An Electronic Health Record Compatible Model to Predict Personalized Treatment Effects from the Diabetes Prevention Program: A Cross-Evidence Synthesis Approach Using Clinical Trial and Real World Data

Objective: Implement in an electronic health record (EHR) a predictive model for people with prediabetes that provides individualized benefit estimates for taking metformin or participating in the Diabetes Prevention Program (DPP). This model stratifies people with prediabetes by the potential to reduce their risk of progression to diabetes based on regression models developed directly on the DPP trial and recalibrated to Optum data. With 1/3 of adults having prediabetes, health systems need a way to prioritize. Study Design: Pre/post implementation study including provider and patient surveys and data on use of the predictive model. The model estimates risk of progression to diabetes with usual care, the DPP, or metformin, based on 11 demographic, biometric and diagnosis variables available in the EHR. Population Studied: Patients with prediabetes at 10 pilot primary care clinics, where providers access the model via an EHR click and the data elements are automatically populated from the EHR. Principal Findings: The predictive model was used on 68% (n=2,304) of patients with prediabetes between 5/1/18 and 1/31/19. A total of 43% of patients were classified as high-risk, 54% as moderate-risk, and 4% as low-risk. Treatment - either referrals to the DPP or prescriptions for metformin - was provided for 63% of high-risk, 15% of moderate-risk, and 4% of low-risk patients. DPP referrals and metformin prescriptions for these high-risk patients increased substantially after implementation of the calculator (DPP: 0% to 44%; Metformin: 2% to 19%). Conclusions: A predictive model, embedded in the EHR, that predicts individual patient risk for developing diabetes at the point of care improved treatment for patients with prediabetes. Use of individualized risk estimates resulted in the prioritization of treatment for patients at greatest risk of developing type 2 diabetes. Disclosure E.L. Ciemins: None. J.E. Powelson: None. J.P. Nelson: None. F.R. Colangelo: None. J.K. Cuddeback: None. D.M. Kent: None. Funding Patient-Centered Outcomes Research Institute

Rates of participation in community-based diabetes prevention programs (DPPs) are low among patients with prediabetes. This may be due, in part, to low rates of referrals to these programs from health systems. One key opportunity to augment clinicians' referrals to and patients' participation in DPPs may be through electronic health record referrals (eReferrals). We undertook a quality improvement initiative in a large, academic health system. Using the EpicCare Link feature of Epic (Epic Systems Corporation), we created an eReferral to local community-based DPPs. Eligibility criteria required that patients have an age of at least 18 years, a body mass index of at least 25 kg/m2, and prediabetes or a history of gestational diabetes. We conducted a retrospective evaluation of implementation outcomes from June 1, 2021 to June 30, 2022 using the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) evaluation framework. During the evaluation period, 577 patients were referred to DPPs and 21% enrolled, defined as attending an information session and registering for a program. Thirty percent of 350 targeted primary care clinicians used the eReferral across 14 primary care clinics. Among all 124 referring clinicians, referral rates varied widely with a range of 1 to 46 referrals per clinician; 11% of referring clinicians contributed more than 50% of all referral orders. The large majority of referred patients (73% to 81%) met DPP eReferral eligibility criteria. An eReferral is a promising, scalable strategy to connect patients with prediabetes to community DPPs. Additional strategies are needed to enhance clinicians' use of the eReferral and patients' subsequent program engagement to fully optimize the reach and effectiveness of DPPs.

