Developing, optimizing, and evaluating patient infographics for diagnosing cardiac amyloidosis.

Objective: Advancements in diagnostics and treatment options for cardiac amyloidosis have improved patient outcomes, yet few patient education materials exist to help patients understand the disease and diagnosis process. We sought to develop and evaluate a set of plain language, patient-centered infographics describing the condition and common diagnostic tests. Methods: Using health literacy best practices, we developed 7 infographics which were further revised based on multilevel stakeholder feedback. To evaluate the materials, we recruited 100 patients from healthcare settings in Chicago, IL; participants completed a web-assisted interview during which they were randomized 1:1 to first view either our infographics or a standard material. Participants completed a knowledge assessment on their assigned material and subsequently reported impressions of both materials. Results: No differences were found between study arms in knowledge. The infographics took significantly less time to read and were more highly rated by participants in terms of appearance and understandability. Over two-thirds of participants preferred the infographics to the standard. Conclusions: The infographics created may improve the learning process about a complex condition and diagnosis process unknown to most adults. Innovation: These infographics are the first of their kind for cardiac amyloidosis and were created using health literacy best practices.

Impact of COVID-19 on the capacity to self-manage health and chronic conditions.

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27 - May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

Development and Validation of COVID-19 Vaccine Messaging Materials for Latinx Communities.

With pervasive health misinformation and mistrust, many of those at greatest risk from COVID-19 have demonstrated lower vaccine acceptance. In Chicago, IL, surveillance data has revealed lower rates of vaccine uptake among Black and Latinx individuals compared with others. We partnered with two local federally qualified health centers (FQHCs) to develop and implement language-concordant, low literacy patient education materials to promote COVID-19 vaccine knowledge, acceptance, and uptake. Our multi-phase study included: 1) iterative content generation and refinement by health literacy experts, health center providers and staff, and community-dwelling adults; and 2) materials testing via a two-arm randomized experiment among adults from Latinx communities in the Chicagoland area. Results indicate that our English and Spanish-language COVID-19 Fact Sheets increase knowledge about COVID-19 vaccination. These materials are publicly available and can be used by health centers or community organizations to promote COVID-19 vaccination among diverse populations.

Development and Validation of the HL6: a Brief, Technology-Based Remote Measure of Health Literacy.

BACKGROUND: Most health literacy measures require in-person administration or rely upon self-report. OBJECTIVE: We sought to develop and test the feasibility of a brief, objective health literacy measure that could be deployed via text messaging or online survey. DESIGN: Participants were recruited from ongoing NIH studies to complete a phone interview and online survey to test candidate items. Psychometric analyses included parallel analysis for dimensionality and item response theory. After 9 months, participants were randomized to receive the final instrument via text messaging or online survey. PARTICIPANTS: Three hundred six English and Spanish-speaking adults with ≥ 1 chronic condition MAIN MEASURES: Thirty-three candidate items for the new measure and patient-reported physical function, anxiety, depression, and medication adherence. All participants previously completed the Newest Vital Sign (NVS) in parent NIH studies. KEY RESULTS: Participants were older (average 67 years), 69.6% were female, 44.3% were low income, and 22.0% had a high school level of education or less. Candidate items loaded onto a single factor (RMSEA: 0.04, CFI: 0.99, TLI: 0.98, all loadings >.59). Six items were chosen for the final measure, named the HL6. Items demonstrated acceptable internal consistency (α=0.73) and did not display differential item functioning by language. Higher HL6 scores were significantly associated with greater educational attainment (r=0.41), higher NVS scores (r=0.55), greater physical functioning (r=0.26), fewer depressive symptoms (r=-0.20), fewer anxiety symptoms (r=-0.15), and fewer barriers to medication adherence (r=-0.30; all p<.01). In feasibility testing, 75.2% of participants in the text messaging arm completed the HL6 versus 66.2% in the online survey arm (p=0.09). Socioeconomic disparities in completion were more common in the online survey arm. CONCLUSIONS: The HL6 demonstrates adequate reliability and validity in both English and Spanish. This performance-based assessment can be administered remotely using commonly available technologies with fewer logistical challenges than assessments requiring in-person administration.

