Scalable and successful patient portal lifestyle coaching training for primary care clinical staff.

Maintaining a healthy weight postintentional weight loss is crucial for preventing chronic health conditions, yet many regain weight postintervention. Electronic health record (EHR) portals offer a promising avenue for weight management interventions, leveraging patient-primary care relationships. Our previous research demonstrated that coaching alongside self-monitoring improves weight maintenance compared to monitoring alone. Integrating weight management into routine clinical practice by training existing staff could enhance scalability and sustainability. However, challenges such as inconsistent staff qualifications and high coach turnover rates could affect intervention effectiveness. Standardizing services, training, and coaching continuity seem crucial for success. To report on developing, testing, and evaluating an EHR-based coaching training program for clinical staff, guided by an implementation tool for the MAINTAIN PRIME study. Conducted across 14 University of Utah primary care sites, we developed, tested, and evaluated a coaching training for clinical staff. Guided by a planning model and the Predisposing, Enabling, and Reinforcing (PER) tool, stakeholders actively participated in planning, ensuring alignment with clinic priorities. All clinical staff were invited to participate voluntarily. Evaluation measures included staff interest, training effectiveness, confidence, and readiness. Data collection utilized REDCap, with survey results analyzed using descriptive statistics. Despite increased clinical workload and reassignments posed by coronavirus disease 2019, we were able to train 39 clinical staff, with 34 successfully coaching patients. Feedback indicated high readiness and positive perceptions of coaching feasibility. Coaches reported satisfaction with training, support, and enjoyed establishing connections with patients. The PER strategies allowed us to implement a well-received training program found effective by primary care coaches.

This report describes a training program for medical staff like nurses and medical assistants. The goal is to teach them how to coach patients through an online portal to help them keep their weight off after making healthy lifestyle changes. We worked with different clinic groups and used a planning tool called PER worksheet (predisposing, enabling, and reinforcing) to set up the training program. From September 2021 to March 2023, we offered the training in 14 clinics, and most interested staff completed it. The results showed that the training worked well. People who took part felt they learned enough to coach patients and felt ready to coach. They liked the training and found it helpful. This study suggests that we can teach coaching skills in just four hours of training and that ongoing support and mentorship are important to the trained coaches. Furthermore, this training set-up allows new staff to be trained as they join, which is especially important in places where staff changes frequently. Overall, using the PER tool enabled us to create a training program that staff can use in outpatient clinics to help patients improve their weight management.

Integration of Patient Reported Quality of Life Data into Risk Assessment in Heart Failure.

INTRODUCTION: Optimal management of outpatients with heart failure (HF) requires serially updating the estimates of their risk for adverse clinical outcomes to guide treatment. Patient-reported outcomes (PROs) are becoming increasingly used in clinical care. The purpose of this study was to determine whether inclusion of PROs can improve the risk prediction for HF hospitalization and death in ambulatory HF patients. METHODS: We included consecutive patients with HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF) seen in a HF clinic between 2015 and 2019 who completed PROs as part of routine care. Cox regression with a least absolute shrinkage and selection operator (LASSO) regularization and gradient boosting machine (GBM) analyses were used to estimate risk for a combined outcome of HF hospitalization, heart transplant, left ventricular assist device implantation or death. The performance of the prediction models was evaluated with the time-dependent concordance index (Cτ). RESULTS: Among 1165 patients with HFrEF (mean age 59.1±16.1, 68% male) the median follow-up was 487 days and among 456 patients with HFpEF (mean age: 64.2±16.0 years, 55% male) the median follow-up was 494 days. Gradient boosting regression that included PROs had the best prediction performance - Cτ 0.73 for patients with HFrEF and 0.74 in patients with HFpEF, and showed very good stratification of risk by time to event analysis by quintile of risk. The Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-12 OSS), Visual Analogue Scale (VAS) and Patient Reported Outcomes Measurement Information System (PROMIS) dimensions of Satisfaction with social roles and Physical function had high variable importance measure in the models. CONCLUSIONS: PROs improve risk prediction in both HFrEF and HFpEF, independent of traditional clinical factors. Routine assessment of PROs and leveraging the comprehensive data in the electronic health record in routine clinical care could help more accurately assess risk and support the intensification of treatment in patients with HF.

Uptake of Cancer Genetic Services for Chatbot vs Standard-of-Care Delivery Models: The BRIDGE Randomized Clinical Trial.

