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Item Changes in Care during the COVID-19 Pandemic for People with Cystic Fibrosis(American Thoracic Society, 2022) Sanders, Don B.; Wu, Runyu; O’Neil, Tom; Elbert, Alexander; Petren, Kris; Jain, Raksha; Ren, Clement L.; Pediatrics, School of MedicineRationale: Cystic fibrosis (CF) centers transitioned to telemedicine during the spring 2020 peak of the coronavirus disease (COVID-19) pandemic. Objectives: We hypothesized that people with CF (pwCF) with more severe disease would be more likely to be seen in-person. Methods: We used paired t tests to compare within-subject changes in body mass index (BMI) and percentage predicted forced expiratory volume in one second (FEV1) and calculated relative risk (RR) to compare pulmonary exacerbations (PEx) between pwCF enrolled in the CF Foundation Patient Registry with at least one in-person clinic visit after March 15 in both 2019 and 2020. Results: Overall, the proportion of clinical encounters that were in-person clinic visits decreased from 91% in 2019 to a low of 9% in April 2020. Among pwCF seen after March 15 in both 2019 and 2020, the mean (95% confidence interval [CI]) FEV1 percentage predicted was 1.3% (0.1-2.4) predicted higher in 2020 for children 6 to <12 years of age, and 7.5% (7.1-7.9) predicted higher in 2020 among pwCF ⩾12 years of age eligible for the highly effective CF transmembrane conductance regulator modulator, elexacaftor-tezacaftor-ivacaftor (ETI). There was no difference in FEV1 percentage predicted for pwCF ⩾12 years of age who were not eligible for ETI. Similarly, the mean (95% CI) BMI was 2.4 (2.0-2.8) percentile higher in 2020 for children 6 to <12 years of age and 5.2 (4.8-5.7) percentile higher in 2020 among children 12 to <18 years of age eligible for ETI. Mean (95% CI) BMI was 1.2 (1.2-1.3) (kg/m2) higher for pwCF ⩾18 years of age eligible for ETI, and 0.2 (0.1-0.3) (kg/m2) higher for pwCF ⩾18 years of age not eligible for ETI. The proportion of in-person clinic visits where any PEx was present was lower in 2020 compared with 2019, 25% compared with 38%, RR 0.82 (0.79-0.86). Conclusions: The care of pwCF was substantially changed during the spring 2020 peak of the COVID-19 pandemic. Among pwCF seen in-person in both 2019 and 2020 after the spring peak of the COVID-19 pandemic, lung function and BMI were higher in 2020 for children 6 to <12 years of age and pwCF eligible for ETI.Item Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial(American Medical Association, 2021) Collins, Sean P.; Liu, Dandan; Jenkins, Cathy A.; Storrow, Alan B.; Levy, Phillip D.; Pang, Peter S.; Chang, Anna Marie; Char, Douglas; Diercks, Deborah J.; Fermann, Gregory J.; Han, Jin H.; Hiestand, Brian; Hogan, Christopher; Kampe, Christina J.; Khan, Yosef; Lee, Sangil; Lindenfeld, JoAnn; Martindale, Jennifer; McNaughton, Candace D.; Miller, Karen F.; Miller-Reilly, Carolyn; Moser, Kelly; Peacock, W. Frank; Robichaux, Chad; Rothman, Russell; Schrock, Jon; Self, Wesley H.; Singer, Adam J.; Sterling, Sarah A.; Ward, Michael J.; Walsh, Cheryl; Butler, Javed; Emergency Medicine, School of MedicineImportance: Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients. Objective: To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED. Design, setting, and participants: Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019. Interventions: Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months. Main outcomes and measures: The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm. Results: Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, -1.9 to 7.2; P = .25). Conclusions and relevance: The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days.Item Effectiveness of Homologous and Heterologous COVID-19 Booster Doses Following 1 Ad.26.COV2.S (Janssen [Johnson & Johnson]) Vaccine Dose Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults - VISION Network, 10 States, December 2021-March 2022(Center for Disease Control, 2022-04-01) Natarajan, Karthik; Prasad, Namrata; Dascomb, Kristin; Irving, Stephanie A.; Yang, Duck-Hye; Gaglani, Manjusha; Klein, Nicola P.; DeSilva, Malini B.; Ong, Toan C.; Grannis, Shaun J.; Stenehjem, Edward; Link-Gelles, Ruth; Rowley, Elizabeth A.; Naleway, Allison L.; Han, Jungmi; Raiyani, Chandni; Vazquez Benitez, Gabriela; Rao, Suchitra; Lewis, Ned; Fadel, William F.; Grisel, Nancy; Griggs, Eric