Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (Anticoagulation with Enhanced Gastrointestinal Safety): a factorial randomized controlled pilot trial.

Background: Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants. Objectives: (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection and (2) assess intervention acceptability. Methods: Pragmatic 2 × 2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs usual care and (2) clinician notification vs clinician notification plus nurse facilitation was performed. The primary feasibility outcome was percentage of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semistructured interviews. Results: Among 47 eligible patients, 35/47 (74.5%; 95% CI, 58.6%-85.7%) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%; 95% CI, 16.9%-64.7%) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet's purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%; 95% CI, 26.4%-75.4%), which was lower for surgeons than nonsurgeons (22.7% vs 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable. Conclusion: The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.

Exploration of individual socioeconomic and health-related characteristics associated with human papillomavirus vaccination initiation and vaccination series completion among adult females: A comprehensive systematic evidence review with meta-analysis.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates among females are lower than the World Health Organization target and vaccination rates specifically among adult females are even much lower. METHODS: We systematically evaluated individual socioeconomic and health-related characteristics associated with HPV vaccination initiation and vaccination series completion among adult females (PROSPERO: CRD42023445721). We performed a literature search on December 14, 2022, and supplemented the search on August 1, 2023. We pooled appropriate multivariable-adjusted results using an inverse variance random-effects model and expressed the results as odds ratios with associated 95 % confidence intervals. A point pooled significantly increased/decreased odds of 30-69 % was regarded to be strongly associated, and ≥ 70 % was very strongly associated. RESULTS: We included 63 cross-sectional studies. There were strongly increased odds of vaccination initiation among White women compared with Black or Asian women, and those with higher education, health insurance, a history of sexually transmitted infection (STI), receipt of influenza vaccination in the preceding year, not married/cohabiting, not smoking, using contraception, and having visited a healthcare provider in the preceding year. We observed very strongly increased odds of vaccination initiation among those younger and having been born in the country of study. Similarly, there were strongly increased odds of completing the vaccination series for the same variables as initiating vaccination, except for higher education, prior STI, smoking and contraception use. Additional variables associated with strongly increased odds of vaccination series completion not seen in initiation were higher annual household income, being lesbian/bisexual, and having a primary care physician. We observed very strongly increased odds of vaccination series completion similar to vaccination initiation but including for White compared with Black women, higher education, and prior cervical cancer screening. CONCLUSIONS: These individual characteristics may be the key to identifying women at increased risk of not being vaccinated against HPV and could inform targeted messaging to drive HPV vaccination.

A Primary Care-Based Weight Navigation Program.

Importance: Evidence-based weight management treatments (WMTs) are underused; strategies are needed to increase WMT use and patients' weight loss. Objective: To evaluate the association of a primary care-based weight navigation program (WNP) with WMT use and weight loss. Design, Setting, and Participants: This cohort study comprised a retrospective evaluation of a quality improvement program conducted from October 1, 2020, to September 30, 2021. Data analysis was performed from August 2, 2022, to March 7, 2024. Adults with obesity and 1 or more weight-related condition from intervention and control sites in a large academic health system in the Midwestern US were propensity matched on sociodemographic and clinical factors. Exposure: WNP, in which American Board of Obesity Medicine-certified primary care physicians offered weight-focused visits and guided patients' selection of preference-sensitive WMTs. Main Outcomes and Measures: Primary outcomes were feasibility measures, including rates of referral to and engagement in the WNP. Secondary outcomes were mean weight loss, percentage of patients achieving 5% or more and 10% or more weight loss, referral to WMTs, and number of antiobesity medication prescriptions at 12 months. Results: Of 264 patients, 181 (68.6%) were female and mean (SD) age was 49.5 (13.0) years; there were no significant differences in demographic characteristics between WNP patients (n = 132) and matched controls (n = 132). Of 1159 WNP-eligible patients, 219 (18.9%) were referred to the WNP and 132 (11.4%) completed a visit. In a difference-in-differences analysis, WNP patients lost 4.9 kg more than matched controls (95% CI, 2.11-7.76; P < .001), had 4.4% greater weight loss (95% CI, 2.2%-6.4%; P < .001), and were more likely to achieve 5% or more weight loss (odds ratio [OR], 2.90; 95% CI, 1.54-5.58); average marginal effects, 21.2%; 95% CI, 8.8%-33.6%) and 10% or more weight loss (OR, 7.19; 95% CI, 2.55-25.9; average marginal effects, 17.4%; 95% CI, 8.7%-26.2%). Patients in the WNP group were referred at higher rates to WMTs, including bariatric surgery (18.9% vs 9.1%; P = .02), a low-calorie meal replacement program (16.7% vs 3.8%; P < .001), and a Mediterranean-style diet and activity program (10.6% vs 1.5%; P = .002). There were no between-group differences in antiobesity medication prescribing. Conclusions and Relevance: The findings of this cohort study suggest that WNP is feasible and associated with greater WMT use and weight loss than matched controls. The WNP warrants evaluation in a large-scale trial.