Importance: Increasing numbers of unaffected individuals could benefit from genetic evaluation for inherited cancer susceptibility. Automated conversational agents (ie, chatbots) are being developed for cancer genetics contexts; however, randomized comparisons with standard of care (SOC) are needed. Objective: To examine whether chatbot and SOC approaches are equivalent in completion of pretest cancer genetic services and genetic testing. Design, Setting, and Participants: This equivalence trial (Broadening the Reach, Impact, and Delivery of Genetic Services [BRIDGE] randomized clinical trial) was conducted between August 15, 2020, and August 31, 2023, at 2 US health care systems (University of Utah Health and NYU Langone Health). Participants were aged 25 to 60 years, had had a primary care visit in the previous 3 years, were eligible for cancer genetic evaluation, were English or Spanish speaking, had no prior cancer diagnosis other than nonmelanoma skin cancer, had no prior cancer genetic counseling or testing, and had an electronic patient portal account. Intervention: Participants were randomized 1:1 at the patient level to the study groups at each site. In the chatbot intervention group, patients were invited in a patient portal outreach message to complete a pretest genetics education chat. In the enhanced SOC control group, patients were invited to complete an SOC pretest appointment with a certified genetic counselor. Main Outcomes and Measures: Primary outcomes were completion of pretest cancer genetic services (ie, pretest genetics education chat or pretest genetic counseling appointment) and completion of genetic testing. Equivalence hypothesis testing was used to compare the study groups. Results: This study included 3073 patients (1554 in the chatbot group and 1519 in the enhanced SOC control group). Their mean (SD) age at outreach was 43.8 (9.9) years, and most (2233 of 3063 [72.9%]) were women. A total of 204 patients (7.3%) were Black, 317 (11.4%) were Latinx, and 2094 (75.0%) were White. The estimated percentage point difference for completion of pretest cancer genetic services between groups was 2.0 (95% CI, -1.1 to 5.0). The estimated percentage point difference for completion of genetic testing was -1.3 (95% CI, -3.7 to 1.1). Analyses suggested equivalence in the primary outcomes. Conclusions and Relevance: The findings of the BRIDGE equivalence trial support the use of chatbot approaches to offer cancer genetic services. Chatbot tools can be a key component of sustainable and scalable population health management strategies to enhance access to cancer genetic services. Trial Registration: ClinicalTrials.gov Identifier: NCT03985852.

Differentiation of Prior SARS-CoV-2 Infection and Postacute Sequelae by Standard Clinical Laboratory Measurements in the RECOVER Cohort.

BACKGROUND: There are currently no validated clinical biomarkers of postacute sequelae of SARS-CoV-2 infection (PASC). OBJECTIVE: To investigate clinical laboratory markers of SARS-CoV-2 and PASC. DESIGN: Propensity score-weighted linear regression models were fitted to evaluate differences in mean laboratory measures by prior infection and PASC index (≥12 vs. 0). (ClinicalTrials.gov: NCT05172024). SETTING: 83 enrolling sites. PARTICIPANTS: RECOVER-Adult cohort participants with or without SARS-CoV-2 infection with a study visit and laboratory measures 6 months after the index date (or at enrollment if >6 months after the index date). Participants were excluded if the 6-month visit occurred within 30 days of reinfection. MEASUREMENTS: Participants completed questionnaires and standard clinical laboratory tests. RESULTS: Among 10 094 participants, 8746 had prior SARS-CoV-2 infection, 1348 were uninfected, 1880 had a PASC index of 12 or higher, and 3351 had a PASC index of zero. After propensity score adjustment, participants with prior infection had a lower mean platelet count (265.9 × 109 cells/L [95% CI, 264.5 to 267.4 × 109 cells/L]) than participants without known prior infection (275.2 × 109 cells/L [CI, 268.5 to 282.0 × 109 cells/L]), as well as higher mean hemoglobin A1c (HbA1c) level (5.58% [CI, 5.56% to 5.60%] vs. 5.46% [CI, 5.40% to 5.51%]) and urinary albumin-creatinine ratio (81.9 mg/g [CI, 67.5 to 96.2 mg/g] vs. 43.0 mg/g [CI, 25.4 to 60.6 mg/g]), although differences were of modest clinical significance. The difference in HbA1c levels was attenuated after participants with preexisting diabetes were excluded. Among participants with prior infection, no meaningful differences in mean laboratory values were found between those with a PASC index of 12 or higher and those with a PASC index of zero. LIMITATION: Whether differences in laboratory markers represent consequences of or risk factors for SARS-CoV-2 infection could not be determined. CONCLUSION: Overall, no evidence was found that any of the 25 routine clinical laboratory values assessed in this study could serve as a clinically useful biomarker of PASC. PRIMARY FUNDING SOURCE: National Institutes of Health.

Discordant Treatment Goals for Patients With Atrial Fibrillation and Clinical Trials Metrics.

