CRANIUM: a quasi-experimental study to improve metabolic screening and HIV testing in community mental health clinics compared to usual care.

BACKGROUND: Individuals with serious mental illness often do not receive guideline-concordant metabolic screening and human immunodeficiency virus (HIV) testing, contributing to increased morbidity and premature mortality. This study evaluates the effectiveness of CRANIUM (Cardiometabolic Risk Assessment and treatment through a Novel Integration model for Underserved populations with Mental illness), an intervention to increase metabolic screening and HIV testing among patients with serious mental illness in a community mental health clinic compared to usual care. METHODS: The study used a quasi-experimental design, prospectively comparing a preventive care screening intervention at one community mental health clinic (n = 536 patients) to usual care at the remaining clinics within an urban behavioural health system (n = 4,847 patients). Psychiatrists at the intervention site received training in preventive health screening and had access to a primary care consultant, screening and treatment algorithms, patient registries, and a peer support specialist. Outcomes were the change in screening rates of A1c, lipid, and HIV testing post-intervention at the intervention site compared to usual care sites. RESULTS: Rates of lipid screening and HIV testing increased significantly at the intervention site compared to usual care, with and without multivariable adjustment [Lipid: aOR 1.90, 95% CI 1.32-2.75, P = .001; HIV: aOR 23.42, 95% CI 5.94-92.41, P < .001]. While we observed a significant increase in A1c screening rates at the intervention site, this increase did not persist after multivariable adjustment (aOR 1.37, 95% CI .95-1.99, P = .09). CONCLUSIONS: This low-cost, reverse integrated care model targeting community psychiatrist practices had modest effects on increasing preventive care screenings, with the biggest effect seen for HIV testing rates. Additional incentives and structural supports may be needed to further promote screening practices for individuals with serious mental illness.

Language-concordant automated telephone queries to assess medication adherence in a diverse population: a cross-sectional analysis of convergent validity with pharmacy claims.

BACKGROUND: Clinicians have difficulty accurately assessing medication non-adherence within chronic disease care settings. Health information technology (HIT) could offer novel tools to assess medication adherence in diverse populations outside of usual health care settings. In a multilingual urban safety net population, we examined the validity of assessing adherence using automated telephone self-management (ATSM) queries, when compared with non-adherence using continuous medication gap (CMG) on pharmacy claims. We hypothesized that patients reporting greater days of missed pills to ATSM queries would have higher rates of non-adherence as measured by CMG, and that ATSM adherence assessments would perform as well as structured interview assessments. METHODS: As part of an ATSM-facilitated diabetes self-management program, low-income health plan members typed numeric responses to rotating weekly ATSM queries: "In the last 7 days, how many days did you MISS taking your …" diabetes, blood pressure, or cholesterol pill. Research assistants asked similar questions in computer-assisted structured telephone interviews. We measured continuous medication gap (CMG) by claims over 12 preceding months. To evaluate convergent validity, we compared rates of optimal adherence (CMG ≤ 20%) across respondents reporting 0, 1, and ≥ 2 missed pill days on ATSM and on structured interview. RESULTS: Among 210 participants, 46% had limited health literacy, 57% spoke Cantonese, and 19% Spanish. ATSM respondents reported ≥1 missed day for diabetes (33%), blood pressure (19%), and cholesterol (36%) pills. Interview respondents reported ≥1 missed day for diabetes (28%), blood pressure (21%), and cholesterol (26%) pills. Optimal adherence rates by CMG were lower among ATSM respondents reporting more missed days for blood pressure (p = 0.02) and cholesterol (p < 0.01); by interview, differences were significant for cholesterol (p = 0.01). CONCLUSIONS: Language-concordant ATSM demonstrated modest potential for assessing adherence. Studies should evaluate HIT assessments of medication beliefs and concerns in diverse populations. TRIAL REGISTRATION: NCT00683020 , registered May 21, 2008.

Group visits to encourage insulin initiation: targeting patient barriers.