Assessment of Frailty Among Older Adults in the Physical Activity Daily Trial.

Frailty is common among cardiac patients; however, frailty assessment data from patients with peripheral arterial disease (PAD) are limited. The purpose of this observational study was to identify the prevalence and factors related to frailty in addition to unique frailty marker groupings in a cohort of sedentary adults with PAD. We grouped three PAD-relevant frailty characteristics using Fried's frailty phenotype -1) exhaustion, (2) weakness, and (3) slowness-and observed the prevalence of pre-frailty (1-2 characteristics) and frailty (3 characteristics) in the PAD cohort. Of the 106 participants, 34.9% were robust/non-frail, 53.8% were pre-frail, and 2.8% were frail. Exhaustion (33.3%) was the most occurring characteristic followed by weakness (20.0%) and slowness (5.0%). The grouping of weakness + slowness (10.0%) was the most prevalent followed by exhaustion + weakness (8.3%) and exhaustion + slowness (5.0%). Among pre-frail participants, ankle brachial index was correlated with a reduction in gait speed.

Weight Loss Treatment and Longitudinal Weight Change Among Primary Care Patients With Obesity.

Importance: Among individuals with obesity, 5% or greater weight loss can improve health. Weight management treatments (WMT) include nutrition counseling, very low-calorie meal replacement (MR), antiobesity medications (AOM), and bariatric surgery; however, little is known about how these WMT are associated with weight change among individual patients and populations. Objective: To characterize weight status and WMT use among primary care patients and assess associations between WMT and weight trajectories. Design, Setting, and Participants: Retrospective, population-based cohort study of primary care patients from 1 academic health system in Michigan between October 2015 and March 2020 using cross-sectional analysis to compare obesity prevalence and WMT utilization. For patients with obesity and WMT exposure or matched controls, a multistate Markov model assessing associations between WMT and longitudinal weight status trajectories was used. Data were analyzed from October 2021 to October 2023. Exposures: Cross-sectional exposure was year: 2017 or 2019. Trajectory analysis exposures were WMT: nutrition counseling, MR, AOM, and bariatric surgery. Main Outcomes and Measures: Cross-sectional analysis compared mean body mass index (BMI), obesity prevalence, and, among patients with obesity, prospective WMT use. The trajectory analysis examined longitudinal weight status using thresholds of ±5% and 10% of baseline weight with primary outcomes being the 1-year probabilities of 5% or greater weight loss for each WMT. Results: Adult patients (146 959 participants) consisted of 83 636 female participants (56.9%); 8940 (6.1%) were Asian, 14 560 (9.9%) were Black, and 116 664 (79.4%) were White. Patients had a mean (SD) age of 49.6 (17.7) years and mean (SD) BMI of 29.2 (7.2). Among 138 682 patients, prevalence of obesity increased from 39.2% in 2017 to 40.7% in 2019; WMT use among patients with obesity increased from 5.3% to 7.1% (difference: 1.7%; 95% CI, 1.3%-2.2%). In a multistate model (10 180 patients; 33 549 patient-years), the 1-year probability of 5% or greater weight loss without WMT exposure was 15.6% (95% CI, 14.3%-16.5%) at reference covariates. In contrast, the probability of 5% or greater weight loss was more likely with year-long exposures to any WMT (nutrition counseling: 23.1%; 95% CI, 21.3%-25.1%; MR: 54.6%; 95% CI, 46.5%-61.2%; AOM: 27.8%; 95% CI, 25.0%-30.5%; bariatric surgery: 93.0%; 95% CI, 89.7%-95.0%). Conclusions and Relevance: In this cohort study of primary-care patients with obesity, all WMT increased the patient-level probability of achieving 5% or greater weight loss, but current rates of utilization are low and insufficient to reduce weight at the population level.

