Feasibility of tracking invasive Escherichia coli disease among older adults in a community setting: A prospective observational study.

PURPOSE: Invasive Escherichia coli disease (IED) encompasses a diverse range of sterile site infections. This study evaluated the feasibility of capturing IED among community-dwelling older adults to inform the implementation of a phase 3 efficacy trial of a novel vaccine against IED (NCT04899336). METHODS: EXPECT-1 (NCT04087681) was a prospective, multinational, observational study conducted in medically stable participants aged ≥ 60 years. At least 50% of participants were selected based on a history of urinary tract infection (UTI) in the previous 10 years. The main outcomes were the incidence of IED and the number of hospitalisations reported by the site vs participant. The length of follow-up was 12 months. In a US-based substudy, a smartphone-based geofencing was evaluated to track hospital entries. RESULTS: In total, 4470 participants were enrolled (median age, 70.0 years); 59.5% (2657/4469) of participants had a history of UTI in the previous 10 years. Four IED events were captured through deployment of different tracking methods: a self-report, a general practitioner (GP) report, and a follow-up call. The incidence rate of IED was 98.6 events per 100,000 person-years. The number of reported hospitalisations was 2529/4470 (56.6%) by the site and 2177/4470 (48.7%) by participants; 13.8% of hospitalisations would have been missed if utilising only site reports. Geofencing detected 72 hospital entries. CONCLUSION: Deployment of multiple tracking methods can optimise detection of IED among community-dwelling older adults. Older adults with a history of UTI could be feasibly targeted for a phase 3 vaccine efficacy trial through a network of GPs.

A Pragmatic Clinical Trial of Hearing Screening in Primary Care Clinics: Effect of Setting and Provider Encouragement.

OBJECTIVES: The prevalence of hearing loss increases with age. Untreated hearing loss is associated with poorer communication abilities and negative health consequences, such as increased risk of dementia, increased odds of falling, and depression. Nonetheless, evidence is insufficient to support the benefits of universal hearing screening in asymptomatic older adults. The primary goal of the present study was to compare three hearing screening protocols that differed in their level of support by the primary care (PC) clinic and provider. The protocols varied in setting (in-clinic versus at-home screening) and in primary care provider (PCP) encouragement for hearing screening (yes versus no). DESIGN: We conducted a multisite, pragmatic clinical trial. A total of 660 adults aged 65 to 75 years; 64.1% female; 35.3% African American/Black completed the trial. Three hearing screening protocols were studied, with 220 patients enrolled in each protocol. All protocols included written educational materials about hearing loss and instructions on how to complete the self-administered telephone-based hearing screening but varied in the level of support provided in the clinic setting and by the provider. The protocols were as follows: (1) no provider encouragement to complete the hearing screening at home, (2) provider encouragement to complete the hearing screening at home, and (3) provider encouragement and clinical support to complete the hearing screening after the provider visit while in the clinic. Our primary outcome was the percentage of patients who completed the hearing screening within 60 days of a routine PC visit. Secondary outcomes following patient access of hearing healthcare were also considered and consisted of the percentage of patients who completed and failed the screening and who (1) scheduled, and (2) completed a diagnostic evaluation. For patients who completed the diagnostic evaluation, we also examined the percentage of those who received a hearing loss intervention plan by a hearing healthcare provider. RESULTS: All patients who had provider encouragement and support to complete the screening in the clinic completed the screening (100%) versus 26.8% with encouragement to complete the screening at home. For patients who were offered hearing screening at home, completion rates were similar regardless of provider encouragement (26.8% with encouragement versus 22.7% without encouragement); adjusted odds ratio of 1.25 (95% confidence interval 0.80-1.94). Regarding the secondary outcomes, roughly half (38.9-57.1% depending on group) of all patients who failed the hearing screening scheduled and completed a formal diagnostic evaluation. The percentage of patients who completed a diagnostic evaluation and received a hearing loss intervention plan was 35.0% to 50.0% depending on the group. Rates of a hearing loss intervention plan by audiologists ranged from 28.6% to 47.5% and were higher compared with those by otolaryngology providers, which ranged from 15.0% to 20.8% among the groups. CONCLUSIONS: The results of the pragmatic clinical trial showed that offering provider encouragement and screening facilities in the PC clinic led to a significantly higher rate of adherence with hearing screening associated with a single encounter. However, provider encouragement did not improve the significantly lower rate of adherence with home-based hearing screening.

Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

"Click and mortar" opportunities for digitization and consumerism in trials.

BACKGROUND: Digitization (using novel digital tools and strategies) and consumerism (taking a consumer-oriented approach) are increasingly commonplace in clinical trials, but the implications of these changes are not well described. METHODS: We assembled a group of trial experts from academia, industry, non-profit, and government to discuss implications of this changing trial landscape and provide guidance. RESULTS: Digitization and consumerism can increase the volume and diversity of trial participants and expedite recruitment. However, downstream bottlenecks, challenges with retention, and serious issues with equity, ethics, and security can result. A "click and mortar" approach, combining approaches from novel and traditional trials with the thoughtful use of technology, may optimally balance opportunities and challenges facing many trials. CONCLUSION: We offer expert guidance and three "click and mortar" approaches to digital, consumer-oriented trials. More guidance and research are needed to navigate the associated opportunities and challenges.

Models for Delivering Weight Management in Primary Care: Qualitative Results from the MOST Obesity Study.

BACKGROUND: Obesity is a leading cause of morbidity and mortality in the United States (US). Primary care medical practices can educate patients about the health effects of obesity and help patients with obesity lose and manage their weight. However, implementation of weight management in primary care is challenging. We sought to examine how practices that implement weight management services do so feasibly. METHODS: Multiple methods including site visits, observations, interviews, and document reviews were utilized to identify and learn from primary care practices located across the US. A qualitative multidimensional classification of empirical cases was performed to identify unique delivery features that were feasible to implement in primary care. RESULTS: Across 21 practices, 4 delivery models were identified: group, integrated into standard primary care, hiring an "other" professional, and using a specific program. Model characteristics included who delivered the weight management services, whether delivered to an individual or group, the types of approaches used, and how the care was reimbursed or paid. Most practices integrated weight management services and primary care delivery, although some created specific carve-out programs. CONCLUSION: This study identified 4 models that may serve to overcome challenges in delivering weight management services in primary care. Based on practice characteristics, preferences, and resources, primary care practices can identify a model for successfully implementing weight management services that best fits their context and needs. It is time for primary care to truly address obesity care as the health issue it is and make it a standard of care for all patients with obesity.

Provider Interaction With an Electronic Health Record Notification to Identify Eligible Patients for a Cluster Randomized Trial of Advance Care Planning in Primary Care: Secondary Analysis.

BACKGROUND: Advance care planning (ACP) improves patient-provider communication and aligns care to patient values, preferences, and goals. Within a multisite Meta-network Learning and Research Center ACP study, one health system deployed an electronic health record (EHR) notification and algorithm to alert providers about patients potentially appropriate for ACP and the clinical study. OBJECTIVE: The aim of the study is to describe the implementation and usage of an EHR notification for referring patients to an ACP study, evaluate the association of notifications with study referrals and engagement in ACP, and assess provider interactions with and perspectives on the notifications. METHODS: A secondary analysis assessed provider usage and their response to the notification (eg, acknowledge, dismiss, or engage patient in ACP conversation and refer patient to the clinical study). We evaluated all patients identified by the EHR algorithm during the Meta-network Learning and Research Center ACP study. Descriptive statistics compared patients referred to the study to those who were not referred to the study. Health care utilization, hospice referrals, and mortality as well as documentation and billing for ACP and related legal documents are reported. We evaluated associations between notifications with provider actions (ie, referral to study, ACP not documentation, and ACP billing). Provider free-text comments in the notifications were summarized qualitatively. Providers were surveyed on their satisfaction with the notification. RESULTS: Among the 2877 patients identified by the EHR algorithm over 20 months, 17,047 unique notifications were presented to 45 providers in 6 clinics, who then referred 290 (10%) patients. Providers had a median of 269 (IQR 65-552) total notifications, and patients had a median of 4 (IQR 2-8). Patients with more (over 5) notifications were less likely to be referred to the study than those with fewer notifications (57/1092, 5.2% vs 233/1785, 13.1%; P<.001). The most common free-text comment on the notification was lack of time. Providers who referred patients to the study were more likely to document ACP and submit ACP billing codes (P<.001). In the survey, 11 providers would recommend the notification (n=7, 64%); however, the notification impacted clinical workflow (n=9, 82%) and was difficult to navigate (n=6, 55%). CONCLUSIONS: An EHR notification can be implemented to remind providers to both perform ACP conversations and refer patients to a clinical study. There were diminishing returns after the fifth EHR notification where additional notifications did not lead to more trial referrals, ACP documentation, or ACP billing. Creation and optimization of EHR notifications for study referrals and ACP should consider the provider user, their workflow, and alert fatigue to improve implementation and adoption. TRIAL REGISTRATION: ClinicalTrials.gov NCT03577002; https://clinicaltrials.gov/ct2/show/NCT03577002.

