Background: Emergent informed consent for clinical trials in acute myocardial infarction (AMI) and stroke is challenging. The role and value of consent are controversial, and insufficient data exist regarding patients’ and surrogates’ experiences. Methods and Results: We conducted structured interviews with patients (or surrogates) enrolled in AMI or acute stroke trials at 6 sites between 2011 and 2016. Primary domains included trial recall, consent experiences, and preferences regarding involvement. Descriptive and test statistics were used to characterize responses and explore relationships between key domains and characteristics. Multivariable logistic regression was used to examine associations between key covariates and consent preferences. There were 176 (84 stroke, 92 AMI) completed interviews. Most stroke respondents (82%) were surrogates; all AMI respondents were patients. Average time from trial enrollment to interview was 1.9years (stroke) and 2.8years (AMI); 89% of stroke and 62% of AMI respondents remembered being in the trial, and among these respondents, 80% (stroke) and 44% (AMI) remembered reading some of the consent form. Over 90% reported not feeling pressure to enroll, being treated in a caring way, and being treated with dignity. A minority (16% stroke and 26% AMI) reported they would have preferred not to be asked for consent. Just over half (61% stroke and 53% AMI) recalled a postenrollment conversation about the study. Conclusions: Most respondents felt they were treated respectfully and were glad they had been asked for consent. Trial recall was relatively low, and many respondents recalled little postenrollment discussion. Further development of context-sensitive approaches to consent is important.

Background Individuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders. Objective We are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications. Methods We are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview. Conclusion Our trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies.

Objective Some experts recommend eliminating “teaspoon” and “tablespoon” terms from pediatric medication dosing instructions, because these terms could inadvertently encourage use of nonstandard tools (ie, kitchen spoons), which are associated with dosing errors. We examined whether use of “teaspoon” or “tsp” on prescription labels affects parents’ choice of dosing tools, and the role of health literacy and language. Methods Analysis of data collected as part of a controlled experiment (SAFE Rx for Kids [Safe Administration For Every Prescription for Kids] study), which randomized English- and Spanish-speaking parents (n = 2110) of children 8 years of age and younger to 1 of 5 groups, which varied in unit of measurement pairings on medication labels and dosing tools. Outcome assessed was parent self-reported choice of dosing tool. Parent health literacy was measured using the Newest Vital Sign. Results Seventy-seven percent had limited health literacy (36.0% low, 41.0% marginal); 35.0% completed assessments in Spanish. Overall, 27.7% who viewed labels containing either “tsp” or “teaspoon” units (alone or with “mL”) chose nonstandard dosing tools (ie, kitchen teaspoon, kitchen tablespoon), compared with 8.3% who viewed “mL”-only labels (adjusted odds ratio [AOR]  = 4.4 [95% confidence interval (CI), 3.3–5.8]). Odds varied based on whether “teaspoon” was spelled out or abbreviated (“teaspoon”-alone: AOR = 5.3 [95% CI, 3.8–7.3] ); “teaspoon” with mL: AOR = 4.7 [95% CI, 3.3–6.5]; “tsp” with mL: AOR = 3.3 [95% CI, 2.4–4.7] ; P  <  .001). Similar findings were noted across health literacy and language groups. Conclusions Use of teaspoon units (“teas poon” or “tsp”) on prescription labels is associated with increased likelihood of parent choice of nonstandard dosing tools. Future studies might be helpful to examine the real-world effect of eliminating teaspoon units from medication labels, and identify additional strategies to promote the safe use of pediatric liquid medications.

Objectives: In 2010, a health literacy instrument designed to measure oral health conceptual knowledge was introduced. This developmental work was limited in that it included a relatively small and homogeneous study population and few oral health measures against which to test concurrent validity. The purpose of the present investigation is to expand upon the earlier work by utilizing a larger study sample and additional outcome variables. Methods: Data for this report came from the Multi-site Oral Health Literacy Research Study (MOHLRS), a large, cross-sectional survey conducted at two university-based dental clinics in the United States. MOHLRS included multiple assessments administered during face-to-face interviews. Conceptual knowledge was measured with the Comprehensive Measure of Oral Health Knowledge (CMOHK). Questions about self-efficacy, utilization, and dental beliefs and attitudes were also asked. Covariates included recruitment site, age, gender, race/ethnicity, education level, and languages spoken. Results: Overall, 18% of 909 adult participants exhibited “low” conceptual knowledge. CMOHK scores were significantly associated with three health literacy instruments, the REALM, Short-test of functional health literacy in adults (TOFHLA), and confidence filling out forms. In both bivariate and multivariable analyses, CMOHK scores were also significantly associated with dental beliefs and attitudes and self-efficacy to prevent both dental caries and periodontal disease. CMOHK scores were not associated with utilization, measured either as having a dental visit or a dental cleaning in the last year. Conclusions: The present investigation provides additional support for the CMOHK's validity. Researchers are encouraged to incorporate oral health conceptual knowledge into their theoretical frameworks, especially as it relates to beliefs and self-efficacy.

