Northern California Research

Hearing loss is a significant communication issue that impacts relationships, safety, and mental and physical health. There is an increased risk of dementia as well as increased mortality associated with untreated hearing loss. Hearing aids are one of the main treatments for hearing loss, but they are frequently not used. Cognitive impairment, osteoarthritis of the hands, cost and complexity are some of the reasons that hearing aids do not get utilized. But research has shown that involving family members and care partners in trainings on how to use hearing aids may increase use of them. The goal of this project was to determine if an educational intervention, using multiple learning modalities, could increase knowledge about hearing loss and hearing aids and augment hearing aid use, specifically by offering training to those with hearing loss and their care partners. A single-group pretest posttest quasi-experimental project was done to measure knowledge gain, and a follow-up survey was conducted to determine if hearing aid use increased. The results showed that both knowledge and reported hearing aid use did increase after the educational intervention. This demonstrates that educating caregivers and family members could be a useful option to prevent the health and safety issues associated with untreated hearing loss.

Catheter-associated urinary tract infections (CAUTIs) significantly contribute to morbidity, prolonged hospitalization, and elevated healthcare costs, underscoring the crucial need for prevention to ensure patient safety. Despite ongoing mitigation efforts, CAUTI prevalence remained a concern in our facility at the time of this study. Catheter insertion and maintenance bundles, a recognized framework utilizing teamwork, collaboration, and focused interventions, were implemented to reduce CAUTIs and improve patient safety. This study evaluated the effectiveness of these bundles in reducing CAUTIs and catheter utilization to identify best practices for enhanced catheter management and care quality.

Purpose: Improved communication and job satisfaction among staff are essential for those working in high-stress critical care environments like the cardiac catheterization laboratory (Cath Lab). The purpose of this investigation was to utilize the quality improvement initiative Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) to improve attitudes and job satisfaction in the Cath Lab. Method: A total of 30 subjects participated in a TeamSTEPPS educational intervention. After obtaining informed consent, a demographic survey, a pre- and post-test TeamSTEPPS Teamwork Attitudes Questionnaire (T-TAQ) and Job Satisfaction Survey (JSS) were administered. The post-test included open-ended questions for feedback that were analyzed using manifest content analysis. Results: Qualitative findings indicated improvements in attitudes towards teamwork and job satisfaction. The qualitative results highlighted effective communication strategies promoted teamwork and patient safety. Teamwork ultimately improved by empowering staff to provide the best care, and positive teamwork impacted job satisfaction. Results of the quantitative analysis showed no significant difference between the mean T-TAQ and JSS scores on pre- and post-tests after the TeamSTEPPS educational intervention. Study limitations included a high leadership turnover, a small sample size and less than 4 months between the pre- and post-tests. Conclusion: This project highlights the critical role of teamwork and strategic communication in enhancing job satisfaction and ultimately better patient care in the interventional service areas, giving valuable insights for future practice and research in this area.

To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment-induced anti-insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment-induced AIA development to the prespecified margins. The percentages of participants positive for treatment-induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of -2.1 percentage points and a 90% CI (-7.6%, 3.5%) (predefined similarity margins: -10.7%, 10.7%). The difference in glycated haemoglobin was -0.08% (90% CI, -0.23, 0.06). The overall percentage of participants with any treatment-emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups. GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy,and safety, based on the current study.

BCI (H/I) has been shown to predict extended endocrine therapy (EET) benefit. We examined BCI (H/I) for EET benefit prediction in NSABP B-42, which evaluated extended letrozole therapy (ELT) in patients with hormone receptor-positive breast cancer after 5 years of ET. A stratified Cox model was used to analyze RFI as the primary endpoint, with DR, BCFI, and DFS as secondary endpoints. Because of a nonproportional effect of ELT on DR, time-dependent analyses were performed. The translational cohort included 2,178 patients (45% BCI (H/I)-High, 55% BCI (H/I)-Low). ELT showed an absolute 10-year RFI benefit of 1.6% (P = 0.10), resulting in an underpowered primary analysis (50% power). ELT benefit and BCI (H/I) did not show a significant interaction for RFI (BCI (H/I)-Low: 10 years absolute benefit 1.1% [HR, 0.70; 95% confidence interval (CI), 0.43-1.12; P = 0.13]; BCI (H/I)-High: 2.4% [HR, 0.83; 95% CI, 0.55-1.26; P = 0.38]; Pinteraction = 0.56). Time-dependent DR analysis showed that after 4 years, BCI (H/I)-High patients had significant ELT benefit (HR = 0.29; 95% CI, 0.12-0.69; P < 0.01), whereas BCI (H/I)-Low patients were less likely to benefit (HR, 0.68; 95% CI, 0.33-1.39; P = 0.29; Pinteraction = 0.14). Prediction of ELT benefit by BCI (H/I) was more apparent in the HER2- subset after 4 years (ELT-by-BCI (H/I) Pinteraction = 0.04). BCI (H/I)-High versus BCI (H/I)-Low did not show a statistically significant difference in ELT benefit for the primary endpoint (RFI). However, in time-dependent DR analysis, BCI (H/I)-High patients experienced statistically significant benefit from ELT after 4 years, whereas (H/I)-Low patients did not. Because BCI (H/I) has been validated as a predictive marker of EET benefit in other trials, additional follow-up may enable further characterization of BCI's predictive ability.

