Search

Background: Electronic health records (EHRs) may help enable reliable, rapid data management for many uses, such as facilitating communication of advance care planning (ACP). However, issues with validity and accuracy of EHRs hinder the use of ACP information for practical applications. Design: We present a cross-sectional pilot study of 433 older adults with cancer from three large health care systems, participating in an ongoing multisite pragmatic trial (4UH3AG060626-02). We compared data extracted from dedicated structured EHR fields for ACP to a chart review of corresponding ACP documentation contained in the medical chart. Results: Structured ACP data existed for 43.2% of patients and varied by site (25.7% −48.9%). Of the identified structured ACP data elements, 59.2% of recorded elements were correct, 23.7% were incorrect, and 17.1% were duplicates with heterogeneity across sites. Conclusion: Structured ACP data in EHRs were frequently incorrect. This represents a problem for patients and their families, as well as quality improvement and research efforts. Clinical Trials Registration: NCT03609177.

Study Objective To characterize the short-term incidence of gynecologic cancer after undergoing uterine artery embolization (UAE). Design Retrospective cohort study. Setting Commercial insurance claims database. Patients Total of 15 393 United States women aged 18 to 64 years who underwent UAE between 2007 and 2017. Interventions We used the IBM MarketScan (Armonk, NY) claims to identify adult women without previous gynecologic cancer diagnoses undergoing UAE between 2007 and 2017. Database queries identified women with any diagnostic or procedure codes related to gynecologic malignancies occurring in the first 3 years after UAE. A malignancy diagnosis was suggested by recurrent malignancy-related claims not linked exclusively to diagnostic testing (e.g., transvaginal ultrasound) and malignancy codes linked to tissue pathology claims. Incidence of malignancy diagnosis was calculated. Rates of endometrial sampling in the year before UAE were identified. Measurements and Main Results Thirty-one women undergoing UAE had gynecologic cancer diagnoses within 3 years of the procedure (22 of 31, 71% uterine cancers; 7 of 31, 23% ovarian cancers; and 2 of 31, 6% cervical cancers). On average, cancer diagnoses were made 1.1 ± 0.9 years after UAE. One in 497 women undergoing UAE was diagnosed with a gynecologic malignancy within 3 years, with an incidence of 1.1 malignancies per 1000 person-years. Cancer incidence increased with age at the time of UAE: short-term malignancy diagnoses were made in 1 in 377 women aged 45 to 54 years, and 1 in 79 women aged 55 to 64 years. In the year before UAE, 28% (4311 of 15 362) of women without cancer, and 23% (5 of 22) of women diagnosed with uterine cancer had preprocedural endometrial sampling. Conclusion These data can inform risk/benefit counseling and shared decision-making regarding UAE and its alternatives. Short-term malignancies after UAE highlight the importance of preprocedure evaluation in symptomatic women and women with age-related risk.

OBJECTIVES: This study is a randomized controlled trial comparing the efficacy of a virtual counselor (VICKY) to the My Family Health Portrait (MFHP) tool for collecting family health history (FHx). METHODS: A total of 279 participants were recruited from a large safety-net hospital and block randomized by health literacy to use one of the digital FHx tools, followed by a genetic counselor interview. A final sample of 273 participants were included for analyses of primary study aims pertaining to tool concordance, which assessed agreement between tool and genetic counselor. RESULTS: Tool completion differed significantly between tools (VICKY=97%, MFHP=51%; p

BACKGROUND: Little is known about the risk of admission for emergency department (ED) visits for ambulatory care sensitive conditions (ACSCs) by limited English proficient (LEP) patients. OBJECTIVE: Estimate admission rates from ED for ACSCs comparing LEP and English proficient (EP) patients and examine how these rates vary at hospitals with a high versus low proportion of LEP patients. DESIGN: Retrospective cohort study of California’s 2017 inpatient and ED administrative data PARTICIPANTS: Community-dwelling individuals ≥ 18 years without a primary diagnosis of pregnancy or childbirth. LEP patients had a principal language other than English. MAIN MEASURES: We used a series of linear probability models with incremental sets of covariates, including patient demographics, primary diagnosis, and Elixhauser comorbidities, to examine admission rate for visits of LEP versus EP patients. We then added an interaction covariate for high versus low LEP-serving hospital. We estimated models with and without hospital-level random effects. KEY RESULTS: These analyses included 9,641,689 ED visits; 14.7% were for LEP patients. . Observed rate of admission for all ACSC ED visits was higher for LEP than for EP patients (26.2% vs. 25.2; p value < .001). Adjusted rate of admission was not statistically significant (27.3% [95% CI 25.4–29.3%] vs. 26.2% [95% CI 24.3–28.1%]). For COPD, the difference was significant (36.8% [95% CI 35.0–38.6%] vs. 33.3% [95% CI 31.7–34.9%]). Difference in adjusted admission rate for LEP versus EP visits did not differ in high versus low LEP-serving hospitals. CONCLUSIONS: In adjusted analyses, LEP was not a risk factor for admission for most ACSCs. This finding was observed in both high and low LEP-serving hospitals. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s11606-020-06523-5.

BACKGROUND: Many national guidelines recommend the use of patient provider agreements (PPAs) when prescribing opioids for chronic pain. There are no standards for PPA content, readability, or administration processes. OBJECTIVE: Conduct a national survey of providers who use PPAs to describe the process of administering them, assess views on their utility, and obtain PPAs to evaluate thematic content and readability. DESIGN: Cross-sectional electronic survey and request for PPAs. PARTICIPANTS: Registrants for the Safer/Competent Opioid Prescribing Education (SCOPE of Pain) Program between March 2013 and June 2017. MAIN MEASURES: Respondents’ reports on how PPAs are administered and views on their usefulness. A sample of PPAs assessed for themes and readability. KEY RESULTS: Using a convenience sample of 62,530 SCOPE of Pain registrants, we obtained a cohort of 430 individuals from 43 states who use PPAs. The majority of respondents worked in primary care (64%) and pain (18%) specialties. Reviewing PPAs with patients was primarily done by prescribers (80%), and the average perceived time to administer PPAs was 13 min. Although 66% of respondents thought PPAs were “often” or “always” worth the effort, only 28% considered them “often” or “always” effective in reducing opioid misuse. The PPA reading burden surpassed recommended patient education standards, with only 2.5% at or below fifth-grade reading level. PPAs focused more on rules and consequences of patients’ non-compliance than on a shared treatment plan. CONCLUSIONS: Most respondents perceive patient provider agreements (PPAs) as time-consuming and minimally effective in reducing opioid misuse yet still view them as valuable. PPAs are written far above recommended reading levels and serve primarily to convey consequences of non-compliance. Because PPAs are recommended by national safer opioid prescribing guidelines as a risk mitigation strategy, it would be beneficial to develop a standard PPA and study its effectiveness.

Literacy is an important predictor of health care utilization and outcomes. We examine literacy among people seeking care in a state funded mental health clinic (Site 1) and a safety-net hospital clinic (Site 2). Limited literacy was defined as literacy at or below the 8th grade level. At Site 1, 53% of participants had limited reading literacy and 78% had limited aural literacy. At Site 2, 72% had limited reading and 90% had limited aural literacy. Regression analyses examined associations among limited literacy and psychiatric, neurocognitive and sociodemographic characteristics. Few associations among psychiatric and neurocognitive factors, and literacy were found. At Site 2, black and "other" race participants had higher odds for limited literacy compared to white participants suggesting that limited literacy may be an under-examined mechanism in understanding racial disparities in mental health. Work is needed to understand the relationships among literacy, mental health and mental health care.

BACKGROUND: Limited health literacy is a driver of cancer disparities and associated with less participation in medical decisions. Mammography screening decisions are an exemplar of where health literacy may impact decision-making and outcomes. OBJECTIVE: To describe informational needs and shared decision-making (SDM) experiences among women ages 40–54 who have limited health literacy and primary care providers (PCPs). DESIGN: Qualitative, in-depth interviews explored experiences with mammography counseling and SDM. PARTICIPANTS: Women ages 40–54 with limited health literacy and no history of breast cancer or mammogram in the prior 9 months were approached before a primary care visit at a Boston academic, safety-net hospital. PCPs practicing at this site were eligible for PCP interviews. APPROACH: Interviews were audio-recorded and transcribed verbatim. A set of deductive codes for each stakeholder group was developed based on literature and the interview guide. Inductive codes were generated during codebook development. Codes were compared within and across patient and PCP interviews to create themes relevant to mammography decision-making. KEY RESULTS: The average age of 25 interviewed patients was 46.5; 18 identified as black, 3 as Hispanic, 2 as non-Hispanic white, and 2 had no recorded race or ethnicity. Of 20 PCPs, 15 were female; 12 had practiced for >5 years. Patients described a lack of technical (appropriate tests and what they do) and process (what happens during a mammogram visit) knowledge, viewing these as necessary for decision-making. PCPs were reluctant to engage patients with limited health literacy in SDM due to time constraints and feared that increased information might confuse patients or deter them from having mammograms. Both groups felt pre-visit education would facilitate mammography-related SDM during clinical visits. CONCLUSION: Both patients and PCPs perceived a need for tools to relay technical and process knowledge about mammography prior to clinical encounters to address the scope of information that patients with limited health literacy desired. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-020-06213-2) contains supplementary material, which is available to authorized users.

