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Background: The CDC estimates that over 40% of Urgent Care visits are for acute respiratory infections (ARI), more than half involving inappropriate antibiotic prescriptions. Previous randomized trials in primary care clinics resulted in reductions in inappropriate antibiotic prescribing, but antibiotic stewardship interventions in telehealth have not been systematically assessed. To better understand how best to decrease inappropriate antibiotic prescribing for ARIs in telehealth, we are conducting a large randomized quality improvement trial testing both patient- and physician-facing feedback and behavioral nudges embedded in the electronic health record., Methods: Teladoc® clinicians are assigned to one of 9 arms in a 3 × 3 randomized trial. Each clinician is assigned to one of 3 Commitment groups (Public, Private, Control) and one of 3 Performance Feedback groups (Benchmark Peer Comparison, Trending, Control). After randomly selecting ⅓ of states and associated clinicians required for patient-facing components of the Public Commitment intervention, remaining clinicians are randomized to the Control and Private Commitment arms. Clinicians are randomized to the Performance Feedback conditions. The primary outcome is change from baseline in antibiotic prescribing rate for qualifying ARI visits. Secondary outcomes include changes in inappropriate prescribing and revisit rates. Secondary analyses include investigation of heterogeneity of treatment effects. With 1530 clinicians and an intra-clinician correlation in antibiotic prescribing rate of 0.5, we have >80% power to detect 1-7% absolute differences in antibiotic prescribing among groups., Discussion: Findings from this trial may help inform telehealth stewardship strategies, determine whether significant differences exist between Commitment and Feedback interventions, and provide guidance for clinicians and patients to encourage safe and effective antibiotic use., Clinicaltrials: gov: NCT05138874., (Copyright © 2022. Published by Elsevier Inc.)

Background: High levels of opioid prescribing in the United States has resulted in an alarming trend in opioid-related harms. The objective of Trial 2 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-2) is to dampen the intensity and frequency of opioid prescribing in accordance with the Centers for Disease Control and Prevention recommendation to "go low and slow". We aim to accomplish this by notifying clinicians of harmful patient outcomes, which we expect to increase the mental availability of risks associated with opioid use., Methods: The trial is multi-site. Random assignment determines if prescribers to persons who suffer an opioid overdose (fatal or nonfatal) learn of this event (intervention) or practice usual care (control). Clinicians in the intervention group receive a letter notifying them of their patient's overdose. The primary outcome is the change in clinician weekly milligram morphine equivalent (MME) prescribed in a 6-month period before and after receiving the letter. Additional outcomes are the change in the proportion of patients prescribed at least 50 daily MME and in the proportion of patients referred to medication assisted treatment. Group differences in these outcomes will be compared using an intent-to-treat difference-in-differences framework with a mixed-effects regression model to estimate clinician MME., Discussion: The AESOPS-2 trial will provide new knowledge about whether increasing prescribers' awareness of patients' opioid-related overdoses leads to a reduction in opioid prescribing. Additionally, this trial may better inform how to reduce opioid use disorder and opioid overdoses by lowering population exposure to these drugs., Trial Registration: ClinicalTrials.gov: NCT04758637., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: Overtesting and treatment of older patients is common and may lead to harms. The Choosing Wisely campaign has provided recommendations to reduce overtesting and overtreatment of older adults. Behavioral economics-informed interventions embedded within the electronic health record (EHR) have been shown to reduce overuse in several areas. Our objective is to conduct a parallel arm, pragmatic cluster-randomized trial to evaluate the effectiveness of behavioral-economics-informed clinical decision support (CDS) interventions previously piloted in primary care clinics and designed to reduce overtesting and overtreatment in older adults., Methods/design: This trial has two parallel arms: clinician education alone vs. clinician education plus behavioral-economics-informed CDS. There are three co-primary outcomes for this trial: (1) prostate-specific antigen (PSA) screening in older men, (2) urine testing for non-specific reasons in older women, and (3) overtreatment of diabetes in older adults. All eligible primary care clinics from a large regional health system were randomized using a modified constrained randomization process and their attributed clinicians were included. Clinicians were recruited to complete a survey and educational module. We randomized 60 primary care clinics with 374 primary care clinicians and achieved adequate balance between the study arms for prespecified constrained variables. Baseline annual overuse rates for the three co-primary outcomes were 25%, 23%, and 17% for the PSA, urine, and diabetes measures, respectively., Discussion: This trial is evaluating behavioral-economics-informed EHR-embedded interventions to reduce overuse of specific tests and treatments for older adults. The study will evaluate the effectiveness and safety of these interventions., (Copyright © 2021. Published by Elsevier Inc.)