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale.

Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.

Primary care provider uptake of intensive behavioral therapy for obesity in Medicare patients, 2013-2019.

BACKGROUND: The delivery of Intensive Behavioral Therapy (IBT) for obesity by primary care providers (PCPs) has been covered by Medicare to support elderly individuals with obesity (BMI > 30 kg/m2) in managing their weight since 2011 for individual therapy and 2015 for group therapy. We conducted a cohort study of PCPs in an attempt to understand patterns of uptake of IBT for obesity services among PCPs serving the Medicare population across the U.S. METHODS: We used the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data from 2013 to 2019 to identify all PCPs who served more than 10 Medicare beneficiaries in each of the seven-year period to form a longitudinal panel. The procedure codes G0447 and G0473 were used to identify PCPs who provided IBT; and the characteristics of these providers were compared by the IBT-uptake status. RESULTS: Of the 537,754 eligible PCPs who served Medicare patients in any of the seven years, only 1.2% were found to be IBT service providers in at least one year from 2013 through 2019 (246 always users, 1,358 early adopters, and 4,563 late adopters). IBT providers shared a few common characteristics: they were more likely to be male, internal medicine providers, saw a higher number of Medicare beneficiaries, and practiced in the South and Northeast regions. Having higher proportion of patients with hyperlipidemia was associated with higher likelihood of a provider being an IBT-user. CONCLUSIONS: Very few PCPs continuously billed IBT services for Medicare patients with obesity. Further investigation is needed to mitigate barriers to the uptake of IBT services among PCPs.

Discriminative Accuracy of the CAPTURE Tool for Identifying Chronic Obstructive Pulmonary Disease in US Primary Care Settings.

Importance: Chronic obstructive pulmonary disease (COPD) is underdiagnosed in primary care. Objective: To evaluate the operating characteristics of the CAPTURE (COPD Assessment in Primary Care To Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening tool for identifying US primary care patients with undiagnosed, clinically significant COPD. Design, Setting, and Participants: In this cross-sectional study, 4679 primary care patients aged 45 years to 80 years without a prior COPD diagnosis were enrolled by 7 primary care practice-based research networks across the US between October 12, 2018, and April 1, 2022. The CAPTURE questionnaire responses, peak expiratory flow rate, COPD Assessment Test scores, history of acute respiratory illnesses, demographics, and spirometry results were collected. Exposure: Undiagnosed COPD. Main Outcomes and Measures: The primary outcome was the CAPTURE tool's sensitivity and specificity for identifying patients with undiagnosed, clinically significant COPD. The secondary outcomes included the analyses of varying thresholds for defining a positive screening result for clinically significant COPD. A positive screening result was defined as (1) a CAPTURE questionnaire score of 5 or 6 or (2) a questionnaire score of 2, 3, or 4 together with a peak expiratory flow rate of less than 250 L/min for females or less than 350 L/min for males. Clinically significant COPD was defined as spirometry-defined COPD (postbronchodilator ratio of forced expiratory volume in the first second of expiration [FEV1] to forced vital capacity [FEV1:FVC] <0.70 or prebronchodilator FEV1:FVC <0.65 if postbronchodilator spirometry was not completed) combined with either an FEV1 less than 60% of the predicted value or a self-reported history of an acute respiratory illness within the past 12 months. Results: Of the 4325 patients who had adequate data for analysis (63.0% were women; the mean age was 61.6 years [SD, 9.1 years]), 44.6% had ever smoked cigarettes, 18.3% reported a prior asthma diagnosis or use of inhaled respiratory medications, 13.2% currently smoked cigarettes, and 10.0% reported at least 1 cardiovascular comorbidity. Among the 110 patients (2.5% of 4325) with undiagnosed, clinically significant COPD, 53 had a positive screening result with a sensitivity of 48.2% (95% CI, 38.6%-57.9%) and a specificity of 88.6% (95% CI, 87.6%-89.6%). The area under the receiver operating curve for varying positive screening thresholds was 0.81 (95% CI, 0.77-0.85). Conclusions and Relevance: Within this US primary care population, the CAPTURE screening tool had a low sensitivity but a high specificity for identifying clinically significant COPD defined by presence of airflow obstruction that is of moderate severity or accompanied by a history of acute respiratory illness. Further research is needed to optimize performance of the screening tool and to understand whether its use affects clinical outcomes.

Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial.

Importance: The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients with mild to moderate symptomatic COVID-19 is unclear. Objective: To evaluate the efficacy of low-dose fluvoxamine (50 mg twice daily) for 10 days compared with placebo for the treatment of mild to moderate COVID-19 in the US. Design, Setting, and Participants: The ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) platform randomized clinical trial was designed to test repurposed medications in outpatients with mild to moderate COVID-19. A total of 1288 participants aged 30 years or older with test-confirmed SARS-CoV-2 infection and experiencing 2 or more symptoms of acute COVID-19 for 7 days or less were enrolled between August 6, 2021, and May 27, 2022, at 91 sites in the US. Interventions: Participants were randomized to receive 50 mg of fluvoxamine twice daily for 10 days or placebo. Main Outcomes and Measures: The primary outcome was time to sustained recovery (defined as the third day of 3 consecutive days without symptoms). There were 7 secondary outcomes, including a composite outcome of hospitalization, urgent care visit, emergency department visit, or death through day 28. Results: Among 1331 participants who were randomized (median age, 47 years [IQR, 38-57 years]; 57% were women; and 67% reported receiving ≥2 doses of a SARS-CoV-2 vaccine), 1288 completed the trial (674 in the fluvoxamine group and 614 in the placebo group). The median time to sustained recovery was 12 days (IQR, 11-14 days) in the fluvoxamine group and 13 days (IQR, 12-13 days) in the placebo group (hazard ratio [HR], 0.96 [95% credible interval, 0.86-1.06], posterior P = .21 for the probability of benefit [determined by an HR >1]). For the composite outcome, 26 participants (3.9%) in the fluvoxamine group were hospitalized, had an urgent care visit, had an emergency department visit, or died compared with 23 participants (3.8%) in the placebo group (HR, 1.1 [95% credible interval, 0.5-1.8], posterior P = .35 for the probability of benefit [determined by an HR <1]). One participant in the fluvoxamine group and 2 participants in the placebo group were hospitalized; no deaths occurred in either group. Adverse events were uncommon in both groups. Conclusions and Relevance: Among outpatients with mild to moderate COVID-19, treatment with 50 mg of fluvoxamine twice daily for 10 days, compared with placebo, did not improve time to sustained recovery. These findings do not support the use of fluvoxamine at this dose and duration in patients with mild to moderate COVID-19. Trial Registration: ClinicalTrials.gov Identifier: NCT04885530.

Opioid dose and pain effects of an online pain self-management program to augment usual care in adults with chronic pain: a multisite randomized clinical trial.

ABSTRACT: Readily accessible nonpharmacological interventions that can assist in opioid dose reduction while managing pain is a priority for adults receiving long-term opioid therapy (LOT). Few large-scale evaluations of online pain self-management programs exist that capture effects on reducing morphine equivalent dose (MED) simultaneously with pain outcomes. An open-label, intent-to-treat, randomized clinical trial recruited adults (n = 402) with mixed chronic pain conditions from primary care and pain clinics of 2 U.S. academic healthcare systems. All participants received LOT-prescriber-provided treatment of MED ≥ 20 mg while receiving either E-health (a 4-month subscription to the online Goalistics Chronic Pain Management Program), or treatment as usual (TAU). Among 402 participants (279 women [69.4%]; mean [SD] age, 56.7 [11.0] years), 200 were randomized to E-health and 202 to TAU. Of 196 E-heath participants, 105 (53.6%) achieved a ≥15% reduction in daily MED compared with 85 (42.3%) of 201 TAU participants (odds ratio, 1.6 [95% CI, 1.1-2.3]; P = 0.02); number-needed-to-treat was 8.9 (95% CI, 4.8, 66.0). Of 166 E-health participants, 24 (14.5%) achieved a ≥2 point decrease in pain intensity vs 13 (6.8%) of 192 TAU participants (odds ratio, 2.4 [95% CI, 1.2-4.9]; P = 0.02). Benefits were also observed in pain knowledge, pain self-efficacy, and pain coping. The findings suggest that for adults on LOT for chronic pain, use of E-health, compared with TAU, significantly increased participants' likelihood of clinically meaningful decreases in MED and pain. This low-burden online intervention could assist adults on LOT in reducing daily opioid use while self-managing pain symptom burdens.