PURPOSE: Low health literacy (HL) and language negatively affect cancer screening and prevention behaviors; less is known about how they affect the patient’s experience during cancer treatment. This study explores associations among HL, spoken language, and dimensions of cancer-related needs within 6 months of receiving a breast cancer diagnosis. METHODS: Women speaking English, Spanish, or Haitian Creole, enrolled in a patient navigation study at diagnosis, completed a survey in their primary spoken language at baseline and 6 months to characterize their cancer-related needs. HL was measured using the Brief Health Literacy Screening Tool. Outcomes included the Cancer Needs Distress Inventory (CaNDI; n = 38 items) and the Communication and Attitudinal Self-Efficacy scale (CASE-Cancer) for cancer (n = 12 items). Linear regressions measured the impact of HL and language on total CaNDI and CASE-Cancer scale for cancer scores and subscales, adjusted for demographics. RESULTS: At baseline, 262 women participated and 228 (87%) followed up at 6 months. Of these, 38% had adequate HL, 33% had marginal HL, and 29% had inadequate HL. Women with inadequate or marginal HL had higher median baseline CaNDI scores ( P = .02) and lower self-efficacy scores ( P = .008), relative to those with adequate HL. Haitian-Creole speakers had significantly lower CANDI scores at baseline ( P = .03). Adjusting for demographics, differences in CaNDI scores at baseline remained significant for those with lower HL and Haitian-Creole speakers. At 6 months, differences in self-efficacy persisted for Haitian-Creole speakers. CONCLUSION: Findings suggest that interventions oriented to mitigating HL and language barriers might reduce distress at the time of diagnosis and improve self-efficacy over the course of treatment.

Half of women undergoing mammography have dense breasts. Mandatory dense breast notification and educational materials have been shown to confuse women, rather than empower them. This study used a mixed method, multi-stakeholder approach to assess acceptability of an interactive, computer-animated agent that provided breast density information to women and changes in knowledge, satisfaction, and informational needs. A pre-post survey and qualitative focus groups assessed the acceptability of the computer-animated agent among women. An anonymous, online survey measuring acceptability was delivered to a multi-stakeholder group. English-speaking, mammography-eligible women ages 40–74 were invited and 44 women participated in one of nine focus groups. In addition, 14 stakeholders representing primary care, radiology, patient advocates, public health practitioners, and researchers completed the online survey. A prototype of a computer-animated agent was delivered to women in a group setting; stakeholders viewed the prototype independently. Data collected included open-ended qualitative questions that guided discussion about the content and form of the computer-animated agent. Structured surveys included domains related to knowledge, acceptability, and satisfaction. Stakeholder acceptability was measured with a series of statements about aspects of the intervention and delivery approach and are reported as the proportion of respondents who endorsed each statement. Six of 12 knowledge items demonstrated improvement post-intervention, satisfaction with the agent was high (81%), but the number of unanswered questions did not improve (67% vs. 54%, p = 0.37). Understanding of the distinction between connective and fatty tissue in the breast did not increase (30% vs. 26%, p = 0.48). Results of the multi-stakeholder survey suggest broad acceptability of the approach and agent. Findings highlight the benefits of a brief interactive educational exposure as well as misperceptions that persisted. Results demonstrate the need for an evidence-based, accessible intervention that is easy to understand for patients.

Gang Fang,1 Stacy Cooper Bailey,2 Izabela E Annis,1 Michael K Paasche-Orlow,3 Michael S Wolf,2 Laurie T Martin,4 Michael Emch,5 M Alan Brookhart,6 Karen B Farris7 1Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; 3Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA; 4RAND Corporation, Arlington, VA, USA; 5Department of Geography and Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA; 6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; 7College of Pharmacy, The University of Michigan, Ann Arbor, MI, USACorrespondence: Gang FangDivision of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 2202, Kerr Hall, Chapel Hill, NC 27599-7573, USATel +1 919-966-7517Fax +1 919-966-8486Email gang_fang@unc.eduPurpose: 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.Keywords: health literacy, diabetes mellitus, adherence, preventive care

Background U.S. medical schools have been unsuccessful in creating a diverse physician workforce. Implicit bias is pervasive in medicine, including potentially in medical school admissions. Methods We invited all 2018-2019 interviewees at one U.S. medical school to complete the eight-item Everyday Discrimination Scale (EDS) asking about experiences of bias during interview experiences to date. Results Three hundred forty-seven (30%) of 1,175 interviewees completed the survey, with participant demographic characteristics matching those of the broader interviewee pool. Seventy-two (21%) responded affirmatively to one or more EDS items. Gender, age, race, religion, and sexual orientation were all sources of discrimination. Those reporting bias had completed more interviews (5.2 vs. 3.9, Pl.05) and were more likely to be Latinx (30.6% vs. 16.4%, Pl.05) than their counterparts. Only three (4%) reported the incident to the institution where it occurred. Conclusion Further work exploring experiences of bias during medical school admissions and how to decrease their frequency is warranted.

Study objective We estimate emergency department (ED) use differences across Medicare enrollees of different race/ethnicity who are residing in the same zip codes. Methods In this retrospective cohort study, we stratified all Medicare fee-for-service beneficiaries aged 66 years and older (2006 to 2012) by residence zip code and identified zip codes with racial/ethnic diversity, defined as containing at least 1 enrollee from each of 3 racial/ethnic groups: Hispanics, (non-Hispanic) blacks, and (non-Hispanic) whites. Our primary study population consisted of a stratified random sample of approximately equal number of each racial/ethnic group from each zip code with racial/ethnic diversity (N=1,563,631). We identified ED visits, comorbidities, primary-care-treatable status, and patient disposition. We characterized socioeconomic status by zip code poverty rate. The main outcome measure was the ratio of ED visit rate (number of visits/100 person-years) between each minority group and whites. Results Of 38,423 zip codes nationally, 41% met the racial/ethnic diversity criterion; these zip codes contained 85% of the Medicare fee-for-service beneficiaries. Among enrollees from zip codes with racial/ethnic diversity, the ED visit rate among whites was 45.4 (95% confidence interval 45.1 to 45.6), and the ED visit rate ratio was 1.34 (95% confidence interval 1.33 to 1.36) among blacks and 1.23 (95% confidence interval 1.22 to 1.24) among Hispanics. ED visit rate ratios for both minority groups were greater than 1.00 among all subgroups by age, comorbidity, zip code poverty rate, urban/rural area, and primary-care-treatable and disposition status. Conclusion Among Medicare enrollees, blacks and Hispanics had higher ED use rates than whites overall and among subgroups by demographics and socioeconomic status.

Background Medicare’s Hospital Readmissions Reduction Program (HRRP), implemented beginning in 2013, seeks to incentivize Inpatient Prospective Payment System (IPPS) hospitals to reduce 30-day readmissions for selected inpatient cohorts including acute myocardial infarction, heart failure, and pneumonia. Performance-based penalties, which take the form of a percentage reduction in Medicare reimbursement for all inpatient care services, have a risk of unintended financial burden on hospitals that care for a larger proportion of Medicare patients. To examine the role of this unintended risk on 30-day readmissions, we estimated the association between the extent of their Medicare share of total hospital bed days and changes in 30-day readmissions. Methods We used publicly available nationwide hospital level data for 2009–2016 from the Centers for Medicare and Medicaid Services (CMS) Hospital Compare program, CMS Final Impact Rule, and the American Hospital Association Annual Survey. Using a quasi-experimental difference-in-differences approach, we compared pre- vs. post-HRRP changes in 30-day readmission rate in hospitals with high and moderate Medicare share of total hospital bed days (“Medicare bed share”) vs. low Medicare bed share hospitals. Results We grouped the 1904 study hospitals into tertiles (low, moderate and high) by Medicare bed share; the average bed share in the three tertile groups was 31.2, 47.8 and 59.9%, respectively. Compared to low Medicare bed share hospitals, high bed share hospitals were more likely to be non-profit, have smaller bed size and less likely to be a teaching hospital. High bed share hospitals were more likely to be in rural and non-large-urban areas, have fewer lower income patients and have a less complex patient case-mix profile. At baseline, the average readmissions rate in the low Medicare bed share (control) hospitals was 20.0% (AMI), 24.7% (HF) and 18.4% (pneumonia). The observed pre- to post-program change in the control hospitals was − 1.35% (AMI), − 1.02% (HF) and − 0.35% (pneumonia). Difference in differences model estimates indicated no differential change in readmissions among moderate and high Medicare bed share hospitals. Conclusions HRRP penalties were not associated with any change in readmissions rate. The CMS should consider alternative options – including working collaboratively with hospitals – to reduce readmissions.

