Creating and testing regulatory focus messages to enhance medication adherence

Abstract

Objectives

Strategies were explored to improve patient adherence to cardioprotective medications by borrowing from a motivational framework used in psychology, regulatory focus theory. The current study is part of a larger randomized control trial and was aimed at understanding what written educational messages, based on patients’ regulatory focus tendency, resonated with each individual as a potential reminder to take medications. This study was also aimed at understanding why messages resonated with the patients.

Methods

Twenty veterans were tested for regulatory fitand presented with messages dependent on focus tendency. In-person semi-structured interviews were conducted to collect feedback of messages. An iterative analysis drawing primarily on matrix and reflexive team analyses was conducted.

Result

Six promotion and six prevention messages emerged, such as “team up with your provider to create a combination of medications to prevent illness” and “Live your best life – Take your medications”. Five themes related to types of health messages that spoke to patients’ regulatory fit were discovered: relatability; empowerment and control; philosophy on life; relationship with provider and medications; and vocabulary effect on the impact of messages.

Discussion

Motivational messages based on regulatory fit may be useful in improving patient medication adherence, leading to improved cardiovascular outcomes.

Keywords

Chronic illness and disability experiencing illness and narratives patient–physician relationship veterans medication adherence

Introduction

Patients with chronic conditions, such as cardiovascular disease, have lower adherence rates than patients with acute conditions.¹ Rates of medication adherence among patients with heart failure have ranged from 40% to 80%.² This lack of adherence is cause for concern as up to 64% of hospital readmissions for patients with cardiovascular diseases may be related to poor medication adherence.³ Both physicians and patients are important players in creating and following a medication regimen,^4,5 but the most effective techniques have not been discovered. Researchers have called for innovative strategies to increase adherence.⁶ This study utilized regulatory focus theory (RFT), a motivational framework from the field of psychology that identifies two motivational tendencies that guide a person’s self-regulation to attain a desired end-state: prevention and promotion⁷ to create motivational messages to improve adherence.

Current strategies to increase adherence

Multiple factors impact medication adherence including: (1) the health care system (lack of access, practice environment, electronic health record); (2) patient attributes (e.g. memory, knowledge, motivation, consequences of missing dosages, tolerance of side-effects, patients’ decision-making in response to medication regimens affecting other aspects of life), attitudes and beliefs, psychiatric conditions, and communication barriers; (3) regimen (e.g. side-effects, medication changes, lifestyle changes required); and (4) attributes of the provider (e.g. interaction style, time commitment, amount of patient support, knowledge, communication style (e.g. does it enable shared decision making)).^1,2,5,8–10 Furthermore, a patient’s identified priority may be different than their provider’s priority, or what the provider believes the patient should prioritize.¹¹ Factors in medication adherence must be thought of holistically to ensure all involved are held accountable to make improvements.¹⁰ Studies testing multifaceted interventions to improve health behaviors and medication adherence among patients with cardiovascular diseases have produced mixed results.^12–14

Interventions found to be successful are typically complex and labor intensive as they incorporate many different components that take a lot of time from providers and patients,⁵ like communication technologies, home monitoring, patient education, and frequent interactions with providers. Therefore, further investigations into innovative, simple, and individualized intervention strategies (e.g. reminders, social support, calls at home) are needed.^15–17 Strategies to increase medication adherence should be easy to implement at home so that it can easily fit into the patient’s lifestyle.¹¹ Often times, a patient may not feel motivated to take medications due to the negative effects it can have on their identity, or they feel they can manage their health in other ways. Therefore, providers should ask questions to understand what medication means to the patient and communicate how taking medication can help what is important to them.¹¹ This can then help build on strategies to increase the individual’s motivation to take medications in accordance to their life perspective. A simple innovative intervention focusing on patient motivation can help providers work with patients to build a medication regimen that they feel fits into their life, and becomes integrated into their lifestyle.