Rural disparities impact response to a web-based physical activity self-management intervention in COPD: A secondary analysis.

PURPOSE: This secondary exploratory analysis examined rural-urban differences in response to a web-based physical activity self-management intervention for chronic obstructive pulmonary disease (COPD). METHODS: Participants with COPD (N = 239 US Veterans) were randomized to either a multicomponent web-based intervention (goal setting, iterative feedback of daily step counts, motivational and educational information, and an online community forum) or waitlist-control for 4 months with a 12-month follow-up. General linear modeling estimated the impact of rural/urban status (using Rural-Urban Commuting Area [RUCA] codes) on (1) 4- and 12-month daily step-count change compared to waitlist-control, and (2) intervention engagement (weekly logons and participant feedback). FINDINGS: Rural (n = 108) and urban (n = 131) participants' mean age was 66.7±8.8 years. Rural/urban status significantly moderated 4-month change in daily step counts between randomization groups (p = 0.041). Specifically, among urban participants, intervention participants improved by 1500 daily steps more than waitlist-control participants (p = 0.001). There was no difference among rural participants. In the intervention group, rural participants engaged less with the step-count graphs on the website than urban participants at 4 months (p = 0.019); this difference dissipated at 12 months. More frequent logons were associated with greater change in daily step counts (p = 0.004); this association was not moderated by rural/urban status. CONCLUSIONS: The web-based intervention was effective for urban, but not rural, participants at 4 months. Rural participants were also less engaged at 4 months, which may explain differences in effectiveness. Technology-based interventions can help address urban-rural disparities in patients with COPD, but may also contribute to them unless resources are available to support engagement with the technology.

A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study.

Background: Given the deleterious effects of physical inactivity in persons with chronic obstructive pulmonary disease (COPD) and/or heart failure (HF), interventions that promote long-term daily physical activity are needed. Mindful Steps, designed to promote walking behaviors in COPD and HF, is a multicomponent intervention that integrates mind-body content with other self-regulatory components. The aim of the current qualitative study was to characterize participants' experiences with Mindful Steps and understand the perceived influence of the intervention on walking and health. Method: In the context of a pilot randomized controlled feasibility trial comparing the year-long Mindful Steps program to usual care among individuals with COPD and HF, semi-structured qualitative interviews were administered at 6- and 12-months. Interviews were audio recorded and transcribed. The constant comparative method was used to code transcripts, identify categories, and develop interrelated themes. Results: Nineteen participants (63% female; Mage = 70.2 years, SD = 6.95) who were randomized to the intervention group completed the 6-month interview and 17 completed the 12-month interview. The pedometer with feedback, live group classes, and mind-body videos were described as the most helpful intervention components. Participants learned several strategies that helped their walking (e.g., breathing regulation and awareness, body awareness, mind-body techniques, pacing), described walking as enjoyable, and identified internal reasons for walking (e.g., to feel good). They also reported several physical and mental health benefits of the intervention. Some participants reported limited influence of the intervention on walking or health. Many participants continued to use the strategies they learned in the first half of the intervention at 12-months. Conclusions: The mind-body content of Mindful Steps appeared to positively influence walking behaviors. Participants' experiences with the intervention helped to identify areas for future intervention refinement. Future quantitative work is needed to corroborate these qualitative findings and assess the efficacy of the intervention on long-term physical activity engagement. Trial Registration: This trial is registered in Clinical Trials.gov, ID number NCT01551953.

