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Background Minority racial/ethnic groups have low colorectal cancer (CRC) screening rates. Objective To evaluate a culturally tailored intervention to increase CRC screening, primarily using colonoscopy, among low income and non-English speaking patients. Design Randomized controlled trial conducted from January to October of 2007. Setting Single, urban community health center serving a low-income, ethnically diverse population. Patients A total of 1,223 patients 52-79 years of age overdue for CRC screening, randomized to intervention (n = 409) vs. usual care control (n = 814) groups. Intervention Intervention patients received an introductory letter with educational material followed by phone or in-person contact by a language-concordant “navigator.” Navigators (n = 5) were community health workers trained to identify and address patient-reported barriers to CRC screening. Individually tailored interventions included patient education, procedure scheduling, translation and explanation of bowel preparation, and help with transportation and insurance coverage. Rates of colorectal cancer screening were assessed for intervention and usual care control patients. Results Over a 9-month period, intervention patients were more likely to undergo CRC screening than control patients (27% vs. 12% for any CRC screening, p < 0.001; 21% vs. 10% for colonoscopy completion, p < 0.001). The higher screening rate resulted in the identification of 10.5 polyps per 100 patients in the intervention group vs. 6.8 in the control group (p = 0.04). Limitations Patients were from one health center. Some patients may have obtained CRC screening outside our system. Conclusions A culturally tailored, language-concordant navigator program designed to identify and overcome barriers to colorectal cancer screening can significantly improve colonoscopy rates for low income, ethnically and linguistically diverse patients. ClinicalTrials.gov registration number: NCT00476970

Annual chest computed tomography (CT) can decrease lung cancer mortality in high‐risk individuals. Patient navigation improves cancer screening rates in underserved populations. Randomized controlled trial was conducted from February 2016 to January 2017 to evaluate the impact of a patient navigation program on lung cancer screening (LCS) among current smokers in five community health centers (CHCs) affiliated with an academic primary care network. We randomized 1200 smokers aged 55–77 years to intervention (n = 400) or usual care (n = 800). Navigators contacted patients to determine LCS eligibility, introduce shared decision making about screening, schedule appointments with primary care physicians (PCPs), and help overcome barriers to obtaining screening and follow‐up. Control patients received usual care. The main outcome was the proportion of patients who had any chest CT. Secondary outcomes were the proportion of patients contacted, proportion receiving LCS CTs, screening results and number of lung cancers diagnosed. Of the 400 intervention patients, 335 were contacted and 76 refused participation. Of the 259 participants, 124 (48%) were ineligible for screening; 119 had smoked <30 pack‐years, and five had competing comorbidities. Among the 135 eligible participants in the intervention group, 124 (92%) had any chest CT performed. In intention‐to‐treat analyses, 124 intervention patients (31%) had any chest CT versus 138 control patients (17.3%, P < 0.001). LCS CTs were performed in 94 intervention patients (23.5%) versus 69 controls (8.6%, P < 0.001). A total of 20% of screened patients required follow‐up. Lung cancer was diagnosed in eight intervention (2%) and four control (0.5%) patients. A patient navigation program implemented in CHCs significantly increased LCS among high‐risk current smokers. This study demonstrates that patient navigation can significantly increase lung cancer screening among current smokers receiving care in community health centers. During an 11‐month randomized controlled trial of 1200 patients, 31% of navigated patients had a chest CT compared to 17% receiving usual care (P < 0.001). Lung cancer screening CT was completed in 23.5% of navigated versus 8.6% in usual care patients (P < 0.001).