Effect of a Patient Decision Aid on Preferences for Colorectal Cancer Screening Among Older Adults: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Guidelines recommend individualized decision-making for colorectal cancer (CRC) screening among adults aged 76 to 84 years, a process that includes a consideration of health state and patient preference. Objective: To determine whether a targeted patient decision aid would align older adults' screening preference with their potential to benefit from CRC screening. Design, Setting, and Participants: This is a prespecified secondary analysis from a randomized clinical trial. Participants aged 70 to 84 years who were not up to date with screening and had an appointment within 6 weeks were purposively sampled by health state (poor, intermediate, or good) at 14 community-based primary care practices and block randomized to receive the intervention or control. Patients were recruited from March 1, 2012, to February 28, 2015, and these secondary analyses were performed from January 15 to March 1, 2022. Interventions: Patient decision aid targeted to age and sex. Main Outcomes and Measures: The primary outcome of this analysis was patient preference for CRC screening. The a priori hypothesis was that the decision aid (intervention) group would reduce the proportion preferring screening among those in poor and intermediate health compared with the control group. Results: Among the 424 participants, the mean (SD) age was 76.8 (4.2) years; 248 (58.5%) of participants were women; and 333 (78.5%) were White. The proportion preferring screening in the intervention group was less than in the control group for those in the intermediate health state (34 of 76 [44.7%] vs 40 of 73 [54.8%]; absolute difference, -10.1% [95% CI, -26.0% to 5.9%]) and in the poor health state (24 of 62 [38.7%] vs 33 of 61 [54.1%]; absolute difference, -15.4% [95% CI, -32.8% to 2.0%]). These differences were not statistically significant. The proportion of those in good health who preferred screening was similar between the intervention and control groups (44 of 74 [59.5%] for intervention vs 46 of 75 [61.3%] for control; absolute difference, -1.9% [95% CI, -17.6% to 13.8%]). Conclusions and Relevance: The findings of this secondary analysis of a clinical trial did not demonstrate statistically significant differences in patient preferences between the health groups. Additional studies that are appropriately powered are needed to determine the effect of the decision aid on the preferences of older patients for CRC screening by health state. Trial Registration: ClinicalTrials.gov Identifier: NCT01575990.

Fluvoxamine for Outpatient Treatment of COVID-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial.

Background: The effectiveness of fluvoxamine to shorten symptom duration or prevent hospitalization among outpatients in the US with mild to moderate symptomatic coronavirus disease 2019 (COVID-19) is unclear. Design: ACTIV-6 is an ongoing, decentralized, double-blind, randomized, placebo-controlled platform trial testing repurposed medications in outpatients with mild to moderate COVID-19. A total of 1288 non-hospitalized adults aged ≥30 years with confirmed COVID-19 experiencing ≥2 symptoms of acute infection for ≤7 days prior to randomization were randomized to receive fluvoxamine 50 mg or placebo twice daily for 10 days. The primary outcome was time to sustained recovery, defined as the third of 3 consecutive days without symptoms. Secondary outcomes included composites of hospitalization or death with or without urgent or emergency care visit by day 28. Results: Of 1331 participants randomized (mean [SD] age, 48.5 [12.8] years; 57% women; 67% reported receiving at least 2 doses of a SARS-CoV-2 vaccine), 1288 completed the trial (n=614 placebo, n=674 fluvoxamine). Median time to recovery was 13 days (IQR 12-13) in the placebo group and 12 days (IQR 11-14) in the fluvoxamine group (hazard ratio [HR] 0.96, 95% credible interval [CrI] 0.86-1.07; posterior probability for benefit [HR>1]=0.22). Twenty-six participants (3.9%) in the fluvoxamine group were hospitalized or had urgent or emergency care visits compared with 23 (3.8%) in the placebo group (HR 1.1, 95% CrI 0.6-1.8; posterior probability for benefit [HR<1]=0.340). One participant in the fluvoxamine group and 2 in the placebo group were hospitalized; no deaths occurred. Adverse events were uncommon in both groups. Conclusions: Treatment with fluvoxamine 50 mg twice daily for 10 days did not improve time to recovery, compared with placebo, among outpatients with mild to moderate COVID-19. These findings do not support the use of fluvoxamine at this dose and duration in patients with mild to moderate COVID-19.

