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IntroductionSmoking is a significant modifiable risk factor for mortality for persons with serious mental illness (SMI), who have a life expectancy 15-20 years shorter than the general population. Individuals with SMI and comorbid diabetes who are smokers face an even higher risk of cardiovascular complications and early death. Yet despite high rates of smoking among people with SMI, tobacco cessation interventions have not been broadly offered to this population.MethodsWe conducted a retrospective cohort study using electronic health records from 2014 in a large integrated care delivery system to examine whether use of smoking cessation pharmacotherapy among smokers with type 2 diabetes varies by serious mental illness (SMI) diagnosis. We analyzed smoking cessation medication prescription fills among adult smokers with diabetes, comparing those with SMI (N = 634) and without SMI (N = 18,021). Risk ratios were adjusted for age, gender, race, urban area type, and medical facility.ResultsOf the SMI group, 19.09% filled at least one smoking cessation prescription compared to 9.73% of the non-SMI group (adjusted risk ratio 1.80 [95% CI 1.52-2.13]; p

BackgroundMail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence.ObjectiveTo assess an intervention to encourage MOP services to increase its use and medication adherence.DesignRandomized encouragement trial.Patients63,012 diabetes patients from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Hawaii (KPHI), and Harvard Pilgrim Health Care (HPHC) who were poorly adherent to at least one class of cardiometabolic medications and had not used MOP in the prior 12 months.InterventionPatients were randomized to receive either usual care (control arm) or outreach encouraging MOP use consisting of a mailed letter, secure email message, and automated telephone call outlining the potential benefits of MOP use (intervention arm). HPHC intervention patients received the letter only.MeasurementsWe compared the percentages of patients that began using MOP and that became adherent to cardiometabolic medication classes during a 12-month follow-up period. We also conducted a race/ethnicity-stratified analysis.ResultsDuring follow-up, 10.6% of intervention patients began using MOP vs. 9.3% of controls (p

BackgroundDiabetes prevalence is twice as high among people with severe mental illness (SMI) when compared to the general population. Despite high prevalence, care outcomes are not well understood.ObjectiveTo compare diabetes health outcomes received by people with and without comorbid SMI, and to understand demographic factors associated with poor diabetes control among those with SMI.DesignRetrospective cohort study PARTICIPANTS: 269,243 adults with diabetes MAIN MEASURES: Primary outcomes included optimal glycemic control (A1c < 7) or poor diabetes control (A1c > 9) in 2014. Secondary outcomes included control of other cardiometabolic risk factors (hypertension, dyslipidemia, smoking) and recommended diabetes monitoring.Key resultsAmong this cohort, people with SMI (N = 4,399), compared to those without SMI (N = 264,844), were more likely to have optimal glycemic control, adjusting for various covariates (adjusted relative risk (aRR) 1.25, 95% CI 1.21-1.28, p < .001) and less likely to have poor control (aRR 0.92, 95% CI 0.87-0.98, p = 0.012). Better blood pressure and lipid control was more prevalent among people with SMI when compared to those without SMI (aRR 1.03; 95% CI 1.02-1.05, p < .001; aRR 1.02; 95% CI 1.00-1.05, p = 0.044, respectively). No differences were observed in recommended A1c or LDL testing, but people with SMI were more likely to have blood pressure checked (aRR 1.02, 95% CI 1.02-1.03, p < .001) and less likely to receive retinopathy screening (aRR 0.80, 95% CI 0.71-0.91, p < .001) than those without SMI. Among people with diabetes and comorbid SMI, younger adults and Hispanics were more likely to have poor diabetes control.ConclusionsAdults with diabetes and comorbid SMI had better cardiometabolic control than people with diabetes who did not have SMI, despite lower rates of retinopathy screening. Among those with comorbid SMI, younger adults and Hispanics were more vulnerable to poor A1c control.