BACKGROUND: Most clinical trials define successful atrial fibrillation (AF) treatment as no AF episodes longer than 30 seconds. Yet, there has been minimal study of how patients define successful treatment and whether their perspectives align with trial outcomes. OBJECTIVES: Survey patients with AF to identify: 1) what aspect of AF is most important to address (frequency, duration, or severity of AF episodes); 2) what AF burden would be considered acceptable to consider treatment successful; and 3) to establish patient preferences for successful treatment thresholds for a validated patient-reported outcome (PRO) score. METHODS: We surveyed patients receiving active care for AF at a single tertiary care center modeled after the Toronto AF Severity Scale (AFSS). The survey consisted of current and "successful treatment" AF frequency, burden, and symptom domains; and baseline socioeconomic information. RESULTS: Of 7,000 invitations, 852 individuals completed the survey (12% response) with a mean age of 65 ± 13 years, 36.5% were female, and they had a mean CHA2DS2-VAsc score of 2.9 ± 1.9. Overall, 114 (13%) selected a decrease in AF episode duration as their top treatment priority, 505 (59%) episode frequency, and 230 (27%) episode severity. Overall, 207 (24%) patients would only consider a treatment successful if they never had AF again, whereas 645 (76%) patients considered success to be fewer AF episodes. A total of 341 (40%) patients would only consider a treatment successful if AF episodes lasted less than a few minutes, whereas 509 (60%) patients would accept AF episodes lasting >30 minutes. An AFSS symptom score ≤5 was considered a good outcome by 80% of respondents. CONCLUSIONS: Patients prioritize decreased AF frequency over improvements in severity or duration, and an AFSS ≤5 would be a reasonable outcome of AF treatment. Most patients would consider treatment successful if they had more than 1 AF episode lasting longer than 30 seconds. Future clinical trial design should consider patients' perspectives when designing outcomes.

Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.

Importance: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. Objective: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. Design, Setting, and Participants: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. Exposures: Randomized exposure to 81 mg or 325 mg of aspirin daily. Main Outcomes and Measures: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. Results: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. Conclusions and Relevance: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

Post-Acute Sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Infection During Pregnancy.

OBJECTIVE: To estimate the prevalence of post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) after infection with SARS-CoV-2 during pregnancy and to characterize associated risk factors. METHODS: In a multicenter cohort study (NIH RECOVER [Researching COVID to Enhance Recovery]-Pregnancy Cohort), individuals who were pregnant during their first SARS-CoV-2 infection were enrolled across the United States from December 2021 to September 2023, either within 30 days of their infection or at differential time points thereafter. The primary outcome was PASC , defined as score of 12 or higher based on symptoms and severity as previously published by the NIH RECOVER-Adult Cohort, at the first study visit at least 6 months after the participant's first SARS-CoV-2 infection. Risk factors for PASC were evaluated, including sociodemographic characteristics, clinical characteristics before SARS-CoV-2 infection (baseline comorbidities, trimester of infection, vaccination status), and acute infection severity (classified by need for oxygen therapy). Multivariable logistic regression models were fitted to estimate associations between these characteristics and presence of PASC. RESULTS: Of the 1,502 participants, 61.1% had their first SARS-CoV-2 infection on or after December 1, 2021 (ie, during Omicron variant dominance); 51.4% were fully vaccinated before infection; and 182 (12.1%) were enrolled within 30 days of their acute infection. The prevalence of PASC was 9.3% (95% CI, 7.9-10.9%) measured at a median of 10.3 months (interquartile range 6.1-21.5) after first infection. The most common symptoms among individuals with PASC were postexertional malaise (77.7%), fatigue (76.3%), and gastrointestinal symptoms (61.2%). In a multivariable model, the proportion PASC positive with vs without history of obesity (14.9% vs 7.5%, adjusted odds ratio [aOR] 1.65, 95% CI, 1.12-2.43), depression or anxiety disorder (14.4% vs 6.1%, aOR 2.64, 95% CI, 1.79-3.88) before first infection, economic hardship (self-reported difficulty covering expenses) (12.5% vs 6.9%, aOR 1.57, 95% CI, 1.05-2.34), and treatment with oxygen during acute SARS-CoV-2 infection (18.1% vs 8.7%, aOR 1.86, 95% CI, 1.00-3.44) were associated with increased prevalence of PASC. CONCLUSION: The prevalence of PASC at a median time of 10.3 months after SARS-CoV-2 infection during pregnancy was 9.3% in the NIH RECOVER-Pregnancy Cohort. The predominant symptoms were postexertional malaise, fatigue, and gastrointestinal symptoms. Several socioeconomic and clinical characteristics were associated with PASC after infection during pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05172024.

Lung Cancer Screening Before and After a Multifaceted Electronic Health Record Intervention: A Nonrandomized Controlled Trial.

