Attitudes Toward COVID-19 Vaccines Among Pregnant and Recently Pregnant Individuals.

Importance: Pregnant people and infants are at high risk of severe COVID-19 outcomes. Understanding changes in attitudes toward COVID-19 vaccines among pregnant and recently pregnant people is important for public health messaging. Objective: To assess attitudinal trends regarding COVID-19 vaccines by (1) vaccination status and (2) race, ethnicity, and language among samples of pregnant and recently pregnant Vaccine Safety Datalink (VSD) members from 2021 to 2023. Design, Setting, and Participants: This cross-sectional surveye study included pregnant or recently pregnant members of the VSD, a collaboration of 13 health care systems and the US Centers for Disease Control and Prevention. Unvaccinated, non-Hispanic Black, and Spanish-speaking members were oversampled. Wave 1 took place from October 2021 to February 2022, and wave 2 took place from November 2022 to February 2023. Data were analyzed from May 2022 to September 2023. Exposures: Self-reported or electronic health record (EHR)-derived race, ethnicity, and preferred language. Main Outcomes and Measures: Self-reported vaccination status and attitudes toward monovalent (wave 1) or bivalent Omicron booster (wave 2) COVID-19 vaccines. Sample- and response-weighted analyses assessed attitudes by vaccination status and 3 race, ethnicity, and language groupings of interest. Results: There were 1227 respondents; all identified as female, the mean (SD) age was 31.7 (5.6) years, 356 (29.0%) identified as Black race, 555 (45.2%) identified as Hispanic ethnicity, and 445 (36.3%) preferred the Spanish language. Response rates were 43.5% for wave 1 (652 of 1500 individuals sampled) and 39.5% for wave 2 (575 of 1456 individuals sampled). Respondents were more likely than nonrespondents to be White, non-Hispanic, and vaccinated per EHR. Overall, 76.8% (95% CI, 71.5%-82.2%) reported 1 or more COVID-19 vaccinations; Spanish-speaking Hispanic respondents had the highest weighted proportion of respondents with 1 or more vaccination. Weighted estimates of somewhat or strongly agreeing that COVID-19 vaccines are safe decreased from wave 1 to 2 for respondents who reported 1 or more vaccinations (76% vs 50%; χ21 = 7.8; P < .001), non-Hispanic White respondents (72% vs 43%; χ21 = 5.4; P = .02), and Spanish-speaking Hispanic respondents (76% vs 53%; χ21 = 22.8; P = .002). Conclusions and Relevance: Decreasing confidence in COVID-19 vaccine safety in a large, diverse pregnant and recently pregnant insured population is a public health concern.

Assessing and Augmenting Predictive Models for Hospital Readmissions With Novel Variables in an Urban Safety-net Population.

BACKGROUND: The performance of existing predictive models of readmissions, such as the LACE, LACE+, and Epic models, is not established in urban safety-net populations. We assessed previously validated predictive models of readmission performance in a socially complex, urban safety-net population, and if augmentation with additional variables such as the Area Deprivation Index, mental health diagnoses, and housing access improves prediction. Through the addition of new variables, we introduce the LACE-social determinants of health (SDH) model. METHODS: This retrospective cohort study included adult admissions from July 1, 2016, to June 30, 2018, at a single urban safety-net health system, assessing the performance of the LACE, LACE+, and Epic models in predicting 30-day, unplanned rehospitalization. The LACE-SDH development is presented through logistic regression. Predictive model performance was compared using C-statistics. RESULTS: A total of 16,540 patients met the inclusion criteria. Within the validation cohort (n=8314), the Epic model performed the best (C-statistic=0.71, P<0.05), compared with LACE-SDH (0.67), LACE (0.65), and LACE+ (0.61). The variables most associated with readmissions were (odds ratio, 95% confidence interval) against medical advice discharge (3.19, 2.28-4.45), mental health diagnosis (2.06, 1.72-2.47), and health care utilization (1.94, 1.47-2.55). CONCLUSIONS: The Epic model performed the best in our sample but requires the use of the Epic Electronic Health Record. The LACE-SDH performed significantly better than the LACE and LACE+ models when applied to a safety-net population, demonstrating the importance of accounting for socioeconomic stressors, mental health, and health care utilization in assessing readmission risk in urban safety-net patients.

