Alosi, Marlena C., Analysis of Efficiency and User Satisfaction Following The
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Alosi, Marlena C., Analysis of Efficiency and User Satisfaction Following the Introduction of Digital Source Documents and Resources in a Clinical Research Setting. Master of Science (Clinical Research Management), November 2015, 111p., 2 tables, 17 figures, reference list of 23 sources. Efficient and accurate data management processes are essential for the successful conduction of clinical trials. The clinical research industry is unique among biomedical fields in that much of the reporting is still conducted using paper-based systems. Recent trends towards exchanging paper-based documentation methods for electronic documentation methods have shown that implementation of digital resources have the potential to expedite clinical development. This practicum sought to evaluate paper-based and electronic documentation processes in a cancer clinic in regards to efficiency and user satisfaction, and determine which documentation form was superior in these areas. Retrospective analyses and a survey were used as the sources of data to assess for these differences. It was determined that the replacement of paper-based methods with electronic methods of documentation at this particular clinic resulted in both greater timeliness and higher user satisfaction. ANALYSIS OF EFFICIENCY AND USER SATISFACTION FOLLOWING THE INTRODUCTION OF DIGITAL SOURCE DOCUMENTS AND RESOURCES IN A CLINICAL RESEARCH SETTING Marlena C. Alosi, B.S. APPROVED BY: _______________________________________________________________________ Lad Dory, Ph.D., FAHA, Major Professor _______________________________________________________________________ Patricia Gwirtz, Ph.D., FACC, Graduate Advisor _______________________________________________________________________ Ray Page, D.O., Ph.D., Committee Member _______________________________________________________________________ Melissa Pool, BSN, RN, Committee Member _______________________________________________________________________ Joseph Warren, Ph.D., Committee Member _______________________________________________________________________ Meharvan Singh, Ph.D., Graduate School of of Biomedical Sciences ANALYSIS OF EFFICIENCY AND USER SATISFACTION FOLLOWING THE INTRODUCTION OF DIGITAL SOURCE DOCUMENTS AND RESOURCES IN A CLINICAL RESEARCH SETTING INTERNSHIP PRACTICUM REPORT Presented to the Graduate Council of the Graduate School of Biomedical Sciences University of North Texas Health Science Center at Fort Worth in Partial Fulfillment of the Requirements For the Degree of MASTER OF SCIENCE IN CLINICAL RESEARCH MANAGEMENT By: Marlena Alosi, B.S., EMT-P Fort Worth, Texas November 2015 ACKNOWLEDGEMENTS This writing piece and the practicum from which it came would have been impossible without the efforts of my advisory committee, whose members are Dr. Patricia Gwirtz, Dr. Ladislav Dory, Dr. Ray Page, Dr. Joseph Warren and Mrs. Melissa Pool. I appreciate your individual efforts during this practicum and hope that my gratitude is some small repayment for all of your assistance and guidance. Additionally, the friendship and team spirit of the staff at The Center ensured that my internship experience was both constructive and memorable. Of particular note, I would like to name Kayla Blough, Brandi Halstead, Lori Hannan, Brian Franklin, Melanie Page, Soraya Patrick and Rosemary Siddens. I am grateful to each and every one these department members and am very fortunate to have had the opportunity to not only work with them, but to find friends in them as well. Lastly, and as always, I would like to recognize my wonderful family, friends, and co-workers at Napoli’s Restaurant for their understanding, flexibility, and encouragement during the months that I’ve been in this program. Above all, I am most fortunate to have the loyalty of Luis Garibay to aid me in my most trying times. His devotion and commitment to my goals will always serve as a source strength for me when I find my own beginning to wane. ii TABLE OF CONTENTS LIST OF TABLES.........................................................................................................v LIST OF FIGURES.......................................................................................................vi CHAPTERS 1. Introduction................................................................................................................1 2. Background and Literature Review...........................................................................3 3. Specific Aims.............................................................................................................7 4. Significance................................................................................................................8 5. Research Design and Methodology a. Training Time to Completion…………………………………...