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BACKGROUND/OBJECTIVES: This protocol describes a study to investigate the feasibility and preliminary efficacy of a novel Teaching Kitchen Multisite Trial (TK-MT) for adults with cardiometabolic abnormalities. The TK-MT protocol describes a hybrid lifestyle intervention combining in-person and virtual instruction in culinary skills, nutrition education, movement, and mindfulness with community support and behavior change strategies. This 18-month-long randomized controlled trial aims to evaluate the feasibility of implementing a 12-month, 24 class program, assess preliminary study efficacy, and identify barriers and facilitators to implementation. METHODS: The intervention program includes 16 weeks of intensive hands-on culinary and lifestyle education classes followed by eight monthly virtual classes. Psychometric assessments and biometric data will be collected at baseline, 4, 12, and 18 months. Semi-structured interviews and open-ended surveys will be conducted during the 12-month follow-up assessment. RESULTS: Feasibility will be assessed through recruitment, attendance, and fidelity data. Secondary outcomes will analyze changes in health behaviors, biometric data, and anthropometric measures using mixed-effects regression models. Qualitative data will undergo thematic analysis. CONCLUSIONS: As envisioned and described in detail in this manuscript, this study will inform the development and implementation of reproducible, scalable teaching kitchen interventions. The protocol described here is intended to set the stage for future investigations to evaluate evidence for the impact of teaching kitchen interventions on dietary habits, physical activity, and overall health and well-being.

OBJECTIVES: The US Preventive Services Task Force recommends screening of adults aged 35-70 with a body mass index ≥25 kg/m2 for type 2 diabetes and referral of individuals who screen positive for pre-diabetes to evidence-based prevention strategies. The diabetes burden in the USA is predicted to triple by 2060 necessitating strategic diabetes prevention efforts, particularly in areas of highest need. This study aimed to identify pre-diabetes hotspots using geospatial mapping to inform targeted diabetes prevention strategies. A hotspot is defined as a cluster of 3 or more neighbouring census tracts with elevated pre-diabetes prevalence. DESIGN: A cross-sectional study using ArcGIS software to geospatially map pre-diabetes prevalence hotspots. We used health system and census data to identify pre-diabetes hotspots using a systematic five-step geoprocessing approach that made use of incremental spatial autocorrelation and Getis-Ord Gi*. SETTING: This study was set in Kaiser Permanente Northern California (KPNC), an integrated health delivery system with over four million members. PARTICIPANTS: KPNC adults ages 35-70 who underwent a haemoglobin A1c (HbA1c) or fasting plasma glucose (FPG) screening test in 2019 were mapped to census tracts in Northern California. People were considered to have pre-diabetes with an HbA1c of 5.7%-6.4% (39-46 mmol/mol) or FPG 100-125 mg/dL. PRIMARY AND SECONDARY OUTCOME MEASURES: Individual and census-level characteristics were compared between hotspots and non-hotspots using χ2 and Wilcoxon rank sum tests, as well as risk differences (RDs) and Hodges-Lehmann (HL) estimates of location shift. Individual-level characteristics were derived from electronic health records and administrative data, while census-level characteristics were derived from the 2019 American Community Survey. RESULTS: A total of 760 044 adults met the study inclusion criteria and 40% had pre-diabetes. Individuals in pre-diabetes hotspots were less likely to be non-Hispanic white (33.6% vs 50.6%, RD: -17.04%, 95% CI -17.26% to -16.81%, p