Motivational messages and regulatory focus theory

In the past, RFT has been utilized to improve intentions to follow prescribed behaviors.¹⁸ In RFT, promotion-focused person is concerned with advancement, growth, and accomplishment; to pursue positive outcomes.^7,19 In contrast, a prevention-focused person is concerned with protection, safety, and responsibility to avoid negative outcomes.⁷ Persuasive messages can be designed using regulatory fit, which may increase the impact of the health message.²⁰

The literature on health communications provides empirical evidence that regulatory fit plays an important role in designing persuasive health-related messages. Researchers found that messages characterized by regulatory fit were perceived as more persuasive than those characterized by misfit. When new information is presented in a way that coincides with individuals’ past experiences, the experiential effect of familiarity and fluency create a sense of “feeling right”, resulting in greater persuasion.²¹

A systematic review of 30 studies on the effects of regulatory fit on effectiveness of health communication further this evidence.²⁰ Anti-smoking advertisements were found to be most persuasive when regulatory focus of the message matched the regulatory focus of the intended audience compared to when the regulatory focus of the message and of the intended audience were incongruent.^22,23 However, a meta-analysis found that messages that was promotion-focused were more effective at encouraging prevention behaviors than prevention-focused messages and called for more research to understand situations in which prevention-focused messages may be more beneficial.²⁰ While RFT has been shown to be useful in health communication, and currently, no other studies have been found that utilized RFT in the context of medication adherence.

Current study question

The current study is part of a larger randomized control trial and was aimed at understanding what written educational messages, based on patients’ regulatory focus tendency, resonated with each individual as a potential reminder to take medications. This study was also aimed at understanding why messages resonated with the patients in order to use this information to develop and strengthen a medication adherence intervention for the randomized control trial. The description of that trial’s outcomes will be provided in a subsequent article. Veterans were used as the patient population for this study as they have been found to have higher rates of heart disease than the civilian population.²⁴ This study was approved by the Colorado Multiple Institution Review Board.

Methods

Creation of proposed messages

Twenty-two promotion- or prevention-focused medication adherence messages were developed by study personnel under the guidance of a regulatory focus expert. Promotion-focused messages were developed to be positive in nature and designed to motivate achievement and activate advancement toward a goal. These messages focused on the positive outcomes of medication adherence, such as: successful treatment effects, longer life, ability to be with family and friends, and ability to return to work.

Prevention-focused messages were designed to motivate avoidance of threats to security and safety. These messages focused on prevention of negative outcomes, such as: having to go to institutions for care, disease progression, further hospitalization, dying, and not being able to return to work. The original promotion and prevention messages are provided in Table 1 in the appendix.

Data collection

In order to capture a real-life sample of veterans, a convenience sample of participants for the study was recruited from a Midwestern Veteran Affairs’ outpatient cardiovascular clinic. Eligible patients had a chronic cardiovascular condition such as hypertension, ischemic heart disease, atrial fibrillation, or heart failure. They were approached in person in clinic and given a description of the study. If they agreed to participate they were consented.

Participants were given the Lockwood Scale to determine each individual’s chronic regulatory focus.²⁵ The Lockwood Scale consists of 18 questions on a 9-point scale from 1 (not at all true of me) to 9 (very true of me). Examples of questions are: “In general, I am focused on preventing negative events in my life” and “I frequently imagine how I will achieve my hopes and aspirations”. The Lockwood Scale was scored immediately after participants completed the survey to determine which messages (promotion or prevention) to present to them. Messages that matched the study participants’ chronic regulatory focus were then presented in a one-on-one interview. Participants were asked to rate each message on a rating scale from 1 (that isn’t effective/wouldn’t motivate me at all) to 5 (that is very effective/would greatly motivate me).