The Enhanced Recovery After Surgery (ERAS) pathway promotes an early recovery after surgery using an evidence-based multidisciplinary approach. The ERAS protocol is aimed at standardizing care to improve patient outcomes. There is consistent evidence that ERAS pathways reduce hospital length of stay (LOS) and readmission rates, decrease healthcare costs, and improve patient satisfaction and outcomes. By attenuating the surgical stress response and supporting the return of physiological function, the ERAS pathway achieves its effectiveness. This scholarly project aimed to evaluate how ERAS improves patient outcomes in gynecology patients at a county hospital. A standardized method for improving patient recovery was not in place at the institution prior to the implementation of the ERAS pathway. ERAS-boarded gynecology surgery patients were reviewed retrospectively as part of this quality improvement project. Through this quality improvement project, hospital LOS was reduced without increasing readmissions or complications. There were no significant relationships between readmission rate and categorical extraneous variables. However, two significant relationships were found among LOS and the categorical extraneous variables. Hispanics had a shorter LOS and women who had an open procedure had longer LOS. As a result of the evaluation of this pathway, modifications may be made to the implementation of ERAS to ensure the high level of success of the program and enhance its expansion to other surgical specialties.

Sexually transmitted infections continue to be a source of significant morbidity in people with a history of incarceration, particularly women. Justice-involved women are at exceptionally high risk of long-lasting and severe health consequences of contracting an STI. This evidence-based practice implementation project used a repeated measures design to compare sexually transmitted infection knowledge acquisition and condom use self-efficacy in a group of incarcerated women before, immediately after, and three weeks following participation in the Safer Sex Self-Efficacy Workshop. Of the participants (N= 21), 100% demonstrated a significant increase in sexually transmitted infection knowledge and condom use self-efficacy between pre- and post-test scores of the Sexually Transmitted Disease Questionnaire and the Condom use Self-efficacy Scale and maintained those increases at the three-week follow-up.

By September 21, 2021, an estimated 182 million persons in the United States were fully vaccinated against COVID-19.* Clinical trials indicate that Pfizer-BioNTech (BNT162b2), Moderna (mRNA-1273), and Janssen (Johnson & Johnson; Ad.26.COV2.S) vaccines are effective and generally well tolerated (1-3). However, daily vaccination rates have declined approximately 78% since April 13, 2021†; vaccine safety concerns have contributed to vaccine hesitancy (4). A cohort study of 19,625 nursing home residents found that those who received an mRNA vaccine (Pfizer-BioNTech or Moderna) had lower all-cause mortality than did unvaccinated residents (5), but no studies comparing mortality rates within the general population of vaccinated and unvaccinated persons have been conducted. To assess mortality not associated with COVID-19 (non-COVID-19 mortality) after COVID-19 vaccination in a general population setting, a cohort study was conducted during December 2020-July 2021 among approximately 11 million persons enrolled in seven Vaccine Safety Datalink (VSD) sites.§ After standardizing mortality rates by age and sex, this study found that COVID-19 vaccine recipients had lower non-COVID-19 mortality than did unvaccinated persons. After adjusting for demographic characteristics and VSD site, this study found that adjusted relative risk (aRR) of non-COVID-19 mortality for the Pfizer-BioNTech vaccine was 0.41 (95% confidence interval [CI]=0.38-0.44) after dose 1 and 0.34 (95% CI=0.33-0.36) after dose 2. The aRRs of non-COVID-19 mortality for the Moderna vaccine were 0.34 (95% CI=0.32-0.37) after dose 1 and 0.31 (95% CI=0.30-0.33) after dose 2. The aRR after receipt of the Janssen vaccine was 0.54 (95% CI=0.49-0.59). There is no increased risk for mortality among COVID-19 vaccine recipients. This finding reinforces the safety profile of currently approved COVID-19 vaccines in the United States.