INTRODUCTION: The University of California (UC) implemented the Diabetes Prevention Program (DPP) to address diabetes and obesity risk. This project examined the reach and effectiveness of this university-based DPP delivery approach. METHODS: This project compared 12-month weight change among three groups of UC beneficiaries with overweight/obesity: (1) those who received invitation letters and enrolled in UC DPP, (2) those mailed invitation letters but did not enroll, and (3) those who were not mailed letters and did not enroll (controls). Using 2012-2022 EHR, administrative and DPP cohort data, an interrupted time series was conducted in 2022-2023 to compare group differences in rate of weight change. RESULTS: Among 6,231 beneficiaries (132 UC DPP aware enrollees, 1,750 DPP aware non-enrollees, 4,349 controls), UC DPP enrollees were older (mean age 49), mostly women (76%), and more diverse (33% Asian, 8% Black, 20% Hispanic, 4% Multi/Other). Over 12 months of follow-up, UC DPP enrollee postenrollment rate of weight loss was -0.68 lbs./month. UC DPP enrollees had significantly greater weight change from pre- to post-enrollment than DPP aware non-enrollees (adjusted Δ-1.02 vs. Δ-0.07 lbs./month, difference= -0.95, p

OBJECTIVE: We sought to evaluate the risk of preterm labor and hypertensive disorders in adolescent pregnancies with and without diabetes. METHODS: We evaluated 1,843,139 adolescents (≤20 years old) with labor and delivery admissions in the national Kids Inpatient Database (KID) in years 2006, 2009, 2012, 2016, and 2019. International classification of disease codes was used to identify diabetes and medical factors affecting pregnancy. Weighted logistic regression was used to evaluate the association between diabetes and complications. RESULTS: Among admissions, 0.2% had type 1 diabetes (T1D), 0.2% had type 2 diabetes (T2D), and 0.7% had gestational diabetes (GDM); 10.1% of admissions were complicated by hypertensive disorders and 5.8% by preterm labor. Compared to adolescents without diabetes, those with diabetes had a higher prevalence of hypertensive disorders (T1D: 35.4%, T2D: 37.8%, GDM: 24.9%, None: 9.9%; p

BackgroundGestational diabetes mellitus (GDM) is a risk factor for the development of type 2 diabetes. Metformin and lifestyle change through a Diabetes Prevention Program (DPP) are equally effective in preventing diabetes in patients with a GDM history, so women can choose a strategy based on their preferences. This study aims to test whether shared decision making (SDM) can help women with a history of GDM increase adoption of evidence-based strategies and lose weight to lower their risk of incident diabetes in real-world settings.MethodsThis pragmatic randomized controlled trial (RCT) will test the effectiveness of SDM for diabetes prevention among 310 overweight/obese women with a history of GDM and prediabetes from two large health care systems (n = 155 from UCLA Health and n = 155 from Intermountain Healthcare). The primary outcome is the proportion of participants who lose ≥5% body weight at 12 months. Secondary outcomes include uptake of DPP and/or metformin and other patient-reported outcomes such as patient activation and health-related quality of life. Rates of GDM in a subsequent pregnancy will be an exploratory outcome. A descriptive analysis of costs related to SDM implementation will also be conducted.ConclusionThis is the first RCT to examine the effectiveness of SDM on weight loss, lifestyle change and/or metformin use, and other patient-reported outcomes in participants with a GDM history at risk of developing diabetes.Trial registrationClinicalTrials.gov, NCT03766256. Registered on 6 December 2018.

IntroductionWhile the Diabetes Prevention Program Study demonstrated that intensive lifestyle change and metformin both reduce type 2 diabetes incidence, there are little data on patient preferences in real-world, clinical settings.MethodsThe Prediabetes Informed Decisions and Education (PRIDE) study was a cluster-randomized trial of shared decision making (SDM) for diabetes prevention. In PRIDE, pharmacists engaged patients with prediabetes in SDM using a decision aid with information about both evidence-based options. We recorded which diabetes prevention option(s) participants chose after the SDM visit. We also evaluated logistic regression models examining predictors of choosing intensive lifestyle change ± metformin, compared to metformin or usual care, and predictors of choosing metformin ± intensive lifestyle change, compared to intensive lifestyle change or usual care.ResultsAmong PRIDE participants (n = 515), 55% chose intensive lifestyle change, 8.5% chose metformin, 15% chose both options, and 21.6% declined both options. Women (odds ratio [OR] = 1.60, P = 0.023) had higher odds than men of choosing intensive lifestyle change. Patients >60 years old (OR = 0.50, P = 0.028) had lower odds than patients

