A Randomized Controlled Study on Clinical Adherence to Evidence-Based Guidelines in the Management of Simulated Patients With Barrett's Esophagus and the Clinical Utility of a Tissue Systems Pathology Test: Results From Q-TAB.

INTRODUCTION: Barrett's esophagus (BE) is a precursor to esophageal adenocarcinoma. Physicians infrequently adhere to guidelines for managing BE, leading to either reduced detection of dysplasia or inappropriate re-evaluation. METHODS: We conducted a three-arm randomized controlled trial with 2 intervention arms to determine the impact of a tissue systems pathology (TSP-9) test on the adherence to evidence-based guidelines for simulated patients with BE. Intervention 1 received TSP-9 results, and intervention 2 had the option to order TSP-9 results. We collected data from 259 practicing gastroenterologists and gastrointestinal surgeons who evaluated and made management decisions for 3 types of simulated patients with BE: nondysplastic BE, indefinite for dysplasia, and low-grade dysplasia. RESULTS: Intervention 1 was significantly more likely to correctly assess risk of progression to high-grade dysplasia/esophageal adenocarcinoma and offer treatment in accordance with US society guidelines compared with the control group (+6.9%, 95% confidence interval +1.4% to +12.3%). There was no significant difference in ordering guideline-recommended endoscopic eradication therapy. However, for cases requiring annual endoscopic surveillance, we found significant improvement in adherence for intervention 1, with a difference-in-difference of +18.5% ( P = 0.019). Intervention 2 ordered the TSP-9 test in 21.9% of their cases. Those who ordered the test performed similarly to intervention 1; those who did not, performed similarly to the control group. DISCUSSION: The TSP-9 test optimized adherence to clinical guidelines for surveillance and treatment of both patients with BE at high and low risk of disease progression. Use of the TSP-9 test can enable physicians to make risk-aligned management decisions, leading to improved patient health outcomes.

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.

Randomized prospective trial to detect and distinguish between medication nonadherence, drug-drug interactions, and disease progression in chronic cardiometabolic disease.

BACKGROUND: Disentangling nonadherence (NA), drug-drug interactions (DDIs), and disease progression from each other is an important clinical challenge for providers caring for patients with cardiometabolic diseases. NAs and DDIs are both ubiquitous and often overlooked. We studied a novel chronic disease management (CDM) test to detect medication adherence and the presence and severity of DDIs. MATERIALS AND METHODS: We conducted a prospective, randomized controlled trial of 236 primary care physicians using computer-based, simulated patients, measuring clinical care with and without access to the CDM test. The primary outcomes were whether use of the CDM test increased the accuracy of diagnoses and ordering better treatments and how effective the intervention materials were in getting participants to order the CDM test. RESULTS: Physicians given the CDM test results showed a + 13.2% improvement in their diagnosis and treatment quality-of-care scores (p < 0.001) in the NA patient cases and a + 13.6% improvement in the DDI cases (p < 0.001). The difference-in-difference calculations between the intervention and control groups were + 10.4% for NA and + 10.8% for DDI (p < 0.01 for both). After controlling for physician and practice co-factors, intervention, compared to control, was 50.4x more likely to recognize medication NA and 3.3x more likely to correctly treat it. Intervention was 26.9x more likely to identify the DDI and 15.7x more likely to stop/switch the interacting medication compared to control. We found no significant improvements for the disease progression patient cases. CONCLUSION: Distinguishing between nonadherence, drug-drug interactions, and disease progression is greatly improved using a reliable test, like the CDM test; improved diagnostic accuracy and treatment has the potential to improve patient quality of life, medication safety, clinical outcomes, and efficiency of health delivery. TRIAL REGISTRATION: clinicaltrials.gov (NCT05192590).

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.

Clinical Variation in the Treatment Practices for Medication Nonadherence, Drug-Drug Interactions, and Recognition of Disease Progression in Patients with Chronic Cardiometabolic Diseases: A Cross-Sectional Patient Simulation Study among Primary Care Physicians.