AIMS AND OBJECTIVES: To evaluate the effect of an 'insulin introduction' group visit on insulin initiation and A1C in adults with type 2 diabetes. BACKGROUND: The clinical course of type 2 diabetes involves eventual beta-cell failure and the need for insulin therapy. Patient psychological insulin resistance, provider-related delays and system barriers to timely initiation of insulin are common. Group visits are widely accepted by patients and represent a potential strategy for improving insulin initiation. DESIGN: A single two-hour group visit in English or Spanish, facilitated by advanced practice nurses, addressed psychological insulin resistance and encouraged mock injections to overcome needle anxiety. METHODS: A retrospective review of 273 patients referred from 2008-2012, determined characteristics of group attenders, rates of mock self-injection, rates of insulin initiation and changes in A1C from baseline to 2-6 and 7-12 months postgroup. Change in A1C was compared to patients referred to the group who did not attend ('nonattenders'). RESULTS: Of 241 patients eligible for analysis, 87·6% were racial/ethnic minorities with an average A1C of 9·99%. Group attendance rate was 66%; 92% performed a mock injection, 55% subsequently started insulin. By 2-6 months, A1C decreased by 1·37% among group attenders, and by 1·6% in those who did a mock injection and started insulin. Fewer nonattenders started insulin in primary care (40%), experiencing an A1C reduction of 0·56% by 2-6 months. A1C improvements were sustained by 7-12 months among group attenders and nonattenders who started insulin. RELEVANCE TO CLINICAL PRACTICE: Nurses can effectively address patient fears and engage patients in reframing insulin therapy within group visits. CONCLUSIONS: This one-time nurse-facilitated group visit addressing psychological barriers to insulin in a predominantly minority patient population resulted in increased insulin initiation rates and clinically meaningful A1C reductions.

Identifying Spanish Language Competent Physicians: The Diabetes Study of Northern California (DISTANCE).

OBJECTIVES: Language barriers negatively impact health care access and quality for US immigrants. Latinos are the second largest immigrant group and the largest, fastest growing minority. Health care systems need simple, low cost and accurate tools that they can use to identify physicians with Spanish language competence. We sought to address this need by validating a simple and low-cost tool already in use in a major health plan. DESIGN SETTING PARTICIPANTS: A web-based survey conducted in 2012 among physicians caring for patients in a large, integrated health care delivery system. Of the 2,198 survey respondents, 111 were used in additional analysis involving patient report of those physicians' fluency. MAIN OUTCOME MEASURES: We compared health care physicians' responses to a single item, Spanish language self-assessment tool (measuring "medical proficiency") with patient-reported physician language competence, and two validated physician self-assessment tools (measuring "fluency" and "confidence"). RESULTS: Concordance between medical proficiency was moderate with patient reports (weighted Kappa .45), substantial with fluency (weighted Kappa .76), and moderate-to-substantial with confidence (weighted Kappas .53 to .66). CONCLUSIONS: The single-question self-reported medical proficiency tool is a low-cost tool useful for quickly identifying Spanish competent physicians and is potentially suitable for use in clinical settings. A reasonable approach for health systems is to designate only those physicians who self-assess their Spanish medical proficiency as "high" as competent to provide care without an interpreter.

Risk factors for reporting poor cultural competency among patients with diabetes in safety net clinics.

BACKGROUND: The Consumer Assessment of Healthcare Providers and Systems Cultural Competency Item Set assesses patient perceptions of aspects of the cultural competence of their health care. OBJECTIVE: To determine characteristics of patients who identify the care they receive as less culturally competent. RESEARCH DESIGN: Cross-sectional survey consisting of face-to-face interviews. SUBJECTS: Safety-net population of patients with type 2 diabetes (n=600) receiving ongoing primary care. MEASURES: Participants completed the Consumer Assessment of Healthcare Providers and Systems Cultural Competency and answered questions about their race/ethnicity, sex, age, education, health status, depressive symptoms, insurance coverage, English proficiency, duration of relationship with primary care provider, and comorbidities. RESULTS: In adjusted models, depressive symptoms were significantly associated with poor cultural competency in the Doctor Communication--Positive Behaviors domain [odds ratio (OR) 1.73, 95% confidence interval, 1.11-2.69]. African Americans were less likely than whites to report poor cultural competence in the Doctor Communication--Positive Behaviors domain (OR 0.52, 95% CI, 0.28-0.97). Participants who reported a longer relationship (≥ 3 y) with their primary care provider were less likely to report poor cultural competence in the Doctor Communication--Health Promotion (OR 0.35, 95% CI, 0.21-0.60) and Trust domains (OR 0.4, 95% CI, 0.24-0.67), whereas participants with lower educational attainment were less likely to report poor cultural competence in the Trust domain (OR 0.51, 95% CI, 0.30-0.86). Overall, however, sociodemographic and clinical differences in reports of poor cultural competence were insignificant or inconsistent across the various domains of cultural competence examined. CONCLUSIONS: Cultural competence interventions in safety-net settings should be implemented across populations, rather than being narrowly focused on specific sociodemographic or clinical groups.