BackgroundPatient activation is associated with better outcomes in chronic conditions.ObjectiveWe evaluated the psychometric properties of the 12-item Altarum Consumer Engagement™ Measure (ACE-12) in patients with prediabetes.ParticipantsACE-12 was administered to patients in the Prediabetes Informed Decisions and Education Study.Main measuresWe conducted an exploratory factor analysis followed by confirmatory factor analytic models. We evaluated item response categories using item characteristic curves. Construct validity was assessed by examining correlations of the ACE-12 scales with education, depressive symptoms, self-rated health, hemoglobin A1c, body mass index, and weight loss.Key resultsParticipants (n = 515) had a median age of 58; 56% were female; 17% Hispanic; 54% were non-White. The scree plot and Tucker and Lewis reliability coefficient (0.95) suggested three factors similar to the original scales. One item loaded on the navigation rather than the informed choice scale. Ordinal alpha coefficients for the original scales were commitment (0.75); informed choice (0.71); and navigation (0.54). ICCs indicated that one or more of the response categories for 5 of the 12 items were never most likely to be selected. Patients with lower education were less activated on the commitment (r = - 0.124, p = 0.004), choice (r = - 0.085, p = 0.009), and overall score (r = - 0.042, p = 0.011). Patients with depressive symptoms had lower commitment (r = - 0.313, p ≤ 0.001) and overall scores (r = - 0.172, p = 0.012). Patients with poorer health scored lower on the Commitment (r = - 0.308, p ≤ 0.001), Navigation (r = - 0.137, p ≤ 0.001), and overall score (r = - 0.279, p ≤ 0.001).ConclusionThe analyses provide some support for the psychometric properties of the ACE-12 in prediabetic patients. Future research evaluating this tool among patients with other chronic conditions are needed to determine whether Q1 (I spend a lot of time learning about health) should remain in the informed choice or be included in the navigation scale. Additional items may be needed to yield acceptable reliability for the navigation scale.

Prediabetes affects one-third of U.S. adults. Lifestyle change interventions, such as the Diabetes Prevention Program (DPP), can significantly lower type 2 diabetes risk, but little is known about how the DPP could be best adapted for women. This mixed-methods study assessed the impact of gender-tailoring and modality choice on DPP engagement among women Veterans with prediabetes. Participants were offered women-only groups and either in-person/peer-led or online modalities. Implementation outcomes were assessed using attendance logs, recruitment calls, and semi-structured interviews about patient preferences. Between June 2016 and March 2017, 119 women Veterans enrolled in the DPP (n = 51 in-person, n = 68 online). We conducted 22 interviews between August and September 2016 (n = 10 early-implementation) and March and July 2017 (n = 12 follow-up). Most interviewees preferred women-only groups, citing increased comfort, camaraderie, and mutual understanding of gender-specific barriers to lifestyle change. More women preferred online DPP, and those using this modality participated at higher rates. Most endorsed the importance of modality choice and were satisfied with their selection; however, selection was frequently based on participants' personal circumstances and access barriers and not on a "preferred choice" of two equally accessible options. Patient engagement and program reach can be expanded by tailoring the DPP for population-specific needs.

BACKGROUND: Medical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations. OBJECTIVE: The objective of this study was to evaluate a care coordination program designed to provide combined whole-person care, integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants. RESEARCH DESIGN: Individual-level interrupted time series with a comparator group, using person-month as the unit of analysis. SUBJECTS: A total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare. MEASURES: Our outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcomes time trend after program enrollment. RESULTS: Overall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%). CONCLUSION: A care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

BACKGROUND/OBJECTIVES: Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices. RESEARCH DESIGN: Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible]. SUBJECTS/MEASURES: Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation. RESULTS: Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories. CONCLUSIONS: Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

Background/objectivesMedicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices.Research designInterrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible].Subjects/measuresEligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation.ResultsAnalyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories.ConclusionsMedicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