Background: There is a lack of evidence that long-term opioid use offers benefit for noncancer pain and an abundance of evidence of harm. Despite clinical guidelines and education, prescribing continues at a higher rate than before the opioids crisis. The objective of trial 1 of the Application of Economics & Social psychology to improve Opioid Prescribing Safety (AESOPS-1) is to discourage unnecessary opioid prescribing in primary care by applying "behavioral insights"-empirically-tested social and psychological interventions that affect choice., Methods: AESOPS-1 randomizes primary care clinics in Illinois and California to behavioral intervention or control. Both arms receive opioid guideline education. Clinics randomized to the behavioral intervention arm receive nudges within the electronic health record (EHR) including: 1) an "accountable justification" entered in the chart, 2) a precommitment to address high-risk prescriptions, and 3) a "PainTracker" that broadens discussions about pain. The control arm receives no EHR-based intervention. The primary outcome is the change in weekly milligram morphine equivalents (MME) prescribed. The secondary outcome is the change in the proportion of patients prescribed at least 50 daily MME. To evaluate these outcomes, we will use a difference-in-differences mixed-effects regression model on clinician MME weekly or daily dose. The analysis will be "intent-to-treat." The intervention period is 18-months, with a 6-month follow-up period to measure persistence of effects., Discussion: The AESOPS-1 trial will evaluate the effect of EHR-based interventions in reducing noncancer opioid prescribing in primary care. AESOPS-1 may demonstrate practical and scalable strategies to lower unnecessary population exposure to opioids., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To determine the prevalence of cognitive impairment no dementia (CIND) among a diverse, community-based population, and establish associations between CIND and health literacy, chronic disease self-management and functional health status., Methods: 863 primary care adults without dementia aged 55-74. Adjusted logistic and linear regressions were used to assess associations between CIND (None, Mild, Moderate/Severe) and outcomes., Results: 36 % participants exhibited CIND. It was strongly associated with limited health literacy (Newest Vital Signs: Mild [OR 3.25; 95 % CI 1.93, 5.49], Moderate/Severe [OR 6.45; 95 % CI 3.16, 13.2]; Test of Functional Health Literacy in Adults: Mild [OR 3.46; 95 % CI 2.08, 5.75], Moderate/Severe [OR 8.82; 95 % CI 4.87, 16.0]; all p's < 0.001) and poor chronic disease self-management (Mild [B = -11.2; 95 % CI -13.5, -8.90], Moderate/Severe CI [B = -21.0; 95 % CI -23.6, -18.4]; both p's < 0.001). Associations between CIND and functional health status were non-significant., Conclusions: CIND was prevalent in this cohort, and strongly associated with requisite skills for managing everyday health needs., Practice Implications: Attention to subtle declines in chronic disease self-care may assist with CIND identification and care management within this population. When CIND is observed, clinicians should also expect and address difficulties with self-management., Competing Interests: Declaration of Competing Interest SDP receives research support from Omron Healthcare and previously received grant support from Pfizer, Inc. MSW receives research funding from Amgen and Merck, Sharpe & Dohme. He also has served as a paid consultant to Luto U.K., Pfizer and AB Imbev Foundation. RML, LMC, JWG, DC and AF have no conflicts of interest to disclose., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Federal incentives for electronic health record (EHR) use typically require quality measure reporting over calendar year or 90-day periods. However, required reporting periods may not align with time frames of real-world quality improvement (QI) efforts. This study described primary care practices' ability to obtain measures with reporting periods aligning with a large QI initiative., Methods: Researchers conducted a substudy of a randomized trial testing practice facilitation strategies for preventive cardiovascular care. Three quality measures (aspirin for ischemic vascular disease; blood pressure control for hypertension; smoking screening/cessation) were collected quarterly over one year. The primary outcome was a binary indicator of whether a practice facilitator obtained all three measures with "rolling 12-month" reporting periods (that is, the year preceding each study quarter)., Results: The study included 107 practices, 63 (58.9%) of which met the primary outcome of obtaining all measures with rolling 12-month reporting periods. Smaller practices were less likely to meet the primary outcome (p < 0.001). Practices used 11 different EHRs, 3 of which were unable to consistently produce rolling 12-month measures; at 33 practices (30.8%) using these 3 EHRs, facilitators met a secondary outcome of obtaining prior calendar year and rolling 3-month measures. Facilitators reported barriers to data collection such as practices lacking optional EHR features, and EHRs' inability to produce reporting periods across two calendar years., Conclusion: EHR vendors' compliance with federal reporting requirements is not necessarily sufficient to support real-world QI work. Improvements are needed in the flexibility and usability of EHRs' quality measurement functions, particularly for smaller practices., (Copyright © 2019 The Joint Commission. Published by Elsevier Inc. All rights reserved.)