Associations between aspects of culturally competent care and clinical outcomes among patients with diabetes.

BACKGROUND: Culturally competent care may be associated with clinical outcomes in diabetes management, which requires effective physician-patient collaboration. The recent development and validation of the Consumer Assessment of Healthcare Providers and Systems Cultural Competence tool enables investigation of possible associations. OBJECTIVE: To assess whether 3 aspects of culturally competent care are associated with glycemic, lipid, and blood pressure control among ethnically diverse patients with diabetes. DESIGN: Survey and chart review study of patients recruited from urban safety net clinics in 2 cities. SUBJECTS: A total of 600 patients with type 2 diabetes and a primary care physician. MEASURES: We used multivariate logistic regression to assess the independent relationships between the 3 domains of the Consumer Assessment of Healthcare Providers and Systems Cultural Competence (Doctor Communication-Positive Behaviors, Trust, and Doctor Communication-Health Promotion) and glycemic, lipid, and systolic blood pressure control after adjusting for sociodemographic and clinical factors. RESULTS: In adjusted analysis, high Trust was associated with lower likelihood of poor glycemic control (odds ratio, 0.59; 95% confidence interval, 0.41-0.84) and high Doctor Communication-Health Promotion was associated with a higher likelihood of poor glycemic control (odds ratio, 1.49, 95% CI, 1.02-2.19). None of the 3 aspects of culturally competent care examined were associated with lipid or systolic blood pressure control after adjustment. DISCUSSION: Trust in physician, a core component of culturally competent care, but not doctor communication behavior, was associated with a lower likelihood of poor glycemic control in a safety net population with diabetes. Glycemic control may be more sensitive to patient physician partnership than blood pressure and hyperlipidemia control.

Advances in measuring culturally competent care: a confirmatory factor analysis of CAHPS-CC in a safety-net population.

BACKGROUND: Providing culturally competent care shows promise as a mechanism to reduce health care inequalities. Until the recent development of the Consumer Assessment of Healthcare Providers and Systems Cultural Competency Item Set (CAHPS-CC), no measures capturing patient-level experiences with culturally competent care have been suitable for broad-scale administration. METHODS: We performed confirmatory factor analysis and internal consistency reliability analysis of CAHPS-CC among patients with type 2 diabetes (n=600) receiving primary care in safety-net clinics. CAHPS-CC domains were also correlated with global physician ratings. RESULTS: A 7-factor model demonstrated satisfactory fit (χ²231=484.34, P<0.0001) with significant factor loadings at P<0.05. Three domains showed excellent reliability-Doctor Communication-Positive Behaviors (α=0.82), Trust (α=0.77), and Doctor Communication-Health Promotion (α=0.72). Four domains showed inadequate reliability either among Spanish speakers or overall (overall reliabilities listed): Doctor Communication-Negative Behaviors (α=0.54), Equitable Treatment (α=0.69), Doctor Communication-Alternative Medicine (α=0.52), and Shared Decision-Making (α=0.51). CAHPS-CC domains were positively and significantly correlated with global physician rating. CONCLUSIONS: Select CAHPS-CC domains are suitable for broad-scale administration among safety-net patients. Those domains may be used to target quality-improvement efforts focused on providing culturally competent care in safety-net settings.

Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

BACKGROUND: Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). METHODS/DESIGN: This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants. DISCUSSION: Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00683020.

Medical Students' Perceptions of and Responses to Health Care Disparities During Clinical Clerkships.

