Transferring care to enhance access to early-phase cancer clinical trials: Protocol to evaluate a novel program.

Involving diverse populations in early-phase (phase I and II) cancer clinical trials is critical to informed therapeutic development. However, given the growing costs and complexities of early-phase trials, trial activation and enrollment barriers may be greatest for these studies at healthcare facilities that provide care to the most diverse patient groups, including those in historically underserved communities (e.g., safety-net healthcare systems). To promote diverse and equitable access to early-phase cancer clinical trials, we are implementing a novel program for the transfer of care to enhance access to early-phase cancer clinical trials. We will then perform a mixed-methods study to determine perceptions and impact of the program. Specifically, we will screen, recruit, and enroll diverse patients from an urban, integrated safety-net healthcare system to open and active early-phase clinical trials being conducted in a university-based cancer center. To evaluate this novel program, we will: (1) determine program impact and efficiency; and (2) determine stakeholder experience with and perceptions of the program. To achieve these goals, we will conduct preliminary cost analyses of the program. We will also conduct surveys and interviews with patients and caregivers to elucidate program impact, challenges, and areas for improvement. We hypothesize that broadening access to early-phase cancer trials conducted at experienced centers may improve equity and diversity. In turn, such efforts may enhance the efficiency and generalizability of cancer clinical research.

Inpatient Costs of Treating Patients With COVID-19.

Importance: With more than 6.2 million hospitalizations due to COVID-19 in the US, recognition of the average hospital costs to provide inpatient care during the pandemic is necessary to understanding the national medical resource use and improving public health readiness and related policies. Objective: To examine the mean cost to provide inpatient care to treat COVID-19 and how it varied through the pandemic waves and by important sociodemographic patient characteristics. Design, Setting, and Participants: This cross-sectional study used inpatient-level data from March 1, 2020, to March 31, 2022, extracted from a repository of clinical, administrative, and financial information covering 97% of academic medical centers across the US. Main Outcomes and Measures: Cost to produce care for each stay was calculated using direct hospital costs to provide care adjusted for geographic differences in labor costs using area wage indices. Results: The sample included 1 333 404 stays with a primary or secondary COVID-19 diagnosis from 841 hospitals. The cohort included 692 550 (52%) men, with mean (SD) age of 59.2 (17.5) years. The adjusted mean cost of an inpatient stay was $11 275 (95% CI, $11 252-$11 297) overall, increasing from $10 394 (95% CI, $10 228-$10 559) at the end of March 2020 to $13 072 (95% CI, $12 528-$13 617) by the end of March 2022. Patients with specific comorbidities had significantly higher mean costs than their counterparts: those with obesity incurred an additional $2924 in inpatient stay costs, and those with coagulation deficiency incurred an additional $3017 in inpatient stay costs. Stays during which the patient required extracorporeal membrane oxygenation (ECMO) had an adjusted mean cost of $36 484 (95% CI, $34 685-$38 284). Conclusions and Relevance: In this cross-sectional study, an adjusted mean hospital cost to provide care for patients with COVID-19 increased more than 5 times the rate of medical inflation overall. This appeared to be explained partly by changes in the use of ECMO, which increased over time.

Odds of Medical Comorbidities in Essential Tremor: Retrospective Analysis of a Large Claims Database in the United States.

INTRODUCTION: Essential tremor (ET) is the most common tremor disorder, estimated to affect 7 million individuals in the USA. There is little empirical evidence on comorbidities among this population beyond higher prevalence of brain-related and stress-related disorders. This study aims to examine differences in the prevalence of the 31 Elixhauser comorbidities among ET patients compared to statistically similar control patients. METHODS: An extract from Optum's de-identified Clinformatics® Data Mart Database (CDM) from 2018 to 2019 of adults aged 40-80 years with at least one claim with an ET diagnosis was propensity score matched to controls. Logistic regression was used to generate doubly robust adjusted odds ratios for each of the 31 Elixhauser comorbidities. RESULTS: In these analyses, ET patients had significantly greater adjusted odds of depression, alcohol abuse, and other neurological disorders, as well as chronic pulmonary disease, renal failure, hyperthyroidism, and cardiac arrhythmias relative to controls. They also had lower odds of uncomplicated diabetes, congestive heart failure, metastatic cancer, paralysis, peripheral vascular disease, and fluid and electrolyte disorders. CONCLUSION: A number of recent studies, including our own, suggest that psychiatric, neurologic, and stress-related disorders may be more prevalent among ET patients than controls. Additional differences in the prevalence of a range of medical comorbidities have also been variably reported across studies, suggesting that some combination of these might be more prevalent. Further studies would be of value in sorting through these associations.