Background: Medication nonadherence in patients with chronic diseases is common, costly, and often underdiagnosed. In the United States, approximately 40-50% of patients with cardiometabolic conditions are not adherent to long-term medications. Drug-drug interactions (DDI) are also underrecognized and may lead to medication nonadherence in this patient population. Treatment complexity associated with cardiometabolic conditions contributes to increased risk for adverse drug events and DDIs. Methods: We recruited a nationally representative sample of 246 board-certified family and internal medicine physicians to evaluate how they assessed, identified, and treated medication nonadherence, DDIs, and worsening disease. Participating physicians were asked to care for three online simulated patients, each with at least one chronic cardiometabolic disease, including atrial fibrillation, heart failure, diabetes mellitus, or hypertension, and who were taking prescription medications for their disease. Physicians' scores were based on evidence-based care recommendation criteria, including overall care quality and treatment for medication nonadherence and DDIs. Results: Overall, quality-of-care scores across all cases ranged from 13% to 87% with an average of 50.8% ± 12.1%. The average overall diagnostic plus treatment score was 21.9% ± 13.6%. Participants identified nonadherence in just 3.6% of cases, DDIs in 8.9% of cases, and disease progression in 30.3% of cases. Conclusions: Based on these study results, primary care physicians were unable to adequately diagnose and treat patients with chronic cardiometabolic diseases who either suffered from medication nonadherence, DDIs, or progression of the disease. Improved standardization and technique in identifying these diagnoses is needed in primary care. Trial Registration. This trial is registered with clinicaltrials.gov, NCT05192590.

Clinical Utility of a Biomarker to Detect Contrast-Induced Acute Kidney Injury during Percutaneous Cardiovascular Procedures.

INTRODUCTION: Contrast-induced acute kidney injury (CI-AKI) is a major clinical complication of percutaneous cardiovascular procedures requiring iodinated contrast. Despite its relative frequency, practicing physicians are unlikely to identify or treat this condition. METHODS: In a 2-round clinical trial of simulated patients, we examined the clinical utility of a urine-based assay that measures liver-type fatty acid-binding protein (L-FABP), a novel marker of CI-AKI. We sought to determine if interventional cardiologists' ability to diagnose and treat potential CI-AKI improved using the biomarker assay for 3 different patient types: pre-procedure, peri-procedure, and post-procedure patients. RESULTS: 154 participating cardiologists were randomly divided into either control or intervention. At baseline, we found no difference in the demographics or how they identified and treated potential complications of AKI, with both groups providing less than half the necessary care to their patients (46.4% for control vs. 47.6% for intervention, p = 0.250). The introduction of L-FABP into patient care resulted in a statistically significant improvement of 4.6% (p = 0.001). Compared to controls, physicians receiving L-FABP results were 2.9 times more likely to correctly identify their patients' risk for AKI (95% CI 2.1-4.0) and were more than twice as likely to treat for AKI by providing volume expansion and withholding nephrotoxic medications. We found the greatest clinical utility in the pre-procedure and peri-procedure settings but limited value in the post-procedure setting. CONCLUSION: This study suggests L-FABP as a clinical marker for assessing the risk of potential CI-AKI, has clinical utility, and can lead to more accurate diagnosis and treatment.

Clinical variation in surveillance and management of Barrett's esophagus: A cross-sectional study of gastroenterologists and gastrointestinal surgeons.

Appropriate surveillance and treatment of Barrett's esophagus (BE) is vital to prevent disease progression and decrease esophageal adenocarcinoma (EAC)-related mortality. We sought to determine the variation in BE care and identify improvement opportunities. 275 physicians (113 general gastroenterologists, 128 interventional gastroenterologists, 34 gastrointestinal surgeons) cared for 3 simulated patients, one each from 3 BE clinical scenarios: non-dysplastic BE (NDBE), BE indefinite for dysplasia (IND), and BE with low grade dysplasia (LGD), and care scores were measured against societal guidelines. Overall quality-of-care scores ranged from 17% to 85% with mean of 47.9% ± 11.8% for NDBE, 50.8% ± 11.7% for IND, and 52.7% ± 12.2% for LGD. Participants appropriately determined risk of progression 20.3% of the time: 14.4% for NDBE cases, 19.9% for LGD cases, and 26.8% for IND cases (P = .001). Treatment and follow-up care scores averaged 12.9% ± 17.5% overall. For the LGD cases, guideline-recommended twice-daily PPI treatment was ordered only 24.7% of the time. Guideline-based follow-up endoscopic surveillance was done in only 27.7% of NDBE cases and 32.7% of IND cases. For the LGD cases, 45.4% ordered endoscopic eradication therapy while 25.1% chose annual endoscopic surveillance. Finally, participants provided counseling on lifestyle modifications in just 20% of cases. Overall care of patients diagnosed with BE varied widely and showed room for improvement. Specific opportunities for improvement were adherence to guideline recommended surveillance intervals, patient counseling, and treatment selection for LGD. Physicians would potentially benefit from additional BE education, endoscopic advances, and better methods for risk stratification.