PURPOSE: To measure the frequency and nature of student-perceived clinician-driven health care disparities, and determine their impact on medical students' professional development. METHOD: Retrospective study of fourth-year medical students at the University of California, San Francisco School of Medicine, August 2016 to June 2017. Conducted via an electronic survey asking about frequency/nature of directly witnessed health care disparities and barriers/facilitators to action during third-year clerkships; and individual, semistructured interviews focusing on clinical details and impact on students' professional development. RESULTS: Respondents were 103/159 students (65%). In internal medicine clerkships, a majority perceived disparities as occurring sometimes (2-7 times in eight-week clerkship) or often (at least once weekly or nearly daily) based on language barriers (90%), patients' homelessness (77%), history of substance abuse (76%), obesity (67%), and race/ethnicity: Latino (72%), black (71%), and Asian (56%). Results from other clerkships were similar. Barriers to student action to perceived disparities included fear of poor evaluations, hierarchy/powerlessness, a "don't speak up" culture, the desire to be a team player, limited clinical experience, and perceiving doctors as "good people" who provide disparate care unintentionally. Impact on professional development varied, ranging from students' normalization of disparities as stemming from clinical constraints to increased motivation to provide equitable care. CONCLUSIONS: Medical students routinely witness health care disparities during clerkships, and their observations spotlight specific clinical practices. For some students, these observations lead to a normalization of disparities; for others, they heighten commitment to equity. Clinical curricula should incorporate responding to health care disparities.

Evaluation of a Medical Student Research and Career Development Program to Increase Diversity in Academic Medicine.

PURPOSE: To describe and evaluate an innovative research program supported by the National Institutes of Health, "Promoting Research Opportunities Fully-Prospective Academics Transforming Health" (PROF-PATH), designed to support medical students from groups underrepresented-in-medicine (URM) interested in pursuing academic careers. METHOD: Based on social cognitive career theory (SCCT), PROF-PATH supplemented a traditional research program (TRP) by providing additional mentorship and a curriculum focused on "assumed knowledge" of academic culture, guidance with research challenges, and emotional competence. The four-year evaluation (2013-2016) consisted of pre- and postprogram surveys of PROF-PATH and TRP students, plus focus groups and individual structured interviews with PROF-PATH students. Survey questions queried students' self-confidence in research- and career-related skills and abilities. The authors mapped themes elicited in focus groups and interviews onto SCCT domains. RESULTS: Of 454 medical students, 343 (75.6%) completed the surveys. According to preprogram surveys, PROF-PATH students (n = 85) were less confident in their ability to find or manage mentor relationships than TRP students (n = 258) and less likely to report having a mentor who provided strong support for their research interests. At program's end, PROF-PATH students showed greater increases in confidence than TRP students in multiple ability domains. Qualitative analysis of themes indicated that PROF-PATH influenced students through seven SCCT domains and increased student academic career self-efficacy. CONCLUSIONS: An innovative program for URM medical students participating in mentored research was successful in supporting academic career interest and academic self-efficacy. Schools motivated to increase diversity in academic medicine should consider adapting PROF-PATH.

The effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women.

OBJECTIVE: This study was undertaken to examine the effect of ultralow-dose transdermal estradiol on sexual function in postmenopausal women. STUDY DESIGN: Analysis of data from a multicenter, randomized, double-blind, placebo-controlled trial of a 0.014 mg/day transdermal estradiol patch in 417 women aged 60 to 80 years. Sexual function was assessed by self-administered questionnaires at baseline and 4, 12, and 24 months. A linear effects model was used to assess treatment effects using data from all on-study assessments. RESULTS: Women randomly assigned to estradiol had a 4.3 point greater improvement in the vaginal pain/dryness domain relative to placebo (95% CI = 0.3-8.4, P = .04). No significant differences in frequency of sexual activity or other sexual function domains (desire, satisfaction, problems, or orgasm) were observed between treatment groups (P > or = .10 for all). CONCLUSIONS: Ultralow-dose estradiol resulted in modest improvement in sexual function related to vaginal pain and dryness, but not in other domains of sexual function.

Association of Rapid Molecular Testing With Duration of Respiratory Isolation for Patients With Possible Tuberculosis in a US Hospital.

