The birth center model of care: Staffing, business characteristics, and core clinical outcomes.

OBJECTIVES: Interest in expanding access to the birth center model is growing. The purpose of this research is to describe birth center staffing models and business characteristics and explore relationships to perinatal outcomes. METHODS: This descriptive analysis includes a convenience sample of all 84 birth center sites that participated in the AABC Site Survey and AABC Perinatal Data Registry between 2012 and 2020. Selected independent variables include staffing model (CNM/CM or CPM/LM), legal entity status, birth volume/year, and hours of midwifery call/week. Perinatal outcomes include rates of induction of labor, cesarean birth, exclusive breastfeeding, birthweight in pounds, low APGAR scores, and neonatal intensive care admission. RESULTS: The birth center model of care is demonstrated to be safe and effective, across a variety of staffing and business models. Outcomes for both CNM/CM and CPM/LM models of care exceed national benchmarks for perinatal quality with low induction, cesarean, NICU admission, and high rates of breastfeeding. Within the sample of medically low-risk multiparas, variations in clinical outcomes were correlated with business characteristics of the birth center, specifically annual birth volume. Increased induction of labor and cesarean birth, with decreased success breastfeeding, were present within practices characterized as high volume (>200 births/year). The research demonstrates decreased access to the birth center model of care for Black and Hispanic populations. CONCLUSIONS FOR PRACTICE: Between 2012 and 2020, 84 birth centers across the United States engaged in 90,580 episodes of perinatal care. Continued policy development is necessary to provide risk-appropriate care for populations of healthy, medically low-risk consumers.

Risk-Based Monitoring in Clinical Trials: 2021 Update.

Clinical trial quality depends on ensuring participant safety and data integrity, which require careful management throughout the trial lifecycle, from protocol development to final data analysis and submission. Recent developments-including new regulatory requirements, emerging technologies, and trial decentralization-have increased adoption of risk-based monitoring (RBM) and its parent framework, risk-based quality management (RBQM) in clinical trials. The Association of Clinical Research Organizations (ACRO), recognizing the growing importance of these approaches, initiated an ongoing RBM/RBQM landscape survey project in 2019 to track adoption of the eight functional components of RBQM. Here we present results from the third annual survey, which included data from 4889 clinical trials ongoing in 2021. At least one RBQM component was implemented in 88% of trials in the 2021 survey, compared with 77% in 2020 and 53% in 2019. The most frequently implemented components in 2021 were initial and ongoing risk assessments (80 and 78% of trials, respectively). Only 7% of RBQM trials were Phase IV, while the proportions of Phase I-III trials ranged 27-36%. Small trials (< 300 participants) accounted for 60% of those implementing RBQM. The therapeutic areas with the largest number of RBQM trials were oncology (38%), neurology (10%), and infectious diseases (9%). The 2021 survey confirmed a pattern of increasing RBM/RBQM adoption seen in earlier surveys, with risk assessments, which have broad regulatory support, driving RBQM growth; however, one area requiring further development is implementation of centralized monitoring combined with reductions in source data verification (SDV) and source data review (SDR).

Risk-Based Monitoring in Clinical Trials: Increased Adoption Throughout 2020.

With the emergence of new technologies for data collection, the continued impact of the COVID-19 pandemic, and the increasing number of partially or fully decentralized clinical trials (DCTs), the importance of risk-based monitoring (RBM) and the larger risk-based quality management (RBQM) framework in clinical trial management is increasing. RBM and RBQM focus on the detection of events or trends that impact trial quality in terms of participant safety and data integrity. In 2019, the Association of Clinical Research Organizations (ACRO) began a landscape survey of RBM/RBQM implementation in ongoing clinical trials. Initial results of this survey, representing full-year data for 2019, were reported previously. Here, we present full-year landscape data for 2020 drawn from 5,987 clinical trials ongoing at the end of 2020, including 908 new studies started that year. Of these trials, 77% implemented at least one RBM/RBQM component, an increase from 47% for studies ongoing at the end of 2019. We also observed increased implementation for three of the five RBM components included in the survey. Centralized monitoring decreased nominally in 2020 compared with 2019. Although the percentages of 2020 trials incorporating reduced source data verification (SDV) and reduced source data review (SDR) increased from 2019 to 2020, these numbers are still low considering the large percentage of trials implementing at least one RBQM component. In the current clinical trial landscape, as more DCTs are launched and new data collection technologies are implemented, there remains a pressing need for greater use of centralized monitoring coupled with reductions in SDR/SDV and, ultimately, greater adoption of RBM and RBQM.