Background Previous research shows that Black and Hispanic patients have longer ED wait times than White patients, but these data do not reflect recent changes such as the Affordable Care Act. In addition, previous research does not account for the non-normal distribution of wait times, wherein a sizable subgroup of patients seen promptly and those not seen promptly experience long wait times. Methods We utilized National Hospital Ambulatory Medical Care Survey (NHAMCS) datasets (2013–2017) to examine mean ED wait time comparing visits by Black, Hispanic, and Asian patients to White patients. Using a two-part regression model, we adjusted for patient, hospital, and health system factors, and estimated differences, for each of five triage levels, in (a) likelihood of waiting at least 5 min and (b) difference in wait time among those not seen promptly. Results Our cohort included 38,800 White, 14,838 Black, 10,619 Hispanic, and 1257 Asian patient visits. Black (triage level 3) and Hispanic (triage levels 3 and 4) patients had longer mean wait times than White patients. Adjusted likelihood of not being seen promptly was lower among Blacks (triage levels 3, 4 and 5), Hispanics (triage level 5) and Asians (triage level 5) compared to Whites. Among those waiting at least 5 min, adjusted wait time was longer among Blacks in triage level 3 (5.2 min, 95% CI, 1.3 to 9.0) and level 4 (2.5 min, 95% CI, 0.2 to 4.9), Hispanics in triage level 4 (4.7 min, 95% CI, 1.7 to 7.7) and Asians in triage level 5 (16.3 min, 95% CI, 0.6 to 31.9) compared to Whites. Conclusions Minority patients were less likely to wait to be seen, but waited longer if not seen promptly. These data exhibit that ED wait time disparities persist for African American and Hispanic patients and extend this observation to Asian patients.

This is the accepted manuscript version of the work published in its final form asBershteyn, A., Schwartz, M. D., Thorpe, L. E., Paasche-orlow, M. K., Kissinger, P., Karita, H. C. S., Laufer, M. K., Hoffman, R. M., Landovitz, R. J., Paolino, K., & Ruanne V. Barnabas. (2021). Taking a stand against the politicization of medical research: How 'swinging the pendulum' poses a hazard to clinical trials, study participants, and the progress of science.Expert Review of Clinical Immunology,17(1), 101-103. https://doi.org/10.1080/1744666x.2020.1860758 Deposited byshareyourpaper.organdopenaccessbutton.org. We've taken reasonable steps to ensure this content doesn't violate copyright. However, if you think it does you can request a takedown by emailinghelp@openaccessbutton.org. &nbsp

Clinical trials have ruled out a role of hydroxychloroquine in the treatment of COVID-19, but it has been hypothesized that hydroxychloroquine's activity against SARS-CoV-2 in the laboratory suggests a role in prevention. This randomized controlled trial tests hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection., Visual Abstract. Postexposure Hydroxychloroquine Prophylaxis to Prevent SARS-CoV-2 Infection Clinical trials have ruled out a role of hydroxychloroquine in the treatment of COVID-19, but it has been hypothesized that hydroxychloroquine's activity against SARS-CoV-2 in the laboratory suggests a role in prevention. This randomized controlled trial tests hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection. Visual Abstract. Postexposure Hydroxychloroquine Prophylaxis to Prevent SARS-CoV-2 Infection Clinical trials have ruled out a role of hydroxychloroquine in the treatment of COVID-19, but it has been hypothesized that hydroxychloroquine's activity against SARS-CoV-2 in the laboratory suggests a role in prevention. This randomized controlled trial tests hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection., Background: Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention. Objective: To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection. Design: Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961) Setting: National U.S. multicenter study. Participants: Close contacts recently exposed ( 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026). Limitation: The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days. Conclusion: This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection. Primary Funding Source: Bill & Melinda Gates Foundation.

Background and objectives The coronavirus disease-2019 (COVID-19) pandemic is transforming the health care sector. As health care organizations move from crisis mobilization to a new landscape of health and social needs, organizational health literacy offers practical building blocks to provide high-quality, efficient, and meaningful care to patients and their families. Organizational health literacy is defined by the Institute of Medicine as "the degree to which an organization implements policies, practices, and systems that make it easier for people to navigate, understand, and use information and services to take care of their health." Methods This article synthesizes insights from organizational health literacy in the context of current major health care challenges and toward the goal of innovation in patient-centered care. We first provide a brief overview of the origins and outlines of organizational health literacy research and practice. Second, using an established patient-centered innovation framework, we show how the existing work on organizational health literacy can offer a menu of effective, patient-centered innovative options for care delivery systems to improve systems and outcomes. Finally, we consider the high value of management focusing on organizational health literacy efforts, specifically for patients in health care transitions and in the rapid transformation of care into myriad distance modalities. Results This article provides practical guidance for systems and informs decisions around resource allocation and organizational priorities to best meet the needs of patient populations even in the face of financial and workforce disruption. Conclusions Organizational health literacy principles and guidelines provide a road map for promoting patient-centered care even in this time of crisis, change, and transformation. Health system leaders seeking innovative approaches can have access to well-established tool kits, guiding models, and materials toward many organizational health literacy goals across treatment, diagnosis, prevention, education, research, and outreach.

Approximately one-third of adults in the United States (U.S.) have limited health literacy. Those with limited health literacy often have difficultly navigating the health care environment, including navigating care across the cancer continuum (e.g., prevention, screening, diagnosis, treatment). Evidence-based interventions to assist adults with limited health literacy improve health outcomes; however, little is known about health literacy interventions in the context of cancer and their impact on cancer-specific health outcomes. The purpose of this review was to identify and characterize the literature on health literacy interventions across the cancer care continuum. Specifically, our aim was to review the strength of evidence, outcomes assessed, and intervention modalities within the existing literature reporting health literacy interventions in cancer. Our search yielded 1036 records (prevention/screening n = 174; diagnosis/treatment n = 862). Following deduplication and review for inclusion criteria, we analyzed 87 records of intervention studies reporting health literacy outcomes, including 45 pilot studies (prevention/screening n = 24; diagnosis/treatment n = 21) and 42 randomized controlled trials or quasi-experimental trials (prevention/screening n = 31; diagnosis/treatment n = 11). This literature included 36 unique interventions (prevention/screening n = 28; diagnosis/treatment n = 8), mostly in the formative stages of intervention development, with few assessments of evidence-based interventions. These gaps in the literature necessitate further research in the development and implementation of evidence-based health literacy interventions to improve cancer outcomes.

Background Large administrative databases often do not capture gender identity data, limiting researchers' ability to identify transgender people and complicating the study of this population. Objective The objective of this study was to develop methods for identifying transgender people in a large, national dataset for insured adults. Research design This was a retrospective analysis of administrative claims data. After using gender identity disorder (GID) diagnoses codes, the current method for identifying transgender people in administrative data, we used the following 2 strategies to improve the accuracy of identifying transgender people that involved: (1) Endocrine Disorder Not Otherwise Specified (Endo NOS) codes and a transgender-related procedure code; or (2) Receipt of sex hormones not associated with the sex recorded in the patient's chart (sex-discordant hormone therapy) and an Endo NOS code or transgender-related procedure code. Subjects Seventy-four million adults 18 years and above enrolled at some point in commercial or Medicare Advantage plans from 2006 through 2017. Results We identified 27,227 unique transgender people overall; 18,785 (69%) were identified using GID codes alone. Using Endo NOS with a transgender-related procedure code, and sex-discordant hormone therapy with either Endo NOS or transgender-related procedure code, we added 4391 (16%) and 4051 (15%) transgender people, respectively. Of the 27,227 transgender people in our cohort, 8694 (32%) were transmasculine, 3959 (15%) were transfeminine, and 14,574 (54%) could not be classified. Conclusion In the absence of gender identity data, additional data elements beyond GID codes improves the identification of transgender people in large, administrative claims databases.