Trajectories of perceived susceptibility to COVID-19 over a year: The COVID-19 & chronic conditions (C3) cohort study.

ABSTRACT: The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults' perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics.This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020-March 3, 2021). Subjects included 627 adults living with ≥1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants' perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories.Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic ("early responders") and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible ("late responders"), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic ("non-responders"). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8).A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

Navigating medication-taking after kidney transplant.

BACKGROUND: Mixed methods are valuable in understanding multifaceted health behaviors like medication adherence. Kidney transplant recipients (KTRs) have complex medication regimens and are more vulnerable to nonadherence relative to other transplant recipients. Yet mixed methods have not been widely applied to examine adherence among KTRs, especially in relation to prescribed medications beyond immunosuppressants. OBJECTIVES: As part of a sequential approach, we used in-depth interviews to better understand findings from a previous quantitative study and to describe additional factors that influence prescription medication-taking among adult KTRs. METHODS: Semi-structured interviews were conducted with a purposive sample of 14 adult KTRs recruited from a transplant center in Chicago, IL. Deductive and inductive content analysis was used to code transcripts and identify key themes. RESULTS: Across the sample, we identified insurance challenges, disruptions in routine, and poor mental well-being as barriers to adherence at the patient level. For Black and Hispanic KTRs, poor communication between providers and disjointed care transitions posed additional barriers at the health system level. Compared with White KTRs, Black and Hispanic KTRs experienced greater medication burden due to comorbidities, while medication and digital literacy challenges were unique to Hispanic KTRs. CONCLUSION: KTRs are often motivated to take medications as prescribed, but sometimes lack the capacity or support to do so. Eliciting KTR perspectives is necessary in addressing knowledge and resource gaps at the patient and health system levels to improve adherence. In addition, recognizing the relative burden of taking comorbidity medications compared with immunosuppressants may important, particularly for Black and Hispanic KTRs.

Implementation of a text-based postpartum blood pressure monitoring program at 3 different academic sites.

BACKGROUND: Up to 30% of patients with hypertensive disorders of pregnancy continue to have elevated blood pressures after delivery, often necessitating medication titration or hospital evaluation in the weeks following hospital discharge. A previous randomized controlled trial demonstrated that remote blood pressure monitoring programs led to an increase in the number of blood pressure measurements obtained and increased compliance with clinical guidelines regarding the monitoring of patients for persistent or worsening postpartum hypertension. OBJECTIVE: The aims of this study were to measure the program participant response rates during the first 10 days after hospital discharge, to assess the replicability and scalability of the program, and to evaluate patient satisfaction at 3 distinct sites. STUDY DESIGN: We conducted a prospective observational cohort study across 3 US academic medical centers during which postpartum participants with hypertensive disorders of pregnancy were enrolled in a previously validated, remote, text message-based blood pressure monitoring program known as Heart Safe Motherhood. English-speaking patients with access to a text message-enabled cell phone and with a diagnosis of hypertensive disorders of pregnancy were candidates for enrollment in the study. Each study site planned to enroll approximately 66 participants in this pilot implementation phase. All the enrolled participants received a validated blood pressure cuff, education on proper use of the device, and were sent text messages as a reminder to check their blood pressures twice daily for 10 days after discharge. They were asked to reply via text message with their blood pressure readings. All blood pressure readings were reviewed via a web-based platform by a physician. Physicians communicated with patients whose blood pressure levels exceeded 160 mm Hg systolic or 100 mm Hg diastolic to determine the next management steps. Enrollees were texted a survey at the end of the 10 days and the responses were recorded. The proportion of eligible parturients who were enrolled, the number of measured blood pressure values, and the postprogram survey results were measured. We assessed the number of patients who reported elevated blood pressures, required antihypertensive medication, and were readmitted for blood pressure control during the program duration. RESULTS: A total of 199 participants were enrolled in the program: 66 at site A, 67 at site B, and 66 at site C. In the 10 days after hospital discharge, 192 (97%) participants submitted at least 1 blood pressure measurement via text message. More enrolled patients submitted a blood pressure measurement on postpartum days 7 to 10 (171, 86%) than on days 1 to 4 (134, 67%). A total of 126 (63%) participants submitted blood pressures during both time frames. Elevated blood pressures were recorded for 70 (35%) participants, 32 (16%) of whom were started on oral antihypertensives after discussing their blood pressure measurements with an on-call provider. A total of 10 participants (5%) required hypertension-related readmission after delivery. The end-of-program survey was completed by 98 (49%) of the participants. Of those who completed the survey, 93% agreed that the program helped them to monitor their blood pressure (89% at site A; 88% at site B, and 100% at site C), and 93% would recommend it to friends or family members (94% at site A, 96% at site, and 88% at site C). CONCLUSION: Postpartum participants are willing and capable of using the Heart Safe Motherhood program for remote blood pressure monitoring and reported high satisfaction with the program across multiple sites. Our study demonstrated that this remote blood pressure monitoring program can be implemented successfully and demonstrated replicable efficacy at diverse sites.