BACKGROUND: Diabetes prevalence is twice as high among people with severe mental illness (SMI) when compared to the general population. Despite high prevalence, care outcomes are not well understood. OBJECTIVE: To compare diabetes health outcomes received by people with and without comorbid SMI, and to understand demographic factors associated with poor diabetes control among those with SMI. DESIGN: Retrospective cohort study PARTICIPANTS: 269,243 adults with diabetes MAIN MEASURES: Primary outcomes included optimal glycemic control (A1c < 7) or poor diabetes control (A1c > 9) in 2014. Secondary outcomes included control of other cardiometabolic risk factors (hypertension, dyslipidemia, smoking) and recommended diabetes monitoring. KEY RESULTS: Among this cohort, people with SMI (N = 4,399), compared to those without SMI (N = 264,844), were more likely to have optimal glycemic control, adjusting for various covariates (adjusted relative risk (aRR) 1.25, 95% CI 1.21-1.28, p < .001) and less likely to have poor control (aRR 0.92, 95% CI 0.87-0.98, p = 0.012). Better blood pressure and lipid control was more prevalent among people with SMI when compared to those without SMI (aRR 1.03; 95% CI 1.02-1.05, p < .001; aRR 1.02; 95% CI 1.00-1.05, p = 0.044, respectively). No differences were observed in recommended A1c or LDL testing, but people with SMI were more likely to have blood pressure checked (aRR 1.02, 95% CI 1.02-1.03, p < .001) and less likely to receive retinopathy screening (aRR 0.80, 95% CI 0.71-0.91, p < .001) than those without SMI. Among people with diabetes and comorbid SMI, younger adults and Hispanics were more likely to have poor diabetes control. CONCLUSIONS: Adults with diabetes and comorbid SMI had better cardiometabolic control than people with diabetes who did not have SMI, despite lower rates of retinopathy screening. Among those with comorbid SMI, younger adults and Hispanics were more vulnerable to poor A1c control.

BackgroundMedication non-adherence is a major contributor to poor outcomes in diabetes. Previous research has shown an association between use of mail order pharmacy delivery and better medication adherence, but little is known about the barriers and facilitators to mail order pharmacy use in diabetes patients. This qualitative study examined factors related to mail order pharmacy use versus traditional "brick and mortar" pharmacies to refill prescriptions.MethodsWe conducted four 90-min focus groups in 2016 among 28 diabetes patients in the Hawaii and Northern California regions of Kaiser Permanente, a large integrated health care delivery system. We queried participants on their preferred mode for refilling prescriptions and perceived barriers and facilitators of mail order pharmacy use. One researcher independently coded each focus group transcript, with two of these transcripts double-coded by a second researcher to promote reliability. We employed thematic analysis guided by the Capability, Opportunity, Motivation, and Behavior (COM-B) framework using NVivo 11 software.ResultsA total of 28 diabetes patients participated. Participants' average age was 64.1 years; 57% were female; and racial/ethnic backgrounds included Asian/Native Hawaiian/Pacific Islander (36%), Black/African-American (21%) Hispanic/Latino (7%), and non-Hispanic White (36%). Analysis uncovered 26 themes related to the decision to use mail order pharmacy, with each theme representing a barrier or facilitator mapped to the COM-B framework. Most themes (20/26) fell into the COM-B category of 'Opportunity.' Opportunity barriers to mail order pharmacy use included unpredictability of medication delivery date, concerns about mail security, and difficulty coordinating refill orders for multiple prescriptions. In contrast, facilitators included greater access and convenience (e.g., no need to wait in line or arrange transportation) compared to traditional pharmacies. Motivational facilitators to mail order pharmacy use included receiving a pharmacy benefit plan incentive of a free one-month supply of prescriptions.ConclusionsThis study found that while patients with diabetes may benefit from mail order pharmacy use, they perceive numerous barriers to using the service. These findings will inform the design of interventions and quality improvement initiatives to increase mail order pharmacy use, which in turn may improve medication adherence and outcomes in diabetes patients, across health care systems.