Undiagnosed atrial fibrillation (AF) is an important cause of stroke. Screening for AF using wrist-worn wearable devices may prevent strokes, but their cost-effectiveness is unknown. To evaluate the cost-effectiveness of contemporary AF screening strategies, particularly wrist-worn wearable devices. This economic evaluation used a microsimulation decision-analytic model and was conducted from September 8, 2020, to May 23, 2022, comprising 30 million simulated individuals with an age, sex, and comorbidity profile matching the US population aged 65 years or older. Eight AF screening strategies, with 6 using wrist-worn wearable devices (watch or band photoplethysmography, with or without watch or band electrocardiography) and 2 using traditional modalities (ie, pulse palpation and 12-lead electrocardiogram) vs no screening. The primary outcome was the incremental cost-effectiveness ratio, defined as US dollars per quality-adjusted life-year (QALY). Secondary measures included rates of stroke and major bleeding. In the base case analysis of this model, the mean (SD) age was 72.5 (7.5) years, and 50% of the individuals were women. All 6 screening strategies using wrist-worn wearable devices were estimated to be more effective than no screening (range of QALYs gained vs no screening, 226-957 per 100 000 individuals) and were associated with greater relative benefit than screening using traditional modalities (range of QALYs gained vs no screening, -116 to 93 per 100 000 individuals). Compared with no screening, screening using wrist-worn wearable devices was associated with a reduction in stroke incidence by 20 to 23 per 100 000 person-years but an increase in major bleeding by 20 to 44 per 100 000 person-years. The overall preferred strategy was wearable photoplethysmography, followed conditionally by wearable electrocardiography with patch monitor confirmation, which had an incremental cost-effectiveness ratio of $57 894 per QALY, meeting the acceptability threshold of $100 000 per QALY. The cost-effectiveness of screening was consistent across multiple scenarios, including strata of sex, screening at earlier ages (eg, ≥50 years), and with variation in the association of anticoagulation with risk of stroke in the setting of screening-detected AF. This economic evaluation of AF screening using a microsimulation decision-analytic model suggests that screening using wearable devices is cost-effective compared with either no screening or AF screening using traditional methods.

Atrial fibrillation (AF) and the decision to anticoagulate is a common problem faced by primary care physicians. Oral anticoagulation (OAC) is underused, despite its clear benefits with regard to stroke prevention. We examined OAC usage between 2010 and 2015, following the introduction of direct oral anticoagulants (DOACs) and specifically assessed whether more patients were anticoagulated over time. The study cohort included adult patients aged 18 and older with AF cared for in an 18-practice primary care network between 2010 and 2015. AF status was assigned each calendar year using a validated electronic health record algorithm. We examined OAC usage over time in all patients with AF, and in patients at high risk of stroke (CHA2DS2-VASc ≥ 2). The proportion of the population with AF increased over time (2010: 4,920 patients [3.5%], 2015: 6,452 patients [4.0%]). There was no increase in the proportion of patients prescribed any OAC treatment from 2010 (57.0%) to 2015 (57.4%) (p = 0.41). Similarly, in patients at high risk of stroke, the proportion anticoagulated did not increase over time (2010: 61.1%, 2015: 61.7%, p = 0.51). Over the study period, DOAC usage increased from 0.31% of all patients with AF in 2010 to 18.3% in 2015 (p < 0.001). Patients prescribed DOACs were younger, with lower risk of stroke. In conclusion, this study showed an increasing proportion of patients with AF over time in a primary care network. The use of DOACs increased over time; however, the proportion of patients treated with OAC did not increase over time.

Screening for atrial fibrillation (AF) using consumer-based devices capable of producing a single lead electrocardiogram (1L ECG) is increasing. There are limited data on the accuracy of physician interpretation of these tracings. The goal of this study is to assess the sensitivity, specificity, confidence, and variability of cardiologist interpretation of point-of-care 1L ECGs. Fifteen cardiologists reviewed point-of-care handheld 1L ECGs collected from patients aged 65 years or older enrolled in the VITAL-AF clinical trial [NCT035115057] who underwent cardiac rhythm assessments with a 1L ECG using an AliveCor KardiaMobile device. Random sampling of 1L ECGs for cardiologist review was stratified by the AliveCor algorithm interpretation. A 12L ECG performed on the same day for clinical purposes was used as the gold standard. Cardiologists each reviewed a common sample of 200 1L ECG tracings and completed a survey associated with each tracing. Cardiologists were blinded to both the AliveCor algorithm and same day 12L ECG interpretation. For each tracing, study cardiologists were asked to assess the rhythm (sinus rhythm, AF, unclassifiable), report their assessment of the quality of the tracing, and rate their confidence in rhythm interpretation. The outcomes included the sensitivity, specificity, variability, and confidence in physician interpretation. Variables associated with each measure were identified using multivariable regression. The average sensitivity for AF was 77.4% (range 50%-90.6%, standard deviation [SD]=11.4%) and the average specificity was 73.0% (range 41.3%-94.6%, SD = 15.4%). The mean variability was 30.8% (range 0%-76.2%, SD = 23.2%). The average reviewer confidence of 1L ECG rhythm assessment was 3.6 out of 5 (range 2.5-4.2, SD = 0.6). Patient and tracing factors associated with sensitivity, specificity, variability, and confidence were identified and included age, body mass index, and presence of artifact. Cardiologist interpretation of point-of-care handheld 1L ECGs has modest diagnostic sensitivity and specificity with substantial variability for AF classification despite high confidence. Variability in cardiologist interpretation of 1L ECGs highlights the importance of confirmatory testing for diagnosing AF. [Display omitted]

