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This study tested the preliminary effectiveness of an electronic health record (EHR)-automated population health management (PHM) intervention for smoking cessation among adult patients of a federally qualified health center in Chicago. Participants (N = 190; 64.7% women, 82.1% African American/Black, 8.4% Hispanic/Latino) were self-identified as smokers, as documented in the EHR, who completed the baseline survey of a longitudinal “needs assessment of health behaviors to strengthen health programs and services.” Four weeks later, participants were randomly assigned to the PHM intervention (N = 97) or enhanced usual care (EUC; N = 93). PHM participants were mailed a single-page self-determination theory (SDT)-informed letter that encouraged smoking cessation or reduction as an initial step. The letter also addressed low health literacy and low income. PHM participants also received automated text messages on days 1, 5, 8, 11, and 20 after the mailed letter. Two weeks after mailing, participants were called by the Illinois Tobacco Quitline. EUC participants were e-referred following a usual practice. Participants reached by the quitline were offered behavioral counseling and nicotine replacement therapy. Outcome assessments were conducted at weeks 6, 14, and 28 after the mailed letter. Primary outcomes were treatment engagement, utilization, and self-reported smoking cessation. In the PHM arm, 25.8% of participants engaged in treatment, 21.6% used treatment, and 16.3% were abstinent at 28 weeks. This contrasts with no quitline engagement among EUC participants, and a 6.4% abstinence rate. A PHM approach that can reach all patients who smoke and address unique barriers for low-income individuals may be a critical supplement to clinic-based care.

Background Intensive lifestyle interventions (ILI) improve weight loss and cardiovascular risk factors, but health systems face challenges implementing them. We engaged stakeholders to cocreate and evaluate feasibility of primary care implementation strategies and of a pragmatic randomization procedure to be used for a future effectiveness trial.Methods The study setting was a single, urban primary care office. Patients with BMI ≥ 27 and ≥ 1 cardiovascular risk factor were sent a single electronic health record (EHR) message between December 2019 and January 2020 offering services to support an initial weight loss goal of about “10 pounds in 10 weeks.” All patients who affirmed weight loss interest were pragmatically enrolled in the trial and offered “Basic Lifestyle Services” (BLS), including a scale that transmits weight data to the EHR using cellular networks, a coupon to enroll in lifestyle coaching resources through a partnering fitness organization, and periodic EHR messages encouraging use of these resources. About half (n = 42) of participants were randomized by an automated EHR algorithm to also receive “Customized Lifestyle Services” (CLS), including weekly email messages adapted to individual weight loss progress and telephonic coaching by a nurse for those facing challenges. Interventions and assessments spanned January to July 2020, with interference by the coronavirus pandemic. Weight measures were collected from administrative sources. Qualitative analysis of stakeholder recommendations and patient interviews assessed acceptability, appropriateness, and sustainability of intervention components.Results Over 6 weeks, 426 patients were sent the EHR invitation message and 80 (18.8%) affirmed interest in the weight loss goal and were included for analysis. EHR data were available to ascertain a 6-month weight value for 77 (96%) patients. Overall, 62% of participants lost weight; 15.0% exhibited weight loss ≥ 5%, with no statistically significant difference between CLS or BLS arms (p = 0.85). CLS assignment increased participation in daily self-weighing (43% versus 21% of patients through 12 weeks) and enrollment in referral-based lifestyle support resources (52% versus 37%).Conclusions This preliminary study demonstrates feasibility of implementation strategies for primary care offices to offer and coordinate ILI core components, as well as a pragmatic randomization procedure for use in a future randomized comparative trial.

BACKGROUND The benefits of moderate to vigorous physical activity (MVPA) for breast cancer survivors are well established. However, most are insufficiently active. Fit2Thrive used the Multiphase Optimization Strategy methodology to determine the effect of 5 intervention components on MVPA in this population. METHODS Two hundred sixty-nine participants (mean age, 52.5 years; SD, 9.9 years) received a core intervention (the Fit2Thrive self-monitoring app and Fitbit) and were randomly assigned to 5 intervention components set to on/off in a full factorial experiment: support calls, deluxe app, buddy, online gym, and text messages. The intervention was delivered over 12 weeks with a 12-week follow-up. MVPA was measured via accelerometry at the baseline (T1), at 12 weeks (T2), and at 24 weeks (T3). The main effects and interaction effects at each time point were examined for all components. RESULTS Trial retention was high: 91.8% had valid accelerometer data at T2 or T3. Across all conditions, there were significant increases in MVPA (+53.6 min/wk; P < .001) and in the proportion of survivors meeting MVPA guidelines (+22.3%; P < .001) at T2 that were maintained but attenuated at T3 (MVPA, +24.6 min/wk; P < .001; meeting guidelines, +12.6%; P < .001). No individual components significantly improved MVPA, although increases were greater for the on level versus the off level for support calls, buddy, and text messages at T2 and T3. CONCLUSIONS The Fit2Thrive core intervention (the self-monitoring app and Fitbit) is promising for increasing MVPA in breast cancer survivors, but the components provided no additional increases in MVPA. Future research should evaluate the core intervention in a randomized trial and determine what components optimize MVPA behaviors in breast cancer survivors.