Controlling Hypertension through Education and Coaching in Kidney Disease (CHECK-D): protocol of a cluster randomised controlled trial.

INTRODUCTION: Chronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3-5. Outcomes in patients with CKD stages 3-5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching. METHODS AND ANALYSIS: We will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3-5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination. ETHICS AND DISSEMINATION: This study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations. TRIAL REGISTRATION NUMBER: NCT04087798.

A very low-carbohydrate diabetes prevention program for veterans with prediabetes: a single-arm mixed methods pilot study.

Introduction: All Veterans Affairs (VA) Medical Centers offer the MOVE! Weight Management Program to help patients achieve and maintain a healthy weight through a calorie-restricted, low-fat diet and increased physical activity. Yet, most MOVE! participants do not achieve clinically significant weight loss of ≥5%. A carbohydrate-restricted diet may help more Veterans to achieve ≥5% weight loss. Methods: This was a single-arm explanatory sequential mixed methods pilot study conducted in one VA health care system. Veterans with prediabetes and body mass index ≥25 kg/m2 were invited to participate in a group-based, virtual, very low-carbohydrate Diabetes Prevention Program (VLC-DPP) consisting of 23 sessions over 12 months. Participants were taught to follow a very low-carbohydrate eating pattern, defined as 20-35 grams of net carbohydrates per day. The primary outcomes were measures of feasibility and acceptability, including program uptake and session attendance. Secondary outcomes included change in weight, hemoglobin A1c, lipids, and patient-reported measures of food cravings, stress eating, perceived health status, and motivation. Interviews were conducted at 6 months to identify factors that facilitated or hindered participants' achievement of ≥5% weight loss. Results: Among 108 screened Veterans, 21 enrolled in the study (19%), and 18 were included in the analytic cohort. On average, participants attended 12.4/16 weekly sessions and 3.6/8 bimonthly or monthly sessions. At 12 months, mean percent weight loss was 9.4% (SD = 10.7) with 9 participants (50%) achieving ≥5% weight loss. Three factors facilitated achievement of ≥5% weight loss among 10/16 interviewees: (1) enjoyment of low-carbohydrate foods; (2) careful monitoring of carbohydrate intake; and (3) reduced hunger and food cravings. Three factors hindered achievement of ≥5% weight loss among 6/16 interviewees: (1) food cravings, particularly for sweets; (2) challenges with maintaining a food log; and (3) difficulty with meal planning. Conclusion: A VLC-DPP is feasible and acceptable and shows preliminary efficacy among Veterans with prediabetes. The program's weight loss effectiveness compared to standard MOVE! should be evaluated in a larger-scale trial. Such a program may be offered in addition to the standard MOVE! program to expand the menu of evidence-based lifestyle counseling options for Veterans. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT04881890, identifier NCT04881890.

Cooking behaviours after Diabetes Prevention Program (DPP) participation among DPP participants in Baltimore, MD.