Evaluation of a Discussion Guide to Promote Patient Understanding of Menopause and Informed Treatment Decision-Making.

Background: Patient-provider communication surrounding menopause symptoms and treatment is often limited. We developed and evaluated a health literacy-appropriate discussion guide to support patient education. Materials and Methods: A cross-sectional randomized study was conducted among 100 English-speaking women, aged 45-60 years, in Chicago, IL, and Durham, NC. Participants were randomly assigned to review either the discussion guide or a standard education material (n = 50 per arm) and to complete an open book knowledge questionnaire; they then rated the appearance and quality of both materials. Bivariate analyses examined knowledge and satisfaction by study arm and across sociodemographic characteristics. Multivariable models tested the effectiveness of the discussion guide to improve knowledge compared with the standard material. Results: Women receiving the discussion guide demonstrated significantly higher knowledge scores compared with those who reviewed the standard material (mean [M] = 20.0, standard deviation [SD] = 2.7, vs. M = 18.1, SD = 2.6; p < 0.001); 82.0% of those exposed to the discussion guide correctly answered ≥85% of knowledge items compared with only 48.0% of those reviewing the standard material (p < 0.001). In multivariable analyses, participants receiving the discussion guide displayed significantly greater knowledge in comparison with those receiving the standard material regardless of whether knowledge was examined as a score (∝ = 1.9, 95% confidence interval [CI]: 0.9-2.9, p < 0.001) or 85% threshold (odds ratio: 5.7, 95% CI: 2.0-16.2, p < 0.001). More than two-thirds of women (68%) preferred the discussion guide; it was rated highly in terms of appearance and content. Conclusions: The discussion guide improved understanding of menopause symptoms and treatment options in comparison with a current standard and was well received by a diverse audience.

Investigating Health Literacy in Systemic Lupus Erythematosus: a Descriptive Review.

PURPOSE OF REVIEW: Inadequate health literacy is common among American adults, but little is known about the impact of health literacy in rheumatic diseases. The purpose of this article is to review studies investigating health literacy and its association with clinical outcomes in systemic lupus erythematosus (SLE). RECENT FINDINGS: Several validated health literacy measures have been examined in SLE patients. Low health literacy is associated with worse patient-reported outcomes and lower numeracy with higher disease activity. Two studies found no association of low health literacy with medication adherence. One randomized controlled trial tested a medication decision aid among patients with low health literacy. We found a paucity of studies exploring health literacy in SLE. Low health literacy is associated with worse patient-reported outcomes and limited numeracy with higher disease activity in SLE. Further studies are needed exploring the impact of low health literacy on clinical outcomes and the effectiveness of literacy-sensitive interventions.