Background Outcomes of hospitalized patients with COVID-19 have been described in health systems overwhelmed with a surge of cases. However, studies examining outcomes of patients admitted to hospitals not in crisis are lacking. Objective To describe clinical characteristic and outcomes of all patients with COVID-19 who are admitted to hospitals not in crisis, and factors associated with mortality in this population. Design A retrospective analysis Participants In total, 470 consecutive patients with COVID-19 requiring hospitalization in one health system in Boston from January 1, 2020 to April 15, 2020. Main Measures We collected clinical outcomes during hospitalization including intensive care unit (ICU) admission, receipt of mechanical ventilation, and vasopressors. We utilized multivariable logistic regression models to examine factors associated with mortality. Key Results A total of 470 patients (median age 66 [range 23–98], 54.0% male) were included. The most common comorbidities were diabetes (38.5%, 181/470) and obesity (41.3%, 194/470). On admission, 41.9% (197/470) of patients were febrile and 60.6% (285/470) required supplemental oxygen. During hospitalization, 37.9% (178/470) were admitted to the ICU, 33.6% (158/470) received mechanical ventilation, 29.4% (138/470) received vasopressors, 16.4% (77/470) reported limitations on their desire for life-sustaining therapies such as intubation and cardiopulmonary resuscitation, and 25.1% (118/470) died. Among those admitted to the ICU (N=178), the median number of days on the ventilator was 10 days (IQR 1–29), and 58.4% (104/178) were discharged alive. Older age (OR=1.04, P

BACKGROUND: Medical interpreters improve care for patients with Limited English Proficiency but are underused. Protocols to improve interpreter use in primary care are needed. METHODS: Medical Assistants (MAs) screened patients for language needs and arranged for telephone interpreters during rooming in two pilot clinics (PCs). We interviewed MAs and providers and analyzed interviews using modified grounded theory, linking themes to the Promoting Action on Research Implementation in Health Services (PARiHS) framework categories of Context, Evidence, and Facilitation. Providers in PCs and four comparison clinics were surveyed. RESULTS: Context themes included issues with the telephone interpreter vendor; having established teams, roles and workflows; and difficulty incorporating time-sensitive tasks. Evidence themes included engagement in language screening; preferring in-person interpreters; improving the patient experience; and having mixed responses to the protocol. Facilitation themes included MAs needing more support. PC providers were more satisfied with care (OR = 12.7) and communication (OR = 7.6) than comparison clinic providers. CONCLUSIONS: The protocol may improve patient care and communication, but implementation was inconsistent. Language screening is a complex process and further research is needed to improve screening questions and procedures. Future interventions should capitalize on team members’ drives to improve patient care and control costs but also need to consider the impacts of health system changes, and to consider the culture, training needs, roles, and relationships of team members.

Background Improving the process of hospital discharge is a critical priority. Interventions to improve care transitions have been shown to reduce the rate of early unplanned readmissions, and consequently, there is growing interest in improving transitions of care between hospital and home through appropriate interventions. Project Re-Engineered Discharge (RED) has shown promise in strengthening the discharge process. Although studies have analyzed the implementation of RED among private-sector hospitals, little is known about how hospitals in the Veterans Health Administration (VHA) have implemented RED. The RED implementation process was evaluated in five VHA hospitals, and contextual factors that may impede or facilitate the undertaking of RED were identified. Methods A qualitative evaluation of VHA hospitals' implementation of RED was conducted through semistructured telephone interviews with personnel involved in RED implementation. Qualitative data from these interviews were coded and used to compare implementation activities across the five sites. In addition guided by the Practical, Robust Implementation and Sustainability Model (PRISM), cross-site analyses of the contextual factors were conducted using a consensus process. Results Progress and adherence to the RED toolkit implementation steps and intervention components varied across study sites. A majority of contextual factors identified were positive influences on sites' implementation. Conclusion Although the study sites were able to tailor and implement RED because of its adaptability, redesigning discharge processes is a significant undertaking, requiring additional support/resources to incorporate into an organization's existing practices. Lessons learned from the study should be useful to both VHA and private-sector hospitals interested in implementing RED and undertaking a care transition intervention.

A patient’s self-management of chronic disease is influenced in part by their explanatory model of illness (EMI) and daily lived experiences (DLE). Unfortunately, assessing patient’s EMI and using this information to engage patients in chronic illness self-management continues to be a challenge. “Health mind mapping” (HMM) is a novel process that captures a patient’s EMI and DLE through the use of a graphic representation of ideas. We aimed to explore patient’s experiences using HMM. Qualitative study utilizing semi-structured interviews. Adult patients with uncontrolled type 2 diabetes from a primary care clinic. A facilitator guided 20 participants through the process of developing a health mind map. Subsequently, each participant completed a semi-structured interview about their experience with the process and perceptions about how their maps could be used. The process and interviews were video and audio recorded. We conducted a content analysis of the maps and a thematic analysis, using an inductive approach, of the interview data. Participants explored a wide range of EMs and DLEs in their HMM process. Participants reported that the HMM process (1) helped to develop insight about self and illness; (2) was a catalyst for wanting to take actions to improve illness; and (3) represented an opportunity to actively share illness experiences. They reported potential uses of the map: (1) to communicate about their illness to others in their social network; (2) to communicate about their illness to providers; (3) to help others with diabetes manage their illness; and (4) to encourage ongoing engagement in diabetes self-care. Participants reported that HMM helped them develop new insight about their illness and was a catalyst for encouraging them to take control of their illness. HMM has the potential to facilitate communication with providers and engage patients in collaborative goal setting to improve self-care in chronic illness.

Background Patients with inflammatory bowel disease (IBD) face complex health tasks and decisions. Limited health literacy is a risk factor for poor health outcomes, but this has not been examined in IBD. This study aims to assess the role of health literacy for patients with IBD. Methods We prospectively enrolled adults with IBD receiving care from the Section of Gastroenterology at the Boston Medical Center. In-person, standardized questionnaires were administered to measure health literacy with the Newest Vital Sign, self-efficacy with the Medication Use and Self-Efficacy Scale, quality of life with the 10-question Short Inflammatory Bowel Disease Questionnaire, depression with the Patient-Reported Outcomes Measurement System Short Form, and clinical disease activity for patients with Crohn's disease with the Harvey-Bradshaw Index and for patients with ulcerative colitis with the Simple Clinical Colitis Activity Index (SCCAI). The relationships between health literacy and these variables were subsequently examined. Results Of 112 patients invited to participate, 99 enrolled and completed the interview. Limited health literacy was identified in 40% (n = 40) of patients. Patients with limited health literacy reported significantly worse overall health (P = 0.03) and more depressive symptoms (P = 0.01). Of the 56 patients with Crohn's disease, those with adequate health literacy were more likely to be in clinical remission (mean Harvey-Bradshaw Index score < 5), compared with those with limited health literacy (odds ratio, 4.15; 95% confidence interval, 1.37 to 13.45; P = 0.01). There was no significant association between health literacy and clinical disease activity (SCCAI) in patients with ulcerative colitis. Conclusions Limited health literacy is associated with lower ratings of subjective health and depression in IBD and more symptoms of active disease in patients with Crohn's disease.

Objective Currently, 30 US states mandate that radiologists notify women when dense breast tissue is found on mammography. Little is understood about how notifications are perceived by recipients. This qualitative study sought to understand how dense breast notifications (DBNs) impact women’s perceptions and their participation in follow-up care. Methods We assessed rates of DBN recall and conducted semi-structured telephone interviews with 30 English-speaking women ages 40 to 74 after receiving a DBN from a Massachusetts hospital. Content coding characterized women’s recall of the notification content, perceptions of breast density, and planned or actual participation in follow-up care. Results Most women (81%) recalled receiving a DBN, but few could recall specific content. Women described struggling to understand the meaning of breast density and created their own explanatory models of dense breasts that differed from medical explanations. Many women planned to or did talk with their doctors about breast density as a result of receiving the notification. Conclusions Women receiving DBNs have limited knowledge and many misperceptions about the implications of having dense breasts. Practice implications Educational support is needed to promote informed decision- making about breast cancer screening that incorporates personal risk in the setting of dense breast legislation.

Background Acute myocardial infarction (AMI) is a common high-risk disease with inpatient mortality of 5% nationally. But little is known about this outcome among Asian Americans (Asians), a fast growing racial/ethnic minority in the country. The objectives of the study are to obtain near-national estimates of differences in AMI inpatient mortality between minorities (including Asians) and non-Hispanic Whites and identify comorbidities and sociodemographic characteristics associated with these differences. Method This is a retrospective analysis of 2010–2011 state inpatient discharge data from 10 states with the largest share of Asian population. We identified hospitalization with a primary diagnosis of AMI using the ICD-9 code and used self-reported race/ethnicity to identify White, Black, Hispanic, and Asian. We performed descriptive analysis of sociodemographic characteristics, medical comorbidities, type of AMI, and receipt of cardiac procedures. Next, we examined overall inpatient AMI mortality rate based on patients’ race/ethnicity. We also examined the types of AMI and a receipt of invasive cardiac procedures by race/ethnicity. Lastly, we used sequential multivariate logistic regression models to study inpatient mortality for each minority group compared to Whites, adjusting for covariates. Results Over 70% of the national Asian population resides in the 10 states. There were 496,472 hospitalizations with a primary diagnosis of AMI; 75% of all cases were Whites, 10% were Blacks, 12% were Hispanics, and 3% were Asians. Asians had a higher prevalence of cardiac comorbidities, including hypertension, diabetes, and kidney failure compared to Whites (p-value

Black patients with chronic kidney disease (CKD) receive more cardiopulmonary resuscitation (CPR) than other racial groups, and knowledge of CPR influences preferences for care. As limited health literacy disproportionately affects Blacks and contributes to disparities in end-of-life (EOL) care, we investigated whether health literacy mediates racial disparities in CPR knowledge. Black and White adult patients with advanced CKD completed CPR knowledge surveys. Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine. Among 149 patients, Black patients were more likely to have limited health literacy and lower mean CPR knowledge scores than White patients. In adjusted analyses, health literacy mediated racial differences in CPR knowledge. Knowledge of CPR is lower among Black compared with White CKD patients and health literacy is a mediator of this difference. Future CPR educational interventions should target health literacy barriers to improve informed decision-making and decrease racial disparities at the end-of-life.