Semi-structured interviews were conducted in order to elicit feedback on the effectiveness of the messages. Participants were asked to provide their opinions for the messages that fit their regulatory focus and to offer suggestions to improve the messages. The interviews, 15–30 minutes in length, were audio-recorded and transcribed verbatim (see Appendix for interview guide). The interviews were brief due to the survey nature and were aimed to only illicit veteran feedback to inform the later randomized control trial. The messages were chosen as a result of the quantitative data, but the interviews helped provide additional information to ensure the strongest messages were retained and to help reword messages to make them stronger. Baseline demographics including age, sex, race, and cardiovascular diagnoses were obtained to characterize the study population and can be found in Table 2 in the appendix.

Data analysis

Quantitative responses to messages

Data analysis began with assessing the participant’s score on the Lockwood Scale. To determine the most popular messages and least popular messages, we collated the rating scale responses to the messages and calculated mean, median, and mode, which can be found in Table 1.

Qualitative responses to messages

An inductive and deductive toolkit of analytical strategies drawing primarily on matrix and reflexive analysis were used to analyze the qualitative data.^26,27 A collaborative matrix analysis was developed that allowed for the ability to see all participant responses in a row and column format. From this, responses were coded and common themes across the data were identified.²⁸ In order to establish validity and reliability in order to ensure themes represented what the data truly indicates, not what the researchers imagine, of each team member of the experienced qualitative team analyzed the initial two transcripts, and came to a consensus on coding, which defined the initial codebook and matrix analysis. Emergent codes were added throughout the analysis. The remaining interviews were divided for individual coding using Microsoft Word and comments. The team members then met with one another on different occasions to develop the themes based off of the codes.

The consistency of coding/interpretation was checked at weekly meetings and discrepancies were addressed through discussion and consensus. Quantitative results were compared with qualitative results to help guide and determine final messages. All analyses and findings were integrated and documented with an audit trail. An audit trail is used to verify the rigor of the work to collect the data. The process includes identifying dates, contacts, and processes to minimize bias and maximize accuracy, and report impartially.²⁸ Illustrative quotes were selected by consensus with all members of the analytic team to ensure representativeness across interviews, to ensure that we were expressing the views of multiple participants not just one or two. Through this analysis, the 12 strongest messages (six promotions and six preventions) were chosen based on the quantitative data backed by qualitative findings to be used in the next phase of the study and five themes emerged.

Results

The following qualitative and quantitative results include the creation of the final regulatory focus messages to be used in the randomized control trial, as well as the responses to messages from the described participants.

Quantitative findings

See Table 2 for further details on participant demographics.

To start, the participants’ Lockwood responses were calculated. The messages that yielded the highest mean scores on a scale of 1 to 5 were kept. Those with the lowest mean scores were discarded. We crafted prevention-oriented messages and created logically symmetrical promotion-oriented messages for participant reaction. For example, the promotion message, “Choose health – Take your medications,” corresponded to the prevention message, “Avoid health problems – Take your medications”.

Promotion messages

The final six promotion messages chosen for the next aim of the study were based on a mean score of at least 4 and qualitative responses from participants. Some messages were also reworded or combined with other messages based on participant reaction. The final messages can be found in Table 3 in the appendix.

Prevention messages

The final six prevention messages chosen for the next aim of the study were based on a mean score of at least 4, correspondence to promotion messages, and qualitative responses from participants. Some messages were reworded or combined with other messages based on participant suggestions. The final messages can be found in Table 3.

Themes

We examined the qualitative responses for each message with the highest mean scores to determine the final messages for the second aim of this study (Table 1), as described above. Five themes emerged through analysis of participant feedback as to why participants preferred specific messages. Examples of the messages will be presented throughout the themes.

Theme 1. Relatability

Overall, the participants responded strongly (either positively or negatively) to a message when they felt the message related to them or if they found the message to be truthful. For instance, in response to the promotion message “Live your best life – Take your medications”, they felt the messages could motivate them to take action for their health because it tapped into a true goal. One participant stated, “That is what I am starting to do and why I got into recovery” (Patient 1).