Integrating Patient-generated Digital Health Data into Electronic Health Records (EHRs) in Ambulatory Care Settings: EHR Vendor Survey and Interviews.

Data traditionally collected in a clinic or hospital setting is now collected electronically in everyday environments from patients, known as patient-generated health data (PGHD). We conducted informal interviews and collected survey data from major ambulatory care EHR vendors that serve the majority of the U.S. market to collect information on how their clients are integrating PGHD into EHRs. Of the 9 EHR vendors contacted, 6 completed the survey and 5 participated in a 45-minute interview. Feedback from the vendors included how PGHD use has steadily risen over the past decade and how the COVID-19 pandemic accelerated PGHD use. Pathways for data from devices or surveys to be brought securely into the EHR are increasing. While promising, adoption of health IT systems has its challenges. There are disparities in EHRs, devices, and applications. We concluded that more supportive policies are needed to advance PGHD integration.

A pragmatic clinical trial of hearing screening in primary care clinics: cost-effectiveness of hearing screening.

BACKGROUND: Hearing loss is a high prevalence condition among older adults, is associated with higher-than-average risk for poor health outcomes and quality of life, and is a public health concern to individuals, families, communities, professionals, governments, and policy makers. Although low-cost hearing screening (HS) is widely available, most older adults are not asked about hearing during health care visits. A promising approach to addressing unmet needs in hearing health care is HS in primary care (PC) clinics; most PC providers (PCPs) do not inquire about hearing loss. However, no cost assessment of HS in community PC settings has been conducted in the United States. Thus, this study conducted a cost-effectiveness analysis of HS using results from a pragmatic clinic trial that compared three HS protocols that differed in the level of support and encouragement provided by the PC office and the PCPs to older adults during their routine visits. Two protocols included HS at home (one with PCP encouragement and one without) and one protocol included HS in the PC office. METHODS: Direct costs of the HS included costs of: (1) educational materials about hearing loss, (2) PCP educational and encouragement time, and (3) access to the HS system. Indirect costs for in-office HS included cost of space and minimal staff time. Costs were tracked and modeled for each phase of care during and following the HS, including completion of a diagnostic assessment and follow-up with the recommended treatment plan. RESULTS: The cost-effectiveness analysis showed that the average cost per patient is highest in the patient group who completed the HS during their clinic visit, but the average cost per patient who failed the HS is by far the lowest in that group, due to the higher failure rate, that is, rate of identification of patients with suspected hearing loss. Estimated benefits of HS in terms of improvements in quality of life were also far greater when patients completed the HS during their clinic visit. CONCLUSIONS: Providing HS to older adults during their PC visit is cost-effective and accrues greater estimated benefits in terms of improved quality of life. TRIAL REGISTRATION: clinicaltrials.gov (Registration Identification Number: NCT02928107).

Dissemination and implementation science resources, training, and scientific activities provided through CTSA programs nationally: Opportunities to advance D&I research and training capacity.

Introduction: Clinical and Translational Science Award (CTSA) Program hubs are well-positioned to advance dissemination and implementation (D&I) research and training capacity nationally, though little is known about what D&I research support and services CTSAs provide. To address this gap, the CTSA Dissemination, Implementation, and Knowledge Transfer Working Group conducted an environmental scan of CTSAs (2017-2018). Methods: Of 67 CTSA institutions, we contacted 43 that previously reported delivering D&I research services. D&I experts from these institutions were emailed a survey assessing D&I resources, services, training, and scientific projects. Responses were categorized and double-coded by study authors using a content analysis approach. Results: Thirty-five of the 43 D&I experts (81.4%) responded. Challenges to CTSAs in developing and supporting D&I science activities were related to inadequate D&I science workforce (45.7%) and lack of understanding of D&I science (25.7%). Services provided included consultation/mentoring programs (68%), pilot funding/grants (50%), and workshops/seminars/conferences (46%). Training and workforce development in D&I were frequently identified as future priorities. Recommendations included increase training to meet demand (68.6%), accessible D&I tools/resources (34.3%), greater visibility/awareness of D&I methods (34.3%), consultation services (22.9%), and expand D&I science workforce (22.9%). Conclusions: CTSAs have tremendous potential to support the advancement and impact of D&I science across the translational continuum. Despite the growing presence of D&I science in CTSAs, continued commitment and prioritization are needed from CTSA and institutional leadership to raise awareness of D&I science and its value, meet training demands, and develop necessary infrastructure for conducting D&I science.