Objective Verbal and non-verbal behaviors, which are known as “relational contextualization cues”, relay information about relationships and how they are structured. We developed a computer-simulated provider conducting an informed consent process for clinical research to investigate the effects of a provider’s alignment of interests with a patient, the research team, or a neutral party on patient trust in the provider. Methods Participants (N = 43) interacted with a simulated provider for a research informed consent process in a three-arm, counterbalanced, within-subjects experiment. Participants reported their trust in the simulated provider after each treatment. Results Participants successfully recognized the alignment manipulation, and perceived the patient-aligned provider as more trustworthy than the other providers. Participants were also more satisfied with the patient-aligned provider, liked this provider more, expressed more desire to continue working with this provider, and stated that they were significantly more likely to sign the consent form after interacting with this provider compared to the other two. Conclusion Relational contextualization that aligns with the patient increases trust, satisfaction, and willingness to enroll in the context of research informed consent. Practice implications Health providers should align themselves with patients’ interests.

This paper explores the relationship between acculturation and oral health in a study of Somali refugees. This cross-sectional survey included structured surveys and dental examinations of a convenience sample of 439 Somali adults living in Massachusetts. Associations between an acculturation scale and: (1) lifetime history of caries and (2) access to oral health services were calculated. In bivariate analyses, many individual questions in the scale were associated with outcomes. In multivariate analysis, speaking English (OR 0.5, CI 0.28-0.84) was associated with better access to, and utilization of, dental health services while reading American books and newspapers in English was associated with increased lifetime history of dental disease (OR 2.6, CI 1.1-6.0). As specific elements of acculturation have different relationships with oral health among Somali refugees, a summary acculturation scale may have limited utility. Ongoing efforts to remove language barriers may improve oral health.

In comparison with patients who have other serious illnesses, patients with advanced kidney disease have a higher rate of intensive care utilization at the end of life and receive palliative care less frequently. Consensus and clinical practice guidelines have therefore recommended the incorporation of palliative care earlier in the disease trajectory. This review summarizes recent literature on this aspect of care and will highlight future directions for patient-centered care within palliative nephrology.Patients with advanced kidney disease and their families frequently do not engage effectively with their clinicians to make informed treatment decisions or plan for care at the end of life. Furthermore, racial and ethnic minority patients continue to receive a lower rate of palliative care services compared to other racial groups. Interventions that promote better palliative care communication and education among nephrology clinicians, patients and their families are becoming increasingly more common in nephrology.Overall, improved understanding of the unique care needs of patients with advanced and end-stage kidney disease provides a solid foundation to improve palliative and end-of-life care delivery among diverse populations in nephrology.

Advancing health literacy (HL) research requires high-quality HL measures. This chapter provides an overview of the state of the science of HL measurement: where the field started, currently is, and should be going. It is divided into eight key sections looking at (1) the history of HL measurement, (2) the relationship between HL definitions and measurement, (3) the HL conceptual domains most and least frequently measured, (4) the methods used to validate HL measures, (5) the characteristics of the participants in the measurement validation studies, (6) the practical considerations related to administering HL measures, (7) the advantages and disadvantages of using objective versus subjective HL measures, and (8) future directions for HL measurement. Based on the material presented in this chapter, the following conclusions can be drawn. First, there is an enormous proliferation of HL measures and this growth presents both opportunities and challenges for the field. Second, to move the field forward, there is an urgent need to better align HL measurement with definitions of HL. Third, some HL domains, such as numeracy, are measured more often than others, such as speaking and listening. Consequently, it is important to think about novel mechanisms to measure HL domains that are rarely measured. Fourth, HL measures are most often developed, validated, and refined using classical measurement approaches. However, strong empirical and practical rationales suggest making an assertive shift toward using modern measurement approaches. Fifth, most HL measures are not well validated for use in minority populations; consequently, future validation studies should be mindful of validation samples. Sixth, HL measures can be administered using multiple modes, most frequently via paper-and-pencil surveys. Identifying which mode of administration is most suitable requires reflecting on the underlying measurement purpose and the characteristics of the participants being measured. These considerations should also be made when deciding between a subjective versus objective HL measure. Cumulatively, this chapter provides tools to help readers select and use the most appropriate measures of HL for their needs. It also provides rationale and strategies for moving the science of HL measurement forward.

The disadvantaged social position of public mental health service users reflects synergistic relationships among tangible disadvantage and stigma and its consequences. Limited literacy, an important factor in social disadvantage and an additional source of stigma, is virtually absent from the discussion. Employing a mixed-methods, service user–informed design, we explore the meaning and impact of limited literacy in the lives of public mental health service users in the United States. Of 267 participants, 184 (69 percent) read at or below an eighth-grade level. Next, we demonstrate levels of and explore relationships among both literacy and mental illness concealment stigma and stigma consciousness (for mental illness). Finally, informed by our qualitative data, we describe how people encounter and manage this double burden of stigma with respect to: contexts of concealment, dilemmas of disclosure, and reduction and exclusion. Limited literacy and its associated stigma are important and underexamined barriers to mental health, well-being, recovery, and social inclusion for public mental health service users. Future work should include further examination of the multiple and layered stigmas in the lives of people with serious mental illness.

OBJECTIVE: To obtain near‐national rates of potentially preventable hospitalization (PPH)—a marker of barriers to outpatient care access—for Hispanics; to examine their differences from other race‐ethnic groups and by Hispanic national origin; and to identify key mediating factors. DATA SOURCES/STUDY SETTING: Data from all‐payer inpatient discharge databases for 15 states accounting for 85 percent of Hispanics nationally. STUDY DESIGN: Combining counts of inpatient discharges with census population for adults aged 18 and older, we estimated age‐sex‐adjusted PPH rates. We examined county‐level variation in race‐ethnic disparities in these rates to identify the mediating role of area‐level indicators of chronic condition prevalence, socioeconomic status (SES), health care access, acculturation, and provider availability. PRINCIPAL FINDINGS: Age‐sex‐adjusted PPH rates were 13 percent higher among Hispanics (1,375 per 100,000 adults) and 111 percent higher among blacks (2,578) compared to whites (1,221). Among Hispanics, these rates were relatively higher in areas with predominantly Puerto Rican and Cuban Americans than in areas with Hispanics of other nationalities. Small area variation in chronic condition prevalence and SES fully accounted for the higher rates among Hispanics, but only partially among blacks. CONCLUSIONS: Hispanics and blacks face higher barriers to outpatient care access; the higher barriers among Hispanics (but not blacks) seem mediated by SES, lack of insurance, cost barriers, and limited provider availability.

Objective Health literacy has been related to health-related conditions and health outcomes. Studies examining the association of health literacy and anticoagulation have had variable results. We sought to investigate the relations of health literacy and percentage of time in therapeutic range (TTR) in a vulnerable Brazilian cohort at two hospital-based anticoagulation clinics. Methods We measured health literacy with the Short Assessment of Health Literacy for Portuguese-speaking Adults (SAHLPA-18) in 2015–2016. We identified the demographic and clinical characteristics associated with health literacy and related health literacy to TTR. Results We enrolled 422 adults prescribed chronic warfarin therapy in our observational study (median age 62.1 years; 58.8% women; monthly income $200.00). The prevalence of inadequate health literacy (score 0–14 points) was 72.3% with a median score of 12 (quartiles, Q1=10; Q3=15) on the SAHLPA-18. The median TTR was 66.1%. In the multivariable logistic analysis, cognitive impairment and assistance with taking warfarin were associated with inadequate health literacy. Prosthetic heart valves and more school years were associated with adequate health literacy. Our analyses showed no significant relation between health literacy and TTR, analysing health literacy as a categorical (adjusted OR 1.05; 95% CI 0.65 to 1.70) or continuous variable (Spearman’s coefficient 0.02; p=0.70). Conclusions Inadequate health literacy was highly prevalent in this impoverished Brazilian cohort receiving anticoagulation with warfarin. However, we did not identify an association between health literacy and TTR. Future investigations may consider the systemic factors that contribute towards successful anticoagulation outcomes for vulnerable patient cohorts with inadequate health literacy.