Hypoglycemia and acute metabolic complications (AMCs; ketoacidosis, hyperosmolarity, and coma) are glycemic outcomes that have high cost and high morbidity; these outcomes must be taken into consideration when choosing initial second-line therapy after metformin. We conducted a retrospective cohort study analyzing national administrative data from adults with type 2 diabetes mellitus who started a second-line diabetes medication (sulfonylureas [SFUs], thiazolidinediones [TZDs], glucagon-like peptide 1 [GLP-1] agonists, dipeptidyl peptidase 4 [DPP-4] inhibitors, basal insulin, or sodium-glucose contransporter 2 [SGLT-2] inhibitors) between April 1, 2011 and September 30, 2015 (N=43,288) and compared rates of hypoglycemia and AMCs. Most patients (24,506 [56.6%]) were prescribed sulfonylurea as second-line treatment, followed by DPP-4 inhibitors (7953 [18.4%]), GLP-1 agonists (3854 [8.9%]), basal insulin (2542 [5.9%]), SGLT-2 inhibitors (2537 [5.9%), and TZDs (1896 [4.4%]). Baseline rates of hypoglycemia varied more than 5-fold across initial second-line antidiabetic medication classes, and rates of AMCs varied 7-fold. Compared with patients taking an SFU, lower adjusted rates of hypoglycemia were associated with taking a DPP-4 inhibitor (63% lower rate; incidence rate ratio [IRR], 0.37; 95% CI, 0.25 to 0.57), SGLT-2 inhibitor (54% lower; IRR, 0.46; 95% CI, 0.22 to 0.94), or TZD (79% lower; IRR, 0.21; 95% CI, 0.08 to 0.56) but not a glucagon-like peptide 1 agonist or basal insulin. For AMCs, only initiation of a DPP-4 inhibitor (43% lower rate; IRR, 0.57; 95% CI, 0.41 to 0.81) was associated with a lower adjusted rate compared with SFU. Use of SGLT-2 inhibitors was not associated with a substantially increased rate of acute metabolic complications compared with SFU. Special attention still needs to be paid to glycemic outcomes when choosing a second-line diabetes therapy following metformin.

In 2021, the US Preventive Services Task Force (USPSTF) expanded the recommended age range for prediabetes and diabetes screening among those with overweight/obesity to 35-70 years. Using 2017 to pre-pandemic March 2020 National Health and Nutrition Examination Survey data, we applied these screening criteria to assess their performance in a nationally representative sample. We included 3243 non-pregnant adults aged ≥18 years without diagnosed diabetes. Screening eligibility was determined based on participants' age and measured body mass index (BMI) [≥23kg/m2 for non-Hispanic (NH) Asian adults and ≥25kg/m2 for other ethnic groups]. Dysglycemia was defined based on A1c ≥5.7% or fasting plasma glucose ≥100mg/dL. We compared participant characteristics by USPSTF eligibility. We also assessed performance [sensitivity, specificity, positive predictive value (PPV) , and negative predictive value (NPV) ] of the screening criteria for detecting dysglycemia overall and by ethnicity. During 2017-2020, 44.4% of US adults aged 35-70 years were eligible for screening, representing 95.9 million US adults. Relative to adults who were ineligible, those who were eligible had a higher burden of diabetes risk factors, as well as greater proportions of some racial ethnic groups, higher proportion of those with less than a high school education, and more likely to be living in poverty. The performance characteristics of the USPSTF screening criteria were: sensitivity 59.4% (95% CI: 56.4-62.4) ; specificity 68.6% (65.1-71.9) ; PPV 62.4% (59.2-65.6) ; and NPV 65.8% (61.9-69.5) . The sensitivity by ethnicity was as follows: NH White adults 59.1% (55.4-62.7) ; NH Black adults 63.6% (57.8-68.9) ; Hispanic adults 62.0% (55.0-68.5) ; and NH Asian adults 57.3% (46.6-67.3) . Screening based on the 2021 USPSTF criteria will detect approximately 60% of US adults with dysglycemia, which was similar across ethnic groups. Disclosure M.J.O'brien: None. K.M.Bullard: None. Y.Zhang: n/a. S.Bailey: Consultant; Lundbeck, Luto, Pfizer Inc., Sanofi, Research Support; Eli Lilly and Company, Gordon and Betty Moore Foundation, Lundbeck, Merck & Co., Inc., Pfizer Inc., Retirement Research Foundation for Aging. S.Khan: None. R.T.Ackermann: Consultant; UnitedHealth Group. M.K.Ali: Advisory Panel; Bayer AG, Research Support; Merck & Co., Inc. S.R.Benoit: None. G.Imperatore: None. C.S.Holliday: None.

Diabetes is an ongoing public health issue in the USA, and, despite progress, recent reports suggest acute and chronic diabetes complications are increasing.The Natural Experiments for Translation in Diabetes 3.0 (NEXT-D3) Network is a 5-year research collaboration involving six academic centers (Harvard University, Northwestern University, Oregon HealthScience University, Tulane University, University of California Los Angeles, and University of California San Francisco) and two funding agencies (Centers for Disease Control and Prevention and National Institutes of Health) to address the gaps leading to persisting diabetes burdens. The network builds on previously funded networks, expanding to include type 2 diabetes (T2D) prevention and an emphasis on health equity. NEXT-D3 researchers use rigorous natural experiment study designs to evaluate impacts of naturally occurring programs and policies, with a focus on diabetes-related outcomes. NEXT-D3 projects address whether and to what extent federal or state legislative policies and health plan innovations affect T2D risk and diabetes treatment and outcomes in the USA; real-world effects of increased access to health insurance under the Affordable Care Act; and the effectiveness of interventions that reduce barriers to medication access (e.g., decreased or eliminated cost sharing for cardiometabolic medications and new medications such as SGLT-2 inhibitors for Medicaid patients). Overarching goals include (1) expanding generalizable knowledge about policies and programs to manage or prevent T2D and educate decision-makers and organizations and (2) generating evidence to guide the development of health equity goals to reduce disparities in T2D-related risk factors, treatment, and complications.

