Impact of the CAPTURE COPD Screening Tool in US Primary Care: A Cluster Randomized Trial.

The impact of COPD screening on US primary care clinician behavior and patient outcomes is unclear. Assess the impact of receiving CAPTURE (COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk) screening scores on clinical and patient outcomes. Cluster randomized trial included 49 usual care (COPD education only) and 51 intervention (COPD and CAPTURE education plus screening scores) primary care practices.

Effect of Screening for Undiagnosed Atrial Fibrillation on Stroke Prevention.

Background: Atrial fibrillation (AF) often remains undiagnosed, and it independently raises the risk of ischemic stroke, which is largely reversible by oral anticoagulation. Although randomized trials using longer term screening approaches increase identification of AF, no studies have established that AF screening lowers stroke rates.

Objectives: To address this knowledge gap, the GUARD-AF (Reducing Stroke by Screening for Undiagnosed Atrial Fibrillation in Elderly Individuals) trial screened participants in primary care practices using a 14-day continuous electrocardiographic monitor to determine whether screening for AF coupled with physician/patient decision-making to use oral anticoagulation reduces stroke and provides a net clinical benefit compared with usual care.

Routine Hearing Screening for Older Adults in Primary Care: Insights of Patients and Clinic Personnel.

Background And Objectives: Hearing loss frequently goes undiagnosed and untreated, with serious sequelae. Hearing screening facilitates diagnosis and treatment but is not routinely conducted in primary care. This study addresses the attitudes and insights of patients and primary care clinic personnel relative to the routinization of hearing screening in primary care for older adults.

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.

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.

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.

"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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.