Importance: New guidelines recommend that molecular testing replace sputum-smear microscopy to guide discontinuation of respiratory isolation in patients undergoing evaluation for active tuberculosis (TB) in health care settings. Objective: To evaluate the implementation and impact of a molecular testing strategy to guide discontinuation of isolation. Design, Setting, and Participants: Prospective cohort study with a pragmatic, before-and-after-implementation design of 621 consecutive patients hospitalized at Zuckerberg San Francisco General Hospital and Trauma Center who were undergoing sputum examination for evaluation for active pulmonary TB from January 2014 to January 2016. Interventions: Implementation of a sputum molecular testing algorithm using GeneXpert MTB/RIF (Xpert; Cepheid) to guide discontinuation of isolation. Main Outcomes and Measures: We measured the proportion of patients with molecular testing ordered and completed; the accuracy of the molecular testing algorithm in reference to mycobacterial culture; the duration of each component of the testing and isolation processes; length of stay; mean days in isolation and in hospital; and mean cost. We extracted data from hospital records and compared measures before and after implementation. Results: Clinicians ordered sputum testing for TB for 621 patients at ZSFG during the 2-year study period. Of 301 patients in the preimplementation period with at least 1 sputum microscopy and culture ordered, clinicians completed the rapid TB testing evaluation process for 233 (77%).Among 320 patients evaluated in the postimplementation period, clinicians ordered molecular testing for 234 (73%) patients and received results for 295 of 302 (98%) tests ordered. Median age was 54 years (interquartile range, 44-63 years), and 161 (26%) were women. The molecular testing algorithm accurately diagnosed all 7 patients with culture-confirmed TB and excluded TB in all 251 patients with Mycobacterium tuberculosis (MTB) culture-negative results. Compared with the preimplementation period, there were significant decreases in median times to final rapid test result (39.1 vs 22.4 hours, P < .001), discontinuation of isolation (2.9 vs 2.5 days, P = .001), and hospital discharge (6.0 vs 4.9 days, P = .003), on average saving $13 347 per isolated TB-negative patient. Conclusions and Relevance: A sputum molecular testing algorithm to guide discontinuation of respiratory isolation for patients undergoing evaluation for active TB was safe, feasible, widely and sustainably adopted, and provided substantial clinical and economic benefits. Molecular testing may facilitate more efficient, patient-centered evaluation for possible TB in US hospitals.

Health Literacy, Health Care Utilization, and Direct Cost of Care Among Linguistically Diverse Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Low functional health literacy (HL) has been associated with poor self-management of chronic conditions, including type 2 diabetes mellitus (T2DM), an inefficient use of health services, and higher health care costs. Low functional HL and limited English language proficiency both independently predict poor glycemic control among Latino and Chinese immigrants in the United States, and is more common among patients with diabetes with limited HL. OBJECTIVE: This study investigated the relationship between low functional HL, health care utilization, and costs of health care among a cohort of low-income patients with T2DM whose primary language was English, Spanish, or Cantonese (N = 277). METHODS: Patient data were collected from Medicaid administrative health care records as part of a low-income managed care program administered by the San Francisco Health Plan between April 2009 and March 2011. HL was measured with the Brief Questions Screening Tool for Health Literacy, administered via telephone survey. We used negative binomial regression with robust standard errors to estimate the effect of low functional HL on health care utilization, adjusting for demographic, socioeconomic, and health covariates. Results were reported as rate-ratios (RRs). We used two-part regression models to estimate the marginal difference in cost per patient associated with low functional HL. Utilization and cost models were also estimated, stratified by patient language. KEY RESULTS: We observed a nonsignificant association between low functional HL and lower health care utilization, and lower total health care costs (-$1,493.53, 95% confidence interval [CI]: $3,602 to $615). While we observed a nonsignificant trend for low functional HL and lower utilization and total cost among people who speak English and Cantonese, low functional HL was significantly associated with more outpatient visits among patients who spoke Spanish (RR 1.31, 95% CI 1 to 1.72). CONCLUSIONS: The relationship between low functional HL and health care utilization among this linguistically diverse cohort of patients with T2DM varied by patient language. Further research is needed to determine if lower utilization and costs in certain linguistic subgroups is indicative of barriers to access. [Health Literacy Research and Practice. 2017;1(3):e116-e126.]. PLAIN LANGUAGE SUMMARY: This study attempts to understand the relationship between health literacy, health care utilization, and costs of health care among an ethnically and linguistically diverse cohort of low-income patients with type 2 diabetes mellitus. We observed differences that could be due to actual differential effects of low HL by language status, or could be explained by unmeasured differences in health-seeking behaviors, access to care, degree of acculturation, or comorbidities.

