McCoy, Rozalina G.

Abstract Introduction: Pragmatic trials aim to speed translation to practice by integrating study procedures in routine care settings. This study evaluated implementation outcomes related to clinician and patient recruitment and participation in a trial of community paramedicine (CP) and presents successes and challenges of maintaining pragmatic study features. Methods: Adults in the pre-hospital setting, emergency department (ED), or hospital being considered for referral to the ED/hospital or continued hospitalization for intermediate-level care were randomized 1:1 to CP care or usual care. Referral and enrollment data were tracked administratively, and patient characteristics were abstracted from the electronic health record (EHR). Enrolled patients completed baseline surveys, and a subset of intervention patients were interviewed. All CPs and a sample of clinicians and administrators were invited to complete a survey and interview. Results: Between January 2022 and February 2023, 240 enrolled patients (42% rural) completed surveys, and 22 completed an interview; 63 staff completed surveys and 20 completed an interview. Ninety-three clinicians in 27 departments made at least one referral. Factors related to referrals included program awareness and understanding the CP practice scope. Most patients were enrolled in the hospital, but characteristics were similar to the primary care population and included older and medically complex patients. Challenges to achieving representativeness included limited EHR infrastructure, constraints related to patient consenting, and clinician concerns about patient randomization disrupting preferred care. Conclusion: Future pragmatic trials in busy clinical settings may benefit from regulatory policies and EHR capabilities that allow for real-world study conduct and representative participation. Trial registration: NCT05232799.

Key Points Sodium-glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor agonists were superior to dipeptidyl peptidase-4 inhibitor and sulfonylurea for preventing kidney complications in patients with type 2 diabetes at moderate cardiovascular disease risk. Sodium-glucose cotransporter 2 inhibitor therapy compared favorably with glucagon-like peptide-1 receptor agonists for kidney disease outcomes. Background CKD is a serious diabetes-related complication. While guidelines recommend use of sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like peptide-1 receptor agonist (GLP-1RA) therapies to mitigate cardiorenal risk in high-risk patients, the benefit of early initiation of these agents relative to other commonly prescribed glucose-lowering agents in patients at lower baseline cardiovascular disease (CVD) risk remains less clear. Methods This retrospective observational study emulated an idealized target trial using claims data from OptumLabs data warehouse to test the comparative association of treatment with a dipeptidyl peptidase-4 inhibitor (DPP-4i), SGLT2i, GLP-1RA, or sulfonylurea (SU) on a primary kidney composite outcome of incident CKD stages 3–5, kidney failure, or need for KRT in patients with type 2 diabetes and moderate CVD risk. A secondary composite outcome included all components of the primary composite outcome plus death. Results A total of 364,714 adults aged 21 years or older initiating treatment with a DPP-4i ( N =78,843), GLP-1RA ( N =42,049), SGLT2i ( N =45,466), or SU ( N =198,356) were identified. Relative to DPP-4i, SGLT2i (hazard ratio [HR], 0.71; 95% confidence interval [CI], 0.67 to 0.74; P < 0.001) and GLP-1RA (HR, 0.87; 95% CI, 0.83 to 0.92; P < 0.001) treatment was superior for the primary composite outcome. Similarly, SGLT2i (HR, 0.69; 95% CI, 0.66 to 0.73) and GLP-1RA (HR, 0.86; 95% CI, 0.82 to 0.91) treatment was associated with risk reductions for the primary outcome relative to SU treatment. When comparing SGLT2i with GLP-1RA therapy, SGLT2is were superior for the primary composite outcome (HR, 0.81; 95% CI, 0.75 to 0.86; P < 0.001). Similar findings were observed for the secondary composite outcome across all comparisons. Conclusions SGLT2is and GLP-1RAs were superior to DPP-4is and SUs for preventing kidney complications in a type 2 diabetes population with moderate baseline CVD risk. Clinical Trial registry name and registration number: NCT05214573.

In this emulated comparative effectiveness target trial of glucagon-like peptide 1 (GLP-1) receptor agonist, sodium–glucose cotransporter 2 (SGLT2) inhibitor, dipeptidyl peptidase 4 (DPP-4) inhibitor, and sulfonylurea therapy among adults with type 2 diabetes at moderate cardiovascular disease risk, sulfonylurea use was associated with a significantly higher risk of hypoglycemia requiring emergency department or hospital care than treatment with DPP-4 inhibitors, GLP-1 receptor agonists, or SGLT2 inhibitors. This consideration can guide the choice of glucose-lowering therapy in this highly prevalent patient population, in whom avoidance of hypoglycemia is important, yet among whom the risk of severe hypoglycemia has not been examined previously.