P.; Dunne, Margaret M.; Stockwell, Melissa S.; Mamawala, Mufaddal; McEvoy, Charlene; Barron, Michelle A.; Goddard, Kristin; Valvi, Nimish R.; Arndorfer, Julie; Patel, Palak; Mitchell, Patrick K.; Smith, Michael; Kharbanda, Anupam B.; Fireman, Bruce; Embi, Peter J.; Dickerson, Monica; Davis, Jonathan M.; Zerbo, Ousseny; Dalton, Alexandra F.; Wondimu, Mehiret H.; Azziz-Baumgartner, Eduardo; Bozio, Catherine H.; Reynolds, Sue; Ferdinands, Jill; Williams, Jeremiah; Schrag, Stephanie J.; Verani, Jennifer R.; Ball, Sarah; Thompson, Mark G.; Dixon, Brian E.; Community and Global Health, Richard M. Fairbanks School of Public HealthCDC recommends that all persons aged ≥18 years receive a single COVID-19 vaccine booster dose ≥2 months after receipt of an Ad.26.COV2.S (Janssen [Johnson & Johnson]) adenovirus vector-based primary series vaccine; a heterologous COVID-19 mRNA vaccine is preferred over a homologous (matching) Janssen vaccine for booster vaccination. This recommendation was made in light of the risks for rare but serious adverse events following receipt of a Janssen vaccine, including thrombosis with thrombocytopenia syndrome and Guillain-Barré syndrome† (1), and clinical trial data indicating similar or higher neutralizing antibody response following heterologous boosting compared with homologous boosting (2). Data on real-world vaccine effectiveness (VE) of different booster strategies following a primary Janssen vaccine dose are limited, particularly during the period of Omicron variant predominance. The VISION Network§ determined real-world VE of 1 Janssen vaccine dose and 2 alternative booster dose strategies: 1) a homologous booster (i.e., 2 Janssen doses) and 2) a heterologous mRNA booster (i.e., 1 Janssen dose/1 mRNA dose). In addition, VE of these booster strategies was compared with VE of a homologous booster following mRNA primary series vaccination (i.e., 3 mRNA doses). The study examined 80,287 emergency department/urgent care (ED/UC) visits¶ and 25,244 hospitalizations across 10 states during December 16, 2021-March 7, 2022, when Omicron was the predominant circulating variant.** VE against laboratory-confirmed COVID-19-associated ED/UC encounters was 24% after 1 Janssen dose, 54% after 2 Janssen doses, 79% after 1 Janssen/1 mRNA dose, and 83% after 3 mRNA doses. VE for the same vaccination strategies against laboratory-confirmed COVID-19-associated hospitalizations were 31%, 67%, 78%, and 90%, respectively. All booster strategies provided higher protection than a single Janssen dose against ED/UC visits and hospitalizations during Omicron variant predominance. Vaccination with 1 Janssen/1 mRNA dose provided higher protection than did 2 Janssen doses against COVID-19-associated ED/UC visits and was comparable to protection provided by 3 mRNA doses during the first 120 days after a booster dose. However, 3 mRNA doses provided higher protection against COVID-19-associated hospitalizations than did other booster strategies during the same time interval since booster dose. All adults who have received mRNA vaccines for their COVID-19 primary series vaccination should receive an mRNA booster dose when eligible. Adults who received a primary Janssen vaccine dose should preferentially receive a heterologous mRNA vaccine booster dose ≥2 months later, or a homologous Janssen vaccine booster dose if mRNA vaccine is contraindicated or unavailable. Further investigation of the durability of protection afforded by different booster strategies is warranted.Item An elective course on current concepts in adult ambulatory care(American Association of Colleges of Pharmacy, 2014-12-15) Vincent, Ashley H.; Weber, Zachary A.; Medicine Faculty Volunteers, School of MedicineObjective. To design and evaluate a doctor of pharmacy course exploring disease states commonly encountered in ambulatory care, while applying literature to clinical practice and promoting a continual learning mindset. Design. This elective incorporated a learner-centered teaching approach. Each week, 2 groups of students were assigned a clinical trial to present to their peers. The focus was on clinical application and impact, rather than literature evaluation. A social networking group on Facebook was used to expose students to pharmacy information outside the classroom. Assessment. Student grades were determined by multiple activities: presentations, participation and moderation of the Facebook group, class participation, quiz scores, and quiz question development. Course evaluations served as a qualitative assessment of student learning and perceptions, quizzes were the most objective assessment of student learning, and presentation evaluations were the most directed assessment of course goals. Conclusion. This elective was an innovative approach to teaching ambulatory care that effectively filled a curricular void. Successful attainment of the primary course goals and objectives was demonstrated through course evaluations, surveys, and quiz and presentation scores.Item Identification of barriers and beliefs influencing engagement by adult and teen Mexican-Americans in oral health behaviors(Dennis Barber, Ltd., 2016-03) Aguirre-Zero, Odette; Westerhold, C.; Goldsworthy, R.; Maupomé, G.; Biomedical and Applied Sciences, School of DentistryOBJECTIVE: To identify barriers and beliefs influencing oral health and dental care-seeking among Mexican-Americans. RESEARCH DESIGN: Interviews and Likert-scale survey questions were utilized to explore urgent and preventive dental care-seeking, oral hygiene habits and lifestyle practices. Thirty-three interviews were conducted with 16 adults (ages 33-52), and 17 adolescents (ages 14-19). RESULTS: Teens identified the same main barriers to accessing dental care as adults: high cost, financial limitations and lack of insurance. Most Mexican-Americans agreed with the belief that everyone will need urgent dental treatment and the majority believed that going to a dentist in private practice instead of the Emergency Room was important. Although adults recognized the importance of preventive dental care, half reported being unlikely to seek such care while half of teens reported that they were likely to do so. Adults reported relying equally on themselves and on peers to make dental care decisions, while teens mostly depended on others to make decisions about urgent and preventive care. Virtually all respondents believed regular brushing to be important and many flossing too. A major barrier to flossing was being unsure of the proper technique. Another barrier to better oral health was not having seen messages encouraging changes in lifestyle. CONCLUSIONS: This study found that Mexican-American teens and adults may experience oral health similarly. Teens do not have more positive oral health beliefs and encounter mostly the same barriers to care as adults.Item Predictors of pulmonary exacerbation treatment in cystic fibrosis(Elsevier, 2020-05) Sanders, Don B.; Ostrenga, Joshua S.; Rosenfeld, Margaret; Fink, Aliza K.; Schechter, Michael S.; Sawicki, Gregory S.; Flume, Patrick A.; Morgan, Wayne J.; Pediatrics, School of MedicineBackground: Most studies of pulmonary exacerbations (PEx) in cystic fibrosis (CF) focus on intravenous (IV)-treated PEx, though most PEx are treated with oral antibiotics. Our objectives were to describe predictors of antibiotic choice and outcomes for PEx initially identified in clinic. Methods: For each patient in the U.S. CF Foundation Patient Registry, we selected the first PEx recorded at a clinic visit in 2013-14 following a clinic visit without a PEx. We used multivariable logistic regression to determine associations between clinical characteristics and antibiotic treatment choice. We determined outcomes in the 90 days after the first PEx. Results: Among 14,265 patients with a PEx initially identified in clinic, 21.4% received no antibiotics, 61.5% received new oral and/or inhaled antibiotics, and 17.0% had IV antibiotics within 14 days. Compared to IV antibiotics, patients more likely to receive new oral and/or inhaled antibiotics: were male, <13 years old, had BMI >10th percentile or 18.5 kg/m2, >90 days between clinic visits, FEV1 > 70% predicted at the PEx, no prior-year IV-treated PEx, FEV1 decline <10% predicted, and private insurance. Following the PEx, 30.3% of patients had no clinical encounters within 90 days. Treatment with IV antibiotics within 90 days occurred for 23.7% treated without antibiotics, 22.8% of new oral and/or inhaled antibiotics, and 27.1% of IV antibiotics. Conclusion: Most PEx identified in clinic are treated with new oral and/or inhaled antibiotics. Markers of disease severity are associated with antibiotic treatment choice. Many patients had no follow-up