An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling.

OBJECTIVE: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. METHODS: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. RESULTS: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). CONCLUSION: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy.

Development and Usability Testing of a Web-based COVID-19 Self-triage Platform.

INTRODUCTION: The development and deployment of a web-based, self-triage tool for severe respiratory syndrome coronavirus 2 (COVID-19 disease) aimed at preventing surges in healthcare utilization could provide easily understandable health guidance with the goal of mitigating unnecessary emergency department (ED) and healthcare visits. We describe the iterative development and usability testing of such a tool. We hypothesized that adult users could understand and recall the recommendations provided by a COVID-19 web-based, self-triage tool. METHODS: We convened a multidisciplinary panel of medical experts at two academic medical schools in an iterative redesign process of a previously validated web-based, epidemic screening tool for the current COVID-19 pandemic. We then conducted a cross-sectional usability study over a 24-hour period among faculty, staff, and students at the two participating universities. Participants were randomly assigned a pre-written health script to enter into the self-triage website for testing. The primary outcome was immediate recall of website recommendations. Secondary outcomes included usability measures. We stratified outcomes by demographic characteristics. RESULTS: A final sample of 877 participants (mean age, 32 years [range, 19-84 years]; 65.3% female) was used in the analysis. We found that 79.4% of the participants accurately recalled the recommendations provided by the website. Almost all participants (96.9%) found the website easy to use and navigate. CONCLUSION: Adult users of a COVID-19 self-triage website, recruited from an academic setting, were able to successfully recall self-care instructions from the website and found it user-friendly. This website appears to be a feasible way to provide evidence-based health guidance to adult patients during a pandemic. Website guidance could be used to reduce unnecessary ED and healthcare visits.

Variability in Acetaminophen Labeling Practices: a Missed Opportunity to Enhance Patient Safety.

Confusion regarding a drug's active ingredient may lead to simultaneous use of multiple acetaminophen-containing prescriptions and increase the risk of unintentional overdose. The objective of this study was to examine prescription labeling practices for commonly prescribed acetaminophen-containing analgesics, specifically focusing on how active ingredient information and concomitant use warnings were conveyed. Patients with new acetaminophen-containing prescriptions were recruited upon discharge from an emergency department in Chicago or at an outpatient, hospital-based pharmacy in Atlanta. Label information was transcribed from prescription bottles and patients' knowledge of active ingredient was assessed by in-person interviews. Among the 245 acetaminophen-containing prescriptions, hydrocodone was the most common second active ingredient (n = 208, 84.8 %) followed by oxycodone (n = 28, 11.4 %). Acetaminophen was identified by its full name on 6.9 % (n = 17) of labels; various abbreviations were used in 93.1 % of cases. One hundred forty-seven bottles used auxiliary warning labels with the majority of labels (n = 130, 88.4 %) warning about maximum dose and 11.5 % (n = 17) about concomitant use. Most of the study participants (n = 177, 72.2 %) were not able to identify acetaminophen as an active ingredient in their prescription. There was no significant association between the use of unabbreviated labels including warning information and patients' awareness of acetaminophen as an active ingredient (36.4 vs. 27.3 %, p = 0.50). We noted high variability in labeling practices and warning information conveyed to patients receiving acetaminophen-containing prescriptions. Missed opportunities to adequately convey risk information may contribute to the burden of acetaminophen-related liver injury.

Literacy disparities in patient access and health-related use of Internet and mobile technologies.

BACKGROUND: Age and race-related disparities in technology use have been well documented, but less is known about how health literacy influences technology access and use. OBJECTIVE: To assess the association between patients' literacy skills and mobile phone ownership, use of text messaging, Internet access, and use of the Internet for health-related purposes. METHODS: A secondary analysis utilizing data from 1077 primary care patients enrolled in two, multisite studies from 2011-2013. Patients were administered an in-person, structured interview. RESULTS: Patients with adequate health literacy were more likely to own a mobile phone or smartphone in comparison with patients having marginal or low literacy (mobile phone ownership: 96.8 vs. 95.2 vs. 90.1%, respectively, P < 0.001; smartphone ownership: 70.6 vs. 62.5 vs. 40.1%, P < 0.001) and to report text messaging (78.6 vs. 75.2 vs. 53.1%, P < 0.001). They were also more likely to have access to the Internet from their home (92.1 vs. 74.7 vs. 44.9%, P < 0.001) and to report using the Internet for email (93.0 vs. 75.7 vs. 38.5%, P < 0.001), browsing the web (93.9 vs. 80.2 vs. 44.5%, P < 0.001), accessing health information (86.3 vs. 75.5 vs. 40.8%, P < 0.001), and communicating with providers (54.2 vs. 29.8 vs. 13.0%, P < 0.001). Relationships remained significant in multivariable analyses controlling for relevant covariates. CONCLUSIONS: Results reveal that literacy-related disparities in technology access and use are widespread, with lower literate patients being less likely to own smartphones or to access and use the Internet, particularly for health reasons. Future interventions should consider these disparities and ensure that health promotion activities do not further exacerbate disparities.