Furthermore, the message “Optimize your health! Use a reminder system to help you remember to take your medications” was found to be truthful and was relatable to most of the participants. They suggested that the message was valid because “some people” need reminder systems to remember to adhere to their medications. Others were self-reflective, identifying they were “at that age” where reminder systems are needed. They also described having their own forms of reminder systems, such as pill boxes, notices on their refrigerators, or friends and family members supporting them with reminders.

Participants indicated that they were more comfortable with messages that did not lead them astray. Many found messages that served as reminders of concrete consequences to be motivating. For example, prevention-oriented participants related to the prevention message: “Manage cardiovascular risk factors and avoid paying higher health care costs” as they described the message as truthful and comprehensive. One participant reported, “I like that it’s specific, if you don’t manage it, you will have to pay more” (Patient 5).

Consequently, claims that participants doubted were not motivating. For example, the message “Taking your medication at the same time each day creates a strong offense against disease” caused some participants hesitation. One participant responded, “I have no idea whether it creates a strong offense against disease…I wouldn’t think it was [true]…but I try to take my medicine every day” (Patient 15).

The reactions of study participants suggest that precise wording is important to adherence. Participants reported that the messages that did not mention their specific condition were less credible. They were also hesitant of the messages that implied a “cure” or an “end all” to the disease. One participant said, “Well, the disease is always there” (Patient 2). Another participant commented, “Medications don’t make me stronger, and that message gives the wrong impression” (Patient 11).

Interestingly, reactions to message content also differed by regulatory focus. Promotion-focused participants did not relate to the message “Manage cardiovascular risk factors and keep more money in your pocket” because saving money was viewed as not relevant to their condition. On the other hand, both prevention-focused individuals were motivated by the corresponding message about saving money.

Theme 2: Empowerment and control

Many participants said that it was important to feel a part of the decision-making process for their health and described themselves as being actively involved in their health care and in communicating with their doctors. Participants felt empowered to have these conversations with their providers. For instance, the most common consensus to the message, “Encourage your provider to create a powerful combination of medications for your health” was that a relationship with one’s provider is important and should be encouraged as it helps the participant gain a feeling of having control over their health choices. Others spoke of the importance of communication and the establishment of a working relationship with their provider. As one participant said about the message above:

I like it…it allows me to participate, says my opinion is valued, and I like the combination because we [he and his provider] just went through that. He’s adding a new med in combination with the others and I think it’s important to give your opinion to your provider. (Patient 1)

Although communication was important, some participants were uncertain of what that communication could do for them because they view the doctor as the expert. One participant said:

Yeah, you do have to talk to the provider but how much can they really do? […] I can encourage them to get the ball rolling […]what more could they do? I don’t know, cuz only they would know that. (Patient 15)

And still a few participants expressed doubt about their doctors listening to them and doubted their doctor wanted what was best for them.

I would say doctors don’t give you information…I feel like you have to hit them over the head to get them to talk to you. (Patient 3)

Good communication with providers also encouraged participants to gain control of their own health. In response to the message: “Take control of your health by remembering to take your medicine every day” one participant related this to the overall culture of veterans by reporting:

The message gives the sense that I am in charge and vets need that. We’ve received orders all our life. (Patient 1)

Conversely, other participants did not want that control and wanted their providers to make all the decisions as it was the provider’s responsibility. In this way, a few participants felt that their doctor should be creating the most powerful combination for them on their own volition. They felt it is the doctor’s responsibility to ensure they are receiving the best care.

Theme 3: Philosophy on life

Participants in the study often reflected that the messages agreed with their personal views and overall life philosophies. For instance, participants described “Live your best life – Take your medications” as being important because it leads to a positive way to live and many felt personally touched by the message, which made them feel good. Several described that this was their overarching goal in life, especially with their experiences and one’s diagnosis that can change their outlook on life and change what motivates them. To live their best life was why they took their medications.