Changes in In-Person, Audio-Only, and Video Visits in California's Federally Qualified Health Centers, 2019-2022.

This study assesses telehealth visit trends among California federally qualified health centers from 2019 to 2022.

Trends in Geographic Proximity to Substance Use Disorder Treatment.

INTRODUCTION: This study aims to assess the trends in the number and characteristics of substance use disorder (SUD) treatment facilities within the county of residence of adults aged 50+ years over time. METHODS: Using retrospective longitudinal data from the 1992-2018 Health and Retirement Study merged with the county-level data on all licensed treatment facilities in the country, linear mixed models were estimated to calculate geographic accessibility to SUD treatment, adjusted for person-level demographics, state-level controls, and calendar year-fixed effects. Analysis was conducted in 2022. RESULTS: Overall, older adults experienced a decline in the average number of SUD treatment facilities within their counties of residence from 4.80 per 100,000 residents (95% CI=4.69, 4.92) in 1992 to 4.50 (95% CI=4.35, 4.64) in 2018. However, the number accepting Medicare increased from 0.26 (95% CI=0.21, 0.30) in 1992 to 1.88 (95% CI=1.80, 1.96) facilities per 100,000 (42% of facilities); Medicaid increased from 0.20 (95% CI=0.13, 0.26) in 1992 to 3.50 (95% CI=3.39, 3.62) facilities per 100,000 (78% of facilities) in 2018. Older adults living in more rural areas experienced the most growth in SUD treatment facilities per capita in their counties but with less significant growth in facilities offering medication for opioid use disorder than those living in more urban areas. CONCLUSIONS: Despite increases in the number of SUD treatment facilities in rural areas, there has been less growth in nearby facilities offering evidence-based medication treatment for opioid use disorder.

Cost-Effectiveness Analysis of CAR T-Cell Therapies vs Antibody Drug Conjugates for Patients with Advanced Multiple Myeloma.

OBJECTIVES: Among advanced multiple myeloma (MM) patients, B-cell maturation antigen (BCMA) specific targets like Belantamab Mafodotin (belamaf) and CAR T-cell therapies have been shown to improve clinical outcomes, but at significant costs. To compare the expected costs per quality-adjusted life years (QALYs) gained among a hypothetical cohort of triple refractory MM patients treated with one of three BCMA-directed therapies: (1) idecabtagene vicleucel (ide-cel), (2) ciltacabtagene autoleucel (cilta-cel), and (3) belamaf for up to 20 months. METHODS: In this cost-effectiveness analysis, we built a Monte Carlo Markov Chain microsimulation model using estimates and parameters from the evidence on MM treatment for 10 000 hypothetical patients between the ages for 40 and 80. We assigned expected years of life remaining and made varying assumptions about survival beyond 5 years. RESULTS: We predicted total cost of treatment for CAR-T therapy to be six times greater than for belamaf, but the QALYs gained from treatment are 6 to 8 times greater. Ide-cel was weakly dominated by cilta-cel and our base-case incremental cost effectiveness ratio (ICER) comparing cilta-cel with belamaf was $109,497 per QALY gained, averaging $123,618 in probabilistic sensitivity analyses. CONCLUSIONS: These findings hinge on the assumption of longer-term survival but suggest that the use of CAR-T therapy is approaching standard ICER thresholds.

Changes in Breastfeeding and Lactation Support Experiences During COVID.

