Measuring Clinical Trial–Associated Workload in a Community Clinical Oncology Program

Abstract

Purpose: The ability to quantify clinical trial-associated workload can have a significant impact on the efficiency and success of a research organization. However, methods to effectively estimate the number of research staff needed for clinical trial recruitment, maintenance, compliance, and follow-up are lacking. To address this need, the Wichita Community Clinical Oncology Program (WCCOP) developed and implemented an acuitybased workload assessment tool to facilitate assessment and balancing of workload among its research nursing staff.Methods: An acuity-based measurement tool was developed, assigning acuity scores for individual clinical trials using six trialrelated determinants. Using trial acuity scores and numbers of patients per trial, acuity scores for individual research nursing staff were then calculated and compared on a monthly basis.Results: During the 11 years that data were collected, acuity scores increased from 65% to 181%. However, during this same period, WCCOP was able to decrease individual research nurse staff full-time equivalent (FTE) acuity scores and number of patients per FTE. These trends reflect the use of the acuity-based measurement tool to determine actual workload and use of the acuity data to direct hiring decisions. Conclusion:Clinical trial workload has been successfully measured and used to guide staffing by one community clinical oncology program. Further research is needed regarding its applicability to other research programs.

NCI–Clinical Trial Accrual in a Community Network Affiliated with a Designated Cancer Center

“…In contrast to published experiences, however, we found that phase I and even non-therapeutic trials did not present an insurmountable barrier to accrual in community oncology practices. In a previous survey of 51 community practices, which included both federally sponsored and private non-academic affiliated practices, half of the practices self-reported that they did not accrue to phase I trials, 53% did not accrue to investigator-initiated trials, and 33% did not enroll on correlative science trials [ 11 ]. It is likely that many investigator-initiated trials and translational “non-therapeutic” trials can meet the needs of community oncology patients, and that academic-affiliated community sites are best poised to engage patients in accrual to these types of studies.…”

Patient Acuity Related to Clinical Research: Concept Clarification and Literature Review

“…Finally, one was a quality improvement study (Cusack et al, 2004a(Cusack et al, , 2000bJones et al, 2004) and two were expert opinion or commentary (Cassidy & Macfarlane, 1991;Smuck et al, 2011). In relation to psychometric assessments, eight had no reliability and validity data reported (Berridge et al, 2010;Ellis et al, 2012;Good et al, 2013;Gwede et al, 2000aGwede et al, , 2000bJames et al, 2011aJames et al, , 2011bMcCarthy, 1997;Roche et al, 2002;Smuck et al, 2011). Five studies mentioned reliability and validity but no data were presented (Briggs, 2008;Coffey et al, 2011;Cusack et al, 2004aCusack et al, , 2000bJones et al, 2004;Oddone et al, 1995;Penberthy et al, 2012).…”

ASCO's Community Research Forum: Addressing Challenges of Community-Based Research from the Grass Roots

“…The Wichita Protocol Acuity Tool, which was used by a single oncology-focused research program for over 10 years, 1 was selected as the model on which the ASCO tool would be based. The Forum adapted this Wichita tool to create the ASCO Clinical Trial Workload Assessment Tool, which is designed to have widespread applicability among community-based research sites.…”