In 1984, the U.S. Preventive Services Task Force (USPSTF) was founded to create evidence-based recommendations guiding the use of diverse preventive services, including screening tests, behavioral interventions, and medications. Recommendations from this independent expert group are widely followed, and in some cases have produced substantial changes in clinical practice. One example, prostate cancer screening with prostate-specific antigen, was routinely performed among middle-aged and elderly men for decades until the USPSTF 2012 recommendation against this practice.1 Like prostate cancer, many diseases that are the subject of their preventive service recommendations disproportionately affect racial/ethnic minorities. This highlights a unique opportunity for USPSTF’s recommendations to reduce health disparities. The USPSTF follows a rigorous, transparent, and dynamic process for reviewing existing evidence and developing its recommendations.2 Using commissioned systematic literature reviews, the USPSTF considers the quality of evidence supporting each preventive service, and the magnitude of net benefit from implementing it. These reviews assess the certainty of the existing evidence, in addition to the magnitude of benefits and harms associated with the service. This process is intended to “maximize population health benefits while minimizing harms.”3 Weighing the potential impacts of preventive service recommendations from a population perspective may help achieve the greatest benefit for the largest number of Americans. However, some subpopulations may derive more benefit or experience greater harm from certain preventive services. If there is insufficient evidence to recommend a preventive service in the entire population, it is unlikely that the same service will benefit high-risk groups such as racial/ethnic minorities. However, it is possible that racial/ethnic differences in benefits and harms of recommended services or differential implementation of those services by race/ethnicity could widen health disparities in some groups. The USPSTF currently addresses high-risk subgroups in several ways.4 Most recommendations target specific groups defined by a limited number of risk factors, such as individuals’ age, sex, and specific exposures like smoking. The USPSTF also targets high-risk subgroups defined by numerous risk factors that are captured in multivariate risk models, like the 2016 statin recommendation,5 which require a calculation to determine eligibility. Although some risk models include race/ethnicity, none of the current USPTSF recommendations use race/ethnicity as a deciding factor.

Multidisciplinary transitional care services reduce readmissions for high-risk patients, but it is unclear if health system costs to offer these intensive services are offset by avoidance of higher downstream expenditures.To evaluate net costs for a health system offering transitional care services DESIGN: One-year pragmatic, randomized trial PARTICIPANTS: Adults aged ≥ 18 without a usual source of follow-up care at the time of hospital discharge were enrolled through a high-volume, urban academic medical center in Chicago, IL, USA, from September 2015 through February 2016.Eligible patients were silently randomized before discharge by an automated electronic health record algorithm allocating them in a 1:3 ratio to receive routine coordination of post-discharge care (RC) versus being offered intensive, multidisciplinary transitional care (TC) services.Health system costs were collected from facility administrative systems and transformed to standardized costs using Medicare reference files. Multivariable generalized linear models estimated proportional differences in net costs over one year.Study patients (489 TC; 164 RC) had a mean age of 44 years; 34% were uninsured, 55% had public insurance, and 49% self-identified as Black or Latinx. Over 90 days, cost differences between groups were not statistically significant. Over 180 days, the TC group had 41% lower ED/observation costs (adjusted cost ratio [aCR], 0.59; 95% CI, 0.36-0.97), 50% lower inpatient costs (aCR, 0.50; 95% CI, 0.27-0.95), and 41% lower total healthcare costs (aCR, 0.59; 95% CI, 0.36-0.99) than the RC group. Over 365 days, total cost differences remained of similar magnitude but no longer were statistically significant.Offering TC services for vulnerable adults at discharge reduced net health system expenditures over 180 days. The promising economic case for multidisciplinary transitional care interventions warrants further research.National Clinical Trials Registry (NCT03066492).

Increased moderate and vigorous physical activity (MVPA) is associated with better health outcomes in breast cancer survivors; yet, most are insufficiently active. Smartphone applications (apps) to promote MVPA have high scalability potential, but few evidence-based apps exist. The purpose is to describe the testing and usability of Fit2Thrive, a MVPA promotion app for breast cancer survivors. A user-centered, iterative design process was utilized on three independent groups of participants. Two groups of breast cancer survivors (group 1 n = 8; group 2: n = 14) performed app usability field testing by interacting with the app for ≥3 days in a free-living environment. App refinements occurred following each field test. The Post-Study System Usability Questionnaire (PSSUQ) and the User Version Mobile Application Rating Scale (uMARS) assessed app usability and quality on a 7- and 5-point scale, respectively, and women provided qualitative written feedback. A third group (n = 15) rated potential app notification content. Quantitative data were analyzed using descriptive statistics. Qualitative data were analyzed using a directed content analysis. The PSSUQ app usability score (M1= 3.8; SD = 1.4 vs. M2= 3.2; SD = 1.1; lower scores are better) and uMARS app quality score (M1 = 3.4; SD = 1.3 vs. M2= 3.4; SD = 0.6; higher scores are better) appeared to improve in Field Test 2. Group 1 participants identified app “clunkiness,” whereas group 2 participants identified issues with error messaging/functionality. Group 3 “liked” 53% of the self-monitoring, 71% of the entry reminder, 60% of the motivational, and 70% of the goal accomplishment notifications. Breast cancer survivors indicated that the Fit2Thrive app was acceptable and participants were able to use the app. Future work will test the efficacy of this app to increase MVPA.

Summary This pilot trial studied a novel intervention that integrated diabetes technologies into team-based primary care for type 2 diabetes. We found clinically significant reductions in blood pressure, weight, and glucose. The latter two were statistically significant.