Changes in COVID-19 Knowledge, Beliefs, Behaviors, and Preparedness Among High-Risk Adults from the Onset to the Acceleration Phase of the US Outbreak.

BACKGROUND: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis. OBJECTIVE: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020). DESIGN: Longitudinal, two-wave telephone survey. PARTICIPANTS: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago. MAIN MEASURES: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness. KEY RESULTS: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.

Effects of Estimated Community-Level Health Literacy on Treatment Initiation and Preventive Care Among Older Adults with Newly Diagnosed Diabetes.

PURPOSE: Individual measures of health literacy are not feasible for administration on a large scale, yet estimates of community-level health literacy in the US recently became available. We sought to investigate whether community-level health literacy estimates are associated with the initiation of oral antihyperglycemic agents (OHA) and the use of standard preventive care services among older adults with newly diagnosed diabetes. PATIENTS AND METHODS: We conducted a retrospective cohort study of 169,758 patients, ≥65 years old with hypertension and newly diagnosed type 2 diabetes using 2007-2011 data from the Center for Medicare and Medicaid Services Chronic Conditions Warehouse. We examined the relationship between community-level health literacy estimates and initiation of OHA, receipt of flu shots, eye exams, Hemoglobin A1c tests, and lipid tests within 12 months post diabetes diagnosis. RESULTS: Patients living in communities with above basic health literacy (vs. basic/below basic) were 15% more likely to initiate OHA (Hazard Ratio=1.15; 95% CI 1.12 to 1.18). After classifying the health literacy distribution as quintiles, the analysis revealed a dose-response relationship with OHA initiation that plateaued at the third and fourth quintiles and declined at the fifth quintile. Individuals residing in communities with higher health literacy were more likely to participate in preventive care services (relative risk ranged from 1.09 for lipid test [95% CI 1.07-1.11] to 1.43 for flu shot [95% CI 1.41-1.46]). CONCLUSION: Community-level health literacy estimates were associated with the initiation of OHA and uptake of standard preventive care services in older adults. Community-level health literacy may help to inform targeted diabetes education and support efforts.

Treatment selection and medication adherence for stable angina: The role of area-based health literacy.

RATIONALE, AIMS, AND OBJECTIVES: Clinical studies show equivalent health outcomes from interventional procedures and treatment with medication only for stable angina patients. However, patients may be subject to overuse or access barriers for interventional procedures and may exhibit suboptimal adherence to medications. Our objective is to evaluate whether community-level health literacy is associated with treatment selection and medication adherence patterns. METHOD: The sample included Medicare fee-for-service beneficiaries (20% random sample) with stable angina in 2007-2013. We used an area-level health literacy variable because of the lack of an individual measure in claims. We measured the association between (a) area-based health literacy with treatment selection (medication only, percutaneous coronary intervention [PCI], or coronary artery bypass grafting (CABG) surgery) and (b) area-based health literacy with medication adherence. We controlled for other factors including demographics, co-morbidity burden, dual eligibility, and area deprivation index. RESULTS: We identified 8300 patients of whom 8.7% lived in a low health literacy area. Overall, 56% of patients received medication only, 28% received PCI, and 15% received CABG. Patients in low health literacy areas were less likely to receive CABG (-3.5 percentage points; 95% CI, -6.8 to -0.3) than were patients in high health literacy areas, but the significance was sensitive to specification. Overall, 81.5% and 71.5% of patients were adherent to antianginals and statins, respectively. Living in low health literacy areas was associated with lower adherence to antianginals (-3.3 percentage points; 95% CI, -6.1 to -0.6) but not statins. CONCLUSIONS: Low area-based health literacy was associated with being less likely to receive CABG and lower adherence, but the differences between low and high health literacy areas were small and sensitive to model specification. Individual factors such as dual eligibility status and race/ethnicity had stronger associations with outcomes than had area-based health literacy, suggesting that this area-based measure was inadequate to account for social determinants in this study.