Objective: We examined patient beliefs about provider awareness of medication use, patient-reported prevalence and nature of provider counseling about medications, and the impact of health literacy on these outcomes. Methods: Structured interviews were conducted at academic general internal medicine clinics and federally qualified health centers with 500 adult patients. Interviewer-administered surveys assessed patients' beliefs, self-reported prevalence and nature of provider counseling for new prescriptions, and medication review. Results: Most patients believed their physician was aware of all their prescription and over the counter medications, and all medications prescribed by other doctors; while a minority reported disclosing over the counter and supplement use. Among those receiving new prescriptions (n= 190): 51.3% reported physician medication review, 77.4% reported receiving instructions on use from physicians and 43.3% from pharmacists. Side effects were discussed 42.9% of the time by physicians and 25.8% by pharmacists. Significant differences in outcomes were observed by health literacy, age, and clinic type. Conclusions: There is a sizable gap between what patients believe physicians know about their medication regimen and what they report to the physician. Practice implications: Discordance between patient beliefs and physician knowledge of medication regimens could negatively impact patient safety and healthcare quality.

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.

Background and Objectives A recent American Academy of Pediatrics policy statement recommends milliliter-exclusive dosing for pediatric liquid medications. Little is known about parent preferences regarding units, perceptions about moving to milliliters only, and the role of health literacy and prior milliliter-dosing experience. Methods Cross-sectional analysis of data collected as part of a randomized controlled study in 3 urban pediatric clinics (SAFE Rx for Kids study). English- and Spanish-speaking parents (n = 493) of children aged ≤8 years were randomized to 1 of 4 study arms and given labels and dosing tools which varied in label instruction format (text plus pictogram, text only) and units (milliliter only [“mL”], milliliter/teaspoon [“mL”/“tsp”]). Outcomes included teaspoon preference in dosing instructions and perceived difficulty with milliliter-only dosing. The predictor variable was health literacy (Newest Vital Sign; low [0–1], marginal [2–3], adequate [4–6]). The mediating variable was prior milliliter-dosing experience. Results Over two-thirds of parents had low or marginal health literacy. The majority (>70%) preferred to use milliliters, perceived milliliter-only dosing to be easy, and had prior milliliter-dosing experience; 11.5% had a teaspoon preference, 18.1% perceived milliliter-only dosing will be difficult, and 17.7% had no prior milliliter-dosing experience. Parents with lower health literacy had a higher odds of having a teaspoon preference (low vs adequate: adjusted odds ratio [AOR] = 2.9 [95% confidence interval [CI] 1.3–6.2]), and greater odds of perceiving difficulty with milliliter-only dosing (low vs adequate: AOR = 13.9 [95% CI 4.8–40.6], marginal vs adequate: AOR = 7.1 [95% CI 2.5–20.4]). Lack of experience with milliliter dosing partially mediated the impact of health literacy. Conclusions Most parents were comfortable with milliliter-only dosing. Parents with low health literacy were more likely to perceive milliliter-only dosing to be difficult; educational efforts will need to target this group to ensure safe medication use.