Background Patient-reported outcomes—symptoms, treatment side effects, and health-related quality of life—are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients’ symptom monitoring, shared decision-making, and effective use of the health care system. Objective The objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes. Methods Co-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized. Results The dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective. Conclusions This protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems. International Registered Report Identifier (IRRID) DERR1-10.2196/38461

Design of a pragmatic trial requires planning of key components (cohort identification, participant recruitment, consent and enrollment, intervention delivery, and outcomes measurements). The delivery of healthcare was significantly disrupted by COVID-19;this also affected research. We applied health services and outcomes research (HSOR) methods to inform design adaptations of trial components. The trial is an intervention to improve self-care of patients with diabetes mellitus (DM), discharged from the hospital on insulin. Key informant interviews, clinical observations (N=5), patient tracers (N=5), and operational data were gathered from health system stakeholders (N=9), clinicians (N=20), and measurement experts (N=2). Table 1 describes the trial components, HSOR approaches, data sources, and results. A cohort identification algorithm was created using enterprise data warehouse (EDW) data and validated by chart review, and 3 clinical care process maps were produced. Multiple options for each trial component, allowing for flexibility should care disruptions occur, were identified and pretested (N=5). HSOR approaches are effective to rapidly adapt trial design components, even during healthcare delivery disruptions that threaten research. Application of these approaches should be considered as a strategy to design resilient, flexible, and effective pragmatic trials.

Purpose The purpose of this study was to examine the development and preliminary effectiveness of a novel Prediabetes Decision Aid on adoption of intensive lifestyle interventions (ILIs) and metformin. Little research has focused on increasing uptake of these evidence-based treatments, especially among non-English speakers and those with low educational attainment. Methods Investigators developed an English and Spanish decision aid displaying information about type 2 diabetes (T2DM) risk and treatments to prevent T2DM and prompting patients to identify next steps for management. This pilot study was a single-arm, pretest-posttest trial of 40 adult patients with prediabetes, obesity, and ≥1 office visit within the prior 12 months. Participants reviewed this tool briefly with a study team member, and data were collected on 3 coprimary outcomes: knowledge about T2DM risk, decisional conflict, and intention to adopt treatment. Exploratory outcomes included subsequent documentation of prediabetes in chart notes and adoption of ILIs or metformin. Results Almost all participants were women, with nearly half expressing Spanish language preference and low educational attainment. A nonsignificant increase in knowledge was observed across all subgroups. Decisional conflict was significantly reduced from pretest to posttest and was similar between subgroups defined by language preference and educational attainment. While intention to adopt ILIs increased across all subgroups, this change was only significant among Spanish speakers and participants with low educational attainment. At 6 months, 17 participants had subsequent provider documentation of prediabetes, and 12 adopted ILIs or metformin. Conclusions The decision aid improved patient-reported outcomes and promoted treatment adoption in a diverse patient sample.

PURPOSE: Despite the benefits of physical activity for breast cancer survivors, the majority remain insufficiently active. Mobile health (mHealth) physical activity interventions may be a more scalable strategy to increase activity among survivors. However, little is known about their preferences for mHealth intervention features. This study explored survivors’ preferences for these features. METHODS: Survivors [N=96; M(age)= 55.8 (SD=10.2)] self-reported demographic and disease characteristics, physical activity. A subset (n=28) completed a semi-structured phone interview. Transcribed interviews were evaluated using a thematic content analysis approach and consensus review. Following interviews, the full sample self-reported interests and preferences for intervention features via online questionnaires. Quantitative data were analyzed using descriptive statistics. RESULTS: Five themes emerged from interview data: (1) importance of relevance to breast cancer survivors; (2) easy to use; (3) integration with wearable activity trackers; (4) provide sense of accomplishment and (5) variability in desired level of structure and personalization. The highest ranked intervention features were: daily and weekly progress feedback (87.5%), newsfeed (86.6%), activity challenges (81.3%) and scheduling tool (79.2%). Survivors were interested in receiving progress feedback (80.2%), motivational (78.1%) and reminder (75.0%) messages. CONCLUSIONS: Breast cancer survivors are interested in mHealth physical activity promotion interventions but preferences varied around themes of relevance, ease of use, and enhancing personal motivation. IMPLICATIONS FOR CANCER SURVIVORS: Engaging survivors in developing and implementing remotely-delivered, mHealth activity promotion interventions may enhance their effectiveness.

Objectives To examine differences in health care costs associated with choice of second-line antidiabetes medication (ADM) for commercially insured adults with type 2 diabetes. Study design Retrospective cohort study with multiple pretests and posttests. Methods Included patients initiated second-line ADM therapy between 2011 and 2015, with variable follow-up through 2017. The 6 index medication classes were sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), basal insulin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and thiazolidinediones (TZDs). Multivariable regression models compared between-class changes in adjusted quarterly costs after second-line ADM initiation. Results The study cohort included 34,963 adults. Most were prescribed a sulfonylurea (46.0%) or DPP-4 inhibitor (30.4%). Adjusted quarterly index medication costs were significantly higher for all patients receiving nonsulfonylurea medications, ranging from $108 (95% CI, $99-$118) for TZDs to $742 (95% CI, $720-$765) for GLP-1 RAs. Changes in quarterly total health care costs were significantly higher for all nonsulfonylurea classes. Conversely, changes in quarterly nonpharmacy medical costs were significantly lower for patients receiving DPP-4 inhibitors (-$67; 95% CI, -$92 to -$43), GLP-1 RAs (-$43; 95% CI, -$85 to -$1), and SGLT-2 inhibitors (-$46; 95% CI, -$87 to -$6); changes in all other quarterly costs besides the index medication were significantly lower for patients receiving DPP-4 inhibitors (-$60; 95% CI, -$94 to -$26) and SGLT-2 inhibitors (-$113; 95% CI, -$169 to -$57). Conclusions The higher cost of nonsulfonylurea medications was the main driver of relative increases in total costs. Relative decreases in nonpharmacy medical costs among patients receiving newer ADM classes reflect these medications' potential value.