ObjectiveIn this study we aimed to investigate the content and process of contraceptive counseling surrounding combined hormonal contraceptive (CHC) methods (combined oral contraceptives, the ring, and the patch).Study designWe performed a mixed methods analysis of data collected as part of the Patient-Provider Communication about Contraception study, in which reproductive age women and their providers were recruited at several San Francisco Bay Area clinics from 2009-2012. Participants completed pre- and post-visit surveys, and had their visits audio recorded and transcribed. We performed descriptive and bivariate analyses of the entire cohort to examine associations between demographic characteristics and pre-existing method preferences with method selection and counseling content, and coded transcripts of a subset of the sample for salient themes related to content and process of counseling about combined hormonal contraceptive methods using a directed content analysis approach.ResultsThe overall sample included 342 women, with 152 women (44%) having a preference for a specific CHC prior to their visit, 127 women (37%) had a preference for a non-CHC method, and 63 (18%) having no existing method preference. Of the women who reported preferring a CHC in their pre-visit survey, the majority (72%) chose that method. We found that women were inconsistently counseled about the range of CHC methods. For example, women who had no pre-visit method preference (52%) or who preferred the ring (54%) or the patch (73%) were more likely to receive comprehensive counseling about the three CHC methods than were women who preferred combined oral contraceptives (35%) or non-CHC methods (33%). Providers mentioned the patch the least often, and in qualitative analysis indicated discomfort with prescribing this method. Side effects and benefits of methods, as well as strategies to enhance successful use of the chosen method, were inconsistently discussed. In only 73% of visits in which a woman chose a CHC did the provider assess the patient's ability to use the chosen method correctly, and in 66% of all visits in which women chose a CHC method, providers discussed what to do if she was dissatisfied with the method.ConclusionsCounseling about combined hormonal contraceptive methods often does not include information about all available methods, or comprehensive information about side effects, benefits, or logistics of use. As this counseling can impact patient's satisfaction with and continuation of their chosen method of contraception, future work should focus on designing interventions to improve providers' ability to meet patients' needs.ImplicationsShort acting hormonal contraception is widely used, but counseling for these methods often neglects key features. Comprehensive counseling about all methods and their individual features can improve contraceptive selection and use.

Purpose of reviewTo advance our understanding of the impacts of policies and programs aimed at improving detection, engagement, prevention, and clinical diabetes management in the USA, we synthesized findings from a network of studies that used natural experiments to evaluate diabetes health policies and programs.FindingsStudies from the Natural EXperiments for Translation in Diabetes (NEXT-D) network used rigorous longitudinal quasi-experimental study designs (e.g., interrupted time series) and analytical methods (e.g., difference-in-differences) to augment causal inference. Investigators partnered with health system stakeholders to evaluate whether glucose testing rates changed from before-to-after clinic interventions (e.g., integrating electronic screening decision prompts in New York City) or employer programs (e.g., targeted messaging and waiving copayments for at-risk employees). Other studies examined participation and behavior change in low- (e.g., wellness coaching) or high-intensity lifestyle modification programs (e.g., diabetes prevention program-like interventions) offered by payers or employers. Lastly, studies assessed how employer health insurance benefits impacted healthcare utilization, adherence, and outcomes among people with diabetes. NEXT-D demonstrated that low-intensity interventions to facilitate glucose testing and enhance engagement in lifestyle modification were associated with small improvements in weight but large improvements in screening and testing when supported by electronic health record-based decision-support. Regarding high-intensity diabetes prevention program-like lifestyle programs offered by payers or employers, enrollment was modest and led to weight loss and marginally lower short-term health expenditures. Health plans that incentivize patient behaviors were associated with increases in medication adherence. Meanwhile, shifting patients to high-deductible health plans was associated with no change in medication use and preventive screenings, but patients with diabetes delayed accessing healthcare for acute complications (e.g., cellulitis). Findings were more pronounced among lower-income patients, who experienced increased rates and acuity of emergency department visits for diabetes complications and other high-severity conditions. Findings from NEXT-D studies provide informative data that can guide programs and policies to facilitate detection, prevention, and treatment of diabetes in practice.

ContextResearch on predictors of clinical outcomes usually focuses on the impact of individual patient factors, despite known relationships between neighborhood environment and health.ObjectiveTo determine whether US census information on where a patient resides is associated with diabetes development among patients with prediabetes.DesignRetrospective cohort study of all 157,752 patients aged 18 years or older from Kaiser Permanente Northern California with laboratory-defined prediabetes (fasting plasma glucose, 100 mg/dL-125 mg/dL, and/or glycated hemoglobin, 5.7%-6.4%). We assessed whether census data on education, income, and percentage of households receiving benefits through the US Department of Agriculture's Supplemental Nutrition Assistance Program (SNAP) was associated with diabetes development using logistic regression controlling for age, sex, race/ethnicity, blood glucose levels, and body mass index.Main outcome measureProgression to diabetes within 36 months.ResultsPatients were more likely to progress to diabetes if they lived in an area where less than 16% of adults had obtained a bachelor's degree or higher (odds ratio [OR] =1.22, 95% confidence interval [CI] = 1.09-1.36), where median annual income was below $79,999 (OR = 1.16 95% CI = 1.03-1.31), or where SNAP benefits were received by 10% or more of households (OR = 1.24, 95% CI = 1.1-1.4).ConclusionArea-level socioeconomic and food assistance data predict the development of diabetes, even after adjusting for traditional individual demographic and clinical factors. Clinical interventions should take these factors into account, and health care systems should consider addressing social needs and community resources as a path to improving health outcomes.