Use of Complementary Health Approaches Among Diverse Primary Care Patients with Type 2 Diabetes and Association with Cardiometabolic Outcomes: From the SF Bay Collaborative Research Network (SF Bay CRN).

PURPOSE: To describe use of complementary health approaches (CHAs) among patients with type 2 diabetes, and independent associations between CHA use and Hemoglobin A1c (A1C) and lower-density lipoprotein (LDL) cholesterol. METHODS: Participants were enrolled onto the SMARTSteps Program, a diabetes self-management support program conducted between 2009 and 2013 in San Francisco. At the 6-month interview, CHA use in the prior 30 days was estimated using a 12-item validated instrument. Demographic and diabetes-related measures A1C were assessed at baseline and 6-month followup. AIC and LDL values were ascertained from chart review over the study period. Medication adherence was measured using pharmacy claims data at 6 and 12 months. RESULTS: Patients (n = 278) completed 6-month interviews: 74% were women and 71.9% were non-English speaking. Any CHA use was reported by 51.4% overall. CHA modalities included vitamins/nutritional supplements (25.9%), spirituality/prayer (21.2%), natural remedies/herbs (24.5%), massage/acupressure (11.5%), and meditation/yoga/tai chi (10.4%). CHA costs per month were $43.86 (SD = 118.08). Nearly one third reported CHA (30.0%) specifically for their type 2 diabetes. In regression models, elevated A1C (>8.0%) was not significantly associated with overall CHA use (odds ratio [OR] = 1.78; 95% confidence interval [CI], 0.7 to 4.52) whereas elevated LDL was (OR = 3.93; 95% CI, 1.57 to 9.81). With medication adherence added in exploratory analysis, these findings were not significant. CONCLUSIONS: CHA use is common among patients with type 2 diabetes and may be associated with poor cardiometabolic control and medication adherence.

Adherence to Newly Prescribed Diabetes Medications Among Insured Latino and White Patients With Diabetes.

Importance: Medication adherence is essential to diabetes care. Patient-physician language barriers may affect medication adherence among Latino individuals. Objective: To determine the association of patient race/ethnicity, preferred language, and physician language concordance with patient adherence to newly prescribed diabetes medications. Design, Setting, and Participants: This observational study was conducted from January 1, 2006, to December 31, 2012, at a large integrated health care delivery system with professional interpreter services. Insured patients with type 2 diabetes, including English-speaking white, English-speaking Latino, or limited English proficiency (LEP) Latino patients with newly prescribed diabetes medication. Exposures: Patient race/ethnicity, preferred language, and physician self-reported Spanish-language fluency. Main Outcomes and Measures: Primary nonadherence (never dispensed), early-stage nonpersistence (dispensed only once), late-stage nonpersistence (received ≥2 dispensings, but discontinued within 24 months), and inadequate overall medication adherence (>20% time without sufficient medication supply during 24 months after initial prescription). Results: Participants included 21 878 white patients, 5755 English-speaking Latino patients, and 3205 LEP Latino patients with a total of 46 131 prescriptions for new diabetes medications. Among LEP Latino patients, 50.2% (n = 1610) had a primary care physician reporting high Spanish fluency. For oral medications, early adherence varied substantially: 1032 LEP Latino patients (32.2%), 1565 English-speaking Latino patients (27.2%), and 4004 white patients (18.3%) were either primary nonadherent or early nonpersistent. Inadequate overall adherence was observed in 1929 LEP Latino patients (60.2%), 2975 English-speaking Latino patients (51.7%), and 8204 white patients (37.5%). For insulin, early-stage nonpersistence was 42.8% among LEP Latino patients (n = 1372), 34.4% among English-speaking Latino patients (n = 1980), and 28.5% among white patients (n = 6235). After adjustment for patient and physician characteristics, LEP Latino patients were more likely to be nonadherent to oral medications and insulin than English-speaking Latino patients (relative risks from 1.11 [95% CI, 1.06-1.15] to 1.17 [95% CI, 1.02-1.34]; P < .05) or white patients (relative risks from 1.36 [95% CI, 1.31-1.41] to 1.49 [95% CI, 1.32-1.69]; P < .05). English-speaking Latino patients were more likely to be nonadherent compared with white patients (relative risks from 1.23 [95% CI, 1.19-1.27] to 1.30 [95% CI, 1.23-1.39]; P < .05). Patient-physician language concordance was not associated with rates of nonadherence among LEP Latinos (relative risks from 0.92 [95% CI, 0.71-1.19] to 1.04 [95% CI, 0.97-1.1]; P > .28). Conclusions and Relevance: Nonadherence to newly prescribed diabetes medications is substantially greater among Latino than white patients, even among English-speaking Latino patients. Limited English proficiency Latino patients are more likely to be nonadherent than English-speaking Latino patients independent of the Spanish-language fluency of their physicians. Interventions beyond access to interpreters or patient-physician language concordance will be required to improve medication adherence among Latino patients with diabetes.

