Congress Abstracts 2006

62

AUTOMATING A NURSING PROCESS: HOW TO DESIGN A COMPUTER TOOL TO VERIFY ELIGIBILITY FOR CLINICAL TRIALS. Vilma Lopez, RN, MSN, OCN^®, University of Texas M.D. Anderson Cancer Center, Houston, TX.

Enrolling eligible patients in Clinical Trials is one of the main roles of the Clinical Trials Nurse. Non-eligible subjects are not evaluable for the final protocol analysis. Protocol managers in our data management center verify eligibility for all subjects enrolled in our trials. The review process requires extensive time for auditing medical history, tests results and demographics to ensure that the subject meets the criteria.

The purpose was to design a commonly available computer tool to simplify the process, facilitate data entry, improve data quality, and cut costs without purchasing specialized software.

To standardize the process I first review the protocol eligibility criteria and the registration eligibility checklist to determine documents required to verify criteria. Next, I determine time frames as stipulated in the protocol, institutional standards or Good Clinical Practice to establish date parameters; analyze each criterion and separate it into its lowest level components; establish the type of answers acceptable for each component: simple, multiple choice, hierarchical, etc; set the hierarchy, if necessary, and validation parameters for numerical values.

A spreadsheet is prepared to collect data. The spreadsheet groups subjects based on their eligibility status: unverified, eligible or non-eligible.

Unverified are subjects with missing documents or data. We query the individuals responsible for registration to complete the information. Eligible subjects have complete documents, within the appropriate time frame, and meet all criteria; 100% completion is required. Non-eligible subjects have failed to meet criteria for varied reasons, i.e. tests out of time frame, incomplete testing, out-of-range values, discrepancies between received documents and the eligibility checklist. We query for more data, alternate documents or reconciliation. The spreadsheet can build automated queries.

The expected outcome is to decrease the processing time and rate of errors in verifying eligibility. We have compared results from the current manual process and the automated one to validate its accuracy. After validation, it might be widely used as standard practice for determining eligibility

The tool is easy to use, may be adjusted for different protocols and can be replicated or adapted for use in other oncology settings.