Objective: This study used real-world data to describe treatment patterns in second-line antidiabetic medication (ADM) regimen (Sulfonylureas, DPP-4 inhibitors, GLP-1 RAs, SGLT2 inhibitors, or TZDs) over a fixed 12 month follow-up period. Methods: Medical and pharmacy claims were used to identify adult commercial and Medicare Advantage Part D health plan enrollees with T2DM initiating second-line ADMs between 2013-2016. The primary outcome was the first pharmacy claim indicating a change in regimen: switch to a new ADM class; treatment discontinuation (gap ≥30 days); or intensification (≥doubling of dose, adding a new ADM class, or switching to/adding insulin). Patients were classified as adherent if no change was observed. Results: Of 73,290 study subjects with 2LADM, 53% were Sulfonylurea, 26% were DPP-4, 7% were GLP-1 RA, 9% SGLT2, and 5% TZD. Changes in treatment within 1 year were observed for over 70% of all patients (Table). There was little switching, about 50% discontinued their 2LADM with the highest rate of discontinuation among those receiving GLP-1 RAs and lowest among those receiving TZDs. About 20% of patients intensified medication regimen. Discussion: The very high rate of observed treatment changes, in particular discontinuation, may indicate that patients face multiple barriers to treatment adherence. Real-world studies can inform patient-centered treatment selection. Disclosure S. Pasricha: None. M. Cherupally: None. E. Koep: Employee; Self; UnitedHealth Group. R.T. Ackermann: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, UnitedHealth Group. C. Aikman: None. A.J. Cooper: None. M. O’Brien: Research Support; Self; UnitedHealth Group. A. Wallia: Research Support; Self; Eli Lilly and Company, Novo Nordisk Inc., UnitedHealth Group. D.T. Liss: None. E.D. Parker: None. Funding UnitedHealth Services (SP0036847)

Sulfonylureas (SFU) and basal insulin (BI) are to be used with caution in older adults due to safety risk (eg hypoglycemia). Using 2013-2017 data from a national insurer, we studied 84,720 Medicare Advantage adults ≥ 65 years (yrs) who started one of six antidiabetic medication (ADM) classes after metformin monotherapy. Outcomes were new start of SFU (vs. GLP-1 receptor agonists [GLP-1], SGLT2 inhibitors [SGLT2], thiazolidinediones [TZD], DPP-4 inhibitors [DPP-4]); or BI (vs. GLP-1, SGLT2, TZD, DPP-4). Multivariable logistic regression models examined associations between prescriber and patient characteristics (demographics, cognitive impairment [none, mild and severe], and diabetes related complications [diabetes complications severity index, DSCI score]). Most older adults received SFU followed by DPP-4, while few received GLP-1 and SGLT2 (SFU N=45,734 [54%], DPP-4 N=15,790 [19%], BI N=12,165 [14%], GLP-1 N=3,298 [4%], SGLT2 N=3,365 [4%], and TZD N=4,368 [5%]). Older subcategories of adults were increasingly more likely to receive SFU than those 65-67 yrs (70-74 yrs, OR1.08, 1.04-1.12; 75-79 yrs OR1.2, 1.13-1.25; ≥80 yrs OR1.35, 1.27-1.42). No differences in SFU use were seen in those with cognitive impairment and minority groups. For those receiving BI, females (vs. male OR 1.10, 1.05-1.15) and blacks (vs. whites OR1.26, 1.17-1.15) were more likely to receive BI. Those with severe cognitive impairment (vs. none OR1.98, 1.75-2.24) and high DSCI score (3+) (vs. 0 OR1.40, 1.31-1.50) were more likely to receive BI. Older subcategories of adults were less likely to receive insulin than 65-67 yrs of age (68-70 yrs, OR0.83, 0.77-0.89; 70-74 yrs, OR0.85, 0.80-0.90; 75-79 yrs OR0.93, 0.87-0.99). Older subcategories of adults were increasingly more likely to receive SFU; younger, cognitively impaired and those with diabetes complications were more likely to receive basal BI. Further research is needed to elucidate factors underlying differences in SFU and BI prescribing patterns. Disclosure K.E. DeCarlo: None. M. O’Brien: Research Support; Self; UnitedHealth Group. D.T. Liss: None. R. Kang: Research Support; Self; UnitedHealth Group. A.J. Cooper: None. M. Cherupally: None. E.D. Parker: None. C. Aikman: None. R.T. Ackermann: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, UnitedHealth Group. A. Wallia: Research Support; Self; Eli Lilly and Company, Novo Nordisk Inc., UnitedHealth Group. Funding UnitedHealth Group (SP0036847)

Intensive lifestyle interventions targeting diet and physical activity are recommended for reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. However, existing interventions often do not reach immigrant populations because of a mismatch between the social, cultural, and environmental context of immigrants and Western bio behavioral models which underpin evidence-based lifestyle interventions. The South Asian Healthy Lifestyle Intervention (SAHELI) study is a type 1 hybrid design randomized controlled trial aimed at reducing ASCVD risk in South Asian Americans, a group at higher ASCVD risk than whites and other Asian Americans. The objective is to evaluate the clinical effectiveness and implementation potential of a community-based, culturally-adapted lifestyle intervention for South Asian adults. Participants (n = 550) will be randomized to printed healthy lifestyle education materials or SAHELI, a group-based lifestyle change program that includes weekly classes for 16 weeks and 4 booster classes though month 11. SAHELI integrates evidence-based behavior change strategies with culturally-adapted strategies and group motivational interviewing to improve diet, physical activity, and stress management. Follow-up assessments will occur at 6 and 12 months. We hypothesize that the SAHELI intervention group will have greater improvements in clinical ASCVD risk factors (weight, blood pressure, glycated hemoglobin, and lipids), physical activity, and psychosocial outcomes than the print material group at 6- and 12- months. We will use mixed-methods to examine SAHELI's potential for reach, adoption, implementation, and maintenance from the perspective of multiple stakeholders. This study offers the potential to increase the reach and effectiveness of evidence-based lifestyle interventions for South Asian adults at increased risk for ASCVD.