Background: We surveyed parents who gave birth from 2019 to 2021 to examine changes in breastfeeding experiences and professional and lay breastfeeding support services due to the coronavirus disease 2019 (COVID-19) pandemic. We also examined racial and ethnic disparities in breastfeeding support. Materials and Methods: A cross-sectional opt-in survey of 1,617 parents was administered on Ovia's parenting app in January 2022. Respondents were 18-45 years of age and delivered in one of three birth cohorts: August-December 2019, March-May 2020, or June-August 2021. We fit linear and logistic regression models wherein the outcomes were six breastfeeding support and experience measures, adjusting for birth cohort and respondent demographics. Results: Parents who gave birth in the early pandemic versus those in the prepandemic had reduced odds of interacting with lactation consultants (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.44-0.90), attending breastfeeding classes (OR: 0.71; 95% CI: 0.54-0.94), meeting breastfeeding goals (OR: 0.65; 95% CI: 0.46-0.92), and reporting it was easy to get breastfeeding help (estimate: -0.36; 95% CI: -0.55 to -0.17). Birth cohort was not associated with use of donor milk or receipt of in-hospital help. The later pandemic cohort differed from the prepandemic cohort for one outcome: they were less likely to meet their breastfeeding goals (OR: 0.67; 95% CI: 0.48-0.95). There were racial and ethnic disparities in the use of multiple types of breastfeeding support. Although one-third of respondents felt that the pandemic facilitated breastfeeding because of more time at home, 18% felt the pandemic posed additional challenges including disruptions to lactation support. Conclusions: Parents who gave birth in the later pandemic did not report significant disruptions to professional breastfeeding support, likely as a result of the growth of virtual services. However, disparities in receipt of support require policy attention and action.

Use of and Attitudes About Telelactation Services among New Parents.

Background: We conducted a national, cross-sectional survey among new parents to explore use and acceptability of telelactation. Methods: Recruitment occurred between October 2021 and January 2022 on Ovia's parenting mobile phone application. Poststratification survey weights were used, and logistic and linear regression models estimated associations between demographics and telelactation use. Results: Among 1,617 respondents, 33.8% had at least one telelactation visit. Odds of any telelactation visit(s) were greater for parents who gave birth in 2021 versus 2019 (odds ratio [OR]: 1.69, 95% confidence interval [CI]: 1.26-2.25), insured by Medicaid (OR: 1.43, 95% CI: 1.02-2.02), and younger parents (OR: 2.07, 95% CI: 1.32-3.34). In total, 56.0% agreed that they would be comfortable breastfeeding over video to get help, and 27.6% agreed that lactation support over video is as good as in-person support. Conclusions: Telelactation is increasingly common and acceptable to many parents.

Access challenges for patients with limited English proficiency: a secret-shopper study of in-person and telehealth behavioral health services in California safety-net clinics.

The recent growth of telehealth may be impacting access to care for patients, including those with limited English proficiency (LEP). Using a secret-shopper design, simulated patients contacted 386 safety-net clinics in California in both Spanish and English from February-March 2023. Callers stated that they were new patients seeking medication for depression, and they documented time to an appointment and available visit modalities (telehealth and in-person). Multinomial logistic regression models examined associations between clinic characteristics and available modalities. English-speaking callers were more likely to speak with a live scheduler and to obtain appointment information from a scheduler who could engage with them in their preferred language. Among Spanish-speaking callers who reached a live scheduler, 22% reached someone who did not engage (eg, were hung up on) and, as a result, could not obtain appointment information. The mean estimated time to a prescribing visit was 36 days and did not differ by language. Sixty-four percent of clinics offered both telehealth and in-person visits, 14% only offered in-person visits, and 22% only offered telehealth visits. More attention and resources are needed to support patients with LEP at the point of scheduling and to ensure choice of visit modality for all patient populations.

Patterns in Geographic Distribution of Substance Use Disorder Treatment Facilities in the US and Accepted Forms of Payment From 2010 to 2021.

