasonable to suggest that if people are making a choice not to follow recommended practices, this choice ought to be fully informed by the available evidence, including evidence about ways that people can best implement behavioral changes in their lives.
Third, the tension between our initial imagery and patients’ reactions to it highlight that people’s acceptance of an intervention may depend on how well their self-perception is represented within it. For health communication materials incorporating visual depictions of potential users, user research should include issues of self-image, which may or may not be possible to address within the constraints of a research study. It remains a challenge to fit design approaches and methods within the bounds of feasibility of health care systems and health research projects. The lack of ability to deliver these materials when patients feel they would be most useful is a challenge to their ultimate effectiveness. Additionally, because design processes are not always predictable, fitting one within a tightly constrained timeline of a research project can present difficulties.
Although this work occurred in the context of paper-based mailings, the tensions presented here apply to design processes more broadly, including the design of Web-based applications. The challenge of finding the balance in responding to feature requests without falling into feature creep occurs regardless of format, as do the tensions of informative versus persuasive communication and adherence versus user experience. Although tailoring imagery to users is more technically feasible in a Web-based format, it requires, at minimum, a database of appropriate images, knowledge of each user’s characteristics, and a matching algorithm. Such requirements can be technically or logistically difficult to fulfill.
We note that mailings, like Web-based applications, have advantages and disadvantages for users, health systems, and also for the design and development process. In this project, the advantages of mailings included their feasibility and relatively low cost within a large health care system that does not yet have widespread Web-based options for patients. Many patients within this system, particularly those who are older or who live in rural or remote areas, may lack reliable Internet access or be uncomfortable using computers or mobile devices. The disadvantages of mailings in this project included lack of tailored content and lack of accessibility for users who have literacy or vision barriers. Using paper as a medium is practical on many levels but also makes approaches such as universal design more difficult. Our trial in progress will help determine whether automated phone calls can help those users who receive mailings but who face barriers to using them effectively. Finally, although the delay in receipt of the first mailing is primarily a function of the transfer of administrative data—a barrier that would exist within this system regardless of format—the delay is arguably longer for a first mailing due to the time required for mail delivery.
Our study has several limitations. First, all of our user testing took place at a single site, all in English, and with a small number of participants recruited by a study team member. Findings may or may not apply in other contexts or with participants who have no connection to the research team. Second, our randomized controlled trial evaluating these materials is currently underway and thus we do not yet know whether our approaches to the design tensions we identified resulted in materials that have desired effects. Third, the thematic groupings described here represent the authors’ judgment and the ability to confirm saturation of key themes was constrained by project timelines.
Tensions between research teams’ evidence and users’ views has been previously described, with 6 design approaches (participatory design, ethnography, lead user approach, contextual design, codesign, and empathic design) presented as offering different ways to address such tension [
Our tensions between informative and persuasive communication are situated within a body of literature reflecting the different approaches that are recommended for risk communication to achieve these 2 different goals [
Finally, our specific finding about the importance of self-image aligns with previous research demonstrating, for example, that people are more influenced by imagery that better reflects them [
Health care systems may not be optimally designed to support patients along their path to recovery after a heart attack. Our study explored whether health systems may be able to better support people in their recovery with a feasible, scalable approach: providing carefully designed educational booklets at specific time points. In designing such booklets by collaboratively working with patients as an interdisciplinary group of researchers and designers, our project revealed design tensions and possible ways to address those tensions. Teams developing similar materials may wish to use similar methods and may anticipate similar tensions requiring resolution. Particularly for teams developing interventions to encourage adherence, it is important to recognize that while the term adherence has largely replaced the previous term compliance, if the functional meaning of the word remains, “doing what others decide is best for you,” nothing has truly changed. Teams must identify and address root causes of tensions and focus on ensuring and highlighting alignment between individual and health care system goals.
Interview guide.
Final mailings.
We would like to thank all those who participated in user testing for their willingness to provide valuable feedback that may help others recovering from a heart attack. Financial support for this study was provided by a Capacity Award from the Health Systems Research Fund at the Ontario Ministry of Health and Long Term Care and by CIHR’s Strategy for Patient Oriented Research, through the Ontario SPOR Support Unit. The views expressed in this publication are the views of the research team and do not necessarily reflect those of the funder. The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report. HOW is supported by a Research Scholar Junior 1 career award from the Fonds de recherche du Québec – Santé. JMG is supported by a Tier 1 Canada Research Chair in Health Knowledge Transfer and Uptake. NMI is supported by a Canadian Institutes of Health Research New Investigator award.
HOW prepared the first draft of this report. JP, EN, IJ, and NMI provided additional details to the first draft. All authors contributed intellectual content to subsequent drafts of this manuscript, reviewed, and approved the final submitted version.
None declared.