Development of the influence, motivation, and patient activation in diabetes (IMPACT-D™) measure.

AIMS: We sought to create a new research and clinical instrument -the Influence and Motivation for Patient ACTivation in Diabetes care (IMPACT-D™) - to measure the degree to which patients with type 2 diabetes (T2DM) value health and believe they can influence it. METHODS: Candidate items were generated via a literature review, expert opinion, and qualitative interviews and focus groups with T2DM patients in Chicago, IL and Chapel Hill, NC. Psychometric testing guided by item response theory was conducted among an online panel of 500 English-speaking adults with T2DM. Differential item functioning analyses evaluated item performance across key participant characteristics. To determine construct validity, IMPACT-D™ scores were compared to other general measures of personality and patient activation. A second study among 300 patients recruited from two internal medicine clinics further assessed associations between the IMPACT-D™ and health outcomes. Cognitive interviews confirmed patient understanding of IMPACT-D™ items and instructions. RESULTS: Exploratory factor analyses revealed a single-factor solution that included 6 items. The IMPACT-D™ demonstrated adequate reliability (α = 0.72) and moderate construct validity with patient activation (r = 0.51, p < 0.001) and personality-conscientiousness subscales (r = 0.29, p < 0.001). Higher scores on the IMPACT-D™ were associated with better physical health (r = 0.17, p = 0.003) and lower severity of depressive (r = -0.35, p < 0.001) and anxiety (r = -0.28, p < 0.001) symptoms. There were no significant differences by blood pressure (r = -0.0021, p = 0.9) or haemoglobin A1c (r = -0.069p = 0.2). CONCLUSIONS: The IMPACT-D holds potential for use in both clinical care and research applications. Future studies should evaluate how to best operationalize its use for both settings.

Longitudinal Investigation of Older Adults' Ability to Self-Manage Complex Drug Regimens.

OBJECTIVES: We sought to investigate older patients' ability to correctly and efficiently dose multidrug regimens over nearly a decade and to explore factors predicting declines in medication self-management. DESIGN: Longitudinal cohort study funded by the National Institute on Aging. SETTING: One academic internal medicine clinic and six community health centers. PARTICIPANTS: Beginning in 2008, 900 English-speaking adults, aged 55 to 74 years, were enrolled in the study, completing a baseline (T1) assessment. To date, 303 participants have completed the same assessment 9 years postbaseline (T4). MEASUREMENTS: At T1, subjects were given a standardized, seven-drug regimen and asked to demonstrate how they would take medicine over 24 hours. The number of dosing errors made and times per day that a participant would take medicine were recorded. Health literacy was measured via the Newest Vital Sign, and cognitive decline was measured by the Mini-Mental State Examination. RESULTS: Participants on average made 2.9 dosing errors (SD = 2.5 dosing errors; range = 0-21 dosing errors) of 21 potential errors at T1 and 5.0 errors (SD = 2.1 errors; range = 1-18 errors; P < .001) at T4. In a multivariate model, limited literacy (ß = .69; 95% confidence interval [CI] = .18-1.20; P = .01), meaningful cognitive decline (ß = 1.72; 95% CI = .70-2.74; P = .01), number of chronic conditions (ß = .21; 95% CI = .07-.34; P = .01), and number of baseline dosing errors (ß = -.76; 95% CI = -.85 to -.67; P < .001) were significant, independent predictors of changes in dosing errors. Most patients overcomplicated their daily medication schedule; no sociodemographic characteristics were predictive of poor regimen organization in multivariate models. In a multivariate model, there were no significant predictors of changes in regimen consolidation over time, except regimen consolidation at T1. CONCLUSIONS: Older patients frequently overcomplicated drug regimens and increasingly made more dosing errors over 9 years of follow-up. Patients with limited literacy, cognitive decline, and multimorbidity were at greatest risk for errors. J Am Geriatr Soc 68:569-575, 2020.