Background: Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission. Methods: In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent control trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive HCQ (400mg BID x1day, followed by 200mg BID x9days) or placebo-equivalent (ascorbic acid) and AZ (500mg, then 250mg daily x4days) or placebo-equivalent (folic acid), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected mid-turbinate nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility. Findings: Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Incident LRTI occurred in six participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in nine (four control, two HCQ, three HCQ/AZ). There were no deaths. Median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. HCQ but not HCQ/AZ had faster time to viral clearance (HR=1.62, 95% CI=1.01-2.60, p=0.047 & HR=1.25, 95% CI=0.75-2.07, p=0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group. Interpretation: Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection. Trial Registration Number: ClinicalTrials.gov: NCT04354428 Funding: The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program. Conflict of Interest: Declaration of interests: CJ reports grants from BMGF for conduct of the study, and grants from CDC and NIH outside of the submitted work. HSK reports funding from NIH. PAN and MJA have a potential financial relationship with AliveCor related to QT assessment using the device, however the investigators would receive no financial benefit for use of the technology for patients at Mayo Clinic or for its use in the current study. AB reports consulting for Gates Ventures and grants from BMGF and NIH outside of the submitted work. HYC reports consulting for BMGF, Pfizer, Ellume, and Merck, and grants from Gates Ventures, NIH, CDC, BMGF, DARPA, Apple Inc., Sanofi-Pasteur, and Roche-Genentech, outside of the submitted work. Ethical Approval: Study visits were conducted via Health Insurance Portability and Accountability Act (HIPAA)-compliant telemedicine. The Western Institutional Review Board (WIRB) approved this study with reliance agreements with collaborating institutions.

Digital family health history tools have been developed but few have been tested with non-English speakers and evaluated for acceptability and usability. This study describes the cultural and linguistic adaptation and evaluation of a family health history tool (VICKY: VIrtual Counselor for Knowing Your Family History) for Spanish speakers. In-depth interviews were conducted with 56 Spanish-speaking participants, a subset of 30 also participated in a qualitative component to evaluate the acceptability and usability of Spanish VICKY. Overall, agreement in family history assessment was moderate between VICKY and a genetic counselor (weighted kappa range: 0.4695 for stroke&mdash, 0.6615 for heart disease), although this varied across disease subtypes. Participants felt comfortable using VICKY and noted that VICKY was very likeable and possessed human-like characteristics. They reported that VICKY was very easy to navigate, felt that the instructions were very clear, and thought that the time it took to use the tool was just right. Spanish VICKY may be useful as a tool to collect family health history and was viewed as acceptable and usable. The study results shed light on some cultural differences that may influence interactions with family history tools and inform future research aimed at designing and testing culturally and linguistically diverse digital systems.

Background Deaf American Sign Language (ASL) users often struggle with limited health literacy compared with their hearing peers. However, the mechanisms driving limited health literacy and how this may impact access to and understanding of health information for Deaf individuals have not been determined. Deaf individuals are more likely than hearing individuals to use the internet, yet they continue to report significant barriers to health information. This study presents an opportunity to identify key targets that impact information access for a largely marginalized population. Objective This study aims to elucidate the role of information marginalization on health literacy in Deaf ASL users and to better understand the mechanisms of health literacy in this population for the purpose of identifying viable targets for future health literacy interventions. Methods This is an exploratory mixed methods study to identify predictors and moderators of health literacy in the Deaf population. These predictors of health literacy will be used to inform the second step that qualitatively explains the findings, including how Deaf individuals access and understand Web-based health information. Multiple interviewer- and computer-based instruments underwent translation and adaptation, from English to ASL, to make them accessible for the Deaf participants in our study. A planned sample of 450 Deaf ASL users and 450 hearing native English speakers, aged 18 to 70 years, will be recruited from 3 partnering sites: Rochester, NY; Flint, MI; and Chicago, IL. These individuals will participate in a single data collection visit. A subset of participants (approximately 30) with key characteristics of interest will be invited for a second data collection visit to observe and inquire more about their ability to directly access, navigate, and comprehend Web-based health information. The study will help assess how the ways health literacy and information are visualized may differ between Deaf individuals and hearing individuals. The study will also survey participants’ ownership and use of computer and mobile devices and their level of Web-based information use, including health information. Results Adaptation and translation of protocols and instruments have been completed and are now in use for the study. Recruitment is underway and will continue until late 2020. Results from this study will be used to provide a guide on how to structure Web-based health information in a way that maximizes accessibility and improves health literacy for Deaf individuals. Conclusions The results from this mixed methods proposal will advance what is known about health literacy and health information accessibility for Deaf individuals. This innovative study will generate rich data on how to formulate health information and health literacy interventions more accurately to take advantage of visual learning skills. International Registered Report Identifier (IRRID) PRR1-10.2196/14889

Key Points Question Are racial/ethnic minorities who use emergency medical services transported to the same emergency department as white residents living in the same zip code? Findings In this cohort study of 864 750 Medicare enrollees from 4175 zip codes, the proportion of white patients transported to the reference (or most frequent) emergency department destination was high (61.3%), compared with the proportion of black patients (difference of −5.3%) and Hispanic patients (difference of −2.5%). Meaning This study suggests that emergency department destination is substantially different on the basis of the race/ethnicity of patients living in the same zip code., This cohort study examines the patterns of emergency department destination of emergency medical services transport for black, Hispanic, and white Medicare beneficiaries residing in the same area., Importance Evidence from national studies indicates systematic differences in hospitals in which racial/ethnic minorities receive care, with most care obtained in a small proportion of hospitals. Little is known about the source of these differences. Objectives To examine the patterns of emergency department (ED) destination of emergency medical services (EMS) transport according to patient race/ethnicity, and to compare the patterns between those transported by EMS and those who did not use EMS. Design, Setting, and Participants This cohort study of US EMS and EDs used Medicare claims data from January 1, 2006, to December 31, 2012. Enrollees aged 66 years or older with continuous fee-for-service Medicare coverage (N = 864 750) were selected for the sample. Zip codes with a sizable count (>10) of Hispanic, non-Hispanic black, and non-Hispanic white enrollees were used for comparison of EMS use across racial/ethnic subgroups. Data on all ED visits, with and without EMS use, were obtained. Data analysis was performed from December 18, 2018, to July 7, 2019. Main Outcomes and Measures The main outcome measure was whether an EMS transport destination was the most frequent ED destination among white patients (reference ED). The secondary outcomes were (1) whether the ED destination was a safety-net hospital and (2) the distance of EMS transport from the ED destination. Results The study cohort comprised 864 750 Medicare enrollees from 4175 selected zip codes who had 458 701 ED visits using EMS transport. Of these EMS-transported enrollees, 26.1% (127 555) were younger than 75 years, and most were women (302 430 [66.8%]). Overall, the proportion of white patients transported to the reference ED was 61.3% (95% CI, 61.0% to 61.7%); this rate was lower among black enrollees (difference of −5.3%; 95% CI, −6.0% to −4.6%) and Hispanic enrollees (difference of −2.5%; 95% CI, −3.2% to −1.7%). A similar pattern was found among patients with high-risk acute conditions; the proportion transported to the reference ED was 61.5% (95% CI, 60.7% to 62.2%) among white enrollees, whereas this proportion was lower among black enrollees (difference of −6.7%; 95% CI, −8.3% to −5.0%) and Hispanic enrollees (difference of –2.6%; 95% CI, –4.5% to –0.7%). In major US cities, a larger black-white discordance in ED destination was observed (−9.3%; 95% CI, −10.9% to −7.7%). Black and Hispanic patients were more likely to be transported to a safety-net ED compared with their white counterparts; the proportion transported to a safety-net ED among white enrollees (18.5%; 95% CI, 18.1% to 18.7%) was lower compared with that among black enrollees (difference of 2.7%; 95% CI, 2.2% to 3.2%) and Hispanic enrollees (difference of 1.9%; 95% CI, 1.3% to 2.4%). Concordance rates of non-EMS–transported ED visits were statistically significantly lower than for EMS-transported ED visits; the concordance rate among white enrollees of 52.9% (95% CI, 52.1% to 53.6%) was higher compared with that among black enrollees (difference of −4.8%; 95% CI, −6.4% to −3.3%) and Hispanic enrollees (difference of −3.0%; 95% CI, −4.7% to −1.3%). Conclusions and Relevance This study found race/ethnicity variation in ED destination for patients using EMS transport, with black and Hispanic patients more likely to be transported to a safety-net hospital ED compared with white patients living in the same zip code.