ContextPrediabetes is prevalent and significantly increases lifetime risk of progression to type 2 diabetes. This review summarizes the evidence surrounding metformin use for type 2 diabetes prevention.Evidence acquisitionArticles published between 1998 and 2017 examining metformin use for the primary indication of diabetes prevention available on MEDLINE.Evidence synthesisForty articles met inclusion criteria and were summarized into four general categories: (1) RCTs of metformin use for diabetes prevention (n=7 and n=2 follow-up analyses); (2) observational analyses examining metformin use in heterogeneous subgroups of patients with prediabetes (n=9 from the Diabetes Prevention Program, n=1 from the biguanides and the prevention of the risk of obesity [BIGPRO] trial); (3) observational analyses examining cost effectiveness of metformin use for diabetes prevention (n=11 from the Diabetes Prevention Program, n=1 from the Indian Diabetes Prevention Program); and (4) real-world assessments of metformin eligibility or use for diabetes prevention (n=9). Metformin was associated with reduced relative risk of incident diabetes, with the strongest evidence for use in those at highest risk (i.e., aged

BackgroundContraceptive nonadherence is an important contributor to unintended pregnancy in the United States. While the elimination of patient cost sharing has been cited as means to improve contraceptive access, little is known about the relationship between cost sharing and ongoing adherence and continuation of chosen methods. The purpose of this study was to examine the relationship between copayment amount and adherence to pharmacy-dispensed contraception in young women.MethodsWe conducted a retrospective cohort study of 39,142 women ages 19-29 with a new prescription for the contraceptive pill, patch, or ring at Kaiser Permanente Northern California during 2011-2014. We examined 12-month nonadherence as measured by timely prescription refills and used multivariable Cox proportional hazards models to assess the association between copayment amount and the risk of nonadherence.ResultsNinety-four percent of women used the pill, and 6% used the patch or ring. Forty percent of patients had no copayment and 25% had a copayment of ≥$30. Nearly 75% of women were nonadherent during the study period. In 2013 and 2014, women with a copayment had a 9% increased risk of nonadherence (adjusted hazard ratio, 1.09; 95% confidence interval, 1.04, 1.14) compared with women with no copayment.ConclusionsPrescription copayments may serve as a barrier to adherence of pharmacy-dispensed contraception. Given recent changes to Affordable Care Act contraceptive coverage requirement, these findings can be used to support state-level and health system-level policies for no-cost contraception, and to determine the potential public health impact of this policy change.

ObjectiveTo identify positive deviant (PD) physician organizations of Accountable Care Organizations (ACOs) with robust performance management systems (PMSYS).Data sourceThird National Survey of Physician Organizations (NSPO3, n = 1,398).Study designOrganizational and external factors from NSPO3 were analyzed.Data collection/extraction methodsLinear regression estimated the association of internal and contextual factors on PMSYS. Two cutpoints (75th/90th percentiles) identified PDs with the largest residuals and highest PMSYS scores.Principal findingsA total of 65 and 41 PDs were identified using 75th and 90th percentiles cutpoints, respectively. The 90th percentile more strongly differentiated PDs from non-PDs. Having a high proportion of vulnerable patients appears to constrain PMSYS development.ConclusionsOur PD identification method increases the likelihood that PD organizations selected for in-depth inquiry are high-performing organizations that exceed expectations.