Effects of ultralow-dose transdermal estradiol on postmenopausal symptoms in women aged 60 to 80 years.

OBJECTIVE: To investigate the effect of ultralow-dose transdermal estradiol on postmenopausal symptoms and side effects in a cohort of largely asymptomatic postmenopausal women aged 60 to 80 years. DESIGN: This secondary analysis used data from the UltraLow-dose Transdermal estRogen Assessment trial, a randomized, placebo-controlled, double-blind trial in postmenopausal women to determine the skeletal effects and safety of ultralow-dose transdermal estradiol. Four hundred seventeen postmenopausal women, aged 60 to 80 years, were randomly assigned to receive either unopposed transdermal estradiol at 0.014 mg/d (n = 208) or placebo (n = 209). Participants were queried at each clinic visit about postmenopausal symptoms and side effects purported to be associated with estrogen therapy using a standardized questionnaire. RESULTS: At baseline, 16% of women reported hot flashes, 32% reported vaginal dryness, and 35% reported trouble sleeping. Women who received ultralow-dose estradiol were no more likely to report improvement of hot flashes, vaginal dryness, or sleep difficulties than those who received placebo. Treatment with ultralow-dose estradiol did not cause breast tenderness, uterine bleeding, or other symptoms often attributed to estrogen, but vaginal discharge was more common in women who received estradiol compared with those who received placebo. CONCLUSION: In this population of older, largely asymptomatic women, ultralow-dose transdermal estradiol did not improve postmenopausal symptoms and did not cause side effects other than vaginal discharge. Further study is needed to determine whether this dose of transdermal estradiol is effective in treating symptoms of postmenopause in younger, more symptomatic women.

Linking High Risk Postpartum Women with a Technology Enabled Health Coaching Program to Reduce Diabetes Risk and Improve Wellbeing: Program Description, Case Studies, and Recommendations for Community Health Coaching Programs.

Background. Low-income minority women with prior gestational diabetes mellitus (pGDM) or high BMIs have increased risk for chronic illnesses postpartum. Although the Diabetes Prevention Program (DPP) provides an evidence-based model for reducing diabetes risk, few community-based interventions have adapted this program for pGDM women. Methods. STAR MAMA is an ongoing randomized control trial (RCT) evaluating a hybrid HIT/Health Coaching DPP-based 20-week postpartum program for diabetes prevention compared with education from written materials at baseline. Eligibility includes women 18-39 years old, ≥32 weeks pregnant, and GDM or BMI > 25. Clinic- and community-based recruitment in San Francisco and Sonoma Counties targets 180 women. Sociodemographic and health coaching data from a preliminary sample are presented. Results. Most of the 86 women included to date (88%) have GDM, 80% were identified as Hispanic/Latina, 78% have migrant status, and most are Spanish-speaking. Women receiving the intervention indicate high engagement, with 86% answering 1+ calls. Health coaching callbacks last an average of 9 minutes with range of topics discussed. Case studies presented convey a range of emotional, instrumental, and health literacy-related supports offered by health coaches. Discussion. The DPP-adapted HIT/health coaching model highlights the possibility and challenge of delivering DPP content to postpartum women in community settings. This trial is registered with ClinicalTrials.gov NCT02240420.

Uterine and vaginal effects of unopposed ultralow-dose transdermal estradiol.