Given the preventable morbidity and mortality associated with atrial fibrillation (AF), increased awareness of undiagnosed AF, and advances in mobile electrocardiogram (ECG) technology, there is a critical need to assess the effectiveness of using such technology to routinely screen for AF in clinical practice. VITAL-AF is a pragmatic trial that will test whether screening for AF using a single-lead handheld ECG in individuals 65 years or older during primary care visits will lead to an increased rate of AF detection. The study is a cluster-randomized trial, with 8 primary care practices randomized to AF screening and 8 primary care practices randomized to usual care. We anticipate studying approximately 16,000 patients in each arm. During the 1-year enrollment period, practice medical assistants will screen eligible patients who agree to participate during office visits using a single-lead ECG device. Automated screening results are documented in the electronic health record, and patients can discuss screening results with their provider during the scheduled visit. All single-lead ECGs are overread by a cardiologist. Screen-detected AF is managed at the discretion of the patient's physician. The primary study end point is incident AF during the screening period. Key secondary outcomes include new oral anticoagulation prescriptions, incident ischemic stroke, and major hemorrhage during a 24-month period following the study start. Outcomes are ascertained based on electronic health record documentation and are manually adjudicated. The results of this pragmatic trial may help identify a model for widespread adoption of AF screening as part of routine clinical practice.

BackgroundOral anticoagulants reduce the risk of stroke in patients with atrial fibrillation. However, many patients with atrial fibrillation at elevated stroke risk are not treated with oral anticoagulants.ObjectiveTo test whether electronic notifications sent to primary care physicians increase the proportion of ambulatory patients prescribed oral anticoagulants.DesignRandomized controlled trial conducted from February to May 2017 within 18 practices in an academic primary care network.ParticipantsPrimary care physicians (n = 175) and their patients with atrial fibrillation, at elevated stroke risk, and not prescribed oral anticoagulants.InterventionPatients of each physician were randomized to the notification or usual care arm. Physicians received baseline email notifications and up to three reminders with patient information, educational material and primary care guidelines for anticoagulation management, and surveys in the notification arm.Main MeasuresThe primary outcome was the proportion of patients prescribed oral anticoagulants at 3 months in the notification (n = 972) vs. usual care (n = 1364) arms, compared using logistic regression with clustering by physician. Secondary measures included survey-based physician assessment of reasons why patients were not prescribed oral anticoagulants and how primary care physicians might be influenced by the notification.Key ResultsOver 3 months, a small proportion of patients were newly prescribed oral anticoagulants with no significant difference in the notification (3.9%, 95% CI 2.8–5.3%) and usual care (3.2%, 95% CI 2.4–4.2%) arms (p = 0.37). The most common, non-exclusive reasons why patients were not on oral anticoagulants included atrial fibrillation was transient (30%) or paroxysmal (12%), patient/family declined (22%), high bleeding risk (20%), fall risk (19%), and frailty (10%). For 95% of patients, physicians stated they would not change their management after reviewing the alert.ConclusionsElectronic physician notification did not increase anticoagulation in patients with atrial fibrillation at elevated stroke risk. Primary care physicians did not prescribe anticoagulants because they perceived the bleeding risk was too high or stroke risk was too low.Trial RegistrationClinicalTrials.gov identifier NCT02950285

