Clinical utility of a novel test for assessing cardiovascular disease risk in type 2 diabetes: a randomized controlled trial.

BACKGROUND: The risk for and treatment of cardiovascular disease (CVD) in type 2 diabetes (T2DM) is often incorrect and delayed. We wished to determine if a novel test improved physicians' ability to risk stratify, diagnose, and treat patients with T2DM. METHODS: In a 2-phase randomized controlled trial comparing the clinical workup, diagnosis, and management of online, simulated patients with T2DM in a nationwide sample of cardiologists and primary care physicians, participants were randomly assigned to control or one of two intervention groups. Intervention participants had access to standard of care diagnostic tools plus a novel diagnostic CVD risk stratification test. RESULTS: In control, there was no change in CV risk stratification of simulated patients between baseline and round 2 (37.1 to 38.3%, p = 0.778). Pre-post analysis showed significant improvements in risk stratification in both Intervention 1 (38.7 to 65.3%) and Intervention 2 (41.9 to 65.8%) (p < 0.01) compared to controls. Both intervention groups significantly increased prescribing SGLT2 inhibitors/GLP1 receptor agonists versus control, + 18.9% for Intervention 1 (p = 0.020) and 1 + 9.4% for Intervention 2 (p = 0.014). Non-pharmacologic treatment improved significantly compared to control (+ 30.0% in Intervention 1 (p < 0.001) and + 22.8% in Intervention 2 (p = 0.001). Finally, monitoring HgbA1C, blood pressure, and follow-up visit frequency improved by + 20.3% (p = 0.004) in Intervention 1 and + 29.8% (p < 0.001) in Intervention 2 compared with control. CONCLUSION: Use of the novel test significantly improved CV risk stratification among T2DM patients. Statistically significant increases treatments were demonstrated, specifically SGLT2 inhibitors and GLP1 receptor antagonists and recommendations of evidence-based non-pharmacologic treatments. Trial registration ClinicalTrials.gov, NCT05237271.

Clinical Variation in the Treatment Practices for Patients With Type 2 Diabetes: A Cross-Sectional Patient Simulation Study Among Primary Care Physicians and Cardiologists.

Background Cardiovascular disease risk stratification is necessary and critically important in patients with type 2 diabetes. Despite its known benefits to guide treatment and prevention, we hypothesized that providers do not routinely incorporate this into their diagnostic and treatment decisions. Methods and Results The QuiCER DM (QURE CVD Evaluation of Risk in Diabetes Mellitus) study enrolled 161 primary care physicians and 80 cardiologists. Between March 2022 and June 2022, we measured the care variation in risk determination among these providers caring for simulated patients with type 2 diabetes. We found a wide variation in the overall assessment of cardiovascular disease in patients with type 2 diabetes. Participants performed half of the necessary care items with quality-of-care scores, ranging between 13% and 84%, averaging 49.4±12.6%. Participants did not assess cardiovascular risk in 18.3% of cases and incorrectly stratified risk in 42.8% of cases. Only 38.9% of participants arrived at the correct cardiovascular risk stratification. Those who correctly identified a cardiovascular risk score were significantly more likely to order nonpharmacologic treatments, advising on their patients' nutrition (38.8% versus 29.9%, P=0.013) and the correct glycated hemoglobin target (37.7% versus 15.6%, P<0.001). Pharmacologic treatments, however, did not vary between those who correctly specified risk and those who did not. Conclusions Physician participants struggled to determine the correct cardiovascular disease risk and specify the appropriate pharmacologic interventions in simulated patients with type 2 diabetes. Additionally, there was a wide variation in the quality of care regardless of risk level, indicating opportunities to improve risk stratification.

Gaps in the Care of Pulmonary Hypertension: A Cross-Sectional Patient Simulation Study Among Practicing Cardiologists and Pulmonologists.

Background Diagnosis of pulmonary hypertension (PH) is often delayed or missed, leading to disease progression and missed treatment opportunities. In this study, we measured variation in care provided by board-certified cardiologists and pulmonologists in simulated patients with potentially undiagnosed PH. Methods and Results In a cross-sectional study (https://www.clinicaltrials.gov, NCT04693793), 219 US practicing cardiologists and pulmonologists cared for simulated patients presenting with symptoms of chronic dyspnea and associated signs of potential PH. We scored the clinical quality-of-care decisions made in a clinical encounter against predetermined evidence-based criteria. Overall, quality-of-care scores ranged from 18% to 74%, averaging 43.2%±11.5%. PH, when present, was correctly suspected 49.1% of the time. Conversely, physicians incorrectly identified PH in 53.7% of non-PH cases. Physicians ordered 2-dimensional echocardiography in just 64.3% of cases overall. Physicians who ordered 2-dimensional echocardiography in the PH cases were significantly more likely to get the presumptive diagnosis (61.9% versus 30.7%; P<0.001). Ordering other diagnostic work-up items showed similar results for ventilation/perfusion scan (81.5% versus 51.4%; P=0.005) and high-resolution computed tomography (60.4% versus 43.2%; P=0.001). Physicians who correctly identified PH were significantly more likely to order confirmatory right heart catheterization or refer to PH center (67.3% versus 15.8%; P<0.001). Conclusions A wide range of care in the clinical practice among simulated patients presenting with possible PH was found, specifically in the evaluation and plan for definitive diagnosis of patients with PH. The delay or misdiagnosis of PH is likely attributed to a low clinical suspicion, nonspecific symptoms, and underuse of key diagnostic tests. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04693793.