Electronic Health Record-Based Strategy to Promote Medication Adherence Among Patients With Diabetes: Longitudinal Observational Study.

BACKGROUND: Poor medication adherence is common; however, few mechanisms exist in clinical practice to monitor how patients take medications in outpatient settings. OBJECTIVE: This study aimed to pilot test the Electronic Medication Complete Communication (EMC2) strategy, a low-cost, sustainable approach that uses functionalities within the electronic health record to promote outpatient medication adherence and safety. METHODS: The EMC2 strategy was implemented in 2 academic practices for 14 higher-risk diabetes medications. The strategy included: (1) clinical decision support alerts to prompt provider counseling on medication risks, (2) low-literacy medication summaries for patients, (3) a portal-based questionnaire to monitor outpatient medication use, and (4) clinical outreach for identified concerns. We recruited adult patients with diabetes who were prescribed a higher-risk diabetes medication. Participants completed baseline and 2-week interviews to assess receipt of, and satisfaction with, intervention components. RESULTS: A total of 100 patients were enrolled; 90 completed the 2-week interview. Patients were racially diverse, 30.0% (30/100) had a high school education or less, and 40.0% (40/100) had limited literacy skills. About a quarter (28/100) did not have a portal account; socioeconomic disparities were noted in account ownership by income and education. Among patients with a portal account, 58% (42/72) completed the questionnaire; 21 of the 42 patients reported concerns warranting clinical follow-up. Of these, 17 were contacted by the clinic or had their issue resolved within 24 hours. Most patients (33/38, 89%) who completed the portal questionnaire and follow-up interview reported high levels of satisfaction (score of 8 or greater on a scale of 1-10). CONCLUSIONS: Findings suggest that the EMC2 strategy can be reliably implemented and delivered to patients, with high levels of satisfaction. Disparities in portal use may restrict intervention reach. Although the EMC2 strategy can be implemented with minimal impact on clinic workflow, future trials are needed to evaluate its effectiveness to promote adherence and safety.

Patient-Clinician Decision Making for Stable Angina: The Role of Health Literacy.

BACKGROUND: Stable angina patients have difficulty understanding the tradeoffs between treatment alternatives. In this analysis, we assessed treatment planning conversations for stable angina to determine whether inadequate health literacy acts as a barrier to communication that may partially explain this difficulty. METHODS: We conducted a descriptive analysis of patient questionnaire data from the PCI Choice Trial. The main outcomes were the responses to the Decisional Conflict Scale and the proportion of correct responses to knowledge questions about stable angina. We also conducted a qualitative analysis on recordings of patient-clinician discussions about treatment planning. The recordings were coded with the OPTION12 instrument for shared decision-making. Two analysts independently assessed the number and types of patient questions and expressions of preferences. RESULTS: Patient engagement did not differ by health literacy level and was generally low for all patients with respect to OPTION12 scores and the number of questions related to clinical aspects of treatment. Patients with inadequate health literacy had significantly higher decisional conflict. However, the proportion of knowledge questions answered correctly did not differ significantly by health literacy level. CONCLUSIONS: Patients with inadequate health literacy had greater decisional conflict but no difference in knowledge compared to patients with adequate health literacy. Inadequate health literacy may act as a barrier to communication, but gaps were found in patient engagement and knowledge for patients of all health literacy levels. The recorded patient-clinician encounters and the health literacy measure were valuable resources for conducting research on care delivery.

Parent Preferences and Perceptions of Milliliters and Teaspoons: Role of Health Literacy and Experience.

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.

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

BACKGROUND: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation. OBJECTIVE: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults. METHODS: Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated. CONCLUSIONS: This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations. CLINICAL TRIAL REGISTRATION: This trial is registered on clinicaltrials.govNCT02820753.

An Electronic Health Record-Based Strategy to Systematically Assess Medication Use Among Primary Care Patients With Multidrug Regimens: Feasibility Study.