Patient recall of health care provider counseling for opioid-acetaminophen prescriptions.

OBJECTIVE: The aim of this study was to determine the frequency and nature of physician, nurse, and pharmacist verbal counseling at the time of a new prescription for an opioid-acetaminophen containing medication as recalled by patients. DESIGN: A mixed methods approach with data from cross sectional, structured interviews was used. SETTING: The settings were one academic emergency department in Chicago, IL and one outpatient pharmacy at a public hospital in Atlanta, GA. PATIENTS: One hundred forty-nine patients receiving a new prescription for an opioid-acetaminophen medication were enrolled. METHODS: Interviews assessed patient recall of counseling they received from their physician, nurse, and pharmacist upon receiving the new prescription. Their responses were unitized and assigned to categories. RESULTS: One hundred forty-nine patients were enrolled; 61.1% African American and 58.4% female. Seven major categories of responses were noted; frequencies of patient recall for counseling in these categories were reported. Four categories related to the content of the counseling discussion were (1) details of administration (patient recall counseling from: physician/nurse only 44.3%, pharmacist only 5.4%, both providers 12.8%); (2) activities to avoid and side effects (36.2%, 4.7%, 8.7%); (3) medication indication (32.9%, 4%, 4%); and (4) addictive potential (9.3%, 1.3%, 0%). Three categories describe patients' recall of the interaction in broad terms: (5) being referred to print informational material accompanying the prescription (MD/RN only 7.4%, pharmacist only 20.1%, both providers 2.7%); (6) having questions solicited (0%, 11.4%, 0%); (7) having no interaction relating to medication counseling (3.4%, 32.2%, 1.3%). CONCLUSIONS: Patients infrequently recall counseling from providers on topics that are important to prevent harm from opioid-acetaminophen prescriptions. Future patient-centered clinical research should target identifying optimal strategies to convey these critical messages.

Take-Wait-Stop: a patient-centered strategy for writing PRN medication instructions.

Recent studies have linked patient misunderstanding of label instructions for as needed (PRN) medications to dosing errors. This study conducted a preliminary field test of patient-centered PRN label instructions. Patients participated in a hypothetical dosing experiment and were randomized to a patient-centered label (referred to as "Take-Wait-Stop") or standard label. Participants were asked to demonstrate dosing the medicine over 24 hours. Three types of independent dosing errors were measured: (a) taking more than two pills at one time, (b) exceeding the maximum daily dose, and (c) waiting fewer than 4 hours between doses. Generalized linear models were used to assess the association between label type, health literacy, and sociodemographic characteristics. Participants' mean age was 39.8 years, 62.1% were female, 43.7% were White, and 72.4% had adequate literacy. Of participants, 31.8% who were shown the standard label demonstrated taking in excess of 6 pills in 24 hours compared with only 14.0% of participants who were shown the Take-Wait-Stop label (p = .05). Overall, only 1 person demonstrated he would take more than 2 pills in a single dose. Of the standard label group, 20.5% demonstrated dosing intervals of fewer than 4 hours compared with 23.3% of the Take-Wait-Stop label group (p=.75). In a multivariate model, participants who were exposed to the standard label were 2.5 times more likely to exceed the recommended maximum daily dose (95% CI [1.05, 7.70], p=.03). The Take-Wait-Stop label was beneficial in preventing participants from exceeding the maximum dose in 24 hours, although it did not significantly reduce other dosing errors.

Doctor talk: physicians' use of clear verbal communication.

Low health literacy negatively affects processes and outcomes of care. Physicians do not routinely use communication techniques recommended for use with low health literate patients. This study was conducted to compare the self-reported and actual use of clear verbal communication among medical residents and to identify characteristics associated with clear communication. Residents self-assessed their communication behaviors and then completed a low health literacy standardized patient encounter. Answers on the self-assessment were compared with behaviors observed in the standardized patient encounter. Residents (N = 82) reported frequent use of techniques recommended for clear verbal communication, including plain language (88%) and teach-back (48%). However, during the standardized patient encounter, they used an average of 2 jargon terms per minute, and only 22% used teach-back. No resident characteristics consistently predicted better communication. In conclusion, the study found that medical residents used clear communication techniques infrequently and tended to overestimate the clarity with which they communicate.

