A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence.

BACKGROUND: Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk. OBJECTIVE: To test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard. DESIGN: Two-arm, multi-site patient-randomized pragmatic trial. PARTICIPANTS: English- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications. INTERVENTION: A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime). MAIN MEASURES: Demonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months. KEY RESULTS: A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15-22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53). CONCLUSIONS: A simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens. Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849.

A randomized trial of a prenatal genetic testing interactive computerized information aid.

OBJECTIVE: The aim of this study was to determine whether an interactive computer program could improve patient knowledge regarding genetic screening and diagnostic concepts. METHODS: In this randomized trial, women 6-26 weeks' gestation were assigned to standard care with provider-based counseling or to augmented counseling with an interactive computer program. The computer-based tool conveyed information about genetic testing options. Women were administered a 23-item test of content knowledge immediately and 2-4 weeks after exposure. Test scores were compared between groups at both points using T-tests. RESULTS: A total of 150 women were randomized equally between groups. Groups were similar with regard to demographic characteristics. Women randomized to the interactive tool correctly answered a significantly greater proportion of questions than those who received standard counseling (69.4% ± 14.2% vs. 46.0% ± 15.2%, p < 0.001) on the immediate questionnaire. One hundred and twenty-three (82%) participants participated in the follow-up test. Women randomized to the tool continued to correctly answer a significantly greater proportion of questions (60.6% ± 16% vs. 49.7% ± 18.9%, p = 0.001). Education, health literacy, electronic health literacy, and other discussions with providers were not associated with a differential benefit from the educational intervention. CONCLUSION: A patient-directed interactive computer program may help providers to convey relevant information about genetic screening and diagnostic concepts.

Usability of FDA-approved medication guides.

BACKGROUND: Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use. OBJECTIVE: To examine the readability, suitability, and comprehensibility of medication guides, particularly for those with limited literacy. DESIGN: Assessments of suitability and readability of 185 medication guides, and a sub-study examining change in suitability and readability from 2006 to 2010 among 32 of the medication guides (Study 1); 'open book' comprehension assessment of medication guides (Study 2). SETTING: Two general internal medicine clinics in Chicago, IL. PATIENTS: Four hundred and forty-nine adults seeking primary care services, ages 18-85. MEASUREMENTS: For Study 1, the Suitability Assessment of Materials (SAM) and Lexile score for readability. For Study 2, a tailored comprehension assessment of content found in three representative medication guides. RESULTS: The 185 analyzed medication guides were on average 1923 words (SD = 1022), with a mean reading level of 10-11th grade. Only one medication guide was deemed suitable in SAM analyses. None provided summaries or reviews, or framed the context first, while very few were rated as having made the purpose evident (8 %), or limited the scope of content (22 %). For Study 2, participants' comprehension of medication guides was poor (M = 52.7 % correct responses, SD = 22.6). In multivariable analysis, low and marginal literacy were independently associated with poorer understanding (ß = -14.3, 95 % CI -18.0 - -10.6, p < 0.001; low: ß = -23.7, 95 % CI -28.3 - -19.0, p < 0.001). CONCLUSION: Current medication guides are of little value to patients, as they are too complex and difficult to understand especially for individuals with limited literacy. Explicit guidance is offered for improving these print materials.

Are informed consent forms for organ transplantation and donation too difficult to read?

Informed consent for organ transplantation and donation is an ethical obligation, legally required, and considered as part of the Patient's Rights Condition of Medicare Participation for hospitals. National policy-makers recommend that informed consent forms and patient education materials be written at a low reading level (5th-8th grade level) to facilitate patient comprehension. We assessed reading levels of informed consent forms (CFs) for adult organ transplant recipients and living organ donors across US transplant centers. CFs were analyzed using three measures of reading level: Lexile Measure, Flesch-Kincaid Grade Level, and the Gunning Fog Index. Of active transplant centers contacted (N=209), 75 (36%) sent a total of 332 CFs. CFs were written, on average, at the college level, which is a considerably higher reading level than the standards set by policy-makers. CF reading levels were negatively correlated with transplant center volume (r=-0.119; p<0.03). CFs for intestine transplantation and for evaluation/listing were the easiest to read, while consent forms for liver transplantation/donation and pre-transplant agreements were the most difficult to read. Reducing CFs' reading level may help to increase patient comprehension for adequate informed consent.

Ask, understand, remember: a brief measure of patient communication self-efficacy within clinical encounters.