BackgroundSevere mental illness (SMI) is associated with increased risk for type 2 diabetes, partly due to adverse metabolic effects of antipsychotic medications. In public health care settings, annual screening rates are 30%. We measured adherence to national diabetes screening guidelines for patients taking antipsychotic medications.ObjectiveTo estimate diabetes screening prevalence among patients with SMI within an integrated health care system, and to assess characteristics associated with lack of screening.DesignRetrospective cohort study.ParticipantsAntipsychotic-treated adults with SMI. We excluded participants with known diabetes.Main measuresPrimary outcome was screening via fasting glucose test or hemoglobin A1c during a 1-year period.Key resultsIn 2014, 16,754 patients with SMI diagnoses were receiving antipsychotics. Seventy-four percent of these patients' providers ordered diabetes screening tests that year, but only 55% (9247/16,754) received screening. When the observation time frame was extended to 2 years, 73% (12,250/16,754) were screened. Adjusting for sex and race/ethnicity, young adults (aged 18-29 years) were less likely to receive screening than older age groups [adjusted RR (aRR) 1.23-1.57, p

BackgroundShared decision making (SDM) is a potentially valuable but underexplored approach to contraceptive counseling.MethodsWe determined the correlation between patient report of SDM and of whether their provider had a method preference with measures of satisfaction.ResultsWomen reporting SDM were more likely to be satisfied with counseling than those reporting a provider-driven decision and were more likely to be satisfied with their method than those reporting a patient-driven decision. Patients who felt that the provider had a method preference were less likely to be satisfied with their method.ConclusionsSDM in contraceptive counseling is associated with patient satisfaction.

PurposeMany Americans continue to smoke, increasing their risk of disease and premature death. Both telephone-based counseling and in-person tobacco cessation classes may improve access for smokers seeking convenient support to quit. Little research has assessed whether such programs are effective in real-world clinical populations.DesignRetrospective cohort study comparing wellness coaching participants with two groups of controls.SettingKaiser Permanente Northern California, a large integrated health care delivery system.SubjectsTwo hundred forty-one patients who participated in telephonic tobacco cessation coaching from January 1, 2011, to March 31, 2012, and two control groups: propensity-score-matched controls, and controls who participated in a tobacco cessation class during the same period. Wellness coaching participants received an average of two motivational interviewing-based coaching sessions that engaged the patient, evoked their reason to consider quitting, and helped them establish a quit plan.MeasuresSelf-reported quitting of tobacco and fills of tobacco cessation medications within 12 months of follow-up.AnalysisLogistic regressions adjusting for age, gender, race/ethnicity, and primary language.ResultsAfter adjusting for confounders, tobacco quit rates were higher among coaching participants vs. matched controls (31% vs. 23%, p < .001) and comparable to those of class attendees (31% vs. 29%, p = .28). Coaching participants and class attendees filled tobacco-cessation prescriptions at a higher rate (47% for both) than matched controls (6%, p < .001).ConclusionTelephonic wellness coaching was as effective as in-person classes and was associated with higher rates of quitting compared to no treatment. The telephonic modality may increase convenience and scalability for health care systems looking to reduce tobacco use and improve health.

ObjectiveTo evaluate the impact of a population-based telephonic wellness coaching program on weight loss.MethodsIndividual-level segmented regression analysis of interrupted time series data comparing the BMI trajectories in the 12 months before versus the 12 months after initiating coaching among a cohort of Kaiser Permanente Northern California members (n = 954) participating in The Permanente Medical Group Wellness Coaching program in 2011. The control group was a 20:1 propensity-score matched control group (n = 19,080) matched with coaching participants based on baseline demographic and clinical characteristics.ResultsWellness coaching participants had a significant upward trend in BMI in the 12 months before their first wellness coaching session and a significant downward trend in BMI in the 12 months after their first session equivalent to a clinically significant reduction of greater than one unit of baseline BMI (P < 0.01 for both). The control group did not have statistically significant decreases in BMI during the post-period.ConclusionsWellness coaching has a positive impact on BMI reduction that is both statistically and clinically significant. Future research and quality improvement efforts should focus on disseminating wellness coaching for weight loss in patients with diabetes and those at risk for developing the disease.