BackgroundMany Diabetes Prevention Program (DPP) translation efforts have been less effective for underresourced populations. In the cluster-randomized Prediabetes Informed Decision and Education (PRIDE) trial, which evaluated a shared decision-making (SDM) intervention for diabetes prevention, Hispanic and non-Hispanic Black participants lost less weight than non-Hispanic White participants at 12-month follow-up.ObjectiveTo explore perspectives about weight loss from PRIDE participants of different racial and ethnic groups.ParticipantsSample of participants with prediabetes who were randomized to the PRIDE intervention arm (n=24).ApproachWe conducted semi-structured interviews within three groups stratified by DPP participation and % weight loss at 12 months: (DPP+/WL+, enrolled in DPP and lost >5% weight; DPP+/WL−, enrolled in DPP and lost <3% weight; DPP−/WL−, did not enroll in DPP and lost <3% weight). Each group was further subdivided on race and ethnicity (non-Hispanic Black (NHB), non-Hispanic White (NHW), Hispanic). Interviews were conducted on Zoom and transcripts were coded and analyzed with Dedoose.Key ResultsCompared to NHW participants, Hispanic and NHB participants more often endorsed weight loss barriers of limited time to make lifestyle changes due to long work and commute hours, inconvenient DPP class locations and offerings, and limited disposable income for extra weight loss activities. Conversely, facilitators of weight loss regardless of race and ethnicity included retirement or having flexible work schedules; being able to identify convenient DPP classes; having a strong, positive support system; and purchasing supplementary resources to support lifestyle change (e.g., gym memberships, one-on-one activity classes).ConclusionsWe found that NHB and Hispanic SDM participants report certain barriers to weight loss more commonly than NHW participants, particularly barriers related to limited disposable income and/or time constraints. Our findings suggest that increased lifestyle change support and flexible program delivery options may be needed to ensure equity in DPP reach, participant engagement, and outcomes.

OBJECTIVES/GOALS: Many economic evaluations rely on clinical trial data that may not represent real world populations and intervention effectiveness. We compare risk and cost-effectiveness for the Diabetes Prevention Program (DPP) clinical trial cohort and a real world population eligible for the national DPP to assess the impact of using real world data. METHODS/STUDY POPULATION: To produce real world (US population) representative results, we identified National Health and Nutrition Examination Survey (NHANES) subjects eligible for the national DPP and adjusted projections using survey weights. We used clinical predictive models to estimate individual diabetes risk, and microsimulation to estimate lifetime costs, benefits, and net monetary benefits (NMB) for lifestyle intervention and metformin. We compared results across the DPP clinical trial and NHANES populations. RESULTS/ANTICIPATED RESULTS: Three-year risk of diabetes onset for the DPP trial population (mean of 19.7%, median of 10.3%) exceeded corresponding risk for the NHANES population (mean of 14.6%, median of 4.8%). The proportion of individuals with a three-year diabetes risk < 10% for the DPP trial population (49%) was less than the corresponding proportion for NHANES (67%). Mean NMB for metformin for the DPP trial population ($9,749) exceeded the corresponding value for NHANES ($5,391). The proportion of subjects with negative NMB was 49% for the DPP trial population and 67% for NHANES. Lifestyle intervention had a mean NMB of $34,889 for the DPP trial population and $28,652 for NHANES. Only 20% of the NHANES population eligible for national DPP met inclusion/exclusion criteria for the DPP trial. DISCUSSION/SIGNIFICANCE: Real world populations eligible for the national DPP include a greater proportion of low-risk individuals, and for these people, prevention programs may confer smaller benefits. Technology assessments based on clinical trial data should be revised using real world population and treatment effect data.

The community pharmacy setting for diabetes prevention: A mixed methods study in people with 'pre-diabetes'.

Background:Incidence and prevalence of type 2 diabetes are one of the major challenges of Iran health system. Despite policies on diabetes prevention and control, Iran is faced with many problems in prevention and control of this disease at the executive level. This study seeks to identify the problems of Type 2 diabetes prevention and control program in Iran.Methods:In this qualitative study, 17 participants were interviewed purposefully. The semi-structured interview guide was designed based on literature review and four initial in-depth interviews. Framework analysis method was used for the analysis of qualitative data.Results:Six themes and 29 subthemes explaining the problems of type 2 diabetes prevention and control program were identified: Referral system, human resources, infrastructure, cultural problems, access, and intersectoral coordination issues.Conclusions:Despite the well-developed policy of type 2 diabetes prevention and control, the implementation is faced with some problems which endangers the effectiveness of the plan. Any attempt to improve the successful implementation of the type 2 diabetes prevention and control program requires effective measures, deep understanding of the problems and solving them.