Importance: Lung cancer is the deadliest cancer in the US. Early-stage lung cancer detection with lung cancer screening (LCS) through low-dose computed tomography (LDCT) improves outcomes. Objective: To assess the association of a multifaceted clinical decision support intervention with rates of identification and completion of recommended LCS-related services. Design, Setting, and Participants: This nonrandomized controlled trial used an interrupted time series design, including 3 study periods from August 24, 2019, to April 27, 2022: baseline (12 months), period 1 (11 months), and period 2 (9 months). Outcome changes were reported as shifts in the outcome level at the beginning of each period and changes in monthly trend (ie, slope). The study was conducted at primary care and pulmonary clinics at a health care system headquartered in Salt Lake City, Utah, among patients aged 55 to 80 years who had smoked 30 pack-years or more and were current smokers or had quit smoking in the past 15 years. Data were analyzed from September 2023 through February 2024. Interventions: Interventions in period 1 included clinician-facing preventive care reminders, an electronic health record-integrated shared decision-making tool, and narrative LCS guidance provided in the LDCT ordering screen. Interventions in period 2 included the same clinician-facing interventions and patient-facing reminders for LCS discussion and LCS. Main Outcome and Measure: The primary outcome was LCS care gap closure, defined as the identification and completion of recommended care services. LCS care gap closure could be achieved through LDCT completion, other chest CT completion, or LCS shared decision-making. Results: The study included 1865 patients (median [IQR] age, 64 [60-70] years; 759 female [40.7%]). The clinician-facing intervention (period 1) was not associated with changes in level but was associated with an increase in slope of 2.6 percentage points (95% CI, 2.4-2.7 percentage points) per month in care gap closure through any means and 1.6 percentage points (95% CI, 1.4-1.8 percentage points) per month in closure through LDCT. In period 2, introduction of patient-facing reminders was associated with an immediate increase in care gap closure (2.3 percentage points; 95% CI, 1.0-3.6 percentage points) and closure through LDCT (2.4 percentage points; 95% CI, 0.9-3.9 percentage points) but was not associated with an increase in slope. The overall care gap closure rate was 175 of 1104 patients (15.9%) at the end of the baseline period vs 588 of 1255 patients (46.9%) at the end of period 2. Conclusions and Relevance: In this study, a multifaceted intervention was associated with an improvement in LCS care gap closure. Trial Registration: ClinicalTrials.gov Identifier: NCT04498052.

Ambulatory antibiotic prescription rates for acute respiratory infection rebound two years after the start of the COVID-19 pandemic.

BACKGROUND: During the COVID-19 pandemic, acute respiratory infection (ARI) antibiotic prescribing in ambulatory care markedly decreased. It is unclear if antibiotic prescription rates will remain lowered. METHODS: We used trend analyses of antibiotics prescribed during and after the first wave of COVID-19 to determine whether ARI antibiotic prescribing rates in ambulatory care have remained suppressed compared to pre-COVID-19 levels. Retrospective data was used from patients with ARI or UTI diagnosis code(s) for their encounter from 298 primary care and 66 urgent care practices within four academic health systems in New York, Wisconsin, and Utah between January 2017 and June 2022. The primary measures included antibiotic prescriptions per 100 non-COVID ARI encounters, encounter volume, prescribing trends, and change from expected trend. RESULTS: At baseline, during and after the first wave, the overall ARI antibiotic prescribing rates were 54.7, 38.5, and 54.7 prescriptions per 100 encounters, respectively. ARI antibiotic prescription rates saw a statistically significant decline after COVID-19 onset (step change -15.2, 95% CI: -19.6 to -4.8). During the first wave, encounter volume decreased 29.4% and, after the first wave, remained decreased by 188%. After the first wave, ARI antibiotic prescription rates were no longer significantly suppressed from baseline (step change 0.01, 95% CI: -6.3 to 6.2). There was no significant difference between UTI antibiotic prescription rates at baseline versus the end of the observation period. CONCLUSIONS: The decline in ARI antibiotic prescribing observed after the onset of COVID-19 was temporary, not mirrored in UTI antibiotic prescribing, and does not represent a long-term change in clinician prescribing behaviors. During a period of heightened awareness of a viral cause of ARI, a substantial and clinically meaningful decrease in clinician antibiotic prescribing was observed. Future efforts in antibiotic stewardship may benefit from continued study of factors leading to this reduction and rebound in prescribing rates.

Barriers to Implementing Registered Nurse-Driven Clinical Decision Support for Antibiotic Stewardship: Retrospective Case Study.