ObjectivesProvider self-disclosure (PSD) - defined as providers making statements regarding personal information to patients - has not been well characterized in the context of contraceptive counseling. In this study, we describe the incidence, content and context of contraceptive PSD.Study designThis mixed methods analysis used data from the Provider-Patient Contraceptive Counseling study, for which 349 family planning patients were recruited from 2009 to 2012 from six clinics in the San Francisco Bay Area. Audio-recordings from their visits were analyzed for the presence or absence of PSD, and those visits with evidence of PSD were analyzed using qualitative methods. The associations of patient and provider demographics and patient satisfaction measures, obtained from survey data, with PSD were analyzed using bivariable and multivariable analyses.ResultsThirty-seven percent of providers showed evidence of PSD during at least one visit, and PSD occurred in 9% of clinic visits. Fifty-four percent of PSD statements were about intrauterine devices. About half of PSD statements occurred prior to the final selection of the contraceptive method and appeared to influence the choice of method. In post-visit surveys, all patients who reported receiving PSD considered it to be appropriate, and patient-reported PSD was not statistically associated with measures of patient satisfaction.ConclusionsThis study provides some support for the appropriateness of PSD during family planning encounters, at least as practiced during the sampled visits. Further research could explore whether this counseling strategy has an impact on patients' ability to identify the best contraceptive methods for them.ImplicationsIn this study, PSD did not have a demonstrated negative effect on the provider-patient relationship. In almost half of visits, PSD appeared to influence patients' choice of a method; whether this influence is beneficial needs further research.

BackgroundHealth communication and interpersonal skills are increasingly emphasized in the measurement of health care quality, yet there is limited research on the association of interpersonal care with health outcomes. As approximately 50% of pregnancies in the United States are unintended, whether interpersonal communication influences contraceptive use is of public health importance.ObjectiveThe aim of this study was to determine whether the quality of interpersonal care during contraceptive counseling is associated with contraceptive use over time.Study designThe Patient-Provider Communication about Contraception study is a prospective cohort study of 348 English-speaking women seen for contraceptive care, conducted between 2009 and 2012 in the San Francisco Bay Area. Quality of communication was assessed using a patient-reported interpersonal quality in family planning care measure based on the dimensions of patient-centered care. In addition, the clinical visit was audio recorded and its content coded according to the validated Four Habits Coding Scheme to assess interpersonal communication behaviors of clinicians. The outcome measures were 6-month continuation of the selected contraceptive method and use of a highly or moderately effective method at 6 months. Results were analyzed using mixed effect logistic regression models controlling for patient demographics, the clinic and the provider at which the visit occurred, and the method selected.ResultsPatient participants had a mean age of 26.8 years (SD 6.9 years); 46% were white, 26% Latina, and 28% black. Almost two-thirds of participants had an income of

ObjectiveConsistent estimation of causal effects with inverse probability weighting estimators is known to rely on consistent estimation of propensity scores. To alleviate the bias expected from incorrect model specification for these nuisance parameters in observational studies, data-adaptive estimation and in particular an ensemble learning approach known as Super Learning has been proposed as an alternative to the common practice of estimation based on arbitrary model specification. While the theoretical arguments against the use of the latter haphazard estimation strategy are evident, the extent to which data-adaptive estimation can improve inferences in practice is not. Some practitioners may view bias concerns over arbitrary parametric assumptions as academic considerations that are inconsequential in practice. They may also be wary of data-adaptive estimation of the propensity scores for fear of greatly increasing estimation variability due to extreme weight values. With this report, we aim to contribute to the understanding of the potential practical consequences of the choice of estimation strategy for the propensity scores in real-world comparative effectiveness research.MethodWe implement secondary analyses of Electronic Health Record data from a large cohort of type 2 diabetes patients to evaluate the effects of four adaptive treatment intensification strategies for glucose control (dynamic treatment regimens) on subsequent development or progression of urinary albumin excretion. Three Inverse Probability Weighting estimators are implemented using both model-based and data-adaptive estimation strategies for the propensity scores. Their practical performances for proper confounding and selection bias adjustment are compared and evaluated against results from previous randomized experiments.ConclusionResults suggest both potential reduction in bias and increase in efficiency at the cost of an increase in computing time when using Super Learning to implement Inverse Probability Weighting estimators to draw causal inferences.

ObjectiveTo compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention.Research design and methodsThis study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI

BackgroundWith 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.ObjectiveTo evaluate the performance of continuous medication gap (CMG) for diverse, low-income managed care members with diabetes.MethodsWe 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.Results429 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).ConclusionsCMG 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.