BackgroundMedical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations.ObjectiveThe objective of this study was to evaluate a care coordination program designed to provide combined "whole-person care," integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants.Research designIndividual-level interrupted time series with a comparator group, using person-month as the unit of analysis.SubjectsA total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare.MeasuresOur outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcome's time trend after program enrollment.ResultsOverall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%).ConclusionA care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

BackgroundChronic kidney disease (CKD) is a global public health problem, exhibiting sharp increases in incidence, prevalence, and attributable morbidity and mortality. There is a critical need to better understand the demographics, clinical characteristics, and key risk factors for CKD; and to develop platforms for testing novel interventions to improve modifiable risk factors, particularly for the CKD patients with a rapid decline in kidney function.MethodsWe describe a novel collaboration between two large healthcare systems (Providence St. Joseph Health and University of California, Los Angeles Health) supported by leadership from both institutions, which was created to develop harmonized cohorts of patients with CKD or those at increased risk for CKD (hypertension/HTN, diabetes/DM, pre-diabetes) from electronic health record data.ResultsThe combined repository of candidate records included more than 3.3 million patients with at least a single qualifying measure for CKD and/or at-risk for CKD. The CURE-CKD registry includes over 2.6 million patients with and/or at-risk for CKD identified by stricter guide-line based criteria using a combination of administrative encounter codes, physical examinations, laboratory values and medication use. Notably, data based on race/ethnicity and geography in part, will enable robust analyses to study traditionally disadvantaged or marginalized patients not typically included in clinical trials.DiscussionCURE-CKD project is a unique multidisciplinary collaboration between nephrologists, endocrinologists, primary care physicians with health services research skills, health economists, and those with expertise in statistics, bio-informatics and machine learning. The CURE-CKD registry uses curated observations from real-world settings across two large healthcare systems and has great potential to provide important contributions for healthcare and for improving clinical outcomes in patients with and at-risk for CKD.

ImportanceIntensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences.ObjectiveTo test the effectiveness of a prediabetes SDM intervention.DesignCluster randomized controlled trial.SettingTwenty primary care clinics within a large regional health system.ParticipantsOverweight/obese adults with prediabetes (BMI ≥ 24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics.InterventionIntervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care.Main outcomes and measuresPrimary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months.ResultsUptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p

ObjectiveTo investigate whether older veterans enrolled in two diabetes prevention programs (DPPs) in the Veterans Health Administration will have similar weight loss as younger veterans.Research design and methodsPost hoc analysis of data from two prospective, pragmatic, nonrandomized studies of behavioral weight management interventions that were delivered in-person (Department of Veterans Affairs [VA]-DPP) or online (Online-DPP), comparing participation and weight loss between participants aged ≥65 years (N = 120) vs. 0.05).ConclusionsDPPs delivered in person or online can be similarly effective in older and younger veterans. Online programs may be an important means to improve the reach of DPPs for older adults.

BackgroundEthnography has been proposed as a valuable method for understanding how implementation occurs within dynamic healthcare contexts, yet this method can be time-intensive and challenging to operationalize in pragmatic implementation. The current study describes an ethnographically-informed method of guided discussions developed for use by a multi-project national implementation program.MethodsThe EMPOWER QUERI is conducting three projects to implement innovative care models in VA women's health for high-priority health concerns - prediabetes, cardiovascular risk, and mental health - utilizing the Replicating Effective Programs (REP) implementation strategy enhanced with stakeholder engagement and complexity science. Drawing on tenets of ethnographic research, we developed a lightly-structured method of guided "periodic reflections" to aid in documenting implementation phenomena over time. Reflections are completed as 30-60 min telephone discussions with implementation team members at monthly or bi-monthly intervals, led by a member of the implementation core. Discussion notes are coded to reflect key domains of interest and emergent themes, and can be analyzed singly or in triangulation with other qualitative and quantitative assessments to inform evaluation and implementation activities.ResultsThirty structured reflections were completed across the three projects during a 15-month period spanning pre-implementation, implementation, and sustainment activities. Reflections provide detailed, near-real-time information on projects' dynamic implementation context, including characteristics of implementation settings and changes in the local or national environment, adaptations to the intervention and implementation plan, and implementation team sensemaking and learning. Reflections also provide an opportunity for implementation teams to engage in recurring reflection and problem-solving.ConclusionsTo implement new, complex interventions into dynamic organizations, we must better understand the implementation process as it unfolds in real time. Ethnography is well suited to this task, but few approaches exist to aid in integrating ethnographic insights into implementation research. Periodic reflections show potential as a straightforward and low-burden method for documenting events across the life cycle of an implementation effort. They offer an effective means for capturing information on context, unfolding process and sensemaking, unexpected events, and diverse viewpoints, illustrating their value for use as part of an ethnographically-minded implementation approach.Trial registrationThe two implementation research studies described in this article have been registered as required: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans (NCT02991534); and Implementation of Tailored Collaborative Care for Women Veterans (NCT02950961).

