Browsing by Subject "Quality Improvement"
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Item A Quality Improvement Initiative: Evaluating the Impact of Standardized Data Tracking Tools in the Radiation Oncology Clinical Research Office at the University of Texas Southwestern Medical Center(2022-05) Acevedo, Katalina V.; Mathew, Stephen O.; Ranjan, Amalendu P.Developing preventative measures through intentional planning and oversight of clinical trials has the potential to increase efficiency and quality of trial processes and data. This practicum report details a Quality Improvement (QI) initiative evaluating implementation and impact of a standardized data-tracking software on clinical research data compliance in the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center (UTSW). The standardized data tracker evaluated in this study was built through Quickbase, a cloud-based, low-code application development platform specializing in project management and operations optimization. This project evaluated data sets from two active radiation oncology clinical trials using repeated cross-sectional methods to compare rates of data non-compliance and trends in the types of non-compliance exhibited at baseline, one-month, and three-month post data-tracker implementation. Trends in non-compliance were reviewed and preventative measures backed by recommendations from the literature were proposed to facilitate future QI initiatives within the department. The Chi-Squared (X2) Test for Independence was used to determine whether there was a statistical difference in rates of data non-compliance across the three timepoints within studies and overall followed by post-hoc tests consisting of pairwise comparisons with Bonferroni corrections. Overall, statistical analysis revealed a significant difference in rates on non- compliance across timepoints, suggesting that implementation of the standardized Quickbase data-tracking management tool does significantly decrease rates of non-compliance. Descriptive statistics were performed to characterize the trends in non-compliance within each study across timepoints. This quality improvement project was the first of its kind to formally examine data management trends and practices within the Radiation Oncology Clinical Research Office at UT Southwestern Medical Center. The results provide positive feedback regarding the implementation of a standardized Quickbase data-tracking management tool and characterization of non-compliant data illuminated pressure points in data management workflow that can inform future QI initiatives in shifting data management from its current reactive state to a more proactive data-driven approach. Future work should evaluate the proposed preventative measurements to provide further insight into best practices that can support continuous improvement initiatives within the department.Item Aggregated student confidence estimates support continuous quality improvements in a competencies-oriented curriculum(BMJ Publishing Group Ltd., 2019-03-08) Papa, Frank Joseph; Alexander, Jerry H.Introduction: Competencies oriented medical curricula are intended to support the development of those specific tasks likely to improve patient care outcomes. In 2005, our institution developed curricular objectives and instructional activities intended to enable our students to competently perform four specific clinical tasks (diagnose, treat, manage and explain phenomena) for each of approximately 100 common and/or important patient presentations (eg, dyspnoea). However, competencies oriented curricula must also develop outcome metrics aligned with their objectives and instructional activities in order to launch a continuous quality improvement (CQI) programme. This investigation describes how a novel course evaluation methodology produced presentation and task-focused outcome metrics sufficient to support CQIs in our competencies-oriented curriculum. Methods: Literature suggests that aggregated, group opinions are much more reliable than individual opinions in a variety of settings, including education. In 2010, we launched a course evaluation methodology using aggregated student self-assessments of their confidence in performing the four tasks trained to in each presentation-focused instructional activity. These aggregated estimates were transformed into a variety of graphic and tabular reports which faculty used to identify, and then remediate, those specific instructional activities associated with suboptimal presentation and task-focused confidence metrics. Results: With academic year 2010-2011 serving as a baseline and academic year 2015-2016 as an endpoint, analysis of variance revealed a sustained and statistically significant gain in student confidence across this 6-year study period (p<0.001). Discussion: This investigation demonstrated that aggregated, presentation and task-specific confidence estimates enabled faculty to pursue and attain CQIs in a competencies-oriented curriculum. Suggestions for new approaches to confidence-related research are offered.Item Continuous quality improvement at the clinical research site: implementing methods for coordinators in the Heart and Lung Transplant and Pulmonary department at Baylor Scott and White Research Institute(2020-05) Norgan Radler, Charlene R.; Mathew, Stephen O.; Chaudhary, Pankaj; Martinez, Horacio; Felius, JoostNorgan Radler, Charlene R. Continuous quality improvement at the clinical research site: implementing methods for coordinators in the Heart and Lung Transplant and Pulmonary department at Baylor Scott and White Research Institute Master of Science (Clinical Research Management), April 2020 Introduction: The following research project is a Quality Improvement (QI) study to assess resource utilization for six ongoing clinical trials and evaluate the impact of quality improvement methods on the completion of critical trial activities in the Heart and Lung Transplant and Pulmonary (HLTP) department at Baylor Scott and White Research Institute (BSWRI). Methods: The project design is a case series in which observations were made on research staff before and after an intervention, with no control group. Non-probability sampling with purposeful, maximum variation was used due to the study's qualitative research design. Metrics were collected regarding the completion of key trial activities of subject screening, subject enrollment, and data entry before and after intervention using a spreadsheet tool. Collected metrics were reviewed to identify areas for improvement and QI interventions were designed and implemented to reallocate resources as appropriate. The data was maintained in a run chart to monitor changes during the pre-intervention and post-intervention periods. Statistical analysis was performed on the data to evaluate the effect of the intervention. Results: The Wilcoxon Signed-Rank test was used to statistically analyze differences in medians of activity metrics across all studies before and after intervention. All variables improved in the direction of the applied interventions except time screening subjects and data entered in the electronic data capture (EDC) system. Median differences were found statistically non-significant, except the combined variable of number of open queries and case report forms (CRF) not entered weekly which demonstrated a statistically significant decrease following intervention. Median time screening subjects demonstrated a non-significant decrease following intervention while median number of subjects screened showed a non-significant increase. Median time enrolling subjects and median number of subjects enrolled increased post intervention, but statistical testing was not performed due to the small sample size below the minimum critical threshold required. Median time entering data in the EDC demonstrated a non-significant increase following intervention while median number of CRFs entered in the EDC showed a non-significant decrease. Conclusion: Implementation of the quality improvement process for clinical research staff provided a tool for our site to continuously assess and improve trial outcomes. Five of the seven variables receiving quality improvement interventions improved in the direction of the intervention, with one demonstrating a statistically significant difference. The small sample size used may have decreased the power of the study to detect statistical significance. Future studies should be completed to apply the quality improvement methodology used to a larger sample size. In conclusion, this study established 'proof of concept' for the completion of future, larger-scale quality improvement projects at our research site.