Background: Individuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders., Objective: We are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications., Methods: We are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview., Conclusions: Our trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Hypertension is a major cause of morbidity and mortality but frequently remains uncontrolled. A smartphone application that provides coaching regarding home blood pressure monitoring and other aspects of hypertension self-care and related behavior change may be a scalable way to help manage hypertension., Methods/design: The Smart Hypertension Control Study is a prospective, randomized controlled trial to assess the effects of a hypertension personal control program (HPCP), which consists of an automated artificial intelligence smartphone application that provides individualized support and coaching to promote home monitoring and healthy behavior changes related to hypertension self-management. Enrolled adults with uncontrolled hypertension will be randomized in a 1:1 fashion to the HPCP with home blood pressure monitoring or to home monitoring alone. We plan to enroll 350 participants, with a target of 300 participants with complete six-month follow-up data. The primary study outcome will be systolic blood pressure at six months. Additional outcomes include measures of antihypertensive medication adherence, home blood pressure monitoring practices, self-management practices, weight, and self-reported health behaviors., Conclusion: The Smart Hypertension Control Study will evaluate blood pressure and hypertension self-management behavior outcomes in participants with uncontrolled hypertension exposed to a smartphone-based hypertension health coaching application in addition to home blood pressure monitoring compared to those exposed to home blood pressure monitoring alone., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: The Healthy Hearts in the Heartland (H3) study is part of a nationwide effort, EvidenceNOW, seeking to better understand the ability of small primary care practices to improve "ABCS" clinical quality measures: appropriate Aspirin therapy, Blood pressure control, Cholesterol management, and Smoking cessation. H3 aimed to assess feasibility of implementing Point-of-Care (POC) or POC plus Population Management (POC + PM) quality improvement (QI) strategies to improve ABCS at practices in Illinois, Indiana, and Wisconsin. We describe the design and randomization of the H3 study., Methods: We conducted a two-arm (1:1, POC:POC + PM), practice-randomized, comparative effectiveness study in 226 primary care practices across four "waves" of randomization with a 12-month intervention period, followed by a six-month sustainability period. Randomization controlled imbalance in nine baseline variables through a modified constrained algorithm. Among others, we used initial, unverified estimates of baseline ABCS values., Results: We randomized 112 and 114 practices to POC and POC + PM arms, respectively. Randomization ensured baseline comparability for all nine key variables, including the ABCS measures indicating proportion of patients at the practice level meeting each quality measure. Median(Inner Quartile Range) values were A: 0.78(0.66-0.86) in POC arm vs. 0.77(0.63-0.86) in POC + PM arm, B: 0.64(0.53-0.73) vs. 0.64(0.53-0.75), C: 0.78(0.63-0.86) vs. 0.75(0.64-0.81), S: 0.80(0.65-0.81) vs. 0.79(0.61-0.91)., Discussion: Surrogate estimates for the true ABCS at baseline coupled with the unique randomization logic achieved adequate baseline balance on these outcomes. Similar practice- or cluster-randomized trials may consider adaptations of this design. Final analyses on 12- and 18-month ABCS outcomes for the H3 study are forthcoming., Trial Registration: This trial is registered on ClinicalTrials.gov (Initial post: 11/05/2015; identifier: NCT02598284; https://clinicaltrials.gov/ct2/show/NCT02598284?term=NCT02598284&rank=1)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: This study aimed to develop and refine a patient education video about pneumococcal polysaccharide vaccination (PPSV23) and to assess patient perceptions regarding video content and receipt of video during a clinic visit., Methods: Focus