OBJECTIVE This study aimed to assess the need for practice-wide quality improvement to support evidence-based type 2 diabetes screening for women with a history of gestational diabetes mellitus (GDM) receiving primary care. We sought to add the diagnosis of GDM to the problem list of women who did not have it at baseline. RESEARCH DESIGN AND METHODS We identified all women in our practice with a history of GDM diagnosed between 2002 and 2023, quantified the proportion with GDM documented in their problem list, and examined patient- and clinician-level factors associated with having GDM appropriately documented at baseline. RESULTS We identified 203 women with GDM receiving primary care within internal medicine. Of the 203 women, 73 (35.0%) did not have GDM documented in their problem list. Of those without GDM included on the problem list, 52% were overdue for type 2 diabetes screening compared with 41% of those with GDM documented before our intervention. We found race, parity, and previous abnormal glycemic laboratory test results to be highly predictive of whether the history of GDM was on patients’ problem list. Upon completion of our intervention, we successfully achieved a 100% documentation rate for GDM diagnosis for women who previously lacked documentation in their problem list. CONCLUSION This work paves the way for targeted interventions aimed at improving care for women with a history of GDM, including delivery of interventions and education to prevent the onset of an appropriate clinical screening for type 2 diabetes.

Introduction: Asymptomatic LV systolic dysfunction is often underdiagnosed, leading to missed opportunities for treatment. In a recently completed pragmatic RCT, an AI algorithm performed on the ECGs ordered as part of routine practice increased early diagnosis of low EF. The current study aimed to understand whether the effectiveness of the AI algorithm integrated into routine care differed by the socioeconomic status of the patient. Methods: The main findings of the RCT were previously published. Clinicians in the intervention group had access to AI results (i.e., a positive or negative screening result, with positive results indicating a high likelihood of low EF). When a positive result was found, clinicians in the intervention group received an alert that encouraged them to order TTE if considered clinically appropriate. Clinicians in the control group did not have access or received alerts. Area deprivation index (ADI) was used to measure area-level social determinants of health. This study included 16,992 patients (control 8,225; intervention: 8,767) who had ECG performed for any indications between 8/5/2019 and 3/31/2020, no prior HF, and a valid address to derive ADI. The primary endpoint was a new diagnosis of EF≤50% within 3 months. Results: The mean age was 60.5±17.6 y. AI increased the diagnosis of low EF in the overall cohort (OR 1.42 [1.13, 1.78], p=0.01). The magnitude of benefit was greater in patients with higher socioeconomic status, e.g., living in an area that is less deprived (OR 1.88 [1.16, 3.05]), with higher median income, lower poverty rate, higher education level, better housing conditions, and higher proportion of white-collar workers, although the interaction was not statistically significant (Figure). Conclusions: AI enables early diagnosis of low EF and the magnitude of benefit might be numerically greater in patients with higher socioeconomic status, possibly due to variations in access to or referral for subsequent testing.

ImportancePreventing diabetes complications requires monitoring and control of hyperglycemia and cardiovascular risk factors. Switching to high-deductible health plans (HDHPs) has been shown to hinder aspects of diabetes care; however, the association of HDHP enrollment with microvascular and macrovascular diabetes complications is unknown.ObjectiveTo examine the association between an employer-required switch to an HDHP and incident complications of diabetes.Design, Setting, and ParticipantsThis retrospective cohort study used deidentified administrative claims data for US adults with diabetes enrolled in employer-sponsored health plans between January 1, 2010, and December 31, 2019. Data analysis was performed from May 26, 2022, to January 2, 2024.ExposuresAdults with a baseline year of non-HDHP enrollment who had to switch to an HDHP because their employer offered no non-HDHP alternative in that year were compared with adults who were continuously enrolled in a non-HDHP.Main Outcomes and MeasuresMixed-effects logistic regression models examined the association between switching to an HDHP and, individually, the odds of myocardial infarction, stroke, hospitalization for heart failure, lower-extremity complication, end-stage kidney disease, proliferative retinopathy, treatment for retinopathy, and blindness. Models were adjusted for demographics, comorbidities, and medications, with inverse propensity score weighting used to account for potential selection bias.ResultsThe study included 42 326 adults who switched to an HDHP (mean [SD] age, 52 [10] years; 19 752 [46.7%] female) and 202 729 adults who did not switch (mean [SD] age, 53 [10] years; 89 828 [44.3%] female). Those who switched to an HDHP had greater odds of experiencing all diabetes complications (odds ratio [OR], 1.11; 95% CI, 1.06-1.16 for myocardial infarction; OR, 1.15; 95% CI, 1.09-1.21 for stroke; OR, 1.35; 95% CI, 1.30-1.41 for hospitalization for heart failure; OR, 2.53; 95% CI, 2.38-2.70 for end-stage kidney disease; OR, 2.23; 95% CI, 2.17-2.29 for lower-extremity complication; OR, 1.17; 95% CI, 1.13-1.21 for proliferative retinopathy; OR, 2.35; 95% CI, 2.18-2.54 for blindness; and OR, 2.28; 95% CI, 2.15-2.41 for retinopathy treatment).Conclusions and RelevanceThis study found that an employer-driven switch to an HDHP was associated with increased odds of experiencing all diabetes complications. These findings reinforce the potential harm associated with HDHPs for people with diabetes and the importance of affordable and accessible chronic disease management, which is hindered by high out-of-pocket costs incurred by HDHPs.