Importance: The drug overdose crisis is a continuing public health problem and is expected to grow substantially in older adults. Understanding the geographic accessibility to a substance use disorder (SUD) treatment facility that accepts Medicare can inform efforts to address this crisis in older adults. Objective: To assess whether geographic accessibility of services was limited for older adults despite the increasing need for SUD and opioid use disorder treatments in this population. Design, Setting, and Participants: This longitudinal cross-sectional study obtained data on all licensed SUD treatment facilities for all US counties and Census tracts listed in the National Directory of Drug and Alcohol Abuse Treatment Programs from 2010 to 2021. Main Outcomes and Measures: Measures included the national proportion of treatment facilities accepting Medicare, Medicaid, private insurance, or cash as a form of payment; the proportion of counties with a treatment facility accepting each form of payment; and the proportion of the national population with Medicare, Medicaid, private insurance, or cash payment residing within a 15-, 30-, or 60-minute driving time from an SUD treatment facility accepting their form of payment in 2021. Results: A total of 11 709 SUD treatment facilities operated across the US per year between 2010 and 2021 (140 507 facility-year observations). Cash was the most commonly accepted form of payment (increasing slightly from 91.0% in 2010 to 91.6% by 2021), followed by private insurance (increasing from 63.5% to 75.3%), Medicaid (increasing from 54.0% to 71.8%), and Medicare (increasing from 32.1% to 41.9%). The proportion of counties with a treatment facility that accepted Medicare as a form of payment also increased over the same study period from 41.2% to 53.8%, whereas the proportion of counties with a facility that accepted Medicaid as a form of payment increased from 53.5% to 67.1%. The proportion of Medicare beneficiaries with a treatment facility that accepted Medicare as a form of payment within a 15-minute driving time increased from 53.3% to 57.0%. The proportion of individuals with a treatment facility within a 15-minute driving time that accepted their respective form of payment was 73.2% for those with Medicaid, 69.8% for those with private insurance, and 71.4% for those with cash payment in 2021. Conclusions and Relevance: Results of this study suggest that Medicare beneficiaries have less geographic accessibility to SUD treatment facilities given that acceptance of Medicare is low compared with other forms of payment. Policy makers need to consider increasing reimbursement rates and using additional incentives to encourage the acceptance of Medicare.

Annual health care costs among Medicare Beneficiaries with essential tremor.

INTRODUCTION: Essential tremor (ET) is one of the most common neurological disorders, affecting an estimated 2.2% of the entire US population. Despite its high prevalence and associated morbidity and mortality, there are no published data on the medical costs associated with ET care. METHODS: This is a retrospective secondary data analysis using the 5% Medicare claims data from 2016 to study age-eligible Medicare beneficiaries diagnosed with ET (diagnostic code G250) relative to a propensity score-matched group of comparison beneficiaries without ET (27,081 in each arm). Comparisons were matched within age strata and on the full set of Charlson comorbidity indicators, race, and sex. We examined encounter-level costs (amounts paid) and total annual costs of care (in constant $2021 dollars) adjusting for age, sex, race/ethnicity, provider specialty, setting, and the most common comorbidities, using a generalized linear model. RESULTS: The final sample included 54,162 total beneficiaries, with an average age of 75, 65% female and 94% Non-Hispanic White. On average, Medicare beneficiaries with at least one outpatient or physician office visit with an ET diagnosis have $1068 (95% CI: $981, $1154) in additional direct medical care expenditures per year relative to statistically similar comparison beneficiaries of the same age. Across the population, we predicted aggregated additional spending attributable to ET among Medicare beneficiaries between $1.5 billion and $5.4 billion per year. CONCLUSION: The estimated direct medical costs among Medicare beneficiaries with an ET diagnosis aggregated to the population-level are non-trivial. These data begin to fill a gap in knowledge.

Enhancing access to and diversity in cancer clinical trials through a financial reimbursement program: Protocol to evaluate a novel program.

As clinical trials have become more complex, with increasing numbers of required procedures and clinic visits, gaining access to promising new treatments has become even more challenging for many individuals. To address these barriers, we implemented a financial reimbursement and outreach program designed to increase the number and diversity of participants in cancer clinical trials at centers in Dallas, Houston, and Philadelphia. As endorsed by U.S. Food and Drug Administration (FDA) and the Texas and Pennsylvania State Legislatures, the program provides financial reimbursement for non-clinical costs (e.g., travel, lodging) to patients on cancer clinical trials with household income up to 700% the Federal poverty rate. The research study described here, centered at the Dallas site, evaluates program impact by assessing (1) numbers and diversity of patients enrolled to cancer clinical trials before and after program implementation; (2) characteristics of patients offered participation in the program who do versus do not enroll; (3) characteristics of patients enrolled in the program who do versus do not complete the reimbursement process. To evaluate perceived barriers and facilitators of program participation, we will conduct semi-structured interviews and administer the Comprehensive Score for Financial Toxicity Patient Reported Outcome Measure (COST PROM) and the Short Assessment of Health Literacy (SAHL). This program will examine how reimbursement of non-clinical costs can improve access to cancer clinical trials, with the eventual goal of increasing trial enrollment, diversity, representativeness, and generalizability.