OBJECTIVE: To investigate uterine effects of unopposed ultralow-dose transdermal estradiol administered to postmenopausal women for 2 years. METHODS: Postmenopausal women (n = 417), aged 60-80 years, with a uterus and with bone mineral density that was normal for age (z score >or=-2.0) were randomly assigned to receive unopposed transdermal estradiol (14 microg per day) or identical placebo patch. We evaluated effects on endometrial histology, vaginal bleeding, and vaginal epithelial cell maturation. RESULTS: At baseline, estradiol and placebo groups were similar in age (67 +/- 5 years) and in median baseline serum estradiol level (4.8 pg/mL, interquartile range 2.7, 8.0 pg/mL). In the estradiol group, median estradiol level increased to 8.6 pg/mL, (interquartile range 4.4, 13.9 pg/mL, P < .001). In the estradiol group, focal atypical endometrial hyperplasia developed in 1 woman, and adenosarcoma of the uterus developed in 1 woman. The placebo group had no endometrial hyperplasia. Endometrial proliferation occurred in 8.5% of the estradiol group and in 1.1% of the placebo group (P = .06). Incidence of vaginal bleeding was 12.4% in the estradiol group and 8.6% in the placebo group (P = .3). Vaginal epithelial cells showed greater maturation in the estradiol group than in the placebo group (P < .001) but less than typically observed with standard doses of estrogen. CONCLUSION: During 2 years of treatment with ultralow-dose unopposed estradiol, treatment and placebo groups had similar rates of endometrial hyperplasia, endometrial proliferation, and vaginal bleeding. This therapy apparently causes little or no endometrial stimulation. LEVEL OF EVIDENCE: I.

Automated Telephone Self-Management Support for Diabetes in a Low-Income Health Plan: A Health Care Utilization and Cost Analysis.

The objective was to determine whether automated telephone self-management support (ATSM) for low-income, linguistically diverse health plan members with diabetes affects health care utilization or cost. A government-sponsored managed care plan for low-income patients implemented a demonstration project between 2009 and 2011 that involved a 6-month ATSM intervention for 362 English-, Spanish-, or Cantonese-speaking members with diabetes from 4 publicly funded clinics. Participants were randomized to immediate intervention or a wait-list. Medical and pharmacy claims used in this analysis were obtained from the managed care plan. Medical claims included hospitalizations, ambulance use, emergency department visits, and outpatient visits. In the 6-month period following enrollment, intervention participants generated half as many emergency department visits and hospitalizations (rate ratio 0.52, 95% CI 0.26, 1.04) compared to wait-listed participants, but these differences did not reach statistical significance (P=0.06). With adjustment for prior year cost, intervention participants also had a nonsignificant reduction of $26.78 in total health care costs compared to wait-listed individuals (P=0.93). The observed trends suggest that ATSM could yield potential health service benefits for health plans that provide coverage for chronic disease patients in safety net settings. ATSM should be further scaled up to determine whether it is associated with a greater reduction in health care utilization and costs.

Reach and Validity of an Objective Medication Adherence Measure Among Safety Net Health Plan Members with Diabetes: A Cross-Sectional Study.

BACKGROUND: With the expansion of Medicaid and low-cost health insurance plans among diverse patient populations, objective measures of medication adherence using pharmacy claims could advance clinical care and translational research for safety net care. However, safety net patients may experience fluctuating prescription drug coverage, affecting the performance of adherence measures. OBJECTIVE: To evaluate the performance of continuous medication gap (CMG) for diverse, low-income managed care members with diabetes. METHODS: We conducted this cross-sectional analysis using administrative and clinical data for 680 members eligible for a self-management support trial at a nonprofit, government-sponsored managed care plan. We applied CMG methodology to cardiometabolic medication claims for English- , Cantonese- , or Spanish-speaking members with diabetes. We examined inclusiveness (the proportion with calculable CMG) and selectivity (sociodemographic and medical differences from members without CMG). For validity, we examined unadjusted associations of suboptimal adherence (CMG > 20%) with suboptimal cardiometabolic control. RESULTS: 429 members (63%) had calculable CMG. Compared with members without CMG, members with CMG were younger, more likely employed, and had poorer glycemic control but had better blood pressure and lipid control. Suboptimal adherence occurred more frequently among members with poor cardiometabolic control than among members with optimal control (28% vs. 12%, P = 0.02). CONCLUSIONS: CMG demonstrated acceptable inclusiveness and validity in a diverse, low-income safety net population, comparable with its performance in studies among other insured populations. CMG may provide a useful tool to measure adherence among increasingly diverse Medicaid populations, complemented by other strategies to reach those not captured by CMG.