Effect of standardized, patient-centered label instructions to improve comprehension of prescription drug use.

OBJECTIVE: To evaluate the effectiveness of standardized, patient-centered label (PCL) instructions to improve comprehension of prescription drug use compared with typical instructions. METHODS: A total of 500 adult patients recruited from 2 academic and 2 community primary care clinics in Chicago, IL and Shreveport, LA were assigned to receive as follows: (1) standard prescription instructions written as times per day (once, twice 3 times per day) (usual care), (2) PCL instructions that specify explicit timing with standard intervals (morning, noon, evening, bedtime) (PCL), or (3) PCL instructions with a graphic aid to visually depict dose and timing of the medication (PCL + Graphic). The outcome was correct interpretation of label instructions. RESULTS: Instructions with the PCL format were more likely to be correctly interpreted compared with standard instructions (adjusted relative risk [RR]: 1.33, 95% confidence interval [CI]: 1.25-1.41). Inclusion of the graphic aid (PCL + Graphic) decreased rates of correct interpretation compared with PCL instructions alone (RR: 0.93; 95% CI: 0.89-0.97). Patients with low literacy were better able to interpret PCL instructions (low literacy: RR: 1.39; 95% CI: 1.14-1.68; P = 0.001). CONCLUSION: The PCL approach could improve patients' understanding and use of their medication regimen.

Improving prescription drug warnings to promote patient comprehension.

BACKGROUND: Prior studies have documented a high prevalence of patients who misunderstand prescription drug warning labels, placing them at risk for medication error. We evaluated whether the use of "enhanced print" drug warnings could improve patient comprehension beyond a current standard. METHODS: An evaluation of enhanced print warning labels was conducted at 2 academic and 2 community health primary care clinics in Chicago, Illinois, and Shreveport, Louisiana. In total, 500 adult patients were consecutively recruited and assigned to receive (1) current standard drug warning labels on prescription containers (standard), (2) drug warnings with text rewritten in plain language (simplified text), or (3) plain language and icons developed with patient feedback (simplified text + icon). The primary outcome was correct interpretation of 9 drug warning labels as determined by a blinded panel review of patients' verbatim responses. RESULTS: Overall rates of correct interpretation of drug warnings varied among standard, simplified text, and simplified text + icon labels (80.3%, 90.6%, and 92.1%, respectively; P < .001). Warnings with simplified text and simplified text + icons were more likely to be correctly interpreted compared with standard labels (simplified text - adjusted odds ratio [AOR] = 2.64; 95% confidence interval [CI], 2.00-3.49; simplified text + icons - AOR = 3.26; 95% CI, 2.46-4.32). Patients' ability to correctly interpret labels was not significantly different with the inclusion of icons (simplified text + icons - AOR = 1.23; 95% CI, 0.90-1.67; P = .20). Low literacy was also an independent predictor of misinterpretation (AOR, 0.65; 95% CI, 0.44-0.94). Patients with marginal and low literacy were better able to correctly interpret warning labels with simplified text + icons compared with labels with simplified text only (marginal literacy - AOR = 2.59; 95% CI, 1.24-5.44; P = .01; low literacy - AOR = 3.22; 95% CI, 1.39-7.50; P = .006). CONCLUSIONS: Simple, explicit language on warning labels can increase patient understanding; the addition of appropriate icons is particularly useful for adults with lower literacy skills. Evidence-based standards are needed to promote patient-centered prescription labeling practices.

Literacy and learning in health care.

The relationship between literacy and health outcomes are well documented in adult medicine, yet specific causal pathways are not entirely clear. Despite an incomplete understanding of the problem, numerous interventions have already been implemented with variable success. Many of those who proposed earlier strategies assumed the problem to originate from reading difficulties only. Given the timely need for more effective interventions, it is of increasing importance to reconsider the meaning of health literacy to advance our conceptual understanding of the problem and how best to respond. One potentially effective approach might involve recognizing the known associations between a larger set of cognitive and psychosocial abilities with functional literacy skills. Here we review the current health literacy definition and literature and draw on relevant research from the fields of education, cognitive science, and psychology. In this framework, a research agenda is proposed that considers an individual's "health-learning capacity," which refers to the broad constellation of cognitive and psychosocial skills from which patients or family members must draw to effectively promote, protect, and manage their own or a child's health. This new, related concept will lead, ideally, to more effective ways of thinking about health literacy interventions, including the design of health-education materials, instructional strategies, and the delivery of health care services to support patients and families across the life span.

Education, literacy, and health: Mediating effects on hypertension knowledge and control.

OBJECTIVE: To determine whether literacy mediates the association between education, hypertension knowledge and control. METHODS: In-person interviews with a literacy assessment and chart review were conducted with 330 hypertensive patients from six primary care safety net clinics. Mediational analysis was used to test the role of literacy skills in explaining the relationship between education and hypertension knowledge and control. RESULTS: In multivariate analyses that did not make an adjustment for the other variable, both lower educational attainment and more limited literacy were found to be significant independent predictors of poorer hypertension knowledge and control. When literacy was entered into models that included education only, the association between education and knowledge was fully attenuated and no longer significant (Grades 1-8: beta=-0.30, 95% CI=-1.44-0.83), while the relationship between education and blood pressure control was only minimally reduced (AOR 2.46, 95% CI 2.10-2.88). More limited literacy skills also was associated with hypertension control in the final model (AOR 2.68, 95% CI 1.54-4.70). CONCLUSION: Patient literacy mediated the relationship between education and hypertension knowledge. Literacy was a significant independent predictor of blood pressure control, but only minimally explained the relationship between education and blood pressure. PRACTICE IMPLICATIONS: Health literacy is critical to the design of educational tools to improve knowledge acquisition. However, in order to impact health outcome, future health literacy studies should also address other psychosocial factors that impact motivation and capability to manage disease.

Provider and patient intervention to improve weight loss: a pilot study in a public hospital clinic.

OBJECTIVE: To assess the efficacy of a literacy-appropriate weight loss intervention targeting providers and patients in improving physicians' weight loss counseling and patients' self-reported beliefs, and self-efficacy. METHODS: The study took place in a public hospital nephrology clinic. The intervention included two physician workshops and a small group patient education. Physician-patient communication was observed and coded. Structured interviews assessed patient recall of weight loss recommendations, weight-related beliefs, and self-efficacy. RESULTS: 64 patient visits were observed before and after the intervention. 75% of patients were African American, 96% lacked private insurance, 71% had low literacy skills; mean body mass index (BMI) of 35 kg/m(2). Physician counseling improved significantly post-intervention, particularly in assessing, supporting and advising patients about weight loss and exercise. Patients reported increases in recall of weight loss recommendations and were more likely to report greater confidence about losing weight (52% vs. 70%, p<0.01). CONCLUSIONS: This pilot study offers promising directions to address provider and patient barriers to weight loss education and counseling in a public hospital. PRACTICE IMPLICATIONS: Hospital-based weight loss interventions need to target both physicians and patients.