COVID-19 vaccine uptake and attitudes among pregnant and postpartum parents.

BACKGROUND: Pregnancy poses increased risks from COVID-19, including hospitalization and premature delivery. Yet pregnant individuals are less likely to have received a COVID-19 vaccine. OBJECTIVE: This study aimed to investigate COVID-19 vaccine uptake and reasons for delay or refusal among perinatal parents. STUDY DESIGN: A total of 1542 eligible parents who delivered between 2019 and 2021 were surveyed through the Ovia parenting app, which has a nationally representative user base. Adjusted and nationally weighted means were calculated. Multivariate logistic regression and survival models were used to examine uptake. RESULTS: At least 1 dose of the COVID-19 vaccine was received by 70% of the parents. Those with a bachelor's or graduate degree were significantly more likely to have received a vaccine relative to those with some college or less (adjusted odds ratio for bachelor's degree, 1.854; 95% confidence interval, 1.19-2.90; adjusted odds ratio for graduate degree, 2.833; 95% confidence interval, 1.69-4.75). Parents living in rural areas were significantly less likely to have received a vaccine relative to those living in urban areas (adjusted odds ratio for small city, 0.62; 95% confidence interval, 0.45-0.86; adjusted odds ratio for rural area, 0.56; 95% confidence interval, 0.35-0.89); 56% (281/502) of unvaccinated parents considered that the vaccine "was too new." Among those pregnant in 2021, 44% (258/576) received at least 1 dose, and 34% (195/576) reported that pregnancy had "no impact" on their vaccine decision. CONCLUSION: There was significant heterogeneity in vaccine uptake and attitudes toward vaccines during pregnancy by sociodemographics and over time. Public health experts need to consider and test more tailored approaches to reduce vaccine hesitancy in this population.

Barriers to Chimeric Antigen Receptor T-Cell (CAR-T) Therapies in Clinical Practice.

Chimeric antigen receptor T-cell (CAR-T) therapy is a revolutionary cancer treatment modality where a patient's own T cells are collected and engineered ex vivo to express a chimeric antigen receptor (CAR). These reprogrammed CAR-T cells, when reinfused into the same patient, stimulate a T-cell mediated immune response against the antigen-expressing malignant cells leading to cell death. The initial results from pivotal clinical trials of CAR-T agents have been promising, leading to multiple approvals in various hematologic malignancies in the relapsed setting, including acute lymphoblastic leukemia (ALL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, follicular lymphoma, and, more recently, multiple myeloma. However, since the initial trials and US Food and Drug Administration approvals, there have been significant barriers to the widespread use of this therapy. The barriers to the use of CAR-T therapy include complex logistics, manufacturing limitations, toxicity concerns, and financial burden. This review discusses potential solutions to overcome these barriers in order to make this life-changing therapy widely accessible.

District-Level Universal Masking Policies and COVID-19 Incidence During the First 8 Weeks of School in Texas.

Texas discontinued state-sponsored business restrictions and mask mandates on March 10, 2021, and mandated that no government officials, including public school officials, may implement mask requirements even in areas where COVID-19 hospitalizations comprised more than 15% of hospitalizations. Nonetheless, some public school districts began the 2021-2022 school year with mask mandates in place. We used quasi-experimental methods to analyze the impact of school mask mandates, which appear to have resulted in approximately 40 fewer student cases per week in the first eight weeks of school. (Am J Public Health. 2022;112(6):871-875. https://doi.org/10.2105/AJPH.2022.306769).

Brief Cost Analysis of Surgical Personal Protective Equipment During the COVID-19 Pandemic.

OBJECTIVES: This study aimed to compare the costs incurred and saved from universal use of N95 respirators with surgical masks for operating room providers in the United States during the COVID-19 pandemic. METHODS: We built a decision analytic model to compare direct medical costs of healthcare workers (HCWs) infected with COVID-19 during operating room procedures from expected transmission when using an N95 respirator relative to a surgical mask. We also examined quarantine costs. RESULTS: Results varied depending upon prevalence and false-negative rates of tests, but if N95 respirators reduce transmission by 2.8%, prevalence is at 1%, and testing yields 20% false negatives, providers should be willing to pay an additional $0.64 per HCW for the additional protection. Under this scenario, approximately 11 COVID-19 cases would be averted among HCWs per day. CONCLUSIONS: Potential savings depend on disease prevalence, rate of asymptomatic patients with COVID-19, accuracy of testing, the marginal cost of respirators, and the quarantine period. We provide a range of calculations to show under which conditions N95 respirators are cost saving.