evaluation within 90 days of treatment.Item Prevalence of pain reports in pediatric primary care and association with demographics, body mass index, and exam findings: a cross-sectional study(BMC, 2018-11-21) Grout, Randall W.; Thompson-Fleming, Rachel; Carroll, Aaron E.; Downs, Stephen M.; Pediatrics, School of MedicineBACKGROUND: Pediatric pain is associated to patient weight and demographics in specialized settings, but pain prevalence and its associated patient attributes in general pediatric outpatient care are unknown. Our objective was to determine the rate of positive pain screenings in pediatric primary care and evaluate the relationship between reported pain and obesity, demographics, and exam findings during routine pediatric encounters. METHODS: Cross-sectional observational study of 26,180 patients ages 2 to 19 seen in five urban pediatric primary care clinics between 2009 and 2016. Data were collected from systematic screening using a computerized clinical decision support system. Multivariable logistic regressions were used to analyze the association between pain reporting and obesity (body mass index), age, sex, race, season, insurance status, clinic site, prior pain reporting, pain reporting method, and exam findings. RESULTS: Pain was reported by the patient or caregiver in 14.9% of visits. In adjusted models, pain reporting was associated with obesity (Odds Ratio (OR) 1.23, 95% Confidence Intervals (CI) 1.11-1.35) and severe obesity (OR 1.32, CI 1.17-1.49); adolescents (OR 1.47, CI 1.33-1.61); and females (OR 1.21, CI 1.12-1.29). Pain reported at the preceding visit increased odds of pain reporting 2.67 times (CI 2.42-2.95). Abnormal abdominal, extremity, ear, nose, throat, and lymph node exams were associated with pain reporting. Pain reporting increased in minority races within clinics that predominantly saw a concordant race. CONCLUSIONS: Pain is common in general pediatric encounters, and occurs more frequently in obese children and those who previously reported pain. Pain reporting may be influenced by seasonal variation and clinic factors. Future pediatric pain screening may be guided by associated risk factors to improve identification and targeted healthcare interventions.Item Segregation by Payer in Obstetrics and Gynecology Residency Ambulatory Care Sites(American Medical Association, 2024-09-03) Vinekar, Kavita; Qasba, Neena; Reiser, Hannah; Banks, Erika; Arora, Kavita S.; Tucker Edmonds, Brownsyne; George, Karen; Obstetrics and Gynecology, School of MedicineImportance: Many teaching hospitals in the US segregate patients by insurance status, with resident clinics primarily composed of publicly insured or uninsured patients and faculty practices seeing privately insured patients. The prevalence of this model in obstetrics and gynecology residencies is unknown. Objectives: To examine the prevalence of payer-based segregation in obstetrics and gynecology residency ambulatory care sites nationally and to compare residents' and program directors' perceptions of differences in quality of care between payer-segregated and integrated sites. Design, setting, and participants: This national survey study included all 6060 obstetrics and gynecology residents and 293 obstetrics and gynecology residency program directors in the US as of January 2023. The proportion of program directors reporting payer segregation was calculated to characterize the national prevalence of this model in obstetrics and gynecology. Perceived differences in care quality were compared between residents and program directors at payer-segregated sites. Main outcome and measures: The primary measure was prevalence of payer-based segregation in obstetrics and gynecology residency programs in the US as reported by residency program directors. The secondary measure was resident and program director perceptions of care quality in these ambulatory care settings. Before study initiation, the study hypothesis was that residents and program directors at ambulatory sites with payer-based segregation would report more disparity in perceived health care quality between resident and faculty practices compared with those from integrated sites. Results: A total of 251 residency program directors (response rate, 85.7%) and 3471 residents (response rate, 57.3%) were included in the study. Resident respondent demographics reflected demographics