Risk-Based Monitoring in Clinical Trials: Past, Present, and Future.

Risk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand the state of RBM implementation across the clinical trial industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey among its member companies across 6,513 clinical trials ongoing at the end of 2019. Of these trials, 22% included at least 1 of the 5 RBM components: key risk indicators (KRIs), centralized monitoring, off-site/remote-site monitoring, reduced source data verification (SDV), and reduced source document review (SDR). The implementation rates for the individual RBM components ranged 8%-19%, with the most frequently implemented component being centralized monitoring and the least frequently implemented being reduced SDR. When the COVID-19 pandemic emerged in early 2020, additional data were collected to assess its impact on trial monitoring, focusing specifically on trials switching from on-site monitoring to off-site/remote-site monitoring. These mid-pandemic data show that the vast majority of monitoring visits were on-site in February 2020, but an even higher percentage were off-site in April, corresponding with the first peak of the pandemic. Despite this shift, similar numbers of non-COVID-related protocol deviations were detected from February through June, suggesting little or no reduction in monitoring effectiveness. The pre- and mid-pandemic data provide two very different snapshots of RBM implementation, but both support the need to promote adoption of this approach while also highlighting an opportunity to capitalize on the recent shift toward greater RBM uptake in a post-pandemic environment.

Medical assistant coaching to support diabetes self-care among low-income racial/ethnic minority populations: randomized controlled trial.

Innovative, culturally tailored strategies are needed to extend diabetes education and support efforts in lower-resourced primary care practices serving racial/ethnic minority groups. A randomized controlled trial (RCT) examined the effect of a diabetes self-care coaching intervention delivered by medical assistants and the joint effect of intervention and ethnicity over time. The randomized repeated-measures design included 270 low-income African American and Hispanic/Latino patients with type 2 diabetes. The 1-year clinic- and telephone-based medical assistant coaching intervention was culturally tailored and guided by theoretical frameworks. A1C was obtained, and a self-care measure was completed at baseline, 6 months, and 12 months. Data were analyzed using mixed-effects models with and without adjustment for covariates. There was a significant overall improvement in mean self-care scores across time, but no intervention effect. Results revealed differences in self-care patterns across racial/ethnic subgroups. No differences were found for A1C levels across time or group.

Supporting diabetes self-care in underserved populations: a randomized pilot study using medical assistant coaches.

PURPOSE: The purpose of this study was to evaluate the impact of an innovative intervention that utilized a certified medical assistant with specific diabetes training to work with a multidisciplinary diabetes care team to help provide basic diabetes education and self-care support in low-income minority populations with type 2 diabetes. METHODS: Enrolled participants were randomized to either the medical assistant coaching (MAC) group (N = 25) or the treatment as usual (TAU) group (N = 25). Deidentified data was obtained on a matched no contact control (NCC) group (N = 50). RESULTS: Analysis of covariance (ANCOVA) comparisons revealed no significant differences between the 3 groups on A1C, but a trend was observed. A1Cs decreased across time for the MAC group, while increasing for the TAU and NCC groups. ANCOVA comparisons also indicated that the MAC group experienced significantly greater increases in perceived empowerment and a larger, although nonsignificant, reduction in perceived diabetes related problems than the TAU group. CONCLUSIONS: This randomized controlled pilot study suggests that the inclusion of a medical assistant self-care coach as part of the diabetes care team holds promise in improving outcomes and should be further examined in a large-scale study.

Utility of esmolol in thyroid crisis.

Thyroid storm is an uncommon but potentially life-threatening manifestation of hyperthyroidism. Mortality can be 30-60% in hospitalized patients unless appropriately treated by combined therapy. We report a case of a 25-year-old African American woman with past medical history of Graves disease and moderately persistent asthma who presented to the emergency department with signs and symptoms of thyrotoxic crisis. Therapy instituted and included the use of an esmolol infusion for control of hypersympathetic activity. A review of the clinical presentation, diagnosis, and management of thyrotoxic crisis is presented along with a discussion on the choice of beta blockade therapy.