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Improving Medication Understanding Among Latinos Through Illustrated Medication Lists
Arun Mohan, MD, MBA; M. Brian Riley, MA; Brian Schmotzer, MS; Dane R. Boyington, PhD; and Sunil Kripalani, MD, MSc

Improving Medication Understanding Among Latinos Through Illustrated Medication Lists

Arun Mohan, MD, MBA; M. Brian Riley, MA; Brian Schmotzer, MS; Dane R. Boyington, PhD; and Sunil Kripalani, MD, MSc
A randomized controlled trial found that plain-language, illustrated medication lists improved medication understanding among Latinos.
ABSTRACT
Objectives
Strategies are needed to improve medication management among vulnerable populations. We tested the effect of providing illustrated, plain-language medication lists on medication understanding, adherence, and satisfaction among Latino patients with diabetes in a safety net clinic.

Study Design
Randomized controlled trial.

Methods
Intervention patients received a PictureRx illustrated medication list that depicted the medication, indication, and dosing instructions, accompanied by plain language bilingual text. Usual care patients received a written list of their medications in their preferred language, with indication but no images. Outcomes were assessed by telephone approximately 1 week later. The Medication Understanding Questionnaire measured patients’ ability to report the indication, strength, dosing, and frequency for their medication regimen. Self-reported adherence and satisfaction were secondary outcomes. Analysis was performed by intention to treat.

Results
Of 200 enrolled participants, 197 (98.5%) completed follow-up. Most (71%) had not graduated high school, and 59% had low health literacy. Patients randomized to illustrated medication instructions had better overall understanding of their medications (P <.001), including greater ability to report the drug indication (P <.01), strength (P <.05), dosing (P <.01), and frequency of administration (P <.001). Self-reported adherence did not differ significantly between study groups. Patients who received illustrated medication lists were very satisfied with them.

Conclusions
In this randomized controlled trial, patients who received illustrated, plain-language medication lists demonstrated significantly greater understanding of their medication regimen. Such tools have the potential to improve medication use and chronic disease control, as well as reduce health disparities—although this requires further study.

Am J Manag Care. 2014;20(12):e547-e555
Plain language, illustrated medication lists improve understanding among Latino patients with diabetes.
  • Successful management of a chronic disease requires management of multiple prescription medications.
  • Current medication information is difficult to understand, particularly among patients with low health literacy and limited English proficiency, such as some Latinos.
  • Our paper is among the first to evaluate plain-language, illustrated medication instructions among Latinos.
  • Plain language, illustrated medication instructions significantly improved medication understanding and were well liked by patients.
  • Providing patients with plain language, illustrated medication instructions appear to be a low-cost approach to improving medication management.
Caring for chronic medical conditions requires successful management of multiple prescription medications. Although successful medication-taking is rooted in a number of social, economic, medical, and behavioral factors, a growing body of evidence demonstrates that limited understanding of medication information contributes to poor adherence and outcomes.1,2

The situation may be particularly challenging for some Latino patients. Disparities in the prevalence, management, and outcomes of chronic diseases between Latinos and non-Latinos are well known,3 and several studies have demonstrated that racial and ethnic minority groups, including Latinos, have significantly lower adherence to prescribed medications.4-9 This may be due in part to challenges understanding health information. According to the National Assessment of Adult Literacy, Latinos, on average, had lower health literacy scores than any other racial or ethnic group.10 Moreover, many Latinos experience language-related difficulties when navigating the US healthcare system, in which information is largely provided in English.11,12

Patient-centered medication lists and illustrated medication instructions may address obstacles to medication-taking caused by low health literacy or limited English proficiency.13 The widespread adoption of medication lists has been championed by the American Society of Health System Pharmacists and supported by the National Quality Forum and American Medical Association.13-15 A 2006 systematic review showed that illustrated medication instructions are generally effective in improving patient satisfaction, comprehension, recall, and adherence.16 However, many of the studies reviewed involved simulated regimens and were conducted internationally. More recent studies from the United States examining the effects of illustrated medication instructions demonstrate mixed results.17-21 For example, in a randomized trial of patients with heart failure, illustrated materials as part of a pharmacist intervention enhanced adherence and reduced costs.18 Another randomized, controlled trial of an illustrated medication list among English-speaking patients in a safety net clinic demonstrated increased adherence only among patients with a more complex regimen or low self efficacy.22

We previously developed an Internet-based tool, known as PictureRx, to facilitate the construction of illustrated, plain-language medication lists.23,24 In qualitative evaluations, pharmacists and Latino patients expressed preference for these illustrated medication lists over traditional formats.24,25 However, the lists' effect on understanding and adherence in this population is not known. We hypothesized that such a tool may be particularly valuable for patients who have low health literacy or limited English proficiency, because these patients are at greater risk for poor communication in clinical encounters and because of the inferior quality of medication information that is routinely provided to patients.14,26-28

Development of a culturally appropriate and effective tool to improve medication management by addressing barriers to health literacy among Latinos could lead to improvements in care and a reduction in health disparities. Here, we report the results of a randomized controlled trial to evaluate the effect of PictureRx medication lists, compared with traditional prescription instructions, on medication understanding, self-reported adherence and satisfaction, among Latinos with diabetes.

METHODS

Setting and Population


The study took place in a safety net clinic serving a predominately Spanish-speaking population in Nashville, TN. Providers and most staff were bilingual. Enrollment occurred between April 2010 and March 2011. The study was reviewed and approved by the New England Institutional Review Board, an independent, central institutional review board.