OBJECTIVE: The Diabetes Prevention Program (DPP) is a widely implemented 12-month behavioural weight loss programme for individuals with prediabetes. The DPP covers nutrition but does not explicitly incorporate cooking skills education. The objective of the current study is to describe food and cooking skills (FACS) and strategies of recent DPP participants. DESIGN: Photo-elicitation in-depth interviews were conducted from June to August, 2021. SETTING: Baltimore, MD, USA. PARTICIPANTS: Thirteen Black women who participated in DPP. RESULTS: The DPP curriculum influenced participants' healthy cooking practices. Many participants reported shifting from frying foods to air-frying and baking foods to promote healthier cooking and more efficient meal preparation. Participants also reported that their participation in DPP made them more mindful of consuming fruits and vegetables and avoiding foods high in carbohydrates, fats, sugars and Na. With respect to food skills, participants reported that they were more attentive to reading labels and packaging on foods and assessing the quality of ingredients when grocery shopping. CONCLUSIONS: Overall, participants reported changing their food preferences, shopping practices and cooking strategies to promote healthier eating after completing the DPP. Incorporating hands-on cooking skills and practices into the DPP curriculum may support sustained behaviour change to manage prediabetes and prevent development of type 2 diabetes among participants.

Comparing Very Low-Carbohydrate vs DASH Diets for Overweight or Obese Adults With Hypertension and Prediabetes or Type 2 Diabetes: A Randomized Trial.

PURPOSE: Adults with a triple multimorbidity (hypertension, prediabetes or type 2 diabetes, and overweight or obesity), are at increased risk of serious health complications, but experts disagree on which dietary patterns and support strategies should be recommended. METHODS: We randomized 94 adults from southeast Michigan with this triple multimorbidity using a 2 × 2 diet-by-support factorial design, comparing a very low-carbohydrate (VLC) diet vs a Dietary Approaches to Stop Hypertension (DASH) diet, as well as comparing results with and without multicomponent extra support (mindful eating, positive emotion regulation, social support, and cooking). RESULTS: Using intention-to-treat analyses, compared with the DASH diet, the VLC diet led to greater improvement in estimated mean systolic blood pressure (-9.77 mm Hg vs -5.18 mm Hg; P = .046), greater improvement in glycated hemoglobin (-0.35% vs -0.14%; P = .034), and greater improvement in weight (-19.14 lb vs -10.34 lb; P = .0003). The addition of extra support did not have a statistically significant effect on outcomes. CONCLUSIONS: For adults with hypertension, prediabetes or type 2 diabetes, and overweight or obesity, the VLC diet resulted in greater improvements in systolic blood pressure, glycemic control, and weight over a 4-month period compared with the DASH diet. These findings suggest that larger trials with longer follow-up are warranted to determine whether the VLC diet might be more beneficial for disease management than the DASH diet for these high-risk adults.

Complex, Varied and Evolving Manifestations of Food Agency in Daily Life Among Diabetes Prevention Program Participants in Baltimore, Maryland.

OBJECTIVE: To characterize food agency (one's capacity to procure and prepare food in particular contexts) among Diabetes Prevention Program (DPP) participants and gather perspectives about experiences with DPP. DESIGN: Photograph-elicitation in-depth interviews and survey measures. SETTING: Baltimore, Maryland (June-August 2021). PARTICIPANTS: Black women (n = 13) who participated in DPP. PHENOMENON OF INTEREST: Food agency and strategies used to procure and prepare food and the influence of DPP on daily food behaviors. Surveys measured food agency using the Cooking and Food Provisioning Action Scale and cooking behaviors. ANALYSIS: Thematic analysis of qualitative in-depth interviews and descriptive statistics for quantitative measures. RESULTS: As quantitative and qualitative data revealed, participants were frequent and confident cooks with high food agency. Participants viewed cooking as a key strategy for healthy eating and desired more hands-on cooking instruction within DPP to develop new healthy cooking skills. The primary barriers identified were related to lack of time or energy. Food procurement and preparation practices shifted over time, and DPP was a key influence on current behaviors. CONCLUSIONS AND IMPLICATIONS: Food agency is complex and manifests heterogeneously in daily life. A life course, contextual, and food agency-based approach could be considered for future diabetes prevention interventions.

Chronic Obstructive Pulmonary Disease Access and Adherence to Pulmonary Rehabilitation Intervention (CAPRI): Protocol for a randomized controlled trial and adaptations during the COVID-19 pandemic.