groups were conducted to obtain patient feedback on a brief video focusing on personal susceptibility to pneumonia and highlighting the importance of both childhood and adult vaccines. Subsequently, interviews were conducted with patients ages 65 and 66 who were shown the revised video at an office visit. We assessed attitudes toward the video and perceptions about its presentation at the point of care. Participants responded to open-ended items as well as Likert-type items with responses from 1 (strongly disagree) to 5 (strongly agree)., Results: Focus group participants (n=26) had positive reactions to the video, but suggested reducing the intensity of messages about pneumonia severity. Participants (n=73) shown the revised video during a clinic visit perceived it to be easy to understand (M=4.83, SD=0.58) and informative (M=4.8, SD=0.75)., Conclusion: Target audience feedback helped refine a video promoting PPSV23 vaccination; the video was well received by patients., Practice Implications: This video may be an effective educational tool to increase rates of PPSV23 vaccination., (Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.)

Objective: To determine whether literacy mediates the association between education, hypertension knowledge and control., Methods: In-person interviews with a literacy assessment and chart review were conducted with 330 hypertensive patients from six primary care safety net clinics. Mediational analysis was used to test the role of literacy skills in explaining the relationship between education and hypertension knowledge and control., Results: In multivariate analyses that did not make an adjustment for the other variable, both lower educational attainment and more limited literacy were found to be significant independent predictors of poorer hypertension knowledge and control. When literacy was entered into models that included education only, the association between education and knowledge was fully attenuated and no longer significant (Grades 1-8: beta=-0.30, 95% CI=-1.44-0.83), while the relationship between education and blood pressure control was only minimally reduced (AOR 2.46, 95% CI 2.10-2.88). More limited literacy skills also was associated with hypertension control in the final model (AOR 2.68, 95% CI 1.54-4.70)., Conclusion: Patient literacy mediated the relationship between education and hypertension knowledge. Literacy was a significant independent predictor of blood pressure control, but only minimally explained the relationship between education and blood pressure., Practice Implications: Health literacy is critical to the design of educational tools to improve knowledge acquisition. However, in order to impact health outcome, future health literacy studies should also address other psychosocial factors that impact motivation and capability to manage disease.

Background: Physician-directed approaches have not eliminated the underuse of effective preventive therapies., Methods: In a cluster-randomized design, 19 physicians caring for 334 eligible patients at least 40 years of age were randomized. All clinicians received computerized reminders at office visits. Intervention physicians received e-mails asking whether aspirin was indicated for each patient. If so, patients received a mailing and nurse telephone call addressing aspirin. The primary outcome was self-reported regular aspirin use., Results: Outcome assessment telephone interviews were completed for 242 (72.5%) patients. At follow-up, aspirin use was reported by 60 (46%) of the 130 intervention patients and 44 (39%) of the 112 reminder-only patients, a nonsignificant 7.2% difference (95% confidence interval: -3.9 to 18 percentage points, p = .20). In the subgroup reporting no aspirin use at baseline and no contraindications, 33 (43%) of the 76 intervention and 22 (30%) of the 74 reminder-only patients used aspirin, a 10% difference accounting for clustering (95% CI: 2.2 to 18 percentage points, p = .013)., Discussion: A patient-directed intervention modestly increased aspirin use among diabetes patients beyond that achieved using computerized clinician reminders for ideal candidates. Obstacles included difficulty contacting patients, real or perceived contraindications, and failure to follow the nurse's advice.