The high prevalence and costs of type 2 diabetes makes it a rapidly evolving focus of policy action. Health systems, employers, community organizations, and public agencies have increasingly looked to translate the benefits of promising research interventions into innovative policies intended to prevent or control diabetes. Though guided by research, these health policies provide no guarantee of effectiveness and may have opportunity costs or unintended consequences. Natural experiments use pragmatic and available data sources to compare specific policies to other policy alternatives or predictions of what would likely have happened in the absence of any intervention. The Natural Experiments for Translation in Diabetes (NEXT-D) Study is a network of academic, community, industry, and policy partners, collaborating to advance the methods and practice of natural experimental research, with a shared aim of identifying and prioritizing the best policies to prevent and control diabetes. This manuscript describes the NEXT-D Study group's multi-sector natural experiments in areas of diabetes prevention or control as case examples to illustrate the selection, design, analysis, and challenges inherent to natural experimental study approaches to inform development or evaluation of health policies.

ObjectiveTo assess the impact of a pharmacy benefit change on mail order pharmacy (MOP) uptake.Data sources/study settingRace-stratified, random sample of diabetes patients in an integrated health care delivery system.Study designIn this natural experiment, we studied the impact of a pharmacy benefit change that conditionally discounted medications if patients used MOP and prepaid two copayments. We compared MOP uptake among those exposed to the benefit change (n = 2,442) and the reference group with no benefit change (n = 8,148), and estimated differential MOP uptake across social strata using a difference-in-differences framework.Data collection/extraction methodsAscertained MOP uptake (initiation among previous nonusers).Principal findingsThirty percent of patients started using MOP after receiving the benefit change versus 9 percent uptake among the reference group (p < .0001). After adjustment, there was a 26 percentage point greater MOP uptake (benefit change effect). This benefit change effect was significantly smaller among patients with inadequate health literacy (15 percent less), limited English proficiency (14 percent less), and among Latinos and Asians (24 and 16 percent less compared to Caucasians).ConclusionsConditionally discounting medications delivered by MOP effectively stimulated MOP uptake overall, but it unintentionally widened previously existing social gaps in MOP use because it stimulated less MOP uptake in vulnerable populations.

IntroductionHealth coaching can improve lifestyle behaviors known to prevent or manage chronic conditions. Little is known about effective ways to encourage health and wellness coaching among people who might benefit. The purpose of this randomized encouragement trial was to assess the relative success of 3 outreach methods (secured email message, telephone message, and mailed letter) on the use of wellness coaching by people with prediabetes.MethodsA total of 14,584 Kaiser Permanente Northern California (KPNC) patients with diagnosed prediabetes (fasting plasma glucose, 110-125mg/dL) were randomly assigned to be contacted via 1 of 4 intervention arms from January through May 2013. The uptake rate (making an appointment at the Wellness Coaching Center [WCC]) was assessed, and the association between uptake rate and patient characteristics was examined via multivariable logistic regression.ResultsThe overall uptake rate across intervention arms was 1.9%. Secured email message had the highest uptake rate (3.0%), followed by letters and telephone messages (P < .05 for all pairwise comparisons). No participants in the usual-care arm (ie, no outreach) made an appointment with the WCC. For each year of increased age, the estimated odds of the uptake increased by 1.02 (odds ratio [OR] = 1.02; 95% CI, 1.01-1.04). Women were nearly twice as likely to make an appointment at the WCC as men (OR = 1.87; 95% CI, 1.40-2.51).ConclusionOur results suggest that the WCC can recruit and encourage KPNC members with prediabetes to participate in the WCC. Future research should focus on increasing participation rates in health coaching among patients who may benefit.

BackgroundAlthough social networks are an increasingly recognized influence on contraceptive use, little is known about if and how social influences are discussed during women's contraceptive counseling visits.MethodsWe performed a mixed-methods analysis of audio recordings of contraceptive counseling visits. We examined predictors of discussion of social influence arising in a contraceptive counseling visit and analyzed the content and process of social influence discussions.ResultsSocial influences were mentioned in 42% of the 342 visits included in the sample, with these discussions most commonly initiated by patients. Younger patients were more likely to have social influence mentioned than older patients. The content of social influence focused on side effects and adverse events, with the sources of influence being predominantly patients' friends and the media, with little input from partners. Providers were more likely to engage around the content of the social influence than the social influence itself.ConclusionThe frequency with which social influence was mentioned in these visits supports the importance of women's social context on their contraceptive decision making. However, the fact that patients initiated the discussion in the majority of cases suggests that providers may not recognize the relevance of these influences or may not be comfortable engaging with them. Increasing providers' ability to elicit and engage patients about their social context with regard to contraception could enhance providers' ability to understand women's contraceptive preferences and provide appropriate counseling to address their specific concerns or questions.