IntroductionOnline Diabetes Prevention Programs (DPPs) can be scaled up and delivered broadly. However, little is known about real-world effectiveness and how outcomes compare with in-person DPP. This study examined online DPP weight loss and participation outcomes and secondarily compared outcomes among participating individuals with parallel in-person interventions.Study designA large non-randomized trial supplemented by a comparative analysis of participating individuals from a concurrent trial of two parallel in-person programs: in-person DPP and the Veterans Administration's standard of care weight loss program (MOVE!).Setting/participantsObese/overweight Veterans with prediabetes enrolled in online DPP (n = 268) between 2013 and 2014. Similar eligibility criteria were used to enroll in-person participants between 2012 and 2014 (n = 273 in-person DPP, n = 114 MOVE!) within a separate trial.InterventionOnline DPP included a virtual group format, live e-coach, weekly modules delivered asynchronously, and wireless home scales. In-person programs included eight to 22 group-based, face-to-face sessions.Main outcomes measuresWeight change at 6 and 12 months using wirelessly uploaded home scale data or electronic medical record weights from clinical in-person visits. Outcomes were analyzed between 2015 and 2017.ResultsFrom 1,182 invitations, 268 (23%) participants enrolled in online DPP. Among these, 158 (56%) completed eight or more modules; mean weight change was -4.7kg at 6 months and -4.0kg at 12 months. In a supplemental analysis of participants completing one or more sessions/modules, online DPP participants were most likely to complete eight or more sessions/modules (87% online DPP vs 59% in-person DPP vs 55% MOVE!, p

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

ObjectivesMental illness may impact outcomes from structured behavioral weight loss interventions. This secondary analysis investigated the influence of mental health on weight loss among Veterans with prediabetes enrolled in either an in-person diabetes prevention program (DPP) or the usual care weight management program (MOVE!) designed to help patients achieve weight loss through changes in physical activity and diet.MethodsPrediabetes was defined by Hemoglobin A1c between 5.7 and 6.4% or Fasting Plasma Glucose 100-125 mg/dL and no use of antiglycemic medications during the past six months. Veterans Health Administrative data were used to assign Veterans into one of three mental health diagnoses: severe mental illness (SMI), affective disorder (AD) without SMI, or No SMI/No AD. The influence of mental health on weight changes at 6 and 12 months was modeled using linear mixed-effects regression.ResultsOn average, Veterans with prediabetes (n = 386) were 59 years old (SD = 10.0 years), with a BMI of 34.8 kg/m2 (SD = 5.3 kg/m2) and A1c of 6.0% (SD = 0.2%). The sample consisted of 12% (n = 47), 39% (n = 150), and 49% (n = 189) diagnosed with SMI, AD and No SMI/No AD, respectively. Across interventions, Veterans with SMI lost less weight than those with AD or No SMI/No AD. From baseline to 6 months, weight loss was significantly less for Veterans with SMI (1.53 kg) compared to Veterans with AD (3.85 kg) or No SMI/No AD (3.73 kg). This weight loss trend by mental health diagnosis continued from baseline to 12 months but was no longer statistically significant at 12 months.ConclusionWeight loss was not clinically or statistically different among Veterans with prediabetes diagnosed with AD or No SMI/No AD. However, Veterans diagnosed with SMI exhibited less weight loss over 6 months than Veterans with AD or No SMI/No AD and though not statistically significant, the trend continued to 12 months, suggesting that SMI may influence weight loss outcomes.