The purpose of this study was to describe the process of implementing a diabetes prevention program provided by homecare nurses to residents of public housing communities. A cluster randomization pilot study was conducted comparing enhanced standard care (2 interactive classes on diabetes prevention) to a diabetes prevention program (7 interactive classes and behavioral support). The sample (n = 67) was primarily female (79%), nonwhite (76%), unpartnered (83%), with a mean age of 40 years, and an average of 3 children. Mixed methods were used to evaluate the implementation process. Data were collected on attendance, attrition, and protocol implementation. Interviews were conducted with nurses and community health workers who assisted with program implementation. Homecare nurses were able to implement a diabetes prevention program in public housing communities, with a protocol implementation of 83% across classes and groups. Attendance was suboptimal with 60% for the enhanced standard care group and 54% for the diabetes prevention group. Nurses and community health workers were resourceful and positive about program implementation. Linking existing resources, such as a homecare agency with a public housing community, is one approach to disseminate diabetes prevention programs.

ObjectivesAlthough lifestyle modification programs are widely implemented for diabetes prevention, the contributions of individual lifestyle factors remain unclear. This study investigated lifestyle risk factors for prediabetes and employed a regression-based approach for estimating their population-attributable fractions (PAFs) using nationally representative data.MethodsWe analyzed data from 3104 adults aged ≥30 years without diabetes from the 2022 Korea National Health and Nutrition Examination Survey. Seven lifestyle factors were assessed: body weight, alcohol consumption, smoking, physical activity, sleep duration, vegetable intake, and breakfast consumption. Prediabetes was defined as fasting blood glucose of 100–125 mg/dL or hemoglobin A1c levels of 5.7–6.4%. Complex survey-adjusted logistic regression was used to identify significant lifestyle risk factors, and their PAFs were estimated using a regression-based sequential method.ResultsFive lifestyle factors were significantly associated with prediabetes: abnormal body weight (odds ratio [OR], 2.05; 95% confidence interval [CI], 1.68 to 2.50), excessive alcohol consumption (OR, 1.27; 95% CI, 1.00 to 1.62), smoking (OR, 1.35; 95% CI, 1.07 to 1.71), insufficient exercise (OR, 1.26; 95% CI, 1.05 to 1.51), and irregular breakfast consumption (OR, 1.31; 95% CI, 1.08 to 1.59). In sequential PAF estimation, abnormal body weight had the largest contribution (22.2%; 95% CI, 16.2 to 28.2), followed by smoking (6.4%; 95% CI, 1.1 to 11.6), insufficient exercise (5.8%; 95% CI, 1.2 to 10.5), irregular breakfast consumption (4.9%; 95% CI, 0.5 to 9.2), and excessive alcohol consumption (3.6%; 95% CI, 0.1 to 7.4). These results remained consistent in sensitivity analyses including undiagnosed diabetes cases.ConclusionsAbnormal body weight emerged as the largest contributor to prediabetes (PAF>20%). Diabetes prevention programs in Korea should prioritize weight management within a comprehensive approach to lifestyle modification.

The researchers conducted this study to test the hypothesis that risk of type 2 diabetes is less following reductions in body size and central adiposity. The Diabetes Prevention Program (DPP) recruited and randomized individuals with impaired glucose tolerance to treatment with placebo, metformin, or lifestyle modification. Height, weight, waist circumference, and subcutaneous and visceral fat at L2-L3 and L4-L5 by computed tomography were measured at baseline and at 1 year. Cox proportional hazards models assessed by sex the effect of change in these variables over the 1st year of intervention upon development of diabetes over subsequent follow-up in a subset of 758 participants. Lifestyle reduced visceral fat at L2-L3 (men -24.3%, women -18.2%) and at L4-L5 (men -22.4%, women -17.8%), subcutaneous fat at L2-L3 (men -15.7%, women -11.4%) and at L4-L5 (men -16.7%, women -11.9%), weight (men -8.2%, women -7.8%), BMI (men -8.2%, women -7.8%), and waist circumference (men -7.5%, women -6.1%). Metformin reduced weight (-2.9%) and BMI (-2.9%) in men and subcutaneous fat (-3.6% at L2-L3 and -4.7% at L4-L5), weight (-3.3%), BMI (-3.3%), and waist circumference (-2.8%) in women. Decreased diabetes risk by lifestyle intervention was associated with reductions of body weight, BMI, and central body fat distribution after adjustment for age and self-reported ethnicity. Reduced diabetes risk with lifestyle intervention may have been through effects upon both overall body fat and central body fat but with metformin appeared to be independent of body fat.