BackgroundWomen with gestational diabetes (GDM) are at high risk of developing diabetes later in life. After a GDM diagnosis, women receive prenatal care to control their blood glucose levels via diet, physical activity and medications. Continuing such lifestyle skills into early motherhood may reduce the risk of diabetes in this high risk population. In the Gestational Diabetes' Effects on Moms (GEM) study, we are evaluating the comparative effectiveness of diabetes prevention strategies for weight management designed for pregnant/postpartum women with GDM and delivered at the health system level.Methods/designThe GEM study is a pragmatic cluster randomized clinical trial of 44 medical facilities at Kaiser Permanente Northern California randomly assigned to either the intervention or usual care conditions, that includes 2,320 women with a GDM diagnosis between March 27, 2011 and March 30, 2012. A Diabetes Prevention Program-derived print/telephone lifestyle intervention of 13 telephonic sessions tailored to pregnant/postpartum women was developed. The effectiveness of this intervention added to usual care is to be compared to usual care practices alone, which includes two pages of printed lifestyle recommendations sent to postpartum women via mail. Primary outcomes include the proportion of women who reach a postpartum weight goal and total weight change. Secondary outcomes include postpartum glycemia, blood pressure, depression, percent of calories from fat, total caloric intake and physical activity levels. Data were collected through electronic medical records and surveys at baseline (soon after GDM diagnosis), 6 weeks (range 2 to 11 weeks), 6 months (range 12 to 34 weeks) and 12 months postpartum (range 35 to 64 weeks).DiscussionThere is a need for evidence regarding the effectiveness of lifestyle modification for the prevention of diabetes in women with GDM, as well as confirmation that a diabetes prevention program delivered at the health system level is able to successfully reach this population. Given the use of a telephonic case management model, our Diabetes Prevention Program-derived print/telephone intervention has the potential to be adopted in other settings and to inform policies to promote the prevention of diabetes among women with GDM.

Introduction Methods Results Conclusions Ongoing crises in the quality, affordability, sustainability, value, and equity of U.S. healthcare call for rapid, massive‐scale innovations across multiple specialties. Physician groups and healthcare organizations commit significant monetary and personnel investments for innovation and improvement efforts, but most lack over‐arching systems theory‐supported conceptual frameworks for efficiently coordinating the timely, large‐volume idea generation, refinement, prioritization, evidence development, implementation, and re‐evaluation strategies needed for rapid‐cycle improvements in health care delivery, outcomes, and value.This article describes one large‐scale, generalizable model: The Permanente Medical Group's (TPMG) Delivery Science and Applied Research (DARE) program within Kaiser Permanente Northern California. This organization‐level initiative was designed to: (1) elicit clinical innovation and quality concerns across clinical specialties; (2) prioritize these questions for next‐step evaluations; (3) create dedicated analytic, research, and clinical expertise to rapidly study the questions generated; (4) develop communities of clinician‐researchers, embedded within their specialties' clinical operations, who gather ideas for evaluation, generate evidence, and facilitate implementation of research results (a.k.a. evidence‐based innovators); and (5) broadly disseminate findings, to connect results with potential next‐step implementation.The DARE program and its components rapidly led to more than 200 recently completed or ongoing projects, informed care changes, influenced national guidelines, developed communities of evidence‐based clinician innovators in 15 specialties, and empowered new paths for career diversity and physician wellness. Key factors in the DARE program's success include explicitly defining high‐impact ideas; engaging researchers with analysts experienced with large clinical data systems; developing several research funding mechanisms scaled to project size; prioritizing rapid and efficient project completion; supporting clinician‐investigators embedded within their specialties; and structured organization‐wide dissemination of findings for informing potential implementation.High‐volume, evidence‐based innovation programs can be important, scale‐able, reproducible models for different settings for increasing quality, affordability, sustainability, value, and equity in healthcare and furthering the difficult‐to‐achieve concept of developing sustainable learning healthcare systems. [ABSTRACT FROM AUTHOR]