BackgroundThe Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA).MethodsA 12-month pragmatic clinical trial compared weight outcomes between the Veterans Affairs Diabetes Prevention Program (VA-DPP) and the usual care MOVE!® weight management program (MOVE!). Eligible participants had a body mass index (BMI) ≥30 kg/m2 (or BMI ≥ 25 kg/m2 with one obesity-related condition), prediabetes (glycosylated hemoglobin (HbA1c) 5.7-6.5% or fasting plasma glucose (FPG) 100-125 mg/dL), lived within 60 min of their VA site, and had not participated in a weight management program within the last year. Established evaluation and implementation frameworks were used to guide the implementation evaluation. Implementation barriers and facilitators, delivery fidelity, participant satisfaction, and implementation costs were assessed. Using micro-costing methods, costs for assessment of eligibility and scheduling and maintaining adherence per participant, as well as cost of delivery per session, were also assessed.ResultsSeveral barriers and facilitators to Reach, Adoption, Implementation, Effectiveness and Maintenance were identified; barriers related to Reach were the largest challenge encountered by site teams. Fidelity was higher for VA-DPP delivery compared to MOVE! for five of seven domains assessed. Participant satisfaction was high in both programs, but higher in VA-DPP for most items. Based on micro-costing methods, cost of assessment for eligibility was $68/individual assessed, cost of scheduling and maintaining adherence was $328/participant, and cost of delivery was $101/session.ConclusionsMulti-faceted strategies are needed to reach targeted participants and successfully implement DPP. Costs for assessing patients for eligibility need to be carefully considered while still maximizing reach to the targeted population.

BACKGROUND:The Enhancing Mental and Physical health of Women through Engagement and Retention or EMPOWER program represents a partnership with the US Department of Veterans Health Administration (VA) Health Service Research and Development investigators and the VA Office of Women's Health, National Center for Disease Prevention and Health Promotion, Primary Care-Mental Health Integration Program Office, Women's Mental Health Services, and the Office of Patient Centered Care and Cultural Transformation. EMPOWER includes three projects designed to improve women Veterans' engagement and retention in evidence-based care for high-priority health conditions, i.e., prediabetes, cardiovascular, and mental health. METHODS/DESIGN:The three proposed projects will be conducted in VA primary care clinics that serve women Veterans including general primary care and women's health clinics. The first project is a 1-year quality improvement project targeting diabetes prevention. Two multi-site research implementation studies will focus on cardiovascular risk prevention and collaborative care to address women Veterans' mental health treatment needs respectively. All projects will use the evidence-based Replicating Effective Programs (REP) implementation strategy, enhanced with multi-stakeholder engagement and complexity theory. Mixed methods implementation evaluations will focus on investigating primary implementation outcomes of adoption, acceptability, feasibility, and reach. Program-wide organizational-, provider-, and patient-level measures and tools will be utilized to enhance synergy, productivity, and impact. Both implementation research studies will use a non-randomized stepped wedge design. DISCUSSION:EMPOWER represents a coherent program of women's health implementation research and quality improvement that utilizes cross-project implementation strategies and evaluation methodology. The EMPOWER Quality Enhancement Research Initiative (QUERI) will constitute a major milestone for realizing women Veterans' engagement and empowerment in the VA system. EMPOWER QUERI will be conducted in close partnership with key VA operations partners, such as the VA Office of Women's Health, to disseminate and spread the programs nationally. TRIAL REGISTRATION:The two implementation research studies described in this protocol have been registered as required: Facilitating Cardiovascular Risk Screening and Risk Reduction in Women Veterans: Trial registration NCT02991534 , registered 9 December 2016. Implementation of Tailored Collaborative Care for Women Veterans: Trial registration NCT02950961 , registered 21 October 2016.