Background Screening for atrial fibrillation (AF) is appealing because AF is common, when undiagnosed may increase stroke risk, and stroke is preventable with anticoagulants. This study assessed patient and primary care practitioner (PCP) acceptability of screening for AF using a 30-s single-lead electrocardiogram (SL-ECG) during outpatient visits. Methods Secondary analyses of a cluster randomized trial. All patients ≥ 65 years old without prevalent AF seen during a 1-year period and their PCPs. Screening using a SL-ECG was performed by medical assistants during check-in at 8 intervention sites among verbally consenting patients. PCPs were notified of “possible AF” results; management was left to their discretion. Control practices continued with usual care. Following the trial, PCPs were surveyed about AF screening. Outcomes included screening uptake and results, and PCP preferences for screening. Results Fifteen thousand three hundred ninety three patients were seen in intervention practices (mean age 73.9 years old, 59.7% female). Screening occurred at 78% of 38,502 individual encounters, and 91% of patients completed ≥ 1 screening. The positive predictive value of a “Possible AF” result (4.7% of SL-ECG tracings) at an encounter prior to a new AF diagnosis was 9.5%. Same-day 12-lead ECGs were slightly more frequent among intervention (7.0%) than control (6.2%) encounters ( p  = 0.07). Among the 208 PCPs completing a survey (73.6%; 78.9% intervention, 67.7% control), most favored screening for AF (87.2% vs. 83.6%, respectively), though SL-ECG screening was favored by intervention PCPs (86%) while control PCPs favored pulse palpation (65%). Both groups were less certain if AF screening should be done outside of office visits with patch monitors (47% unsure) or consumer devices (54% unsure). Conclusions Though the benefits and harms of screening for AF remain uncertain, most older patients underwent screening and PCPs were able to manage SL-ECG results, supporting the feasibility of routine primary care screening. PCPs exposed to a SL-ECG device preferred it over pulse palpation. PCPs were largely uncertain about AF screening done outside of practice visits. Trial registration ClinicalTrials.gov NCT03515057. Registered May 3, 2018.

BackgroundNo-shows, or missed appointments, are a problem for many medical practices. They result in fragmented care and reduce access for all patients.ObjectiveTo determine whether telephone reminder calls targeted to patients at high risk of no-show can reduce no-show rates.DesignSingle-center randomized controlled trial.ParticipantsA total of 2247 primary care patients in a hospital-based primary care clinic at high risk of no-show (>15 % risk) for their appointment in 7 days.InterventionSeven days prior to their appointment, intervention arm patients were placed in a calling queue to receive a reminder phone call from a patient service coordinator. Coordinators were trained to engage patients in concrete planning. All patients received an automated phone call (usual care).Main MeasuresPrimary outcome was no-show rate. Secondary outcomes included arrival rate, cancellation rate, reschedule rate, time to cancellation, and change in revenue.Key ResultsThe no-show rate in the intervention arm (22.8 %) was significantly lower (absolute risk difference −6.4 %, p < 0.01, 95 % CI [−9.8 to −3.0 %]) than that in the control arm (29.2 %). Arrival, cancellation, and reschedule rates did not differ significantly. In the intervention arm, rescheduling and cancellations occurred further in advance of the appointment (mean difference, 0.35 days; 95 % CI [0.07–0.64]; p = 0.01). Reimbursement did not differ significantly.ConclusionsA phone call 7 days prior to an appointment led to a significant reduction in no-shows and increased reimbursement among patients at high risk of no-show. The use of targeted interventions may be of interest to practices taking on increased accountability for population health.

BackgroundPopulation-based strategies can expand the reach of tobacco cessation treatment beyond clinical encounters.ObjectiveTo determine the effect of two population-based tobacco cessation strategies, compared with usual care, on providing tobacco treatment outside of clinical encounters.Design3-arm pragmatic randomized controlled trial.ParticipantsCurrent smokers ≥ 18 years old with a primary care provider at one of five community health centers in Massachusetts were identified via the electronic health record (n = 5225) and recruited using automated phone calls.InterventionsOne intervention group involved engagement with a health system–based tobacco coach (internal care coordination), and the other connected patients to a national quitline (external community referral).MeasurementsProportion of smokers with documentation of any evidence-based cessation treatment in the 6 months after enrollment.Key ResultsOf 639 individuals who responded to the proactive treatment offer, 233 consented and were randomized 1:1:1 to study arm. At 6-month follow-up, the pooled intervention group, compared with usual care, had higher documentation of any smoking cessation treatment (63% vs. 34%, p < 0.001), cessation medication prescription (52% vs. 30%, p = 0.002), and counseling (47% vs. 9%, p < 0.001). Internal care coordination was more effective than external community referral at connecting smokers to any cessation treatment (76% vs. 50%, p = 0.001) and at providing cessation medication (66% vs. 39%, p < 0.001), but comparable at linking smokers to cessation counseling resources.ConclusionsSmokers responding to a population-based, proactive outreach strategy had better provision of tobacco cessation treatment when referred to either a health system–based or community-based program compared with usual care. The health system–based strategy outperformed the quitline-based one in several measures. Future work should aim to improve population reach and test the effect on smoking cessation rates.Trial RegistrationClinicalTrials.gov NCT03612895