BACKGROUND: Up to 50% of antibiotic prescriptions for upper respiratory infections (URIs) are inappropriate. Clinical decision support (CDS) systems to mitigate unnecessary antibiotic prescriptions have been implemented into electronic health records, but their use by providers has been limited. OBJECTIVE: As a delegation protocol, we adapted a validated electronic health record-integrated clinical prediction rule (iCPR) CDS-based intervention for registered nurses (RNs), consisting of triage to identify patients with low-acuity URI followed by CDS-guided RN visits. It was implemented in February 2022 as a randomized controlled stepped-wedge trial in 43 primary and urgent care practices within 4 academic health systems in New York, Wisconsin, and Utah. While issues were pragmatically addressed as they arose, a systematic assessment of the barriers to implementation is needed to better understand and address these barriers. METHODS: We performed a retrospective case study, collecting quantitative and qualitative data regarding clinical workflows and triage-template use from expert interviews, study surveys, routine check-ins with practice personnel, and chart reviews over the first year of implementation of the iCPR intervention. Guided by the updated CFIR (Consolidated Framework for Implementation Research), we characterized the initial barriers to implementing a URI iCPR intervention for RNs in ambulatory care. CFIR constructs were coded as missing, neutral, weak, or strong implementation factors. RESULTS: Barriers were identified within all implementation domains. The strongest barriers were found in the outer setting, with those factors trickling down to impact the inner setting. Local conditions driven by COVID-19 served as one of the strongest barriers, impacting attitudes among practice staff and ultimately contributing to a work infrastructure characterized by staff changes, RN shortages and turnover, and competing responsibilities. Policies and laws regarding scope of practice of RNs varied by state and institutional application of those laws, with some allowing more clinical autonomy for RNs. This necessitated different study procedures at each study site to meet practice requirements, increasing innovation complexity. Similarly, institutional policies led to varying levels of compatibility with existing triage, rooming, and documentation workflows. These workflow conflicts were compounded by limited available resources, as well as an implementation climate of optional participation, few participation incentives, and thus low relative priority compared to other clinical duties. CONCLUSIONS: Both between and within health care systems, significant variability existed in workflows for patient intake and triage. Even in a relatively straightforward clinical workflow, workflow and cultural differences appreciably impacted intervention adoption. Takeaways from this study can be applied to other RN delegation protocol implementations of new and innovative CDS tools within existing workflows to support integration and improve uptake. When implementing a system-wide clinical care intervention, considerations must be made for variability in culture and workflows at the state, health system, practice, and individual levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT04255303; https://clinicaltrials.gov/ct2/show/NCT04255303.

Implementing weight maintenance with existing staff and electronic health record tools in a primary care setting: Baseline results from the MAINTAIN PRIME trial.

BACKGROUND: There is need for interventions that can assist with long-term maintenance of healthy body weight and be sustainably integrated into existing primary care teams. The goal of MAINTAIN PRIME (Promoting Real (World) IMplEmentation) is to evaluate whether a successful electronic health record (EHR)-based weight maintenance intervention can be adapted to a new clinical setting with primary care staff serving as coaches. METHODS: EHR tools include tracking tools, standardized surveys, and standardized "SmartPhrases" for coaching. Inclusion criteria were age 18-75 years, voluntary 5% weight loss in the past 2 years with prior BMI ≥ 25 kg/m2, and no bariatric procedures in past 2 years. Participants were randomized 1:1 to tailored online coaching with EHR tracking tools (coaching) or EHR tracking tools alone (tracking). RESULTS: We screened 405 individuals between September 2021 and April 2023; 269 participants enrolled (134 coaching; 135 tracking). The most common reason for not enrolling was ineligibility (55%). At baseline, participants were 50.3 (SD 15.02) years old, 66.4% female, and 84% White; 83.7% reported moderate physical activity. Average weight and BMI at baseline were 205.0 (SD 48.9) lbs. and 33.2 (6.8) kg/m2, respectively. Participants lost an average of 10.7% (SD 5.2) of their body weight before enrolling. We recruited 39 primary care coaches over the same period. Conclusion The study successfully identified and recruited primary care patients with recent intentional weight loss for participation in a weight maintenance program that uses EHR-based tools. We also successfully recruited and trained primary care staff as coaches.

The Role of Sexual Function in Quality of Life Among Midlife and Older Women: The Study of Women's Health Across the Nation.