BACKGROUND: Pulmonary rehabilitation (PR) is the standard of care for chronic obstructive pulmonary disease (COPD) management. However, significant barriers limit access and adherence to PR and alternatives are needed. The purpose of this randomized controlled trial is to test the efficacy of a web-based, pedometer-mediated intervention to increase physical activity (PA) for persons with COPD who decline PR or meet U.S. guidelines for referral to PR but have not participated (CAPRI-1). In addition, we will test whether the intervention maintains PA following PR in an exploratory aim (CAPRI-2). METHODS: Participants with COPD (N = 120) will be recruited and randomized 1:1 to a 12-week web-based, pedometer-mediated intervention or usual care (UC) (CAPRI-1). The intervention provides: 1) objective monitoring of walking and iterative feedback, 2) individualized step-count goals, 3) motivational messages and educational content, and 4) an online community. The primary outcome is change in daily step count from baseline to 12 weeks. Secondary outcomes include: (a) exercise capacity; (b) self-reported PA; (c) PA intensity; (d) exercise self-regulatory efficacy, (e) health-related quality of life, (f) dyspnea, (g) depression symptoms, and (h) healthcare utilization. CAPRI-2 will test whether participants (N = 96) assigned to the intervention following PR completion show greater maintenance of daily step count compared to UC at 3, 6, 9, and 12 months. DISCUSSION: If the intervention is efficacious, it may be an alternative for those who cannot attend PR or a maintenance program following completion of conventional PR. We also present adaptations made to the protocol in response to the COVID-19 pandemic.

Coordinated Care to Optimize Cardiovascular Preventive Therapies in Type 2 Diabetes: A Randomized Clinical Trial.

Importance: Evidence-based therapies to reduce atherosclerotic cardiovascular disease risk in adults with type 2 diabetes are underused in clinical practice. Objective: To assess the effect of a coordinated, multifaceted intervention of assessment, education, and feedback vs usual care on the proportion of adults with type 2 diabetes and atherosclerotic cardiovascular disease prescribed all 3 groups of recommended, evidence-based therapies (high-intensity statins, angiotensin-converting enzyme inhibitors [ACEIs] or angiotensin receptor blockers [ARBs], and sodium-glucose cotransporter 2 [SGLT2] inhibitors and/or glucagon-like peptide 1 receptor agonists [GLP-1RAs]). Design, Setting, and Participants: Cluster randomized clinical trial with 43 US cardiology clinics recruiting participants from July 2019 through May 2022 and follow-up through December 2022. The participants were adults with type 2 diabetes and atherosclerotic cardiovascular disease not already taking all 3 groups of evidence-based therapies. Interventions: Assessing local barriers, developing care pathways, coordinating care, educating clinicians, reporting data back to the clinics, and providing tools for participants (n = 459) vs usual care per practice guidelines (n = 590). Main Outcomes and Measures: The primary outcome was the proportion of participants prescribed all 3 groups of recommended therapies at 6 to 12 months after enrollment. The secondary outcomes included changes in atherosclerotic cardiovascular disease risk factors and a composite outcome of all-cause death or hospitalization for myocardial infarction, stroke, decompensated heart failure, or urgent revascularization (the trial was not powered to show these differences). Results: Of 1049 participants enrolled (459 at 20 intervention clinics and 590 at 23 usual care clinics), the median age was 70 years and there were 338 women (32.2%), 173 Black participants (16.5%), and 90 Hispanic participants (8.6%). At the last follow-up visit (12 months for 97.3% of participants), those in the intervention group were more likely to be prescribed all 3 therapies (173/457 [37.9%]) vs the usual care group (85/588 [14.5%]), which is a difference of 23.4% (adjusted odds ratio [OR], 4.38 [95% CI, 2.49 to 7.71]; P < .001) and were more likely to be prescribed each of the 3 therapies (change from baseline in high-intensity statins from 66.5% to 70.7% for intervention vs from 58.2% to 56.8% for usual care [adjusted OR, 1.73; 95% CI, 1.06-2.83]; ACEIs or ARBs: from 75.1% to 81.4% for intervention vs from 69.6% to 68.4% for usual care [adjusted OR, 1.82; 95% CI, 1.14-2.91]; SGLT2 inhibitors and/or GLP-1RAs: from 12.3% to 60.4% for intervention vs from 14.5% to 35.5% for usual care [adjusted OR, 3.11; 95% CI, 2.08-4.64]). The intervention was not associated with changes in atherosclerotic cardiovascular disease risk factors. The composite secondary outcome occurred in 23 of 457 participants (5%) in the intervention group vs 40 of 588 participants (6.8%) in the usual care group (adjusted hazard ratio, 0.79 [95% CI, 0.46 to 1.33]). Conclusions and Relevance: A coordinated, multifaceted intervention increased prescription of 3 groups of evidence-based therapies in adults with type 2 diabetes and atherosclerotic cardiovascular disease. Trial Registration: ClinicalTrials.gov Identifier: NCT03936660.

