Judy Quan

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 ≥–2.0) were randomly assigned to receive unopposed transdermal estradiol (14 μg 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

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

BackgroundHealth 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/DesignThis 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.DiscussionOutcomes 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 RegistrationClinicalTrials.gov: NCT00683020

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.

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.

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 (&khgr;2 231=484.34, P<0.0001) with significant factor loadings at P<0.05. Three domains showed excellent reliability—Doctor Communication-Positive Behaviors (&agr;=0.82), Trust (&agr;=0.77), and Doctor Communication-Health Promotion (&agr;=0.72). Four domains showed inadequate reliability either among Spanish speakers or overall (overall reliabilities listed): Doctor Communication-Negative Behaviors (&agr;=0.54), Equitable Treatment (&agr;=0.69), Doctor Communication-Alternative Medicine (&agr;=0.52), and Shared Decision-Making (&agr;=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.

Diabetes health information technology innovation to improve quality of life for health plan members in urban safety net.

Safety net systems need innovative diabetes self-management programs for linguistically diverse patients. A low-income government-sponsored managed care plan implemented a 27-week automated telephone self-management support/health coaching intervention for English-, Spanish-, and Cantonese-speaking members from 4 publicly funded clinics in a practice-based research network. Compared to waitlist, immediate intervention participants had greater 6-month improvements in overall diabetes self-care behaviors (standardized effect size [ES] = 0.29, P < .01) and 12-Item Short Form Health Survey physical scores (ES = 0.25, P = .03); changes in patient-centered processes of care and cardiometabolic outcomes did not differ. Automated telephone self-management is a strategy for improving patient-reported self-management and may also improve some outcomes.

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.

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.

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.

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.