Gynecologic surgery has potential for adjunct vascular interventions, given the proximity of major intra-abdominal and pelvic blood vessels. Our goal was to determine contemporary incidence, associations, and outcomes of vascular repairs in gynecologic operations.The American College of Surgeons National Surgical Quality Improvement Program database (2005-2017) was queried for patients undergoing elective gynecologic operations. Vascular repairs were performed concurrently or during reoperation. Univariable and multivariable analyses evaluated associations with vascular repairs and 30-day morbidity.A total of 201,224 gynecologic operations were identified: hysterectomy (88.3%), myomectomy (5.9%), adnexal surgery (3.5%), vulvovaginectomy/other (1.1%), nonadnexal tumor or cyst excision (0.5%), ectopic pregnancy treatment (0.4%), and pelvic lymphadenectomy (0.3%). There were 187 vascular repairs in 176 (0.09%) patients. Repairs were typically concurrent (89.8%) and most commonly included open abdominal blood vessel repair (51.8%), major abdominal artery ligation (25%), vena cava reconstruction/ligation (6%), common iliac vein ligation (4.2%), and aorta/great vessel repair (4.2%). A minority were performed endovascularly (1.7%). Patients undergoing vascular repairs were older (56 vs 46 years), were more likely to have an open vs minimally invasive/vaginal operation (71.6% vs 28.4%), and were more likely to have a hysterectomy (85.2%; P .001 for all). In multivariable analysis, vascular repairs were observed more often with hysterectomy (odds ratio [OR]; 7.63, 95% confidence interval [CI], 2.28-25.55; P = .001) and open vs minimally invasive/vaginal operations (OR, 5.24; 95% CI, 2.64-10.42; P .001). Vascular repairs were also more common for patients with malignant disease (OR, 2.84; 95% CI, 1.78-4.53; P .001), patients assigned to American Society of Anesthesiologists class 3 or class 4 (OR, 1.85; CI, 1.36-2.53; P = .002), and patients without obesity (OR, 1.45; 95% CI, 1.08-1.96; P = .014). Vascular repairs independently predicted major morbidity and mortality (OR, 7.26; 95% CI, 5.26-10.03; P .001) after adjustment for open operative approach, American Society of Anesthesiologists class 3 or class 4, and hysterectomy.Whereas vascular repairs during gynecologic operations are rare, they are associated with morbidity and mortality. These findings provide an evidence base for risk assessment and informed consent.

Background Use of antibiotics without a prescription may increase unnecessary and inappropriate drug use or doses as well as global risk for antimicrobial resistance. Purpose To perform a scoping review of research on the prevalence of nonprescription antibiotic use in the United States and to examine the factors that influence it. Data sources Searches of PubMed, EMBASE, CINAHL, Scopus, and relevant Web sites without language restrictions from January 2000 to March 2019. Study selection Studies reporting nonprescription use of antibiotics, storage of antibiotics, intention to use antibiotics without a prescription, and factors influencing nonprescription use. Data extraction Two reviewers independently screened citations and full texts and performed data abstraction. Data synthesis Of 17 422 screened articles, 31 met inclusion criteria. Depending on population characteristics, prevalence of nonprescription antibiotic use varied from 1% to 66%, storage of antibiotics for future use varied from 14% to 48%, and prevalence of intention to use antibiotics without a prescription was 25%. Antibiotics were obtained without a prescription from various sources, including previously prescribed courses, local markets or stores, and family or friends. Reported factors contributing to nonprescription use included easy access through markets or stores that obtain antibiotics internationally for under-the-counter sales, difficulty accessing the health care system, costs of physician visits, long waiting periods in clinics, and transportation problems. Limitation Scarce evidence and heterogeneous methods and outcomes. Conclusion Nonprescription antibiotic use is a seemingly prevalent and understudied public health problem in the United States. An increased understanding of risk factors and pathways that are amenable to intervention is essential to decrease this unsafe practice. Primary funding source None.

Key Points Question Have perceptions of discrimination in health care changed in California over the last decade? Findings This repeated cross-sectional study of a racially, ethnically, and linguistically diverse adult population using results from the California Health Interview Survey found a significant overall decrease in perceptions of discrimination in health care (from 6.0% to 4.0%). In subanalyses this finding was significant among Latino respondents, immigrants, and those with limited English proficiency; however, perceptions of discrimination in health care among African American individuals have not improved and remain relatively high. Meaning This study suggests that perceptions of discrimination in health care have improved for some populations, but interventions to reduce discrimination in health care are still necessary., This cross-sectional study investigates changes in perceptions of discrimination in health care on the basis of race/ethnicity, immigration status, and English proficiency in California from 2003 to 2017., Importance Research in the early 2000s in California demonstrated that racial and ethnic minorities, immigrants, and those with limited English proficiency (LEP) experienced high rates of discrimination in health care. Less is known about how patients’ perceptions of discrimination in health care have changed since then. Objective To determine whether perceptions of discrimination in health care have changed overall and for specific vulnerable populations. Design, Setting, and Participants This cross-sectional study used data from the California Health Interview Survey for state residents aged 18 years and older for 2 periods, 2003 to 2005 and 2015 to 2017. χ2 analyses and multivariate logistic regression were performed to compare recent discrimination in health care in late vs early periods controlling for race/ethnicity, poverty level, education, insurance status, usual source of care, self-reported health, and LEP. Additional subanalyses were performed by race/ethnicity, immigrant status, and LEP status. Jackknife replicate weights were provided by the California Health Interview Survey. Exposure Survey year was dichotomized as combined 2003 to 2005 and combined 2015 to 2017. Main Outcomes and Measures Survey respondents were identified as having experienced recent discrimination in health care if they responded “yes” to the question, “Was there ever a time when you would have gotten better medical care if you had belonged to a different race or ethnic group?” and reported that this occurred within the last 5 years. Results There were 84 088 participants in 2003 to 2005 (51.0% female; 14.7% aged ≥65 years) and 63 242 participants in 2015 to 2017 (51.1% female; 18.0% aged ≥65 years). Rates of recent discrimination in health care decreased from 6.0% to 4.0% (difference, 2.0%; 95% CI, 1.5%-2.5%; P

Background The Hospital Value Based Purchasing Program (HVBP) in the United States, announced in 2010 and implemented since 2013 by the Centers for Medicare and Medicaid Services (CMS), introduced payment penalties and bonuses based on hospital performance on patient 30-day mortality and other indicators. Evidence on the impact of this program is limited and reliant on the choice of program-exempt hospitals as controls. As program-exempt hospitals may have systematic differences with program-participating hospitals, in this study we used an alternative approach wherein program-participating hospitals are stratified by their financial exposure to penalty, and examined changes in hospital performance on 30-day mortality between hospitals with high vs. low financial exposure to penalty. Methods Our study examined all hospitals reimbursed through the Medicare Inpatient Prospective Payment System (IPPS) – which include most community and tertiary acute care hospitals – from 2009 to 2016. A hospital’s financial exposure to HVBP penalties was measured by the share of its annual aggregate inpatient days provided to Medicare patients (“Medicare bed share”). The main outcome measures were annual hospital-level 30-day risk-adjusted mortality rates for acute myocardial infarction (AMI), heart failure (HF) and pneumonia patients. Using difference-in-differences models we estimated the change in the outcomes in high vs. low Medicare bed share hospitals following HVBP. Results In the study cohort of 1902 US hospitals, average Medicare bed share was 61 and 41% in high (n = 540) and low (n = 1362) Medicare bed share hospitals, respectively. High Medicare bed share hospitals were more likely to have smaller bed size and less likely to be teaching hospitals, but ownership type was similar among both Medicare bed share groups.. Among low Medicare bed share (control) hospitals, baseline (pre-HVBP) 30-day mortality was 16.0% (AMI), 10.9% (HF) and 11.4% (pneumonia). In both high and low Medicare bed share hospitals 30-day mortality experienced a secular decrease for AMI, increase for HF and pneumonia; differences in the pre-post change between the two hospital groups were small ( Conclusions HVBP was not associated with a meaningful change in 30-day mortality across hospitals with differential exposure to the program penalty.