If you don’t want to live your life best, then you’re your own worst enemy. I mean, everybody has medical problems […] but the problem lies is that if you don’t take advantage while your still breathing…you’ll never experience the joy of living. (Patient 10)

Furthermore, this theme reflected an overarching sentiment about “Veteran attitudes” in general. The participants shared a unique philosophy about their perspective of the “Veteran population” in regard to views on teamwork, achievement, and empowerment. These are values that have been found to resonate with veterans when thinking about what they see as important in their life. Specifically, most participants described liking the action oriented wording of “win the battle” and messages that implied working as a team. Messages related to “win the battle”, “strong offense”, “work with provider” and other such verbiage resonated with participants. Some of the participants spoke about how these messages reminded them of their military or veteran culture, which informs many veterans’ philosophies on life.

Theme 4: Relationships with providers and medications

Participants’ relationship with providers and medications became an apparent theme when describing their opinions of the medication adherence messages.

Some participants felt that it was important to be knowledgeable about the medications they were taking and that having open communication with one’s provider was an important step to healthy living. One stated:

You need to know what the meds are doing and how they are making you better. (Patient 15)

Others described bad experiences with medications and side-effects and some felt that medications would not help their situation or that they did not know what their medications were doing for them. Some made the point that medications are not a cure but are management.

It might not work […] if you have the disease in your system already, it’s not gonna make a difference (Patient 14)

Still others believed the health care system is too focused on allopathic medicine leading to being overmedicated. For example, one participant’s reaction to the message “Team-up with your provider to create a combination of medications to prevent illness” was:

There’s one problem. The doctors, they want to give you medication. As soon as you walk in the doctor’s office that’s the first thing they want to do is put you on some kind of medication…They throw you on medication for anything. (Patient 4)

Theme 5: Vocabulary effects on the impact of messages

Participant vocabulary emerged as important factors when choosing preferred messages. Most felt messages that were simple, direct, and straight to the point were ideal because the meaning was easy to understand and remember.

Some participants just did not like the wording of the messages. In response to “Encourage your provider to create a powerful combination of medications for your health” one participant felt the message was not appropriate because it was not a “powerful combination” of medications that was warranted but just “the medications that [he] needs” (Patient 5).

A few participants were not comfortable with specific words, such as the word “optimize” in the message: “Optimize your health! Use a reminder system to help you remember to take your medications”. They believed that “optimization” could be misunderstood or confusing to some individuals who may not know the meaning and suggested different wording as it might “go over easier” (Patient 2) for readers.

Others expressed liking a message due to the verbiage. The majority of the promotion focused participants responded positively to the message “Win the battle against your heart disease; take your medication as prescribed”. Many of them liked the wording and as one described “It’s good wording for vets” (Patient 1). Those who liked it seemed to agree that having a chronic heart disease was similar to a battle and that they lived it every day.

Discussion

This analysis provided an understanding of what types of cardiovascular health messages speak to patients’ regulatory fit supporting the creation of 12 regulatory focus messages addressing medication adherence for a cardiovascular population. We also gathered information about patients’ overall attitudes and beliefs regarding medication adherence. Patient reactions have given us a growing confidence that tailoring health communications to an individual’s chronic motivational orientation may resonate with a patient in a way to enhance health behaviors.

Veterans’ stories highlighted their opinions of messages that related to their personal health care experiences, reflecting typical factors in existing literature.⁴ For example, in previous studies on medication adherence participants spoke about the importance of their interactions with their health care providers and their effect on their medication adherence.^29,30 Innovations in patient-centered care and shared decision making concepts emphasize the importance of including the patient in the decision-making process of prescribing and following a medicine regimen. Due to this change in thinking, the word “adherent,” rather than “compliant”, is now used more often as it includes the patient in the definition.^1,2,4,6 Adherence implies that the patient agreed on the medical decision, as compared to compliance which implies a patient is simply following advice given. A second term has also emerged from the literature regarding providers’ inclusion of patients in the adherence cycle which may highlight this agreeance more than adherence. The term concordance is used to highlight that providers not only need contact with their patients in order to improve adherence, but also need to change communication from simply instructing patients on how to use medication to coming to a mutual agreement on a medication plan and how to follow it.⁶ The changes in vocabulary to be more patient-centered indicates that wording is important, which was also evident in the feedback on the messages as defined in the theme “vocabulary effects on the impact of message.”