Measuring and Improving Evidence-Based Patient Care Using a Web-Based Gamified Approach in Primary Care (QualityIQ): Randomized Controlled Trial.

BACKGROUND: Unwarranted variability in clinical practice is a challenging problem in practice today, leading to poor outcomes for patients and low-value care for providers, payers, and patients. OBJECTIVE: In this study, we introduced a novel tool, QualityIQ, and determined the extent to which it helps primary care physicians to align care decisions with the latest best practices included in the Merit-Based Incentive Payment System (MIPS). METHODS: We developed the fully automated QualityIQ patient simulation platform with real-time evidence-based feedback and gamified peer benchmarking. Each case included workup, diagnosis, and management questions with explicit evidence-based scoring criteria. We recruited practicing primary care physicians across the United States into the study via the web and conducted a cross-sectional study of clinical decisions among a national sample of primary care physicians, randomized to continuing medical education (CME) and non-CME study arms. Physicians "cared" for 8 weekly cases that covered typical primary care scenarios. We measured participation rates, changes in quality scores (including MIPS scores), self-reported practice change, and physician satisfaction with the tool. The primary outcomes for this study were evidence-based care scores within each case, adherence to MIPS measures, and variation in clinical decision-making among the primary care providers caring for the same patient. RESULTS: We found strong, scalable engagement with the tool, with 75% of participants (61 non-CME and 59 CME) completing at least 6 of 8 total cases. We saw significant improvement in evidence-based clinical decisions across multiple conditions, such as diabetes (+8.3%, P<.001) and osteoarthritis (+7.6%, P=.003) and with MIPS-related quality measures, such as diabetes eye examinations (+22%, P<.001), depression screening (+11%, P<.001), and asthma medications (+33%, P<.001). Although the CME availability did not increase enrollment in the study, participants who were offered CME credits were more likely to complete at least 6 of the 8 cases. CONCLUSIONS: Although CME availability did not prove to be important, the short, clinically detailed case simulations with real-time feedback and gamified peer benchmarking did lead to significant improvements in evidence-based care decisions among all practicing physicians. TRIAL REGISTRATION: ClinicalTrials.gov NCT03800901; https://clinicaltrials.gov/ct2/show/NCT03800901.

Randomized Trial to Improve Primary Care Patient Management and Patient Outcomes Using a Drug-Drug Interaction Test: Confirmation of the DECART Simulated Patient Clinical Utility Trial Results.

Drug-drug interactions (DDIs) are a serious problem in the healthcare system, leading to excess healthcare utilization and costs. We conducted a second prospective randomized, controlled trial to further establish the real-world clinical utility of a novel assay that objectively identifies potentially serious DDIs in real-world patients. Re-recruiting primary care physicians (PCPs) from our first randomized, controlled, simulated-patients study on DDIs, we experimentally introduced a definitive, urine-based mass spectrometry test intervention that the physicians could use when caring for their eligible patients. Patients were eligible if taking four or more prescription medications or suspected of taking other non-prescribed substances with potential medication interactions. The primary outcome was whether DDI testing changed clinical care. We explored a secondary outcome to see if the change in practice improved symptoms in patients with potential DDIs. A total of 169 control and 162 intervention patients were enrolled in the study, and their medical records were abstracted. In real-world patients, intervention physicians identified and/or treated a DDI at 3.0x the rate in their patient population compared to controls (21.6% vs. 7.1%, p < 0.001). Intervention physicians were more likely to discontinue or adjust the interacting agent compared to controls (62.9% vs. 8.3%, p = 0.001), and patient-reported symptoms also significantly declined (29.6% vs. 20.1%, p = 0.045). These results were nearly identical to concurrent measurements that used simulated patients, wherein intervention was more likely to both make a DDI diagnosis (56.3% vs. 21.6%, p < 0.001) and stop the interacting medications (58.3% versus 26.6%, p < 0.001). Bringing a new diagnostic test to market, particularly for an under-recognized clinical problem, requires robust data on both clinical validity and clinical utility. The results of this follow-up study showed that the use of DDI testing in real-world patients significantly improved (1) primary care patient management of drug interactions and (2) patient outcomes.