IntroductionThis clinical demonstration trial compared the effectiveness of the Veterans Affairs Diabetes Prevention Program (VA-DPP) with an evidence-based usual care weight management program (MOVE!®) in the Veterans Health Administration health system.DesignProspective, pragmatic, non-randomized comparative effectiveness study of two behavioral weight management interventions.Setting/participantsObese/overweight Veterans with prediabetes were recruited from three geographically diverse VA sites between 2012 and 2014.InterventionVA-DPP included 22 group-based intensive lifestyle change sessions.Main outcome measuresWeight change at 6 and 12 months, hemoglobin A1c (HbA1c) at 12 months, and VA health expenditure changes at 15 months were assessed using VA electronic health record and claims data. Between- and within-group comparisons for weight and HbA1c were done using linear mixed-effects models controlling for age, gender, race/ethnicity, baseline outcome values, and site. Analyses were conducted in 2015-2016.ResultsA total of 387 participants enrolled (273 VA-DPP, 114 MOVE!). More VA-DPP participants completed at least one (73.3% VA-DPP vs 57.5% MOVE! p=0.002); four (57.5% VA-DPP vs 42.5% MOVE!, p=0.007); and eight or more sessions (42.5% VA-DPP vs 31% MOVE!, p=0.035). Weight loss from baseline was significant at both 6 (p

ObjectiveSeveral barriers challenge resident engagement in learning quality improvement (QI). We investigated whether the incorporation of team-based game mechanics into an evidence-based online learning platform could increase resident participation in a QI curriculum.DesignRandomized, controlled trial.SettingTertiary-care medical center residency training programs.ParticipantsResident physicians (n = 422) from nine training programs (anesthesia, emergency medicine, family medicine, internal medicine, ophthalmology, orthopedics, pediatrics, psychiatry and general surgery) randomly allocated to a team competition environment (n = 200) or the control group (n = 222).InterventionSpecialty-based team assignment with leaderboards to foster competition, and alias assignment to de-identify individual participants.Main outcome measuresParticipation in online learning, as measured by percentage of questions attempted (primary outcome) and additional secondary measures of engagement (i.e. response time). Changes in participation measures over time between groups were assessed with a repeated measures ANOVA framework.ResultsResidents in the intervention arm demonstrated greater participation than the control group. The percentage of questions attempted at least once was greater in the competition group (79% [SD ± 32] versus control, 68% [SD ± 37], P= 0.03). Median response time was faster in the competition group (P= 0.006). Differences in participation continued to increase over the duration of the intervention, as measured by average response time and cumulative percent of questions attempted (each P< 0.001).ConclusionsTeam competition increases resident participation in an online course delivering QI content. Medical educators should consider game mechanics to optimize participation when designing learning experiences.

BackgroundThe Diabetes Prevention Program (DPP) study showed that lifestyle intervention resulted in a 58% reduction in incidence of type 2 diabetes among individuals with prediabetes. Additional large randomized controlled trials have confirmed these results, and long-term follow-up has shown sustained benefit 10-20 years after the interventions ended. Diabetes is a common and costly disease, especially among Veterans, and despite strong evidence supporting the feasibility of type 2 diabetes prevention, the DPP has not been widely implemented. The first aim of this study will evaluate implementation of the Veterans Affairs (VA) DPP in three VA medical centers. The second aim will assess weight and hemoglobin A1c (A1c) outcomes, and the third aim will determine the cost-effectiveness and budget impact of implementation of the VA DPP from a health system perspective.Methods/designThis partnered multi-site non-randomized systematic assignment study will use a highly pragmatic hybrid effectiveness-implementation type III mixed methods study design. The implementation and administration of the VA DPP will be funded by clinical operations while the evaluation of the VA DPP will be funded by research grants. Seven hundred twenty eligible Veterans will be systematically assigned to the VA DPP clinical demonstration or the usual care VA MOVE!® weight management program. A multi-phase formative evaluation of the VA DPP implementation will be conducted. A theoretical program change model will be used to guide the implementation process and assess applicability and feasibility of the DPP for VA. The Consolidated Framework for Implementation Research (CFIR) will be used to guide qualitative data collection, analysis, and interpretation of barriers and facilitators to implementation. The RE-AIM framework will be used to assess Reach, Effectiveness, Adoption, Implementation, and Maintenance of the VA DPP. Twelve-month weight and A1c change will be evaluated for the VA DPP compared to the VA MOVE!ProgramMediation analyses will be conducted to identify whether program design differences impact outcomes.DiscussionFindings from this pragmatic evaluation will be highly applicable to practitioners who are tasked with implementing the DPP in clinical settings. In addition, findings will determine the effectiveness and cost-effectiveness of the VA DPP in the Veteran population.