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.

Initiative to Improve Evidence-Based Chronic Obstructive Pulmonary Disease Hospitalist Care Using a Novel On-Line Gamification Patient Simulation Tool: A Prospective Study.

Chronic obstructive pulmonary disease (COPD) remains a leading cause of morbidity and mortality. Much of the disease burden comes from exacerbations requiring hospitalization. Unwarranted care variation and divergence from evidence-based COPD management guidelines among hospitalists is a leading driver of the poor outcomes and excess costs associated with COPD-related hospitalizations. We engaged with Novant Health hospitalists to determine if measurement and feedback using fixed-choice simulated patients improves evidence-based care delivery and reduces costs. We created a series of gamified acute-care COPD case simulations with real-time feedback over 16 weeks then performed a year-over-year analytic comparison of the cost, length of stay (LOS), and revisits over the six months prior to the introduction of the simulated patients, the four months while caring for the simulated patients, and the six months after. In total, 245 hospitalists from 15 facilities at Novant Health participated. At baseline, the overall quality-of-care was measured as 58.4% + 12.3%, with providers correctly identifying COPD exacerbation in 92.4% of cases but only identifying the grade and group in 61.9% and 49.5% of cases, respectively. By the study end, the quality-of-care had improved 10.5% (p < 0.001), including improvements in identifying the grade (+9.7%, p = 0.044) and group (+8.4%, p = 0.098). These improvements correlated with changes in real-world performance data, including a 19% reduction in COPD-related pharmacy costs. Overall, the annualized impact of COPD improvements led to 233 fewer inpatient days, 371 fewer revisit days, and inpatient savings totaling nearly $1 million. Engaging practicing providers with patient simulation-based serial measurements and gamified evidence-based feedback potentially reduces inpatient costs while simultaneously reducing patient LOS and revisit rates.

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.

Measuring the Variation in the Prevention and Treatment of CI-AKI Among Interventional Cardiologists.

Contrast-induced acute kidney injury (CI-AKI) occurs in up to 10% of cardiac catheterizations and coronary interventions, resulting in increased morbidity, mortality, and cost. One main reason for these complications and costs is under-recognition of CI-AKI risk and under-treatment of patients with impaired renal status. 157 interventional cardiologists each cared for three simulated patients with common conditions requiring intravascular contrast media in three typical settings: pre-procedurally, during the procedure, and post-procedure. We evaluated their ability to assess the risk of developing CI-AKI, make the diagnosis, and treat CI-AKI, including proper volume expansion and withholding nephrotoxic medications. Overall, the quality-of-care scores averaged 46.0% ± 10.5, varying between 18% to 78%. The diagnostic scores for accurately assessing risk of CI-AKI were low at 57.1% ± 21.2% and the accuracy of diagnosis pre-existing chronic kidney disease was 50.2%. Poor diagnostic accuracy led to poor treatment: proper volume expansion done in only 30.7% of cases, in-hospital repeat creatinine evaluation performed in 32.1%, and avoiding nephrotoxic medications occurred in 14.2%. While volume expansion was relatively similar across the three settings (P = 0.287), the cardiologists were less likely to discontinue nephrotoxic medications in pre-procedurally (9.7%) compared to the other settings (27.0%), and to order in-hospital creatinine testing in peri-procedurally (18.8%) compared to post-procedure (57.8%) (P < 0.05 for both). The overall care of patients at risk for contrast-induced acute kidney injury varied widely and showed room for improvement. Improving care for this condition will require greater awareness by cardiologists and better diagnostic tools to guide them.

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.

Randomized Trial on the Clinical Utility of a Novel Biomarker Panel to Identify Treatable Determinants of Chronic Pain.