Objectives: To introduce a multi-site assessment of oral health literacy and to describe preliminary analyses of the relationships between health literacy and selected oral health outcomes within the context of a comprehensive conceptual model. Methods: Data for this analysis came from the Multi-Site Oral Health Literacy Research Study (MOHLRS), a federally funded investigation of health literacy and oral health. MOHLRS consisted of a broad survey, including several health literacy assessments, and measures of attitudes, knowledge, and other factors. The survey was administered to 922 initial care-seeking adult patients presenting to university-based dental clinics in California and Maryland. For this descriptive analysis, confidence filling out forms, word recognition, and reading comprehension comprised the health literacy assessments. Dental visits, oral health functioning, and dental self-efficacy were the outcomes. Results: Overall, up to 21% of participants reported having difficulties with practical health literacy tasks. After controlling for sociodemographic confounders, no health literacy assessment was associated with dental visits or dental caries self-efficacy. However, confidence filling out forms and word recognition were each associated with oral health functioning and periodontal disease self-efficacy. Conclusions: Our analysis showed that dental school patients exhibit a range of health literacy abilities. It also revealed that the relationship between health literacy and oral health is not straightforward, depending on patient characteristics and the unique circumstances of the encounter. We anticipate future analyses of MOHLRS data will answer questions about the role that health literacy and various mediating factors play in explaining oral health disparities.

Background: Kidney and liver transplant recipients must manage a complex care regimen after kidney transplant. Although the use of Web-based patient portals is known to improve patient-provider communication and health outcomes in chronic disease populations by helping patients manage posttransplant care, disparities in access to and use of portals have been reported. Little is known about portal usage and disparities among kidney and liver transplant recipients. Objective: The aim of this study was to examine patient racial/ethnic, socioeconomic, and clinical characteristics associated with portal usage among kidney and liver transplant recipients. Methods: The study included all adult kidney and liver transplant recipients (n=710) at a large academic transplant center in the Southeastern United States between March 2014 and November 2016. Electronic medical record data were linked with Cerner portal usage data. Patient portal use was defined as any portal activity (vs no activity) recorded in the Cerner Web-based portal, including viewing of health records, lab results, medication lists, and the use of secure messaging. Multivariable log-binomial regression was used to determine the patient demographic, clinical, and socioeconomic characteristics associated with portal usage, stratified by organ. Results: Among 710 transplant recipients (n=455 kidney, n=255 liver), 55.4% (252/455) of kidney recipients and 48.2% (123/255) of liver recipients used the patient portal. Black patients were less likely to use the portal versus white patients among both kidney (57% black vs 74% white) and liver (28% black vs 55% white) transplant recipients. In adjusted multivariable analyses, kidney transplant recipients were more likely to use the portal if they had higher education; among liver recipients, patients who were white versus black and had higher education were more likely to use the portal. Conclusions: Despite studies showing that patient portals have the potential to benefit transplant recipients as a tool for health management, racial and socioeconomic disparities should be considered before widespread implementation. Transplant centers should include portal training and support to all patients to encourage use, given its potential to improve outcomes.

Background: While many healthcare providers (HCPs) have navigated patients’ vaccine concerns and questions prior to the rollout of the COVID-19 vaccines, sentiments surrounding the COVID-19 vaccines have presented new and distinct challenges. Objective: To understand the provider experience of counseling patients about COVID-19 vaccinations, aspects of the pandemic environment that impacted vaccine trust, and communication strategies providers found supportive of patient vaccine education. Methods: 7 focus groups of healthcare providers were conducted and recorded during December 2021 and January 2022, at the height of the Omicron wave in the United States. Recordings were transcribed, and iterative coding and analysis was applied. Results: 44 focus group participants representing 24 US states with the majority (80%) fully vaccinated at the time of data collection. Most participants were doctors (34%) or physician’s assistants and nurse practitioners (34%). The negative impact of COVID-19 misinformation on patient-provider communication at both intrapersonal and interpersonal levels as well as barriers and facilitators to patient vaccine uptake are reported. People or sources that play a role in health communication (“messengers”) and persuasive messages that impact behavior or attitudes towards vaccination (“messages”) are described. Providers expressed frustration in the need to continuously address vaccine misinformation in clinical appointments among patients who remained unvaccinated. Many providers found value in resources that provided up-to-date and evidence-based information as COVID-19 guidelines continued to change. Additionally, providers indicated that patient-facing materials designed to support vaccination education were not frequently available, but they were the most valuable to providers in a changing information environment. Conclusions: While vaccine decision-making is complex and hinges on diverse factors such as health care access (i.e., convenience, expense) and individual knowledge, providers can play a major role in navigating these factors with their patients. But to strengthen provider vaccine communication and promote vaccine uptake, a comprehensive communication infrastructure must be sustained to support the patient-provider dyad. The findings provide recommendations to maintain an environment that facilitates effective provider-patient communication at the community, organizational and policy levels. There is a need for a unified multisectoral response to reinforce the recommendations in patient settings.