Type 2 diabetes is common, burdensome, and preventable. Landmark trials such as the Diabetes Prevention Program (DPP) demonstrated that resource–intensive lifestyle support interventions resulting in modest weight loss via healthy diet changes and physical activity can lower the rate of diabetes development by 58%. We performed a review of efforts to translate and implement DPP-like programs throughout the USA to identify challenges and opportunities for improvement. For more than a decade, multiple stakeholders have worked to translate evidence-based principles of diabetes prevention to reach 84 million Americans with prediabetes. DPP-like programs have been delivered by over 1500 organizations, reaching almost 300,000 people, but this number represents less than 1% of the target population. Research has uncovered large gaps in efforts to diagnose, raise awareness, and provide access to DPP-like programs for adults with prediabetes, requiring further stakeholder engagement and coordination to resolve. Efforts to address prevailing gaps in diabetes prevention must address distinct and sometimes conflicting priorities and concerns of stakeholders. Our review recommends several areas of further research and action to improve type 2 diabetes prevention on a population scale.

More than 80 million Americans are living today with a high risk for developing type 2 diabetes in the near future. This poses a considerable threat to population health, sparing no segment of our society and disproportionately affecting the poor, the aged, and racial and ethnic minorities. Though unhealthy diets and physical inactivity have been linked to increases in obesity and type 2 diabetes, these behaviors are driven less by individual decisions than by an existing social and physical environment where unhealthy behaviors have become more normative, enjoyable to most people, and easier to perform than healthier alternatives. Policy solutions designed to shift this environment have been slow to take hold, creating a missed opportunity for many people who will develop diabetes in the short term. Strong research has demonstrated the effectiveness of resource-intensive lifestyle support interventions to prevent or delay diabetes for people who participate. Unfortunately, only a small percentage of people at high risk for diabetes are currently taking part in such a program, despite their increasing availability in the community or via the Internet. A “complete” solution for type 2 diabetes prevention on a population scale will require multipronged approaches that combine efforts to increase the adoption of resource-intensive lifestyle support programs, along with longer-range, “macro-level” strategies such as policy, systems, and environmental changes. This chapter will review what is currently known about the prevention of type 2 diabetes, including the role of behavioral intervention programs combined with more “macro-level” solutions to achieve this goal.

Fit2Thrive is a theory-guided physical activity promotion trial using the Multiphase Optimization Strategy (MOST) to test efficacy for improving physical activity of five technology-supported physical activity promotion intervention components among breast cancer survivors. This trial will recruit 256 inactive breast cancer survivors nationwide. All participants will receive the core intervention which includes a Fitbit and standard self-monitoring Fit2Thrive smartphone application which will be downloaded to their personal phone. Women will be randomized to one of 32 conditions in a factorial design involving five factors with two levels: support calls (No vs. Yes), app type (standard vs. deluxe), text messaging (No vs. Yes), online gym (No vs. Yes) and Fitbit Buddy (No vs. Yes). The proposed trial examines the effects of the components on physical activity at 12 and 24 weeks. Results will support the selection of a final package of intervention components that has been optimized to maximize physical activity and is subject to an upper limit of cost. The optimized intervention will be tested in a future trial. Fit2Thrive is the first trial to use the MOST framework to develop and test a physical activity promotion intervention in breast cancer survivors and will lead to an improved understanding of how to effectively change survivors’ physical activity. These findings could result in more scalable, effective physical activity interventions for breast cancer survivors, and, ultimately, improve health and disease outcomes.

Introduction Although the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes. Study design RCT. Setting/participants Ninety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m 2 , and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013–2015 and analyzed in 2016. Intervention The 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers ( promotoras ) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care. Main outcome measures Weight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months. Results ILI participants demonstrated significantly greater mean weight loss (–4.0 kg, 5.0%) than metformin (–0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) ( p p =0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care ( p =0.063). Conclusions In the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.

This article summarizes outcomes of the behavioral interventions work group for the Veterans Health Administration (VHA) State of the Art Conference (SOTA) for Weight Management. Sixteen VHA and non-VHA subject matter experts, representing clinical care delivery, research, and policy arenas, participated. The work group reviewed current evidence of efficacy, effectiveness, and implementation of behavioral interventions for weight management, participated in phone- and online-based consensus processes, generated key questions to address gaps, and attended an in-person conference in March 2016. The work group agreed that there is strong evidence for efficacy and effectiveness of core behavioral intervention components and processes, but insufficient evidence to determine the comparative effectiveness of multiple clinician-delivered weight management modalities, as well as technologies that may or may not supplement clinician-delivered treatments. Effective strategies for implementation of weight management services in VHA were identified. The SOTA work group’s foremost policy recommendations are to establish a system-wide culture for weight management and to identify a population-level health metric to measure the impact of weight management interventions that can be tracked and clearly communicated throughout VHA. The work group’s top research recommendation is to determine how to deploy and scale the most effective behavioral weight management interventions for Veterans.

Healthcare systems are challenged by steady increases in the number of patients who are overweight and obese. Large-scale, evidence-based behavioral approaches for addressing overweight and obesity have been successfully implemented in systems such as the Veterans Health Administration (VHA). These population-based interventions target reduction in risk for obesity-associated conditions through lifestyle change and weight loss, and are associated with modest weight loss. Despite the fact that VHA has increased the overall reach of these behavioral interventions, the number of high-risk overweight and obese patients continues to rise. Recommendations for weight loss medications and bariatric surgery are included in clinical practice guidelines for the management of overweight and obesity, but these interventions are underutilized. During a recent state of the art conference on weight management held by VHA, subject matter experts identified challenges and gaps, as well as potential solutions and overarching policy recommendations, for implementing an integrated system-wide approach for improving population-based weight management.