Latino patients who received care at the clinic were eligible if they were 18 years or older, had a diagnosis of diabetes recorded in the medical chart, and were prescribed at least 1 chronic medication. Patients were excluded if a list of their medications could not be located or if they had a corrected visual acuity >20/50 using a Rosenbaum Pocket Screener; had a hearing deficit; had dementia, psychosis, or disorientation; belonged to a special human subjects population (eg, pregnant or prisoner); were unable to communicate in English or Spanish; or lacked a regular phone number.

Procedures

Research assistants (RAs) screened patient charts and received referrals from clinic staff to identify patients with reported diabetes. RAs directly approached patients in the clinic waiting room and other clinic areas to describe the study. Eligibility was assessed to the best of the RAs’ ability at this time and was confirmed after enrollment, which resulted in exclusion of a few subjects for prespecified reasons. Participants provided written informed consentand received $30 each on the day of enrollment.

Consenting patients provided demographic information (age, gender, race, education, nationality, and preferred language). They completed a brief test of cognitive function, the Mini-Cog, which consisted of a 3-item recall and a clock-drawing test.29 Participants also completed a 3-item test of health literacy, the Brief Health Literacy Screen (BHLS).30,31 This assessment, which is now commonly used in health literacy research32,33 and has been validated in English and Spanish,34,35 asks patients questions such as “how confident are you filling out medical forms by yourself?” BHLS scores range from 3 to 15. Scores less than 12 can be taken to indicate limited health literacy.34 A list of the patient’s medications was abstracted from clinic charts.

Upon completion of baseline data collection, participants were randomized to receive their usual care or usual care plus the intervention. The randomization codes were prepared in advance using a computer random number generator, in permuted blocks of varying size, and sealed individually in opaque envelopes to maintain concealment of treatment allocation. Research staff and patients were not blinded. Investigators and the biostatistician were blinded.

For patients randomized to receive the intervention, an RA documented the patient’s prescribed medication regimen, inclusive of any changes made that day by the clinic provider. While the patient was still in the clinic, the RA entered the patient’s prescribed medication regimen into a secure website (www.mypicturerx.com) to prepare and print a color, PictureRx illustrated medication schedule. This patient education tool (Figure 1) showed the patient’s full medication regimen laid out in a simple grid, which has been called the Universal Medication Schedule,36 showing how much should be taken at each time of day (morning, noon, evening, and night). The tool also included a picture of each medication, a labeled icon to show its purpose, and medication instructions printed in plain language, in both Spanish and English. The RA oriented the patient to the PictureRx card layout and showed the patient a 2-minute video about it. Patients also received a 1-page sheet with tips on how to use the PictureRx card as an aid for medication management, such as advice to keep it near their medicines or to post it on the refrigerator as a reminder.

Patients randomized to the control group received their usual care. This consisted of the treating provider reviewing medication instructions with the patient and the patient receiving a handwritten list of medications in their preferred language, with instructions for use and the

drug indications, but no illustrations.

Follow-up and Outcome Assessment

Approximately 1 week after enrollment, an RA contacted patients by telephone. Patients completed instruments to assess their understanding of the medication regimen (primary outcome) and their self-reported adherence (secondary outcome). Patients in the intervention group were also asked several questions about the perceived utility of the PictureRx tool.

Medication understanding was assessed using the Medication Understanding Questionnaire (MUQ).37 This method is a slight adaptation of other published measures of medication understanding that have been validated against cognitive and functional outcomes.38 The MUQ assesses knowledge of the patient’s own regimen, as opposed to a simulated regimen, and it can be administered effectively by telephone in a limited amount of time. For each medication tested, the RA states the generic and brand name of the medication and asks the patient to state its indication (1 point), strength (1/2 point), number of pills or units taken at a time (1/2 point), and dosing frequency (1 point). For patients prescribed 5 medications or less, each medication is tested. For patients prescribed more than 5 medications, 5 are selected using a random number table. The MUQ scores range from 0 to 3 per medication. Each patient’s overall medication understanding score may range from 0 to 100, representing the percent correct for the medications tested. Prior to commencing the study, the MUQ was translated, checked for accuracy, and pilot-tested among a small population of Spanish-speaking patients.

To assess medication adherence, patients were administered a Spanish translation of the Adherence to Refills and Medications Scale (ARMS), a validated self-report measure.39 The full ARMS is a 12-item instrument that assesses patients’ self-reported adherence under a variety of different circumstances. An 8-item subscale, which assesses adherence with taking medication (as opposed to medication refills), was used in this study as the secondary outcome. Scores on this subscale may range from 8 (most adherent) to 32 (least adherent). The ARMS correlates well with other subjective and objective measures of adherence.39

To assess the presence of mild cognitive impairment, participants completed the Mini-Cog, a short validated instrument that consists of a 3-item recall and a clockdrawing test.29

Statistical Analysis

The primary analysis was an intention-to-treat comparison of medication understanding among patients randomized to receive the intervention versus patients randomized to usual care alone. Medication understanding was treated as a continuous variable and summarized as mean ± SD for the overall score, as well as for each domain of understanding (ie, medication indication, strength, units, and frequency). A multivariable linear regression model was used to determine the adjusted difference in medication understanding between usual careand intervention patients, controlling for several baseline characteristics: BHLS score, presence of cognitive impairment, number of medications, age, gender, and years of education. This technique controls for residual confounding that may persist despite randomization, and it also allows estimation of the effect of covariates (other than treatment assignment) on outcomes. The variables in the model were determined a priori. Additional analyses were performed separately to assess the presence of an interaction between treatment effect and health literacy or cognition.

 
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