BACKGROUND: Medication nonadherence and misuse are public health and patient safety concerns. With the increased adoption of electronic health records (EHRs), greater opportunities exist to communicate directly with, and collect data from, patients through secure portals linked to EHRs. OBJECTIVE: The study objectives were to develop and pilot test a method of monitoring patient medication use in outpatient settings and determine the feasibility and acceptability of this approach. METHODS: Adult primary care patients on multidrug regimens were recruited from an academic internal medicine clinic by a trained research assistant. After completing a baseline, in-person interview, patients were sent a link to a questionnaire about medication use via the patient portal. One week later, the RA contacted patients to complete a follow-up telephone interview assessing patient satisfaction and experience with the questionnaire. Patient EHRs were also reviewed to determine the questionnaire completion rate. RESULTS: Of 100 patients enrolled, 89 completed the follow-up interview and 82 completed the portal questionnaire. The mean age of the sample was 61.8 (range 31-88) years. Approximately half (54/100, 54%) of the sample was male, two-thirds were white (67/100, 67%) and 26% (26/100) African-American. A total of 44% reported an annual household income of <$50,000 per year, and 17% (17/100) reported a high school or less level of education. No significant differences were found in questionnaire completion rates by sociodemographic characteristics or prior portal use. Most (68/73, 93%) found the questionnaire easy to access, easy to complete (72/73, 99%), and valuable (73/89, 82%). Time constraints and log-in difficulties were the main reasons for noncompletion. CONCLUSIONS: The portal questionnaire was well received by a socioeconomically diverse group of patients with high completion rates achieved. Routine use of a portal-based questionnaire could provide a valuable signal to providers and care teams about patient medication use and identify patients needing additional support.

Pictograms, Units and Dosing Tools, and Parent Medication Errors: A Randomized Study.

BACKGROUND AND OBJECTIVES: Poorly designed labels and dosing tools contribute to dosing errors. We examined the degree to which errors could be reduced with pictographic diagrams, milliliter-only units, and provision of tools more closely matched to prescribed volumes. METHODS: This study involved a randomized controlled experiment in 3 pediatric clinics. English- and Spanish-speaking parents (n = 491) of children ≤8 years old were randomly assigned to 1 of 4 groups and given labels and dosing tools that varied in label instruction format (text and pictogram, or text only) and units (milliliter-only ["mL"] or milliliter/teaspoon ["mL/tsp"]). Each parent measured 9 doses of liquid medication (3 amounts [2, 7.5, and 10 mL] and 3 tools [1 cup, 2 syringes (5- and 10-mL capacities)]) in random order. The primary outcome was dosing error (>20% deviation), and large error (>2× dose). RESULTS: We found that 83.5% of parents made ≥1 dosing error (overdosing was present in 12.1% of errors) and 29.3% of parents made ≥1 large error (>2× dose). The greatest impact on errors resulted from the provision of tools more closely matched to prescribed dose volumes. For the 2-mL dose, the fewest errors were seen with the 5-mL syringe (5- vs 10-mL syringe: adjusted odds ratio [aOR] = 0.3 [95% confidence interval: 0.2-0.4]; cup versus 10-mL syringe: aOR = 7.5 [5.7-10.0]). For the 7.5-mL dose, the fewest errors were with the 10-mL syringe, which did not necessitate measurement of multiple instrument-fulls (5- vs 10-mL syringe: aOR = 4.0 [3.0-5.4]; cup versus 10-mL syringe: aOR = 2.1 [1.5-2.9]). Milliliter/teaspoon was associated with more errors than milliliter-only (aOR = 1.3 [1.05-1.6]). Parents who received text only (versus text and pictogram) instructions or milliliter/teaspoon (versus milliliter-only) labels and tools made more large errors (aOR = 1.9 [1.1-3.3], aOR = 2.5 [1.4-4.6], respectively). CONCLUSIONS: Provision of dosing tools more closely matched to prescribed dose volumes is an especially promising strategy for reducing pediatric dosing errors.