Novel Opioid Safety Clinic Initiative to Deliver Guideline-Concordant Chronic Opioid Therapy in Primary Care.

OBJECTIVE: To develop and evaluate a novel Opioid Safety Clinic (OSC) initiative to enhance adherence to guidelines on the assessment and monitoring of patients prescribed chronic opioid therapy (COT). PATIENTS AND METHODS: The OSC was developed at an urban Federally Qualified Health Center to provide guideline-concordant care for COT, standardize workflows, and efficiently use clinic staff. We evaluated the OSC using a matched cohort study. Five hundred thirty-nine patients participated in the clinic between July 1, 2014, and March 31, 2016. Of these, 472 clinic participants were matched to 472 nonparticipants by sex and age on the date of the OSC visit. The OSC was evaluated by its completion rates of standardized pain assessments, urine toxicology, and naloxone dispensings. We conducted logistic regression comparing OSC participants to OSC nonparticipants. RESULTS: A total of 539 patients attended an OSC visit, representing approximately 53% of patients in the chronic opioid registry. The OSC participants were more likely than nonparticipants to have completed a pain assessment (adjusted odds ratio [aOR], 169.8; 95% CI, 98.3-293.5), completed a urine toxicology (aOR, 46.1; 95% CI, 30.4-69.9), or had naloxone dispensed (aOR, 2.8; 95% CI, 1.9-4.3) over 12 months of follow-up. CONCLUSION: The OSC model improved adherence to guideline-concordant COT in primary care. Future research is needed to assess the impact of these interventions on pain, quality of life, and adverse events from opioid analgesics.

RCT of Centralized Vaccine Reminder/Recall for Adults.

INTRODUCTION: A proven, but underutilized, method to increase current low vaccination rates is reminder/recall. Centralized reminder/recall using an Immunization Information System reduces the burden of an individual practice conducting reminder/recall. The objectives were to assess the effectiveness of centralized vaccine reminder/recall on improving adult vaccination rates using Colorado's Immunization Information System. STUDY DESIGN: This study is a pragmatic RCT. SETTING/PARTICIPANTS: Denver Health patients were divided into three strata: 25,039 individuals aged 19-64 years without a high-risk condition for pneumococcal disease, 16,897 individuals aged 19-64 years with a high-risk condition, and 5,332 individuals aged ≥65 years. Data were collected from October 2015 to April 2016 and analyzed between September 2016 and June 2017. INTERVENTION: Adults aged 19-64 years without a high-risk condition who needed influenza or tetanus, diphtheria, acellular pertussis vaccine or both, and adults with a high-risk condition and adults aged ≥65 years who needed influenza, or tetanus, diphtheria, acellular pertussis, or pneumococcal vaccine, or all three vaccines were randomized to receive up to three reminder/recalls or usual care. MAIN OUTCOME MEASURES: Documentation of receipt of any needed vaccine in Immunization Information System ≤6 months after the reminder/recall was the primary outcome. A secondary outcome included implementation costs of the reminder/recall effort. A mixed effects model assessed the association between the intervention and receipt of any needed vaccine while controlling for gender, age, race, ethnicity, insurance type, and history of vaccine refusal. RESULTS: The intervention was associated with receipt of any needed vaccine in the adults aged ≥65 years population (AOR=1.15, 95% CI=1.02, 1.30), but not the other two populations. Influenza vaccine was the source of this difference, with 32.0% receiving a vaccine in intervention versus 28.6% in usual-care groups (p≤0.01). Start-up and implementation costs per person were $0.86. In the population aged ≥65 years, 29.4 patients would need to be contacted to gain one additional vaccination. CONCLUSIONS: Centralized reminder/recall was effective at increasing influenza vaccination rates in adults aged ≥65 years over a short time period, without burdening the practices, and at a reasonable cost. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02133391.

Prediction Model for Two-Year Risk of Opioid Overdose Among Patients Prescribed Chronic Opioid Therapy.