A randomized prospective trial of a worksite intervention program to increase physical activity.

PURPOSE: To evaluate the effectiveness of addressing multiple barriers to physical activity (PA) using interventions at the workplace. DESIGN: The Physical Activity and Lifestyle Study used a randomized controlled trial in which 60 university departments were randomized into five groups. SETTING: Large Southeastern university. SUBJECTS: Physically inactive nonfaculty employees in the participating departments (n = 410) were interviewed five times over 9 months, with 82% completing all surveys. INTERVENTION: Departments were randomly assigned to (1) control, (2) gym membership, (3) gym + PA education, (4) gym + time during the workday, and (5) gym + education + time. MEASURES: PA intensity and quantity were measured using the 7-day Physical Activity Recall instrument, with PA then classified as the number of days meeting Centers for Disease Control and Prevention guidelines. ANALYSIS: The outcome was modeled with generalized linear mixed model methodology. RESULTS: There was no significant improvement when a group received gym alone compared to the control (Rate Ratio [RR]) 1.22 [.90, 1.67]). However, gym + education, gym + time, and gym + education + time were significantly better than the control (RR 1.51 [1.15, 1.98], RR 1.46 [1.13, 1.88], RR 1.28 [1.01, 1.62]), with improvements sustained over the 9 months. CONCLUSION: Among sedentary adults who had access to indoor exercise facilities, addressing environmental and cognitive barriers simultaneously (i.e., time and education) did not encourage more activity than addressing either barrier alone.

Developing consumer-centered, nonprescription drug labeling a study in acetaminophen.

BACKGROUND: In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. PURPOSE: Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. METHODS: Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. RESULTS: Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. CONCLUSIONS: With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers.

A qualitative evaluation of a health literacy intervention to improve medication adherence for underserved pharmacy patients.

OBJECTIVE: To evaluate the implementation of a health literacy intervention to improve medication adherence among patients in an inner-city health system. METHODS: Interviews with pharmacists and focus groups with pharmacy patients were conducted one month and six months after beginning the intervention. Patients and pharmacists described their experiences with the intervention, consisting of an automated telephone call reminder system, an illustrated medication schedule, and pharmacist training in clear health communication. RESULTS: Despite initial technical problems, patients and pharmacists reported positive experiences. Pharmacists thought the intervention made counseling easier. Patients appreciated the design and portability of the illustrated medication schedule and found the reminder calls helpful as well. CONCLUSION: Successful health literacy interventions require tools that are easy to comprehend, accessible, and personalized to the special needs and interests of the target population. Moreover, providers must be well-trained, and adequate resources must be provided to assure the fidelity of the intervention's implementation.

Does social support help limited-literacy patients with medication adherence? A mixed methods study of patients in the Pharmacy Intervention for Limited Literacy (PILL) study.

OBJECTIVE: To explore whether social support helps patients with limited health literacy adhere to their medication regimens. METHODS: We interviewed 275 pharmacy patients and assessed social support's influence on medication adherence for those with limited vs. adequate health literacy. We talked with patients (n=26) and pharmacists (n=7) to explore possible explanations for the quantitative findings. RESULTS: Social support was associated with better medication adherence for patients with adequate health literacy but not those with limited health literacy (p<0.05). When individual subscales for social support were analyzed, having a trusted confidant was the only type of social support associated with better medication adherence for limited-literacy patients (p<0.05). Comments from patients and pharmacists suggest that limited-literacy patients were less likely to ask the pharmacists questions and infrequently brought relatives with them to the pharmacy. CONCLUSION: Unless they have a trusted confidant, limited-literacy patients might be reluctant to ask others for the kind of help needed to take their medicines correctly. PRACTICE IMPLICATIONS: Pharmacists need training to increase their awareness of limited health literacy and to communicate effectively with all patients, regardless of their literacy skills. To succeed, pharmacists also need the support of the health care systems where they work.

Effect of a pharmacy-based health literacy intervention and patient characteristics on medication refill adherence in an urban health system.