Objective: To examine how (1) partnered sexual activity, and (2) sexual functioning, contribute to global quality of life (QOL) and health-related quality of life (HRQL) among midlife and older women, and whether importance of sex modifies these associations. Materials and Methods: Women in the Study of Women's Health Across the Nation (SWAN), a multiethnic/racial cohort study, aged 42-52 at recruitment, were followed for ∼20 years. The Ladder of Life and Short Form-36 physical component summary (PCS) and mental component summary (MCS) assessed Global QOL (N = 3,263) and HRQL (N = 2,576), respectively. Primary predictors were (1) having partnered sexual activity (yes/no), and (2) sexual functioning among those with partnered sexual activity. Sociodemographic, health, lifestyle, and psychosocial covariates were included. Results: Importance of sex modified covariate-adjusted association of having partnered sexual activity with global QOL. Adjusted associations of partnered sexual activity with PCS and MCS were not statistically significant. Sexual functioning, among women with partnered sexual activity, was positively associated with global QOL (adjusted p = 0.03), regardless of importance of sex; unrelated to PCS; but positively associated with MCS (adjusted p = 0.03), particularly when sex was "very/quite important." Conclusions: Partnered sexual activity and better sexual functioning are related to QOL for mid-aged and older women, and are stronger when sex is considered important. Partnered sexual activity and sexual functioning are less consistently related to HRQL when adjusted for covariates, and importance modifies only the association between sexual functioning and MCS. Understanding the importance of sex to midlife and older women contextualizes the impact of sex on QOL.

Reducing prescribing of antibiotics for acute respiratory infections using a frontline nurse-led EHR-Integrated clinical decision support tool: protocol for a stepped wedge randomized control trial.

BACKGROUND: Overprescribing of antibiotics for acute respiratory infections (ARIs) remains a major issue in outpatient settings. Use of clinical prediction rules (CPRs) can reduce inappropriate antibiotic prescribing but they remain underutilized by physicians and advanced practice providers. A registered nurse (RN)-led model of an electronic health record-integrated CPR (iCPR) for low-acuity ARIs may be an effective alternative to address the barriers to a physician-driven model. METHODS: Following qualitative usability testing, we will conduct a stepped-wedge practice-level cluster randomized controlled trial (RCT) examining the effect of iCPR-guided RN care for low acuity patients with ARI. The primary hypothesis to be tested is: Implementation of RN-led iCPR tools will reduce antibiotic prescribing across diverse primary care settings. Specifically, this study aims to: (1) determine the impact of iCPRs on rapid strep test and chest x-ray ordering and antibiotic prescribing rates when used by RNs; (2) examine resource use patterns and cost-effectiveness of RN visits across diverse clinical settings; (3) determine the impact of iCPR-guided care on patient satisfaction; and (4) ascertain the effect of the intervention on RN and physician burnout. DISCUSSION: This study represents an innovative approach to using an iCPR model led by RNs and specifically designed to address inappropriate antibiotic prescribing. This study has the potential to provide guidance on the effectiveness of delegating care of low-acuity patients with ARIs to RNs to increase use of iCPRs and reduce antibiotic overprescribing for ARIs in outpatient settings. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04255303, Registered February 5 2020, https://clinicaltrials.gov/ct2/show/NCT04255303 .

Food Insecurity Disparities Among Immigrants in the U.S.

Introduction: Food insecurity negatively impacts public health and costs the U.S. healthcare system $53 billion annually. Immigrants are at higher risk of food insecurity. We sought to (1) characterize the prevalence of food insecurity among immigrants (i.e., noncitizens and naturalized citizens) and U.S.-born citizens and (2) determine whether Supplemental Nutrition Assistance Program utilization and income-poverty ratio levels impact the relationship between immigration status and food insecurity. Methods: Multivariable logistic regression models were used to determine the odds of food insecurity (dependent variables) using nationally representative data from the 2019-2020 National Health Interview Survey. Independent variables included immigration status, Supplemental Nutrition Assistance Program utilization, income-poverty ratio, and other important demographics. AORs with their 95% CIs are reported. Analysis was conducted in 2022. Results: After controlling for independent variables, noncitizens had 1.28 (95% CI=1.02, 1.61) times higher odds of food insecurity than U.S.-born citizens. There was no food insecurity disparity between naturalized citizens and U.S.-born citizens. However, the association between immigration status and food insecurity varied significantly at different levels of Supplemental Nutrition Assistance Program utilization and income-poverty ratio. There were no food insecurity disparities between immigrants and U.S.-born citizens when they utilized the Supplemental Nutrition Assistance Program and when they had an income below 200% federal poverty level. Noncitizens who did not utilize the Supplemental Nutrition Assistance Program or those with an income above 200% federal poverty level were more likely to report food insecurity than their U.S.-born counterparts (AOR=1.32, 95% CI=1.01, 1.73 and AOR=1.88, 95% CI=1.24, 2.86, respectively). Moreover, naturalized citizens with an income above 200% federal poverty level were also more likely to report food insecurity than their U.S.-born counterparts (AOR=1.61, 95% CI=1.21, 2.14). Conclusions: Supplemental Nutrition Assistance Program utilization may likely eliminate food insecurity disparities among immigrants and U.S.-born citizens. However, among non-Supplemental Nutrition Assistance Program utilizers, significant food insecurity disparities remained between noncitizens and U.S.-born citizens after adjusting for independent variables. In addition, among individuals with incomes above 200% federal poverty level, significant food insecurity disparities were observed between immigrants and U.S.-born citizens. More research is needed to further understand the role that fear of deportation, ineligibility or lack of awareness about eligibility for the Supplemental Nutrition Assistance Program, and other factors such as structural racism play in food insecurity disparities between immigrants and U.S.-born citizens.