Patients' ability to effectively communicate with their health care providers is an essential aspect of proper self-care, especially for those with chronic conditions. We wanted to develop and validate a brief, reliable measure of patient communication self-efficacy within clinical encounters. Consecutively recruited patients (n = 330) with diagnosed hypertension from seven primary care clinics in Chicago, Illinois, Grand Rapids, Michigan, and Shreveport, Louisiana completed an in-person interview including chronic disease self-efficacy, hypertension knowledge, health literacy assessments, and items modified from the Communication and Attitudinal Self-Efficacy (CASE) - Cancer scale. Six items from the CASE were candidates for a new scale due to their focus on the patient-provider relationship. Using principal components analysis with varimax rotation, four items strongly loaded onto one factor (Eigenvalue = 2.33; proportion of variance explained = 58%) with a Cronbach's α coefficient of 0.75. The measure, referred to as the Ask, Understand, Remember Assessment, (AURA) was moderately correlated with the total score from an existing chronic disease management self-efficacy scale (r = 0.31) and disease knowledge (beta coefficient = 0.2, 95% Confidence Interval 0.04 - 0.3, p = .03). Patients with low health literacy had lower scores on the AURA than those with marginal or adequate health literacy (p < .05). The AURA demonstrated high internal consistency and was correlated with both hypertension knowledge and a chronic disease self-efficacy scale. The AURA is brief, valid, has low reading demands, and is an appropriate tool for use among patients with chronic illness. It may also be useful in identifying and assisting patients who are at risk for errors or non-adherence with self-care behaviors.

Impact of electronic prescribing on medication use in ambulatory care.

OBJECTIVES: To investigate differences before and after rollout of electronic prescribing (e-prescribing) in (1) patients' primary adherence to newly prescribed medications, (2) patients' understanding of how to use their medications, and (3) multiple pharmacy use. STUDY DESIGN: Postvisit interviews and follow-up phone calls were done with 344 patients at an academic general internal medicine clinic. METHODS: Patient interviews and follow-up phone calls were done (1) before e-prescribing, (2) 1 to 6 months after e-prescribing, and (3) 12 to 18 months after e-prescribing. RESULTS: Overall, rates of abandoned prescriptions were 6.9% before e-prescribing, 10.6% 1 to 6 months after e-prescribing, and 2.5% 12 to 18 months after e-prescribing (P = .07). There was a reduction in awareness of the indication for a newly prescribed medicine among patients after e-prescribing (95.4%, 97.9%, and 89.8%, respectively; P = .03). There was a decrease in patients' ability to demonstrate proper use of their new medicine after e-prescribing (69.0% before e-prescribing, 67.1% 1-6 months after e-prescribing, 51.9% 12 -18 months after e-prescribing; P = .02). There was an increasing trend in the percentage of patients using multiple pharmacies after e-prescribing was implemented. CONCLUSIONS: We found both potential benefits and unexpected consequences as a result of the rollout of electronic prescribing. Adaptation to e-prescribing might be improved with outreach and education, including explicitly informing patients of the change during the first months of rollout. Tangible prescription information for reminder purposes only may also be beneficial.

Measuring patients' self-efficacy in understanding and using prescription medication.

OBJECTIVE: To create a brief assessment tool, the Medication Understanding and Use Self-Efficacy Scale (MUSE). METHODS: An existing scale (Communication and Attitudinal Self-Efficacy Scale) was modified, augmented, and piloted among 267 primary care patients in Chicago, New York City, and Shreveport, LA. Participant sociodemographics, literacy, current medication use, understanding medication instructions, and medication self-efficacy were measured. RESULTS: Using principal components analysis, two scales emerged: taking medication and learning about medication; these two factors accounted for 55% of the total variance of understanding medication instructions. Performance on the MUSE differed by literacy level; multivariate analysis detected no interaction between literacy level and MUSE score. Regression analysis, adjusted for age, education, literacy level and number of current prescription medications indicated that participants' MUSE scores predicted patient understanding of common medication instructions (beta=0.07, 95% CI 0.001-0.14, p=0.04). CONCLUSION: The MUSE is a valid and reliable tool measuring self-efficacy of understanding and using prescription medication. This scale differs from existing medication-specific self-efficacy scales as it addresses both learning about one's medications and adherence to the prescribed regimen. PRACTICE IMPLICATIONS: The MUSE is an effective and brief research tool that can be utilized among participants with varying literacy levels.