A nationwide program to improve clinical care quality in the Kyrgyz Republic.

BACKGROUND: To assess baseline quality of care in the Kyrgyz Republic in 2019 and determine the effect of online simulated patients in changing doctors' practice in three specific disease areas: non-communicable disease, neonatal/child health, and maternal health. METHODS: Over 2000 family health, pediatric, neonatology, therapy, and obstetric-gynecologic doctors from every rayon (district) hospital and at least one associated family health (Primary) care clinic participated. To adequately scale the project, the Ministry of Health used online simulated Clinical Performance and Value (CPV) vignettes. All doctors cared for the same set of patients in their clinical area. Over eight months in 2019, we gathered three rounds of CPV data in seven oblasts. RESULTS: Overall quality scores were highly variable at baseline (59.2% + 13.5%). After three rounds the average score increased 6.5% (P < 0.001). By the end of round three, the lowest scoring oblast was providing higher quality care compared to the highest scoring oblast in the initial round (64.2% in round 3 vs 62.4% in round 1), indicating greater adherence to the evidence base. Additionally, family health doctors ordered 26% fewer unnecessary tests (P < 0.05), while specialists ordered 39% fewer unnecessary tests (P < 0.05). If trends continue, this translates into a net annual savings of 63 million Kyrgyz som. CONCLUSIONS: This study demonstrates serial measurement of care provided by over 2000 physicians in the Kyrgyz Republic can be improved as measured by CPVs. This project may be a useful template to improve health care quality at a national level in other low- and middle-income country settings.

Variation in Diabetes Management: A National Assessment of Primary Care Providers.

BACKGROUND: Glucose control is monitored primarily through ordering HbA1c levels, which is problematic in patients with glycemic variability. Herein, we report on the management of these patients by board-certified primary care providers (PCPs) in the United States. METHODS: We measured provider practice in a representative sample of 156 PCPs. All providers cared for simulated patients with diabetes presenting with symptoms of glycemic variability. Provider responses were reviewed by trained clinicians against evidence-based care standards and accepted standard of care protocols. RESULTS: Care varied widely-overall quality of care averaged 51.3%±10.6%-with providers performing just over half the evidence-based practices necessary for their cases. More worryingly, provider identified the underlying etiology of the poor glycemic control only 36.3% of the time. HbA1c was routinely ordered in 91.3% of all cases but often (59.5%) inappropriately. Ordering other tests of glycemic control (done in 15% of cases) led to significant increases in identifying the etiology of the hyperglycemia. Correctly modifying their patient's treatment was more likely to occur if doctors first identified the underlying etiology (65.9% vs 49.0%, P<0.001). We conservatively estimated a US $65/patient/visit in unnecessary testing and US $389 annually in additional care costs when the etiology was missed, translating potentially into millions of dollars of wasteful spending. CONCLUSION: Despite established evidence that HbA1c misses short-term changes in diabetes, we found PCPs consistently ordered HbA1c, rarely using other available blood tests. However, if the factors leading to poor glycemic control were recognized, PCPs were more likely to correctly alter their patient's hypoglycemic therapy.

A Direct Comparison of the Clinical Practice Patterns of Advanced Practice Providers and Doctors.

BACKGROUND: Rising health care costs, physician shortages, and an aging patient population have increased the demand and utilization of advanced practice providers (APPs). Despite their expanding role in care delivery, little research has evaluated the care delivered by APPs compared with physicians. METHODS: We used clinical patient simulations to measure and compare the clinical care offered by APPs and physicians, collecting data from 4 distinct health care systems/hospitals in the United States between 2013 and 2017. Specialties ranged from primary care to hospital medicine and oncology. Primary study outcomes were to 1) measure any differences in practice patterns between APPs and physicians, and 2) determine whether the use of serial measurement and feedback could mitigate any such differences. RESULTS: At baseline, we found no major differences in overall performance of APPs compared with physicians (P = .337). APPs performed 3.2% better in history taking (P = .013) and made 10.5% fewer unnecessary referrals (P = .025), whereas physicians ordered 17.6% fewer low-value tests per case (P = .042). Regardless of specialty or site, after 4 rounds of serial measurement and provider-specific feedback, APPs and physicians had similar increases in average overall scores-7.4% and 7.6%, respectively (P < .001 for both). Not only did both groups improve, but practice differences between the groups disappeared, leading to a 9.1% decrease in overall practice variation. CONCLUSIONS: We found only modest differences in quality of care provided by APPs and physicians. Importantly, both groups improved their performance with serial measurement and feedback so that after 4 rounds, the original differences were mitigated entirely and overall variation significantly reduced. Our data suggest that APPs can provide high quality care in multiple clinical settings.