BackgroundUrinary tract infections (UTIs) are common in women but most epidemiology studies occurred in specialized settings (university health clinics) or used outdated methods (random digit dialing). Currently, women receive UTI care in systems with electronic health records (EHR), thus documenting care of a wider female demographic in real-world settings. We estimated the prevalence of acute, uncomplicated UTIs in community-dwelling women in a health claims database using various operational definitions of UTI.MethodsWe conducted a retrospective analysis of claims data from the OptumLabs® Data Warehouse (OLDW), a de-identified claims and clinical information repository for privately insured and Medicare Advantage enrollees in a large, private US health plan. Non-pregnant female patients ≥ 15 years of age with two years of continuous enrollment between 2007-2015 and a visit encounter in an outpatient office, urgent care, or emergency department were included. Women with lower urinary tract disease/abnormalities, neurological disease, urological treatment, procedures or urinary catheter use, cancer or HIV treatment were excluded. Decision rules for identifying UTIs were derived using one or more combinations of: relevant ICD-9 codes, UTI symptom diagnosis codes, positive urine test results, and/or antibiotic prescription recorded in the EHR and claims. Prevalence rates were calculated for each decision rule.ResultsOf the 7,337,700 females in the claims database, 947,041 (12.97%) had an index UTI diagnosis or symptoms and met eligibility criteria. The table below illustrates prevalence rates according to each decision rule. As shown, applying decision rules based on common UTI definitions resulted in large differences in prevalence rates.TableConclusionUsing common definitions for UTI to analyze claims data from an insurer of large proportions of the US, we obtained significantly different prevalence rates. This study highlights major limitations in using EHR and claims data for UTI quality initiatives such as tracking of practices associated with antimicrobial stewardship and lends credibility to proposals to track these infections as a reportable disease.DisclosuresAll Authors: No reported disclosures

IntroductionObesity has reached epidemic proportions in children and adolescents in the United States. Children’s behaviors are strongly influenced by parental behaviors, and weight loss in parents is positively associated with weight changes in their overweight/obese children. Research is limited on how parents’ National Diabetes Prevention Program (DPP) participation affects the health outcomes of their dependent children. Analyzing the impact of parental DPP participation on weight loss in their dependent children may provide valuable insight into an important secondary benefit of DPP participation.MethodsIn this study, we identified 128 adults with prediabetes who were offered the opportunity to participate in a DPP (n = 54 DPP participants and n = 74 DPP non-participants) and who had at least one child 3 to 17 years of age living with them. Age and BMI percentile for dependent children were collected from insurance claims data for 203 children (n = 90 children of DPP participants and n = 113 children of DPP non-participants). Parental practices related to diet and physical activity were assessed by surveys.ResultsThere were no significant changes in BMI percentiles of overweight or obese children (i.e. BMI percentile ≥ 50%) of DPP participants vs DPP non-participants with prediabetes over one-year. Parents who enrolled and did not enroll in the DPP did not report differences in their parenting practices related to diet and physical activity.DiscussionThese results are not consistent with the literature that suggests parent-based interventions may influence their children’s weight trajectories. Limitations include small sample size, short time span of intervention, and limited availability of additional health/biographic data on dependent children. Future studies should collect primary outcome data on children, investigate whether there is a minimum duration of parental involvement and level of parental adherence, and assess the effect of parent–child dynamics on child weight trajectories.

BackgroundThe prevalence of diabetes is increasing rapidly. Previous research has demonstrated the efficacy of a diabetes prevention program (DPP) in lifestyle modifications that can prevent or delay the onset of type 2 diabetes among individuals at risk. Digital DPPs have the potential to use technology, in conjunction with behavior change science, to prevent prediabetes on a national and global scale.ObjectiveThe aim of this study is to investigate the effects of a digital DPP (Virgin Pulse [VP] Transform for Prediabetes) on weight and physical activity among participants who had completed 12 months of the program.MethodsThis study was a secondary analysis of retrospective data of adults with prediabetes who were enrolled in VP Transform for Prediabetes for 12 months of the program. The program incorporates interactive mobile computing, remote monitoring, an evidence-based curriculum, behavior tracking tools, health coaching, and online peer support to prevent or delay the onset of type 2 diabetes.ResultsThe sample (N=1095) was comprised of people with prediabetes who completed at least 9 months of the VP Transform for Prediabetes program. Participants were 67.7% (n=741) female, with a mean age of 53.6 (SD 9.75) years. After 12 months, participants decreased their weight by an average of 10.9 lbs (5.5%; P<.001) and increased their physical activity by 91.2 (P<.001) minutes.ConclusionsThese results suggest that VP Transform for Prediabetes is effective at preventing type 2 diabetes through a significant reduction in body weight and increase of physical activity. Furthermore, these results suggest that the DPP remains effective 12 months after beginning the program. A prospective randomized controlled clinical study is warranted to validate these findings.