BACKGROUND: Limited health literacy is associated with poor understanding of medication instructions and may be related to medication adherence. OBJECTIVE: To evaluate a 3-part intervention (automated telephone reminder calls to refill prescriptions, picture prescription card, and clear health communication training for pharmacists) intended to increase refill adherence through attention to health literacy. METHODS: Three pharmacies that serve a primarily indigent, minority population served as the intervention sites, and one pharmacy served as the control site. To evaluate the impact of the 6-month intervention on medication adherence, pharmacy refill data were used to calculate the cumulative medication gap (CMG), in which values close to zero indicate better adherence. The primary measure of treatment effect was a comparison of the change in refill adherence within each group, from baseline to follow-up. RESULTS: A total of 173 patients were enrolled in the intervention group and 102 patients in the control group. Medication adherence was significantly different between intervention (CMG = 0.25) and control (CMG = 0.18) groups at baseline (p = 0.004). Refill adherence in the intervention group improved slightly during follow-up (CMG = 0.23), while it worsened slightly in the control group (CMG = 0.21), but the change in adherence between intervention and control groups was not significantly different (p = 0.4). Between 80% and 90% of intervention participants indicated that receiving the picture prescription and phone call interventions helped them remember when and how to take their medications and refill their prescriptions. No patient characteristics, including health literacy, were consistently associated with adherence. CONCLUSIONS: Implementation of a 3-part intervention--automated telephone reminders, picture prescription card, and pharmacist communication skills training--did not significantly improve refill adherence among inner-city patients. Further study should explore whether other aspects of medication management, such as dosing or adverse events, can be improved through these types of interventions, implemented either alone or in combination.

Relationships between beliefs about medications and adherence.

PURPOSE: The relationships between beliefs about medications, health literacy, and self-reported medication adherence are examined. METHODS: Patients from an inner-city hospital pharmacy completed an in-person, interviewer-assisted questionnaire that included the Morisky 8-item Medication Adherence Scale (MMAS-8), the Beliefs About Medicines Questionnaire (BMQ), and the Rapid Estimate of Adult Literacy in Medicine (REALM). Multivariable logistic regression was used to determine predictors of self-reported medication adherence as determined by the MMAS-8. Variables included in the model were summary scores from the BMQ, REALM, and patient or regimen characteristics that were significantly associated with the MMAS-8. RESULTS: A majority of the 275 study participants were African-American (86.2%), were women (73.1%), and could read at less than a high school reading level (59.7%). The average age was 53.9 years. Approximately half of the patients (52.7%) reported low medication adherence (MMAS-8 score of >2). Multivariate analyses indicated several factors were associated with low self-reported adherence, including negative beliefs about medications, younger age, low medication self-efficacy, and hyperlipidemia. Health literacy was not independently associated with beliefs or adherence. CONCLUSION: Patients who had negative beliefs about medications, who were <65 years of age, or who had low medication self-efficacy reported low medication adherence.

Development and Implementation of a Health Literacy Training Program for Medical Residents.

Nearly 50 percent of Americans lack the literacy skills needed to function effectively in today's health care environment. Experts recommend that health professionals be trained to better communicate with low-literacy patients, but few educational programs have been described. We developed a training program for medical residents that includes a videotaped standardized patient encounter, interactive small-group workshop, one-on-one feedback with a faculty member, and an individual behavioral prescription for improved communication. The program employs key principles of adult learning theory and evidence-based teaching approaches. Residents felt that the topic was relevant and that their communication skills benefited from the intervention. They enjoyed the teaching methods, particularly the individual feedback on their videotaped encounter. A qualitative process evaluation is provided to facilitate the teaching of similar programs elsewhere. Response to this curriculum indicates that residency appears to be a suitable time to raise awareness of health literacy and build appropriate communication skills.

An assessment of obesity among African-American women in an inner city primary care clinic.

Despite multiple patient assessments and interventions, obesity continues to cause significant morbidity and mortality nationwide. This study assesses the prevalence of obesity and weight control practices among middle-aged African-American women. In 1995, 307 women 30 years of age and older were consecutively selected in a non-random fashion from three clinic sites located within a public university hospital that served largely indigent, inner city African-American populations. Interviewers surveyed the respondents using the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). The prevailing demographic profile of patients in the clinic was middle-aged, indigent, ill, and of low educational attainment. Over 35% of individuals were classified as being overweight (BMI 25 to 29.9 kg/m2) and 45% were classified as being obese (BMI > or = 30 kg/m2). Therefore, more than 80% of individuals in this study were either overweight or obese, with BMI exceeding 25 kg/m2. Of the overweight and obese African-American women in this study, only 40% were attempting current weight loss practices, and weight loss attempts varied directly with body mass index. Although 80% of women attempted weight loss by restricting caloric intake, only 50% were also using physical activity as part of their regime. African-American women in this population have a higher prevalence of obesity and encounter great difficulty losing weight. Counselors should emphasize the value and ease of adopting a moderate regimen of physical activity and not just reducing caloric intake when advising African-American women and their peer network.