OBJECTIVE Lifestyle interventions slow development of type 2 diabetes by half, but the impact of health payer reimbursement for delivery of intervention programs is not well known. We evaluated net commercial health payer expenditures when offering reimbursement for access to YMCA’s Diabetes Prevention Program (YDPP) in 42 states. RESEARCH DESIGN AND METHODS We used a nonequivalent comparison group design to evaluate net health care expenditures for adults with prediabetes who attended one or more YDPP visit between 1 July 2009 and 31 May 2013 (“YDPP users”). Rolling, 1:1 nearest neighbor propensity score (PS) matching was used to identify a comparison group of nonusers. Administrative data provided measures of YDPP attendance, body weight at YDPP visits, and health care expenditures. Random effects, difference-in-difference regression was used to estimate quarterly health care expenditures before and after participants’ first visit to YDPP. RESULTS Worksite screening identified 9.7% of the target population; 39.1% of those identified (19,933 participants through June 2015) became YDPP users. Mean weight loss for YDPP users enrolled before June 2013 (n = 1,725) was 7.5 lb (3.4%); 29% achieved ≥5% weight loss. Inclusive of added costs to offer YDPP, there were no statistically significant differences in mean per-person net health care expenditures between YDPP users and PS-matched nonusers over 2 years ($0.2 lower [95% CI $56 lower to $56 higher]). Mean reimbursement to the YMCA was $212 per YDPP user, with 92.8% of all expenditures made for those who attended at a high rate (≥9 completed YDPP visits). CONCLUSIONS Worksite screening was inefficient for identifying the population with prediabetes, but those identified achieved modest YDPP attendance and clinically meaningful weight loss. Over 2 years, added costs to offer the intervention were modest, with neutral effects on net health care costs.

PURPOSE OF REVIEW: To advance our understanding of the impacts of policies and programs aimed at improving detection, engagement, prevention, and clinical diabetes management in the United States, we synthesized findings from a network of studies that used natural experiments to evaluate diabetes health policies and programs FINDINGS: Studies 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. SUMMARY: Findings from NEXT-D studies provide informative data that can guide programs and policies to facilitate detection, prevention, and treatment of diabetes in practice.

Background: Moderate weight loss and physical activity (PA) can prevent or delay type 2 diabetes however there is a need for innovative, effective programs to promote PA in high-risk individuals. Purpose: We examined the effect of a group-based adaption of the DPP lifestyle intervention implemented in partnership with the YMCA (YDPP) on changes in moderate-vigorous physical activity (MVPA) in economically disadvantaged adults with prediabetes. The effects of psychosocial and community-level factors were explored. Methods: Participants were randomly assigned to YDPP or brief counseling. Accelerometer data from 216 participants were used to identify: 1) change in MVPA and 2) sedentary behavior over 24 months. Results: YDPP had no significant effect on either outcome. Baseline PA and crime were associated with less MVPA while higher perceived health and green space were associated with more MVPA over time. Baseline sedentary behavior, perceived health, and green space were inversely related to being sedentar...

Objectives. We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention. Methods. Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons. Results. In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone. Conclusions. The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.

PURPOSE OF REVIEW: Evidence-based treatments for prediabetes can prevent and delay the development of type 2 diabetes in adults. In this review, we propose a framework for population-based diabetes prevention that links screening and prevention activities across key stakeholders. We also discuss gaps in current practice, while highlighting opportunities to improve diabetes screening and prevention efforts population-wide. RECENT FINDINGS: Awareness of diabetes risk is low, and many adults with prediabetes are not identified through existing screening efforts. Accumulating evidence and policies support expansion of the Diabetes Prevention Program (DPP) into clinical and community settings. However, the infrastructure to facilitate referrals and promote data exchange among patients, clinical settings, and community-based DPP programs is lacking. SUMMARY: Development of evidence-driven, scalable processes for assessing diabetes risk, screening eligible adults, and delivering preventive treatments are needed to effectively improve the glycemic health of the US adult population.

This retrospective cohort study compared the effectiveness of six antidiabetic medication (ADM) classes on major adverse cardiovascular events. Using nationwide U.S. administrative claims data from 2011-2015, we studied 132,737 insured adults with type 2 diabetes who started one of six ADM after taking metformin alone or no prior ADM. The key exposure was the new ADM class, which was filled ≥2 times. The composite primary outcome included hospitalization for one of the following conditions: heart failure, stroke, ischemic heart disease, and peripheral artery disease. Eligibility criteria and outcomes were ascertained using claims data. We used Cox regression to model the association between new ADM class and composite cardiovascular events, adjusting for baseline characteristics of patients, including prior use of metformin and cardiovascular medications, as well as prescribers and health plans. DPP-4 inhibitors (DPP-4) were the comparator given evidence of their cardiovascular neutrality. Overall, 5.5% of patients had a history of prior cardiovascular disease. There were 3,603 cardiovascular events during a mean follow-up of 1.3 years. Compared to DPP-4, the adjusted hazard ratios for each ADM class were: [sulfonylureas (SFU): HR 1.36, 95% CI: 1.23-1.49; basal insulin: HR 2.03, 1.81-2.27; thiazolidinediones (TZD): HR 0.89, 0.73-1.08; SGLT2 inhibitors (SGLT2): HR 0.80, 0.56-1.14; and GLP-1 receptor agonists (GLP-1): HR 0.78, 0.63-0.96]. The GLP-1 benefit was not robust across alternate modeling approaches. Among low-risk patients with type 2 diabetes, we found higher cardiovascular risk associated with SFU and basal insulin compared to newer ADM classes. Cardiovascular outcomes associated with DPP-4, GLP-1, and SGLT2 were similar in this population. Providers may consider prescribing these newer drugs routinely after metformin. Future clinical trials and data describing total costs of care will further inform providers’ choice of second-line ADM. Disclosure M. O'Brien: None. S.L. Karam: Research Support; Self; United Healthcare Services. A. Wallia: Research Support; Self; UnitedHealth Group. Consultant; Self; Glytec Systems, Lexicon Pharmaceuticals, Inc.. Research Support; Self; Eli Lilly and Company. R. Kang: Research Support; Self; UnitedHealth Group. A.J. Cooper: Research Support; Self; UnitedHealth Group. N. Lancki: Research Support; Self; United Healthcare Services. M.R. Moran: Research Support; Self; United Healthcare Services. D.T. Liss: Research Support; Self; United Healthcare Services. T.A. Prospect: Employee; Self; UnitedHealth Group. R.T. Ackermann: Consultant; Self; UnitedHealth Group.