Millions suffer daily from chronic pain diagnosed anatomically and treated with opioids. Research shows that underlying nutritional, metabolic and oxidative stressors, which drive the development or worsening of chronic pain, are not diagnosed despite the fact that treatment of these primary pain pathways relieves pain and increases function. One of the main reasons for this gap in care is the lack of a simple diagnostic assay to help clinicians make these diagnoses. We examined the clinical utility of a urine-based pain biomarker panel. Primary care physicians were randomized into the test group and compared to controls. We measured their ability to make the diagnosis and treat a total of nine standardized patients, with common but challenging cases of chronic pain, over two rounds of data collection in a pre-post design using a fixed-effects model. Intervention doctors received educational materials on a novel pain biomarker panel after the baseline round and had access to biomarker test results. Provider responses were measured against evidence-based criteria. The two study arms at baseline provided similar, poor care for three different primary pain pathways: nutritional deficiencies (5.0% control versus 9.2% intervention treated, p = 0.208), metabolic abnormalities (1.0% control versus 0% for intervention treated, p = 0.314), and oxidative stress (1.2% control versus 0% intervention treated, p = 0.152). After the introduction of the Foundation Pain Index (FPI) biomarker test, physicians in the intervention group were 41.5% more likely to make the diagnosis of a micronutrient deficiency, 29.4% more likely to identify a treatable metabolic abnormality and 26.1% more likely to identify an oxidative stressor. These diagnostic and treatment improvements were seen across all three case types, ranging from a relative +54% (p = 0.004) for chronic neuropathic pain to +35% (p = 0.007) in chronic pain from other causes to +38% (p = 0.002) in chronic pain with associated mental health issues. Intervention doctors were also 75.1% more likely to provide a non-opioid treatment to patients on chronic opioids (O.R. 1.8, 95% C.I. 0.8-3.7), 62% less likely to order unnecessary imaging for their patients with low back pain (O.R. 0.38, 95% C.I. 0.15-0.97) and 66% less likely to order an unnecessary pain referral (O.R. 0.34, 95% C.I. 0.13-0.90). This experimental study showed significant clinical utility of a validated pain biomarker panel that determines nutritional deficiencies, metabolic abnormalities and oxidative stressors that drive underlying treatable causes of pain. When integrated into routine primary care practice, this testing approach could considerably improve diagnostic accuracy and provide more targeted, non-opioid treatments for patients suffering from chronic pain.

Finding the clinical utility of 1,5-anhydroglucitol among primary care practitioners.

BACKGROUND: HbA1c is widely used as the standard measure to track glycemic control in patients with diabetes and pre-diabetes but measures average levels of glycated hemoglobin over two to three months, with limited utility in the presence of recent and/or short-term fluctuations in glycemic control, which are correlated with worse patient outcomes. METHODS: We examined the clinical utility of 1-5-anhydroglucitol (1,5-AG) in six different, but common, case types of diabetes patients with short-term glycemic variability. We conducted a randomized controlled trial of simulated patients to examine the clinical practice patterns of primary care physicians before and after introducing 1,5-AG. The 145 participants were randomly assigned into standard care or standard care + 1,5-AG arms. Provider care was reviewed against explicit evidence-based care standards. RESULTS: At baseline, we saw no difference between the two study arms in clinical quality of care provided (p = 0.997). After introduction of 1,5-AG, standard care + 1,5-AG providers performed 3.2% better than controls (p = 0.025. In diagnosis and treatment, there was a slight, but nonsignificant trend toward better care (+1.1%, p = 0.507) for intervention providers. Upon disaggregation by case, almost all the improvement occurred in the medication-induced hyperglycemia patients (+8.1%, p = 0.047). CONCLUSIONS: A nationally representative sample of primary care physicians demonstrated that of six different cases used in this study, 1,5-AG was found to be most effective increasing awareness of poor glucose control in medication-induced hyperglycemia. If 1,5-AG is used in this particular circumstance, the overall savings to the healthcare system is estimated to be $28 million.

Randomized clinical trial of a novel donor-derived cfDNA test to detect rejection in CPV-simulated renal transplant patients.