…………..9 b. Quarterly Document Turn-Around Time......................................................10 c. Physician Assessment of Laboratory Results Time to Completion………...11 d. User Satisfaction and Opinion Survey……………………………...………12 6. Results and Discussion a. Training Time to Completion……………………………………...………..13 b. Quarterly Document Turn-Around Time.......................................................16 c. Physician Assessment of Laboratory Results Time to Completion…………20 d. User Satisfaction and Opinion Survey………………………………………29 iii 7. Summary and Conclusions a. Electronic Source Documents and Resources...................................................35 b. User Satisfaction and Opinions Regarding Electronic Processes………….....37 8. Internship Experience and Journal Summary..........................................................39 APPENDIX A: User Satisfaction and Opinion Survey...............................................41 APPENDIX B: Internship Practicum Journal..............................................................46 REFERENCE LIST ....................................................................................................101 iv LIST OF TABLES TABLE 1: Median Times to Completion for Physician Assessments and their corresponding statistical values …………………………………....................................25 TABLE 2: Statistical testing results from parametric Paired t-test and non-parametric Wilcoxon sign-rank test…………………………………........................34 v LIST OF FIGURES FIGURE 1: Mean time to completion per training requirement in days for paper-based reporting method………………………….……………..................................................14 FIGURE 2: Mean time to completion per training requirement in days for electronic- based reporting method……………...………………………………………….………15 FIGURE 3: Histograms displaying time to completion in days for Contract documents…………….....………………………………………………………….…..17 FIGURE 4: Histograms displaying time to completion in days for Regulatory documents…………………………………………….………………………..………..17 FIGURE 5: Boxplot graph showing TTC of paper-based signature acquisition method (PaperCon) compared to SIGNiX signature acquisition method (SXCon) for Contract documents………………………….…..…..19 FIGURE 6: Boxplot graph showing TTC of paper-based signature acquisition method (PaperReg) compared to SIGNiX signature acquisition method (SXReg) for Regulatory documents…………..........................…...20 FIGURE 7: Histograms displaying time to completion in days for assessments completed by Physician A………………………………………………………………...…..……23 FIGURE 8: Histograms displaying time to completion in days for assessments completed by Physician B ……………………..……………………………………….….....……23 vi FIGURE 9: Histogram displaying time to completion in days for assessments completed by Physician C ………………………………………..………………………….……24 FIGURE 10: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician A…………………………………….…..……...26 FIGURE 11: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician B………………………………………....……..27 FIGURE 12: Boxplot graph showing time to completion for electronic method compared to paper-based method for Physician C……………………………………..….….…..28 FIGURE 13: Bar graph displaying mean scores per survey Question………………………………………………………….…………..….……..30 FIGURE 14: Histogram displaying non-normality of score differences for Ease of Understanding responses……………………………………….……………...….…...31 FIGURE 15: Histogram displaying skewed frequency distribution of score differences for Ease of Use responses……………………………........................……31 FIGURE 16: Histogram displaying a slightly skewed frequency distribution of score differences for Facilitates Learning and Retention responses…..…………....32 FIGURE 17: Histogram displaying skewed frequency distribution of score differences for User Satisfaction with Reporting Method responses………………….32 vii CHAPTER 1 INTRODUCTION Effective data management practices are vital for the proper execution of clinical research trials1,2. Reporting requirements generally mandate that data be manually inputted into several different areas and the large volume of data required by the sponsor that funds the trial ensures that documentation-related tasks are a significant portion of what occurs in a clinical research setting2. It has been estimated that the average clinical research trial will require reporting of 125 points of data per patient per month3. For a phase III clinical trial enrolling 2,000 patients, this can generate 3 million points of entered data over a 12-month period. Considering that many of the data points will be reported multiple times throughout the clinical trial period,