BACKGROUND: Naloxone is a life-saving opioid antagonist. Chronic pain guidelines recommend that physicians co-prescribe naloxone to patients at high risk for opioid overdose. However, clinical tools to efficiently identify patients who could benefit from naloxone are lacking. OBJECTIVE: To develop and validate an overdose predictive model which could be used in primary care settings to assess the need for naloxone. DESIGN: Retrospective cohort. SETTING: Derivation site was an integrated health system in Colorado; validation site was a safety-net health system in Colorado. PARTICIPANTS: We developed a predictive model in a cohort of 42,828 patients taking chronic opioid therapy and externally validated the model in 10,708 patients. MAIN MEASURES: Potential predictors and outcomes (nonfatal pharmaceutical and heroin overdoses) were extracted from electronic health records. Fatal overdose outcomes were identified from state vital records. To match the approximate shelf-life of naloxone, we used Cox proportional hazards regression to model the 2-year risk of overdose. Calibration and discrimination were assessed. KEY RESULTS: A five-variable predictive model showed good calibration and discrimination (bootstrap-corrected c-statistic = 0.73, 95% confidence interval [CI] 0.69-0.78) in the derivation site, with sensitivity of 66.1% and specificity of 66.6%. In the validation site, the model showed good discrimination (c-statistic = 0.75, 95% CI 0.70-0.80) and less than ideal calibration, with sensitivity and specificity of 82.2% and 49.5%, respectively. CONCLUSIONS: Among patients on chronic opioid therapy, the predictive model identified 66-82% of all subsequent opioid overdoses. This model is an efficient screening tool to identify patients who could benefit from naloxone to prevent overdose deaths. Population differences across the two sites limited calibration in the validation site.

Vaccine adverse events in a safety net healthcare system and a managed care organization.

BACKGROUND: The Institute of Medicine, in a 2013 report, recommended that the Vaccine Safety Datalink (VSD) expand collaborations to include more diversity in the study population. Kaiser Permanente Colorado (KPCO), an established VSD site, partnered with Denver Health (DH), an integrated safety net healthcare system, to demonstrate the feasibility of integrating DH data within the VSD. Prior to incorporating the data, we examined the identification of specific vaccine associated adverse events (VAEs) in these two distinct healthcare systems. METHODS: We conducted retrospective cohort analyses within KPCO and DH to compare select VAEs between the two populations. We examined the following associations between January 1, 2004 and December 31, 2013: Measles, Mumps, and Rubella (MMR) vaccine and febrile seizures in children 2years and younger, intussusception after rotavirus vaccine in infants 4-34weeks, syncope after adolescent vaccines (Tetanus, Diphtheria, acellular Pertussis; Meningococcal and Human Papillomavirus) in adolescents 13-17years and medically attended local reactions after pneumococcal polysaccharide (PPSV23) vaccine in adults 65years and older. Both sites used similar data procurement methods and chart review processes. RESULTS: For seizures after MMR vaccine (KPCO - 3.15vs. DH - 2.97/10,000 doses) and syncope after all adolescent vaccines (KPCO - 3.0vs. DH - 2.37/10,000 doses), the chart confirmed rates were comparable at the two sites. However, for medically attended local reactions after PPSV23, there were differences in chart confirmed rates between the sites (KPCO - 31.65vs. DH - 14.90/10,000 doses). For intussusception after rotavirus vaccine, the number of cases was too low to make a valid comparison (KPCO - 0vs. DH - 0.13/10,000 doses). CONCLUSION: We demonstrated that data on important targeted VAEs can be captured at DH and rates appear similar to those at KPCO. Work is ongoing on the optimal approach to assimilate DH data as a potential safety net healthcare system in the VSD.

Integration of data from a safety net health care system into the Vaccine Safety Datalink.