PURPOSE: Five-year kidney graft loss currently stands at about 30%. We evaluate the clinical utility of a blood test measuring donor-derived cell-free DNA that detects rejection earlier and, potentially, improves diagnostic and therapeutic accuracy. METHODS: In a randomized controlled experiment, we measured the clinical practice of 175 practicing nephrologists, both with and without the use of dd-cfDNA testing. Providers cared for six simulated post-renal transplant patient cases whose ages ranged from 30 to 75 years and were 3-24 months post-transplant with typical presentations. RESULTS: 154 nephrologists completed two rounds of simulated cases. At baseline, the study arms performed similarly, demonstrating no significant differences either in primary diagnosis (p = 0.853), decisions to biopsy or refer to transplant center (p = 1.000), or therapeutic management (p = 0.488). After introduction of the dd-cfDNA test, intervention nephrologists were more likely to arrive at the diagnosis of rejection (OR 4.00, 95% CI 1.93-8.30), make a correct decision on biopsy/transplant center referral (OR 11.07, 95% CI 4.87-25.16), and properly adjust therapeutic management (OR 2.37, 95% CI 1.07-5.24). CONCLUSION: A sample of nationally representative, practicing nephrologists given dd-cfDNA to evaluate post-transplant patients were more likely to correctly diagnose early and subclinical allograft rejection, to send for biopsy or refer to transplant center, and to appropriately change treatment than those nephrologists without dd-cfDNA access.

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.

Reducing Unwarranted Oncology Care Variation Across a Clinically Integrated Network: A Collaborative Physician Engagement Strategy.

PURPOSE: Addressing unwarranted clinical variation in oncology is a high priority for health systems that aspire to ensure consistent levels of high-quality and cost-effective care. Efforts to improve clinical practice and standardize care have proven challenging. Advocate Physician Partners undertook a patient simulation-based practice measurement and feedback project that was focused on breast and lung cancer to engage oncologists in the care standardization process. METHODS: One hundred three medical oncologists cared for online simulated patients using the Clinical Performance and Value platform, receiving feedback on how their care decisions compared with evidence-based guidelines and their peers. We repeated this process every 4 months over six rounds, measuring changes in quality-of-care scores. We then compared simulated patient results with available patient-level claims data. RESULTS: Over the course of the project, overall quality-of-care scores improved 11.9% (P < .001). Diagnostic accuracy increased 6.7% (P < .001) and correlated with improved treatment scores, including a nearly 10-percentage point increase in evidence-based chemotherapy regimens (P = .009) and a 56% increase in addressing palliative needs for patients with late-stage disease (P < .001). Unnecessary test ordering declined 25% (P < .001). We compared these results with available patient data and observed concordance with the metastatic imaging workup order rate for early-stage breast cancer. As unnecessary workups declined in the simulations and became more closely aligned with evidence-based guidelines, we saw similar rates of decline in the patient-level data. CONCLUSION: This study demonstrates that an oncology care standardization system that combines simulated patients with serial feedback increases evidence-based and cost-effective clinical decisions in patient simulations and patient-level data.

Clinical Utility of a Blood-based Protein Assay on Diagnostic Colonoscopy Referrals for Elevated-risk Colorectal Cancer Patients in Primary Care.

BACKGROUND: Colonoscopies are effective in finding early stage colorectal cancer (CRC), which when found in a timely manner, dramatically improve survival rates. A significant number of at-risk patients are still not screened. We investigated the utility of a blood-based protein assay to assess for CRC in patients with elevated risk on the quality of preventive care delivered by board-certified primary care physicians (PCPs) in the United States. METHODS: We report on the results of a 3-part, longitudinal, randomized controlled trial. Part 1 assessed physicians' ability to identify simulated patients at risk for CRC and found PCPs missed colonoscopy referrals for high-risk patients ~40% of the time. Part 2 randomized PCPs into control and intervention arms and demonstrated that a novel blood-based protein assay increased referral rates for a diagnostic colonoscopy when caring for simulated patients. Part 3, reported herein, compares real-world colonoscopy rates of actual patients cared for by control versus intervention physicians. Part 3 was executed to confirm whether the use of the assay demonstrated the same utility in their real world, high-risk patients as found in part 2 using simulated patients. RESULTS: In the simulations, physicians with access to the assay were significantly more likely to order diagnostic colonoscopies. Similarly, in real-world practice, patients were also more likely to be referred for a diagnostic colonoscopy (odds ratio, 4.57; 95% confidence interval, 1.19-17.57). CONCLUSIONS: An increase in CRC risk, as indicated by the assay in simulated and real-life patients, was associated with a higher likelihood of appropriate patients being referred to diagnostic colonoscopy.