Using Peer Support to Prevent Diabetes: Results of a Pragmatic RCT.

INTRODUCTION: High-contact structured diabetes prevention programs are effective in lowering weight and HbA1cs, yet their intensity level can create barriers to participation. Peer support programs improve clinical outcomes among adults with Type 2 diabetes, but their effectiveness in diabetes prevention is unknown. This study examined whether a low-intensity peer support program improved outcomes more than enhanced usual care in a diverse population with prediabetes. STUDY DESIGN: The intervention was tested in a pragmatic 2-arm RCT. SETTING/PARTICIPANTS: Participants were adults with prediabetes at three healthcare centers. INTERVENTION: Participants randomized to the enhanced usual care arm received educational materials. Participants in the Using Peer Support to Aid in Prevention and Treatment in Prediabetes arm were matched with a peer supporter: another patient who had made healthy lifestyle changes and was trained in autonomy-supportive action planning. Peer supporters were instructed to provide weekly telephone support to their peers on specific action steps toward behavioral goals for 6 months, then monthly support for 6 months. MAIN OUTCOME MEASURES: Changes in primary outcomes of weight and HbA1c and secondary outcomes of enrollment in formal diabetes prevention programs, self-reported diet, physical activity, health-specific social support, self-efficacy, motivation, and activation at 6 and 12 months were examined. RESULTS: Data collection occurred from October 2018 to March 2022, with analyses completed in September 2022. Among 355 randomized patients, in intention-to-treat analyses, there were no between-group differences in HbA1c or weight changes at 6 and 12 months. Using Peer Support to Aid in Prevention and Treatment in Prediabetes participants were more likely to enroll in structured programs at 6 (AOR=2.45, p=0.009) and 12 (AOR=2.21, p=0.016) months and to report eating whole grains at 6 (4.49, p=0.026) and 12 (4.22, p=0.034) months. They reported greater improvements in perceived social support for diabetes prevention behaviors at 6 (6.39, p<0.001) and 12 (5.48, p<0.001) months, with no differences in other measures. CONCLUSIONS: A stand-alone, low-intensity peer support program improved social support and participation in formal diabetes prevention programs but not weight or HbA1c. It will be important to examine whether peer support could effectively complement higher-intensity, structured diabetes prevention programs. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov, NCT03689530. Full protocol available at https://clinicaltrials.gov/ct2/show/NCT03689530.

Coordinating Cardiology clinics randomized trial of interventions to improve outcomes (COORDINATE) - Diabetes: rationale and design.

