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

Norgan 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.