Limited English proficiency (LEP) is associated with poor health status and worse outcomes.To examine disparities in hypertension between National Health and Nutrition Examination Survey (NHANES) respondents with LEP versus adequate English proficiency.Retrospective analysis of multi-year survey data.Adults 18 years of age and older who participated in the NHANES survey during the period 2003-2012.We defined participants with LEP as anyone who completed the NHANES survey in a language other than English or with the support of an interpreter. Using logistic regression, we estimated the odds ratio for undiagnosed or uncontrolled hypertension (systolic blood pressure (SBP) 140 mmHg or diastolic blood pressure (DBP) 90 mmHg) among LEP participants relative to those with adequate English proficiency. We adjusted for sociodemographic, acculturation-related, and hypertension-related variables.Fourteen percent (n = 3,269) of the participants had limited English proficiency: 12.4% (n = 2906) used a Spanish questionnaire and 1.6% (n = 363) used an interpreter to complete the survey in another language. Those with LEP had higher odds of elevated blood pressure on physical examination (adjusted odds ratio [AOR] = 1.47 [1.07-2.03]). This finding persisted among participants using an interpreter (AOR = 1.88 [1.15-3.06]) but not among those using the Spanish questionnaire (AOR = 1.32 [0.98-1.80]). In a subgroup analysis, we found that the majority of uncontrolled hypertension was concentrated among individuals with a known diagnosis of hypertension (AOR = 1.80 [1.16-2.81]) rather than those with undiagnosed hypertension (AOR = 1.14 [0.74-1.75]). Interpreter use was associated with increased odds of uncontrolled hypertension, especially among patients who were not being medically managed for hypertension (AOR = 6.56 [1.30-33.12]).In a nationally representative sample, participants with LEP were more likely to have poorly controlled hypertension than those with adequate English proficiency. LEP is an important driver of disparities in hypertension management and outcomes.

Background: Conversations about goals of care and cardiopulmonary resuscitation (CPR)/intubation for patients with advanced heart failure can be difficult. This study examined the impact of a video decision support tool and patient checklist on advance care planning for patients with heart failure. Methods: This was a multisite, randomized, controlled trial of a video-assisted intervention and advance care planning checklist versus a verbal description in 246 patients ≥64 years of age with heart failure and an estimated likelihood of death of >50% within 2 years. Intervention participants received a verbal description for goals of care (life-prolonging care, limited care, and comfort care) and CPR/intubation plus a 6-minute video depicting the 3 levels of care, CPR/intubation, and an advance care planning checklist. Control subjects received only the verbal description. The primary analysis compared the proportion of patients preferring comfort care between study arms immediately after the intervention. Secondary outcomes were CPR/intubation preferences and knowledge (6-item test; range, 0–6) after intervention. Results: In the intervention group, 27 (22%) chose life-prolonging care, 31 (25%) chose limited care, 63 (51%) selected comfort care, and 2 (2%) were uncertain. In the control group, 50 (41%) chose life-prolonging care, 27 (22%) selected limited care, 37 (30%) chose comfort care, and 8 (7%) were uncertain ( P P P P Conclusions: Patients with heart failure who viewed a video were more informed, more likely to select a focus on comfort, and less likely to desire CPR/intubation compared with patients receiving verbal information only. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01589120.

Objectives To examine health literacy as a mediator of racial disparities in cognitive decline as measured by executive function in elderly adults. Design Prospective cohort study. Setting Secondary analysis of ElderWalk trial in Boston, Massachusetts. Participants English-speaking African-American and Caucasian individuals in a walking intervention for community-dwelling adults aged 65 and older without dementia at baseline who completed baseline and 12-month evaluations (N = 198). Measurements Health literacy was measured using the Short Test of Functional Health Literacy in Adults. Fluid and crystallized cognitive functions were measured at baseline and 12 months using the Trail-Making Test Part B minus Part B (TMT B–A) and the Controlled Oral Word Association Test (COWAT). Associations between health literacy and 12-month cognitive decline were modeled using multivariate linear regression. Results Participants with higher health literacy and education experienced less cognitive decline than those with limited health literacy according to the TMT B–A (P = .01). After adjusting for covariates, Caucasian participants (n = 63) experienced less decline than African-American participants (n = 135) on TMT B–A (P = .001) and COWAT (P = .001). Adjusting for health literacy led to a 25.3% decrease in the point estimate for racial difference in TMT B–A and a 19.5% decrease in COWAT. Although independently related to cognitive decline, educational attainment did not mediate racial differences. Conclusion Health literacy is a partial mediator of racial disparities in cognitive decline. These results indicate the need to develop interventions to mitigate cognitive decline that individuals with low heath literacy can use and to modify the healthcare environment to better accommodate this population.

Health literacy (HL) is the extent to which individuals have the capacity to obtain, process, and understand basic health information that is needed to make appropriate health decisions. As adults with inflammatory bowel disease engage in complex health decisions throughout their lives, attention is needed regarding the influence of HL on the lives of people with inflammatory bowel disease. About one-third of adults in the United States have limited HL. Limited HL is a potentially modifiable risk factor that has been associated with barriers to patient-provider communication and worse health outcomes for people with a range of chronic diseases. Gastroenterologists must recognize the role of HL in their practice. Limited HL can affect a patient's ability to understand the purpose of a screening test for colorectal cancer, understand the concept of an asymptomatic yet chronic disease, ask questions in an office visit and engage in shared decision making. Gastroenterologists must approach each patient as potentially having limited HL and use clear communication strategies in all encounters. Currently, there is a lack of training, education, and support for health care providers to meet the needs of patients with limited HL. More research is needed in inflammatory bowel disease to understand the impact of limited health literacy on health outcomes in this population and develop effective systems-based interventions to reduce the health literacy burden on patients.

Background The Re-Engineered Discharge (RED) program is a hospital-based initiative shown to decrease hospital reutilization. We implemented the RED in 10 hospitals to study the implementation process. Design We recruited 10 hospitals from different regions of the United States to implement the RED and provided training for participating hospital leaders and implementation staff using the RED Toolkit as the basis of the curriculum followed by monthly telephone-based technical assistance for up to 1 year. Methods Two team members interviewed key informants from each hospital before RED implementation and then 1 year later. Interview data were analyzed according to common and comparative themes identified across institutions. Readmission outcomes were collected on participating hospitals and compared pre- versus post-RED implementation. Results Key findings included (1) wide variability in the fidelity of the RED intervention; (2) engaged leadership and multidisciplinary implementation teams were keys to success; (3) common challenges included obtaining timely follow-up appointments, transmitting discharge summaries to outpatient clinicians, and leveraging information technology. Eight out of 10 hospitals reported improvement in 30-day readmission rates after RED implementation. Conclusions A supportive hospital culture is essential for successful RED implementation. A flexible implementation strategy can be used to implement RED and reduce readmissions.

IntroductionPredialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education—COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.Methods and analysisThis is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score 2), prefer to speak English during clinical encounters and self-report as black or white race. Enrolled patients will be randomised 1:1, with stratification by race, to receive enhanced usual care or usual care and in-person education about conservative kidney management and ACP (COPE). The primary outcome is change in knowledge of CKM and ACP. We will also explore intervention feasibility and acceptability, change in communication of preferences and differences in the intervention’s effects on knowledge and communication of preferences by race. We will assess outcomes at baseline, immediately post-education and at 2 and 12 weeks.Ethics and disseminationThis protocol has been approved by the Institutional Review Board at the University of Pennsylvania. We will obtain written informed consent from all participants. The results from this work will be presented at academic conferences and disseminated through peer-reviewed journals.Trial registration numberThis trial is registered at ClinicalTrials.gov under NCT03229811.

Background Atrial fibrillation (AF) is a common arrhythmia that adversely affects health-related quality of life (HRQoL). We conducted a pilot trial of individuals with AF using a smartphone to provide a relational agent as well as rhythm monitoring. We employed our pilot to measure acceptability and adherence and to assess its effectiveness in improving HRQoL and adherence. Objective This study aims to measure acceptability and adherence and to assess its effectiveness to improve HRQoL and adherence. Methods Participants were recruited from ambulatory clinics and randomized to a 30-day intervention or usual care. We collected baseline characteristics and conducted baseline and 30-day assessments of HRQoL using the Atrial Fibrillation Effect on Quality of Life (AFEQT) measure and self-reported adherence to anticoagulation. The intervention consisted of a smartphone-based relational agent, which simulates face-to-face counseling and delivered content on AF education, adherence, and symptom monitoring with prompted rhythm monitoring. We compared differences in AFEQT and adherence at 30 days, adjusted for baseline values. We quantified participants’ use and acceptability of the intervention. Results A total of 120 participants were recruited and randomized (59 to control and 61 to intervention) to the pilot trial (mean age 72.1 years, SD 9.10; 62/120, 51.7% women). The control group had a 95% follow-up, and the intervention group had a 93% follow-up. The intervention group demonstrated significantly higher improvement in total AFEQT scores (adjusted mean difference 4.5; 95% CI 0.6-8.3; P=.03) and in daily activity (adjusted mean difference 7.1; 95% CI 1.8-12.4; P=.009) compared with the control between baseline and 30 days. The intervention group showed significantly improved self-reported adherence to anticoagulation therapy at 30 days (intervention 3.5%; control 23.2%; adjusted difference 16.6%; 95% CI 2.8%-30.4%; P Conclusions Individuals randomized to a 30-day smartphone intervention with a relational agent and rhythm monitoring showed significant improvement in HRQoL and adherence. Participants had favorable acceptability of the intervention with both objective use and qualitative assessments of acceptability.