Several medications that are proven to reduce cardiovascular events exist for individuals with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease, however they are substantially underused in clinical practice. Clinician, patient, and system-level barriers all contribute to these gaps in care; yet, there is a paucity of high quality, rigorous studies evaluating the role of interventions to increase utilization. The COORDINATE-Diabetes trial randomized 42 cardiology clinics across the United States to either a multifaceted, site-specific intervention focused on evidence-based care for patients with T2DM or standard of care. The multifaceted intervention comprised the development of an interdisciplinary care pathway for each clinic, audit-and-feedback tools and educational outreach, in addition to patient-facing tools. The primary outcome is the proportion of individuals with T2DM prescribed three key classes of evidence-based medications (high-intensity statin, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and either a sodium/glucose cotransporter-2 inhibitor (SGLT-2i) inhibitor or glucagon-like peptide 1 receptor agonist (GLP-1RA) and will be assessed at least 6 months after participant enrollment. COORDINATE-Diabetes aims to identify strategies that improve the implementation and adoption of evidence-based therapies.

Does mainstream BRCA testing affect surgical decision-making in newly-diagnosed breast cancer patients?

BACKGROUND: Germline pathogenic variants mutations) in the BRCA1 and BRCA2 genes cause an increased risk of breast cancer and ovarian cancer. Mainstream cancer genetic testing (MCG) was introduced for breast cancer patients in our unit in 2013. Non-geneticist clinicians have been trained to offer genetic testing during initial treatment planning. We assessed the impact of timely test results on surgical decision-making. METHODS: Women who had undergone mainstream genetic testing for breast cancer between September 2013 and September 2018 were identified from a prospective database. Surgical data were collected retrospectively. RESULTS: 580 eligible women had mainstream genetic testing. For 474 this was their first breast cancer diagnosis. The median age was 46 years (interquartile range (IQR) 38-57). The indications were: age ≤45 years for 233 (49%); triple negative disease for 192 women (40.5%); bilateral breast cancer age <60 for 39 (8%) and other for 72 (14%) women. The median time for test initiation to result was 18 days (IQR 15-21). 302 (64% received results before surgery. 88% of those found to have a BRCA mutation before surgery opted for bilateral mastectomy (compared to 5% with BRCA wild type). An additional 106 patients had a new diagnosis on a background of previous treatment. Of these all with a pathogenic variant chose bilateral mastectomy. CONCLUSION: Timely BRCA gene testing influences surgeons' and patients' choice of surgery. It reassures women with a negative result and allows those with a positive result to take an active decision about the management of their future risk.

Cost savings associated with a web-based physical activity intervention for COPD.

OBJECTIVE: To estimate the cost savings associated with a pedometer-based, web-mediated physical activity intervention in a cohort of US veterans with chronic obstructive pulmonary disease (COPD). STUDY DESIGN: Economic analysis. METHODS: We constructed a decision tree from the health care system perspective incorporating adjusted relative risk of a pedometer-based, web-mediated intervention for COPD-related acute exacerbations, acute exacerbation-related costs (ie, emergency department visits and hospitalizations), and intervention-related costs. Total COPD-related costs were estimated per patient across 12 months. Probabilistic sensitivity analysis with Monte Carlo simulation was used to estimate uncertainty in the model findings. RESULTS: In the deterministic (base case) model, the model estimated costs to be $4236 per participant who used the pedometer-based, web-mediated intervention compared with $7913 per participant in the control group (estimated $3677 saved in 1 year compared with the control group). The model findings were robust to probabilistic sensitivity analysis, with a difference in mean costs of $4582 (95% probability interval, $4084-$5080; P < .001). Cost savings in the model were driven by the adjusted relative risk of the web-based intervention, probability of a COPD-related acute exacerbation, rate of hospitalization, probability of hospitalization, and cost of hospitalization. CONCLUSIONS: A pedometer-based, web-mediated physical activity intervention yielded substantial cost savings. Increased implementation of the intervention could markedly reduce the economic burden of COPD for payers and patients.

Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial.

BACKGROUND: The Center for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP's weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control. METHODS: We propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time. DISCUSSION: The NDPP is the dominant public health strategy for T2DM prevention. Changing the program's dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program's effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome. TRIAL REGISTRATION: NCT05235425. Registered February 11, 2022.