BACKGROUND: There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations. OBJECTIVE: Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients’ medical and psychosocial needs following hospital discharge. DESIGN: Pragmatic, randomized comparative effectiveness trial. PATIENTS: Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care. INTERVENTIONS: TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients’ medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred. MAIN MEASURES: The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days. KEY RESULTS: Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74–1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43–0.91) and 180 days (RR 0.65; 95% CI 0.47–0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37–0.90). CONCLUSIONS: Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT03066492.

Aims To estimate the real-world effects of offering a group-based lifestyle intervention (GLI) to adults with diabetes. Methods This randomized encouragement trial included adult primary care patients in metropolitan Chicago with type 2 diabetes and body mass index ≥24 kg/m2. Participants were randomized to standard care (brief dietary and lifestyle counseling) or standard care plus being encouraged, but not required, to participate in a free-of-charge GLI offered by the YMCA. The GLI was a group-based adaptation of the Look AHEAD lifestyle intervention. Results Of 331 participants, 167 were randomized to standard care and 164 to the GLI encouragement arm. About one third of participants were non-Hispanic White (34.4%). In the GLI arm, 75 (45.7%) attended ≥1 GLI visits. In the primary intention-to-treat analysis, the effect of GLI encouragement was 0.95% weight loss at six months (95% confidence interval [CI], 0.13–1.77%; P = 0.02), and 1.20% weight loss at 12 months (95% CI, 0.05–2.36%; P = 0.04). At 12 months, there was a 0.30% (3.3 mmol/mol) reduction in hemoglobin A1c, but this result did not achieve statistical significance (P = 0.054). In instrumental variable analysis estimating effects among the subgroup of participants who attended any GLI visits, the effect of GLI attendance was 2.30% weight loss at six months (95% CI, 0.30–4.30%; P = 0.02), and 2.07% weight loss at 12 months (95% CI, 0.25–3.88%; P = 0.02). We detected no significant blood pressure or cholesterol effects. Conclusions Among adults with type 2 diabetes, a group-based lifestyle intervention in a community-based setting achieved modest weight loss at 6 and 12 months. Clinical trial registration: ClinicalTrials.gov Identifier NCT01435603.

Objective Educational attainment is inversely associated with type 2 diabetes risk, but it is unknown whether education impacts individuals' diabetes prevention efforts. We examined the comparative efficacy of intensive lifestyle intervention and metformin by educational attainment among participants in the Diabetes Prevention Program (DPP), an ongoing U.S. multi-site trial beginning in 1996. Methods We studied 2,910 DPP participants randomized to receive lifestyle intervention, metformin, or placebo. Stratifying by educational attainment, diabetes incidence and relative risk reductions by treatment assignment were estimated using Cox proportional hazards regression. Results 47% of participants had completed college and 53% had not. Compared to placebo, lifestyle participants who had completed college demonstrated a 68% reduction in diabetes incidence (95% CI = 56, 77), whereas those with less education experienced a 47% risk reduction (95% CI = 29, 61). For metformin participants, college graduates experienced a 49% relative risk reduction (95% CI = 33, 62), compared to 23% (95% CI = 1, 41) among those with lower educational attainment. There was a statistically significant education-by-treatment interaction with incident diabetes (p = 0.03). Conclusions Intensive lifestyle intervention and metformin have greater efficacy among highly educated individuals. Future efforts to deliver these treatments and study their dissemination may be more effective if tailored to individuals' educational background.

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.

Women with gestational diabetes (GDM) have a fivefold higher risk of developing type 2 diabetes (T2DM). Furthermore, Hispanic and African-American women are disproportionately affected by GDM, but their views on prevention of T2DM after gestational diabetes are largely unknown. We conducted semi-structured interviews with 23 women (8 Hispanic, 8 African-American, 7 non-Hispanic White) from two academic clinics in Chicago, IL. Interview questions elicited perspectives on prevention of T2DM; the interview protocol was developed based on the Health Belief Model. Two investigators applied template analysis to identify emergent themes. Women conceptualized risk for T2DM based on family history, health behaviors, and personal history of GDM. A subgroup of women expressed uncertainty about how GDM influences risk for T2DM. Women who described a strong link between GDM and T2DM often viewed the diagnosis as a cue to action for behavior change. T2DM was widely viewed as a severe condition, and desire to avoid T2DM was an important motivator for behavior change. Children represented both a key motivator and critical barrier to behavior change. Women viewed preventive care as important to alert them to potential health concerns. Identified themes were congruent across racial/ethnic groups. Diagnosis with GDM presents a potent opportunity for engaging women in behavior change. To fully harness the potential influence of this diagnosis, healthcare providers should more clearly link the diagnosis of GDM with risk for future T2DM, leverage women's focus on their children to motivate behavior change, and provide support with behavior change during healthcare visits in the postpartum period and beyond.