Associations of a National Tax on Non-Essential High Calorie Foods with Changes in Consumer Prices.

Several governments are considering taxes on non-essential energy-dense, high calorie foods (NEDF) to increase their prices and thereby encourage better diet and health. Alongside a tax on sugary drinks in January 2014, Mexico implemented such a tax: an 8 percent ad-valorem tax on NEDF, defined as those with energy density equal or larger than 275kcal/100g. We study the changes in the prices of taxed and tax-exempt foods following this tax both on average and by tax-eligible foods across store types and cities, using monthly price data between 2012 and 2016. We compare within-product price changes before and after the tax adjusting for product fixed effects, seasonality, and trends, and find that prices of taxed foods increased by 4.8 % on average, but differentially across foods. Prices of candies, cookies and packaged pastries increased by eight or more percent post-tax (vs pre-tax); prices of cakes, and savory snacks increased by less. Prices of fresh pastry and ready-to-eat cereal increased, but only in 2014. Prices of chocolate and pizza did not increase after the tax. For tax-exempt foods, no significant price changes were observed. Variability in price changes for taxed foods were observed by cities as well as by stores: increases were larger in supermarkets compared to smaller grocery stores on average and for most foods. Differences in how prices changed across foods, cities and stores have implications for who is likely to be affected by the tax and how tax effects on diet may vary due to the differential tax pass-through in addition to a heterogenous demand response to changed prices.

Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial.

BACKGROUND & AIMS: Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies. METHODS: We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs. RESULTS: Mailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained. CONCLUSION: Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.

Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial.

BACKGROUND: Breastfeeding offers many medical and neurodevelopmental advantages for birthing parents and infants; however, the majority of parents stop breastfeeding before it is recommended. Professional lactation support by the International Board Certified Lactation Consultants (IBCLCs) increases breastfeeding rates; however, many communities lack access to IBCLCs. Black and Latinx parents have lower breastfeeding rates, and limited access to professional lactation support may contribute to this disparity. Virtual "telelactation" consults that use two-way video have the potential to increase access to IBCLCs among disadvantaged populations. We present a protocol for the digital Tele-MILC trial, which uses mixed methods to evaluate the impact of telelactation services on breastfeeding outcomes. The objective of this pragmatic, parallel design randomized controlled trial is to assess the impact of telelactation on breastfeeding duration and exclusivity and explore how acceptability of and experiences with telelactation vary across Latinx, Black, and non-Black and non-Latinx parents to guide future improvement of these services. METHODS: 2400 primiparous, pregnant individuals age > 18 who intend to breastfeed and live in the USA underserved by IBCLCs will be recruited. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by over one million pregnant individuals in the USA annually. Participants will be randomized to (1) on-demand telelactation video calls on personal devices or (2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for 8 months (including 6 months postpartum). Primary outcomes include breastfeeding duration and breastfeeding exclusivity. We will quantify differences in these outcomes across racial and ethnic groups. Both intention-to-treat and as-treated (using instrumental variable methods) analyses will be performed. This study will also generate qualitative data on the experiences of different subgroups of parents with the telelactation intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model. DISCUSSION: This is the first randomized study evaluating the impact of telelactation on breastfeeding outcomes. It will inform the design and implementation of future digital trials among pregnant and postpartum people, including Black and Latinx populations which are historically underrepresented in clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04856163. Registered on April 23, 2021.

Access to Medical Treatment for Injured Workers in California: Year 3 Annual Report.

The California workers' compensation program provides medical care and indemnity benefits to workers who suffer on-the-job injuries or illnesses. California law mandates an annual assessment of whether injured workers in the state have adequate access to quality care, and the RAND Corporation was asked to help answer that question over three years. This article describes access to medical care among injured workers in California using medical billing data from Version 2.0 of the Workers' Compensation Information System. Overall, the estimates using such data suggest stability or slight improvements in most measures analyzed when compared with the Year 2 estimates.