BACKGROUND: In 2013 the Institute of Medicine suggested that the Vaccine Safety DataLink (VSD) should broaden its population by including data of more patients from low income and racially and ethnically diverse backgrounds. In response, Kaiser Permanente Colorado (KPCO) partnered with Denver Health (DH), an integrated safety net health care system, to explore the integration of DH data. METHODS: We compared three different methods (reference date of September 1, 2013): "Empanelment" (any patient who has had a primary care visit in the past 18months), "Proxy-enrollment" (two health care visits in 3years separated by 90days), and "Enrollment" in a managed care plan. For each of these methods, we compared cohort size, vaccination rates, socio-demographic characteristics, and health care utilization. RESULTS: The empaneled population at DH provided the best comparison to KPCO. DH's empaneled population was 111,330 (57,173 adults; 54,157 children), while KPCO had 436,290 empaneled patients (336,462 adults; 99,828 children). Vaccination rates in both health care systems for empaneled patients were comparable. Two year-old up-to-date coverage rates were 83.2% (KPCO) and 86.9% (DH); rates for adolescent Tdap and MCV4 were 85.5% (KPCO) and 90.6% (DH). There were significant differences in the two populations in age, gender, race, preferred language, and % Federal Poverty Level (FPL) (DH 70.7%<100% FPL; KPCO 17.4%), as well as in healthcare utilization - for example pediatric emergency department utilization was twice as high at DH. CONCLUSIONS: Using a cohort of "empaneled" patients, it is possible to integrate data from a safety net health care system that does not have a uniform managed care population into the VSD, and to compare vaccination rates, socio-demographic characteristics, and health care utilization across the two systems. The KPCO-DH collaboration may serve as a model for incorporating data from a safety net healthcare system into the VSD.

Achieving High Adolescent HPV Vaccination Coverage.

BACKGROUND AND OBJECTIVE: Despite national recommendations for adolescent human papillomavirus (HPV) vaccination, rates have lagged behind those of other adolescent vaccines. We implemented interventions and examined rates of vaccination coverage in a large, urban, safety net health care system to understand whether our tactics for achieving high rates of adolescent vaccination were successful. METHODS: Denver Health is an integrated urban safety net health system serving >17 000 adolescents annually. The process for achieving high vaccination rates in our health system includes "bundling" of vaccines, offering vaccines at every visit, and standard orders. Data from vaccine registry and utilization statistics were used to determine vaccination rates in adolescents aged 13 to 17 years from 2004 to 2014, and these findings were compared with state and national rates for 2013. Regression analysis was used to identify characteristics associated with vaccination. RESULTS: In 2013 (N = 11 463), HPV coverage of ≥1 dose was 89.8% (female subjects) and 89.3% (male subjects), compared with national rates of 57.3% and 34.6%. Rates of HPV coverage (≥3 doses) were 66.0% for female subjects and 52.5% for male subjects, versus 37.6% and 13.9% nationally. For both sexes, tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis, adsorbed, vaccine coverage was 95.9% (86.0% nationally), and meningococcal conjugate vaccine coverage was 93.5% (77.8% nationally). Female subjects, Hispanic subjects, non-English speakers, and teenagers <200% below the federal poverty level were more likely to have received 3 doses of HPV. CONCLUSIONS: Through low-cost, system-wide standard procedures, Denver Health achieved adolescent vaccination rates well above national coverage rates. Avoiding missed opportunities for vaccination and normalizing the HPV vaccine were key procedures that contributed to high coverage rates.

Outpatient course and complications associated with home oxygen therapy for mild bronchiolitis.

BACKGROUND: Home oxygen has been incorporated into the emergency department management of bronchiolitis in high-altitude settings. However, the outpatient course on oxygen therapy and factors associated with subsequent admission have not been fully defined. METHODS: We conducted a retrospective cohort study in consecutive patients discharged on home oxygen from the pediatric emergency department at Denver Health Medical Center from 2003 to 2009. The integration of inpatient and outpatient care at our study institution allowed comprehensive assessment of follow-up rates, outpatient visits, time on oxygen, and subsequent admission. Admitted and nonadmitted patients were compared by using a χ(2) test and multivariable logistic regression. RESULTS: We identified 234 unique visits with adequate follow-up for inclusion. The median age was 10 months (interquartile range [IQR]: 7-14 months). Eighty-three percent of patients were followed up within 24 hours and 94% within 48 hours. The median length of oxygen use was 6 days (IQR: 4-9 days), and the median number of associated encounters was 3 (range: 0-9; IQR: 2-3). Ninety-three percent of patients were on room air at 14 days. Twenty-two patients (9.4%) required subsequent admission. Fever at the initial visit (>38.0°C) was associated with admission (P < .02) but had a positive predictive value of 15.4%. Age, prematurity, respiratory rate, oxygen saturation, and history of previous bronchiolitis or wheeze were not associated with admission. CONCLUSIONS: There is a significant outpatient burden associated with home oxygen use. Although fever was associated with admission, we were unable to identify predictors that could modify current protocols.