While wording of messages was found to be influential to patient impact, considering message content and the intended population, such as veterans, is important as well. As for content, if a patient related to a message or found it to be truthful for them, the potential for enhanced motivation was expressed. We propose further investigation as to whether a promotion or prevention message should match a patient’s regulatory focus as a way of enhancing medication adherence with motivational messages. It is also important to attempt to incorporate these types of messages into other successful adherence interventions. Perhaps by including it and removing, a more burdensome aspect could lead to even more positive changes. This exploratory work suggests merit in doing so.

Limitations

This study is an exploratory investigation that is meant to pave the way for the next arm of this research, a larger study about factors that enhance medication adherence. One limitation of this small-scale inquiry is that the design of this study did not fully cross message regulatory focus with patient regulatory focus in a way that we could measure the differential impact of messages that meet regulatory fit conditions. Due to the small number in our sample, we were sensitive to the burden on participants’ viewing multiple messages. As this was the first part of a larger study, we were also sensitive about not burdening patients with too many questions. However, this led to a lack of understanding how this study’s patients’ unique life situations contribute to their relationship with medication and adherence. Due to the small sample size and limited inclusion criteria, we were also unable to capture if there were any differences based on type of cardiovascular diagnosis.

Another limitation to the study is the small number of participants who were categorized as having a chronic prevention focus. Consistent with the literature that suggests that North Americans tend to be more promotion focused, we found only 2 out of 22 respondents could be categorized as prevention focused.³¹ While this is a low number of individuals who are prevention focused in North America, the ability to use motivational messages based on regulatory fit is important for other populations. A future study should use purposeful sampling on a larger population to ensure the complete effects of regulatory fit are examined.

Practice implications

This study provides a glimpse into messaging practices with a population of veterans. As described in the theme “Relationship with providers and medications” participant perceptions on health care and medication could be a powerful positive or negative influence on a patient’s adherence. Many patients spoke about their relationships with providers as being important in their lives. Perhaps some of the positive and negative reactions to messages shed light on how to make this a positive relationship. Motivational interventions should consider these perceptions. Additionally, an individual’s diagnosis and life circumstances are valuable to consider when creating an intervention that fits with a patient’s motivational orientation to address medication adherence.

We incorporated the opinions and suggestions of participants into our final versions of RFT messages and mechanism for the delivery of messages. The final version of the specific regulatory focus messages will be used in the next arm of the study, which is a pilot intervention to assess the effectiveness of using regulatory focus messages on patient medication adherence. As previously cited research has called for simple and easy-to-use techniques in order to improve medication adherence in heart condition patients, assessment of this type of innovative motivational intervention to improve patient medication adherence may provide additional knowledge and insight to improve cardiovascular outcomes.

Conclusion

Creation of motivational messages based on patients’ RFT and personal input gives insight into creating innovative interventions to improve medication adherence in patients with cardiovascular diagnoses. While the introduction of regulatory focus theory is relatively new to the field of health care communications, incorporating this psychological theory can affect messaging strategies to help increase medication adherence. In doing so, better partnerships between health care providers and patients can exist. This can lead to more effective communications around taking medications as prescribed.

Footnotes

Authors' Note

Ashley O'Connor is now affiliated to Iowa City VA Health Care System, Iowa City, IA, USA.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. The opinions expressed in the manuscript are those of the authors and, therefore, do not necessarily reflect the views of the Department of Veterans Affairs.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The research was supported by the American Heart Association under the AHA award. The AHA had no involvement in study design, data collection specifics, writing of the report, or submission.

Appendix

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