Relationships between the vaginal microbiota and genitourinary syndrome of menopause symptoms in postmenopausal women: the Study of Women's Health Across the Nation.

OBJECTIVE: To describe vaginal microbiota classified by community state types (CST) in a diverse cohort of postmenopausal women and evaluate relationships among genitourinary syndrome of menopause (GSM) symptoms (vaginal dryness, vulvovaginal irritation, sexual pain, dysuria, urinary urgency), CSTs, estrogen, vaginal maturation index (VMI), and vaginal pH. METHODS: In the Study of Women's Health Across the Nation, 1,320 women aged 60.4 to 72.5 years self-collected (2015-2017) vaginal samples analyzed for microbiota composition and structure (CSTs) using 16S rRNA gene amplicon sequencing, VMI, and pH. GSM symptoms were collected with self-administered questionnaires; interviewers elicited estrogen use and measured body mass index. Serum E2 and E1 were measured using high-performance liquid chromatography. We analyzed data using Pearson χ2 tests, analysis of variance, Kruskal-Wallis tests, and binomial logistic regression. RESULTS: The most frequently occurring CST was low Lactobacillus species IV-C (49.8%); 36.4% of women had CSTs dominated by Lactobacillus species. More than half of the women with vaginal atrophy biomarkers (VMI <50 and pH >5) had CST IV-C0, whereas women using estrogen or with higher E1 and E2 levels had a higher prevalence of Lactobacillus crispatus -dominated CST I ( P values < 0.001). Sexual pain was associated with atrophy biomarkers and independently associated with Streptococcus species-dominated CST IV-C1 (odds ratio, 2.26; 95% confidence intervals, 1.20-4.23). For all other GSM symptoms, we found no consistent associations with E1 or E2 levels, atrophy biomarkers, or any CST. CONCLUSIONS: Although close relationships exist among estrogen, CSTs, VMI, and pH, sexual pain was the only GSM symptom associated with the structure of vaginal microbiota and atrophy biomarkers.

Disparities in food insecurity between sexual minority and heterosexual adults - a higher burden on bisexual individuals.

Background: Sexual minorities-individuals who identify as gay/lesbian, bisexual, or other non-heterosexual individuals-experience higher rates of food insecurity (FI) compared to heterosexual individuals. During the COVID-19 pandemic, discrimination and structural racism, which are known risk factors for food insecurity, were perpetuated against sexual and racial/ethnic minorities. However, to our knowledge, a nationally representative analysis of the impact of the pandemic on food insecurity by sexual minority status and based on race/ethnicity is missing. We aimed to determine the degree of association between FI and sexual minority adults overall, before (2019) and during (2020-2021) the pandemic, and stratified by race/ethnicity. Methods: We used nationally representative data from the 2019-2021 National Health Interview Survey (NHIS). We specified multivariable logistic regression models to determine the association between FI and identifying as a sexual minority adult (≥18 years old), including gay/lesbian, bisexual, and other non-heterosexual individuals. Results: Overall, we only observed FI disparities between bisexuals and heterosexuals (aOR 1.61 [95% CI 1.31-1.99]). Stratified by year, this association was significant only during the pandemic. Stratified by race/ethnicity, non-Hispanic white and non-Hispanic black individuals identifying as bisexual also experienced a significantly higher FI rate than their heterosexual counterparts. Conclusion: Our results may be a manifestation of the disproportionate impact of discrimination on bisexual individuals' FI experiences. With the growing number of legislative bills targeting the rights of sexual minorities, we expect to see a higher burden of FI among bisexuals, particularly, bisexual people of color. Future intersectional research regarding FI among bisexual and racial/ethnic minority individuals would further elucidate how membership in multiple minority groups may contribute to a higher risk of FI.

The STOP COVID 2 Study: Fluvoxamine vs Placebo for Outpatients With Symptomatic COVID-19, a Fully Remote Randomized Controlled Trial.