OBJECTIVE To determine the relative hazards of acute and chronic diabetes complications among people with diabetes across the U.S. rural-urban continuum. RESEARCH DESIGN AND METHODS This retrospective cohort study used the OptumLabs Data Warehouse, a deidentified data set of U.S. commercial and Medicare Advantage beneficiaries, to follow 2,901,563 adults (age ≥18 years) with diabetes between 1 January 2012 and 31 December 2021. We compared adjusted hazard ratios (HRs) of diabetes complications in remote areas (population &lt;2,500), small towns (population 2,500–50,000), and cities (population &gt;50,000). RESULTS Compared with residents of cities, residents of remote areas had greater hazards of myocardial infarction (HR 1.06 [95% CI 1.02–1.10]) and revascularization (HR 1.04 [1.02–1.06]) but lower hazards of hyperglycemia (HR 0.90 [0.83–0.98]) and stroke (HR 0.91 [0.88–0.95]). Compared with cities, residents of small towns had greater hazards of hyperglycemia (HR 1.06 [1.02–1.10]), hypoglycemia (HR 1.15 [1.12–1.18]), end-stage kidney disease (HR 1.04 [1.03–1.06]), myocardial infarction (HR 1.10 [1.08–1.12]), heart failure (HR 1.05 [1.03–1.06]), amputation (HR 1.05 [1.02–1.09]), other lower-extremity complications (HR 1.02 [1.01–1.03]), and revascularization (HR 1.05 [1.04–1.06]) but a smaller hazard of stroke (HR 0.95 [0.94–0.97]). Compared with small towns, residents of remote areas had lower hazards of hyperglycemia (HR 0.85 [0.78–0.93]), hypoglycemia (HR 0.92 [0.87–0.97]), and heart failure (HR 0.94 [0.91–0.97]). Hazards of retinopathy and atrial fibrillation/flutter did not vary geographically. CONCLUSIONS Adults in small towns are disproportionately impacted by complications of diabetes. Future studies should probe for the reasons underlying these disparities.

Abstract Background: While brief duration primary care appointments may improve access, they also limit the time clinicians spend evaluating painful conditions. This study aimed to evaluate whether 15-minute primary care appointments resulted in higher rates of opioid prescribing when compared to ≥30-minute appointments. Methods: We performed a retrospective cohort study using electronic health record (EHR), pharmacy, and administrative scheduling data from five primary care practices in Minnesota. Adult patients seen for acute Evaluation & Management visits between 10/1/2015 and 9/30/2017 scheduled for 15-minute appointments were propensity score matched to those scheduled for ≥30-minutes. Sub-groups were analyzed to include patients with acute and chronic pain conditions and prior opioid exposure. Multivariate logistic regression was performed to examine the effects of appointment length on the likelihood of an opioid being prescribed, adjusting for covariates including ethnicity, race, sex, marital status, and prior ED visits and hospitalizations. Results: We identified 45,471 eligible acute primary care visits during the study period with 2.7% (N=1233) of the visits scheduled for 15 minutes and 98.2% (N=44238) scheduled for 30 minutes or longer. Rates of opioid prescribing were significantly lower for opioid naive patients with acute pain scheduled in 15-minute appointments when compared to appointments of 30 minutes of longer (OR 0.55, 95% CI 0.35-0.84). There were no significant differences in opioid prescribing among other sub-groups. Conclusions: For selected indications and for selected patients, shorter duration appointments may not result in greater rates of opioid prescribing for common painful conditions.

Introduction/Objectives: To describe health outcomes of older adults enrolled in the Mayo Clinic Care Transitions (MCCT) program before and during the COVID-19 pandemic compared to unenrolled patients. Methods: We conducted a retrospective cohort study of adults (age >60 years) in the MCCT program compared to a usual care control group from January 1, 2019, to September 20, 2022. The MCCT program involved a home, telephonic, or telemedicine visit by an advanced care provider. Outcomes were 30- and 180-day hospital readmissions, emergency department (ED) visit, and mortality. We performed a subgroup analysis after March 1, 2020 (during the pandemic). We analyzed data with Cox proportional hazards regression models and hazard ratios (HRs) with 95% CIs. Results: Of the 1,012 patients total, 354 were in the MCCT program and 658 were in the usual care group with a mean (SD) age of 81.1 (9.1) years overall. Thirty-day readmission was 16.9% (60 of 354) for MCCT patients and 14.7% (97 of 658) for usual care patients (HR, 1.24; 95% CI, 0.88-1.75). During the pandemic, the 30-day readmission rate was 15.1% (28 of 186) for MCCT patients and 14.9% (68 of 455) for usual care patients (HR, 1.20; 95% CI, 0.75-1.91). There was no difference between groups for 180-day hospitalization, 30- or 180-day ED visit, and 30- or 180-day mortality. Conclusions: Numerous factors involving patients, providers, and health care delivery systems during the pandemic most likely contributed to these findings.