BackgroundReducing patient cost-sharing and engaging patients in disease management activities have been shown to increase uptake of evidence-based care.ObjectiveTo evaluate the effect of employer purchase of a disease-specific plan with reduced cost-sharing and disease management (the Diabetes Health Plan/DHP) on medication adherence among eligible employees and dependents.DesignEmployer-level "intent to treat" cohort study, including data from eligible employees and their dependents with diabetes, regardless of whether they were enrolled in the DHP.SettingEmployers that contracted with a large national health plan administrator in 2009, 2010, and/or 2011.ParticipantsTen employers that purchased the DHP and 191 employers that did not (controls). Inverse probability weighting (IPW) estimation was used to adjust for inter-group differences.InterventionThe DHP includes free or low-cost medications and physician visits. Enrollment strategies and specific benefit designs are determined by the employer and vary in practice. DHP participants are notified up front that they must engage in their own health care (e.g., receiving diabetes-related screening) in order to remain enrolled.Main outcome measureMean employee adherence to metformin, statins, and ACE/ARBs at the employer level at one year post-DHP implementation, as measured by the proportion of days covered (PDC).ResultsBaseline adherence to the three medications was similar across DHP and control employers, ranging from 64 to 69 %. In the first year after DHP implementation, predicted employer-level adherence for metformin (+4.9 percentage points, p = 0.017), statins (+4.8, p = 0.019), and ACE/ARBs (+4.4, p = 0.02) was higher with DHP purchase.LimitationsNon-randomized, observational study.ConclusionsThe Diabetes Health Plan, an innovative health plan that combines reduced cost-sharing and disease management with an up-front requirement of enrollee participation in his or her own health care, is associated with a modest improvement in medication adherence at 12 months.

BackgroundMany health programs struggle with low enrollment rates.ObjectivesTo compare the characteristics of populations enrolled in a new health plan when employer groups implement voluntary versus automatic enrollment approaches.Study designWe analyzed enrollment rates resulting from 2 different strategies: voluntary and automatic enrollment. We used regression modeling to estimate the associations of patient characteristics with the probability of enrolling within each strategy. The subjects were 5014 eligible employees from 11 self-insured employers who had purchased the Diabetes Health Plan (DHP), which offers free or discounted copayments for diabetes related medications, testing supplies, and physician visits. Six employers used voluntary enrollment while 5 used automatic enrollment. The main outcome of interest was enrollment into the DHP. Predictors were gender, age, race/ethnicity, dependent status, household income, education level, number of comorbidities, and employer group.ResultsOverall, the proportion of eligible members who were enrolled within the automatic enrollment strategy was 91%, compared with 35% for voluntary enrollment. Income was a significant predictor for voluntary enrollment but not for automatic enrollment. Within automatic enrollment, covered dependents, Hispanics, and persons with 1 nondiabetes comorbidity were more likely to enroll than other subgroups. Employer group was also a significant correlate of enrollment. Notably, all demographic groups had higher DHP enrollment rates under automatic enrollment than under voluntary enrollment.ConclusionsFor employer-based programs that struggle with low enrollment rates, especially among certain employee subgroups, an automatic enrollment strategy may not only increase the total number of enrollees but may also decrease some enrollment disparities.