Background: Prior randomized clinical trials have reported benefit of fluvoxamine ≥200 mg/d vs placebo for patients infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: This randomized, double-blind, placebo-controlled, fully remote multisite clinical trial evaluated whether fluvoxamine prevents clinical deterioration in higher-risk outpatients with acute coronavirus disease 2019 (COVID-19). Between December 2020 and May 2021, nonhospitalized US and Canadian participants with confirmed symptomatic infection received fluvoxamine (50 mg on day 1, 100 mg twice daily thereafter) or placebo for 15 days. The primary modified intent-to-treat (mITT) population included participants who started the intervention within 7 days of symptom onset with a baseline oxygen saturation ≥92%. The primary outcome was clinical deterioration within 15 days of randomization, defined as having both (1) shortness of breath (severity ≥4 on a 0-10 scale or requiring hospitalization) and (2) oxygen saturation <92% on room air or need for supplemental oxygen. Results: A total of 547 participants were randomized and met mITT criteria (n = 272 fluvoxamine, n = 275 placebo). The Data Safety Monitoring Board recommended stopping early for futility related to lower-than-predicted event rates and declining accrual concurrent with vaccine availability in the United States and Canada. Clinical deterioration occurred in 13 (4.8%) participants in the fluvoxamine group and 15 (5.5%) participants in the placebo group (absolute difference at day 15, 0.68%; 95% CI, -3.0% to 4.4%; log-rank P = .91). Conclusions: This trial did not find fluvoxamine efficacious in preventing clinical deterioration in unvaccinated outpatients with symptomatic COVID-19. It was stopped early and underpowered due to low primary outcome rates. Clinical Trials Registration: ClinicalTrials.gov Identifier: NCT04668950.

Atopic Dermatitis: A Qualitative Study on the Burdens of Living with Itchiness.

Objective: We sought to understand the consequences itchiness has on daily life that may not be immediately obvious in clinical assessments for patients with atopic dermatitis (AD). Methods: Focus groups and interviews involving 21 patients with AD and 12 family members examined aspects of the effects of itchiness on health-related quality of life (HRQL). Investigators conducted a thematic analysis where two researchers independently coded the narratives and arrived at a consensus on major themes. Results: Five themes emerged from our discussions. 1) Miserable experience: Itchiness was difficult to control and cease. 2) Physical damage: Damage to skin and hair occurred from scratching to alleviate the itchiness. 3) Effects on daily activities: Itchiness could affect everything participants did, including how they dressed, used make-up, and slept. 4) Effects on social activities and relationships: The discomfort and embarrassment from scratching in public and others' reactions hindered participants' social lives. 5) Emotional consequences: Various emotional responses to itchiness were reported, including embarrassment, depression, and irritation. Limitations: Though qualitative research provides a level of detail not often found in quantitative analyses, this study design is limited by small sample size and generalizability. Conclusion: Understanding these challenges can help clinicians open deeper conversations with their patients to learn more about what patients need from their dermatologic care. While itchiness from AD is well-known, this study shows that its effects on HRQL are not minimal and that patients may need further care for the consequences of this symptom.

Lifestyle strategies after intentional weight loss: results from the MAINTAIN-pc randomized trial.

Introduction/Purpose: Weight maintenance following intentional weight loss is challenging and often unsuccessful. Physical activity and self-monitoring are strategies associated with successful weight loss maintenance. However, less is known about the type and number of lifestyle strategies used following intentional weight loss. The purpose of this study was to determine the types and amounts of strategies associated with successful long-term weight loss maintenance. Methods: Data from the 24-month Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) trial were analyzed. MAINTAIN-pc recruited adults (n=194; 53.4±12.2 years of age, body mass index (BMI): 30.4±5.9 kg/m2, 74% female) with recent intentional weight loss of ≥5%, randomized to tracking tools plus coaching (i.e., coaching group) or tracking tools without coaching (i.e., tracking-only group). At baseline, 6, 12, and 24 months, participants reported lifestyle strategies used in the past 6 months, including self-monitoring, group support, behavioral skills, and professional support. General linear models evaluated changes in the number of strategies over time between groups and the consistency of strategies used over the 24-month intervention. Results: At baseline, 100% used behavioral skills, 73% used group support, 69% used self-monitoring, and 68% used professional support in the past 6 months; at 24 months, these rates were 98%, 60%, 75%, and 61%, respectively. While the number of participants utilizing individual strategies did not change significantly over time, the overall number of strategies participants reported decreased. More strategies were used at baseline and 6 months compared to 12- and 24-month follow-ups. The coaching group used more strategies at months 6 and 12 than the tracking-only group. Consistent use of professional support strategies over the 24-month study period was associated with less weight regain. Conclusion: Weight loss maintenance interventions that incorporate continued follow-up and support from healthcare professionals are likely to prevent weight regain after intentional weight loss.