of obstetrics and gynecology residents nationally in terms of racial and ethnic distribution (6 [0.2%] American Indian or Alaska Native; 425 [13.0%] Asian; 239 [7.3%] Black or African American; 290 [8.9%] Hispanic, Latinx, or Spanish; 7 [0.2%] Native Hawaiian or Other Pacific Islander; 2052 [62.7%] non-Hispanic White; 49 [1.5%] multiracial; 56 [1.7%] other [any race not listed]; and 137 [4.2%] preferred not to say) and geographic distribution (regional prevalence of payer-based segregation: 36 of 53 [67.9%] in the Northeast, 35 of 44 [79.5%] in the Midwest, 43 of 67 [64.2%] in the South, and 13 of 22 [59.1%] in the West), with 2837 respondents (86.9%) identifying as female. Among program directors, 127 (68.3%) reported payer-based segregation in ambulatory care. University programs were more likely to report payer-based segregation compared with community, hybrid, and military programs (63 of 85 [74.1%] vs 31 of 46 [67.4%], 32 of 51 [62.7%], and 0, respectively; P = .04). Residents at payer-segregated programs were less likely than their counterparts at integrated programs to report equal or higher care quality from residents compared with faculty (1662 [68.7%] vs 692 [81.6%] at segregated and integrated programs, respectively; P < .001). Conclusions and relevance: In this survey study of residents and residency program directors, payer-based segregation was prevalent in obstetrics and gynecology residency programs, particularly at university programs. These findings reveal an opportunity for structural reform to promote more equitable care in residency training programs.Item A Telehealth-Based Randomized Controlled Trial: A Model for Outpatients Trials of Off-Label Medications During the COVID-19 Pandemic(Sage, 2021-08) Keyhani, Salomeh; Kelly, J. Daniel; Bent, Stephen; Boscardin, W. John; Shlipak, Michael G.; Leonard, Sam; Abraham, Ann; Lum, Emily; Lau, Nicholas; Austin, Charles; Oldenburg, Catherine E.; Zillich, Allan; Lopez, Lenny; Zhang, Ying; Lietman, Tom; Bravata, Dawn M.; Medicine, School of MedicineThe study was registered at clinicaltrials.gov: NCT04363203Item The VA National Teleneurology Program (NTNP): Implementing Teleneurology to Improve Equitable Access to Outpatient Neurology Care(Springer, 2023) Wilkinson, Jayne; Myers, Laura; Daggy, Joanne; Martin, Holly; Bastin, Grace; Yang, Ziyi; Damush, Teresa; Narechania, Aditi; Schriber, Steve; Williams, Linda S.; Biostatistics and Health Data Science, School of MedicineBackground: Telehealth is increasingly utilized in many healthcare systems to improve access to specialty care and better allocate limited resources, especially for rurally residing persons who face unique barriers to care. Objectives: The VHA sought to address critical gaps in access to neurology care by developing and implementing the first outpatient National Teleneurology Program (NTNP). Design: Pre-post evaluation of intervention and control sites. Participants: NTNP sites and VA control sites; Veterans completing an NTNP consult and their referring providers. Intervention: Implementation of the NTNP at participating sites. Main measures: NTNP and community care neurology (CCN) volume of consults before and after implementation; time to schedule and complete consults; Veteran satisfaction. Key results: In FY2021, the NTNP was implemented at 12 VA sites; 1521 consults were placed and 1084 (71.3%) were completed. NTNP consults were scheduled (10.1 vs 29.0 days, p < 0.001) and completed (44.0 vs 96.9 days, p < 0.001) significantly faster than CCN consults. Post-implementation, monthly CCN consult volume was unchanged at NTNP sites compared to pre-implementation (mean change of 4.6 consults per month, [95% CI - 4.3, 13.6]), but control sites had a significant increase (mean change of 24.4 [5.2, 43.7]). The estimated difference in mean change in CCN consults between NTNP and control sites persisted after adjusting for local neurology availability (p < 0.001). Veterans (N = 259) were highly satisfied with NTNP care (mean (SD) overall satisfaction score 6.3 (1.2) on a 7-point Likert scale). Conclusions: Implementation of NTNP resulted in more timely neurologic care than care in the community. The observed significant increase in monthly CCN consults at non-participating sites during the post-implementation period was not seen at NTNP sites. Veterans were highly satisfied with Teleneurology care.