Introduction Type 2 diabetes (T2D) is a chronic condition linked to obesity that affects millions of people within England. Behaviour change interventions implemented worldwide targeting weight loss have been effective in preventing T2D. In response to this, the NHS Diabetes Prevention Programme (NHS-DPP) was introduced in 2016, and was the first initiative in England to implement a diabetes prevention programme at scale. The current study investigates service users’ experiences of attending in-person sessions of the NHS-DPP when the programme was first rolled out. Methods Semi-structured interviews were conducted with service users (n = 20) after they completed the programme. Interviews were transcribed verbatim and analysed using a framework approach to thematic analysis. Results Three themes were produced. Mindset Shift: whilst the participants did not always maintain their behaviour changes, they experienced a change in mindset towards T2D and their current behaviours. Content tailoring: the participants described how the lack of content tailoring towards culture and the starting weight of participants within the programme negatively impacted their experiences. Social experiences: participants reported that the programme’s group format and wider social support from their friends and family were important for engaging with and maintaining behaviour change. Discussion The current study identifies how diabetes prevention programmes can promote behaviour changes and mindset shifts to support diabetes prevention. However, greater content tailoring, particularly concerning culturally informed food preferences and encouraging social support for participants, may improve the long-term effectiveness and engagement of diabetes prevention programmes.

BackgroundDigital diabetes prevention programs (digital-DPPs) are being implemented as population-based approaches to type 2 diabetes mellitus prevention in several countries to address problems with the uptake of traditional face-to-face diabetes prevention programs. However, assessments of digital-DPPs have largely focused on clinical outcomes and usability among those who have taken them up, whereas crucial information on decision-making about uptake (eg, whether a user downloads and registers on an app) and engagement (eg, the extent of use of an app or its components over time) is limited. Greater understanding of factors that influence uptake and engagement decisions may support large-scale deployments of digital-DPPs in real-world settings.ObjectiveThis study aimed to explore the key influences on uptake and engagement decisions of individuals who were offered the National Health Service Healthier You: Digital Diabetes Prevention Programme (NHS-digital-DPP).MethodsA qualitative interview study was conducted using semistructured interviews. Participants were adults, aged ≥18 years, diagnosed with nondiabetic hyperglycemia, and those who had been offered the NHS-digital-DPP. Recruitment was conducted via 4 providers of the NHS-digital-DPP and 3 primary care practices in England. Interviews were conducted remotely and were guided by a theoretically informed topic guide. Analysis of interviews was conducted using an inductive thematic analysis approach.ResultsInterviews were conducted with 32 participants who had either accepted or declined the NHS-digital-DPP. In total, 7 overarching themes were identified as important factors in both decisions to take up and to engage with the NHS-digital-DPP. These were knowledge and understanding, referral process, self-efficacy, self-identity, motivation and support, advantages of digital service, and reflexive monitoring. Perceptions of accessibility and convenience of the NHS-digital-DPP were particularly important for uptake, and barriers in terms of the referral process and health care professionals’ engagement were reported. Specific digital features including health coaches and monitoring tools were important for engagement.ConclusionsThis study adds to the literature on factors that influence the uptake of and engagement with digital-DPPs and suggests that digital-DPPs can overcome many barriers to the uptake of face-to-face diabetes prevention programs in supporting lifestyle changes aimed at diabetes prevention.

Implementing a Low-Calorie diet to Enhance weight loss in the diabetes Prevention Program during a humanitarian Crisis: A pilot pragmatic randomized trial in Venezuela.