Lean Six Sigma is a data-driven methodology used to solve problems in areas that do not meet business objectives and customer needs. Since its introduction, Lean Six Sigma has evolved to require not only that defects are reduced but also that the correct problem is improved. Oncology Solutions recently worked with a cancer center clinical research team and utilized a Lean Six Sigma methodology to:
- Reveal inefficiencies in the clinical research process
- Determine the staffing needs of the clinical research department
This case study details the background of the engagement, the steps taken to identify clinical research staffing efficiencies, and the realized outcomes.
In a span of two years, the cancer center’s clinical research department underwent many changes, including the departure of the director and the hiring of a new director charged with the task of rebuilding the clinical research department. The staff in the research department included one full-time equivalent (FTE) director; three FTE registered nurses (RNs), one of which provided additional administrative support with reporting and the department billing/financials; and a total of 2.2 FTEs for data and regulatory functions.
The clinical research team believed there to be a need to hire an additional FTE RN due to current nurses insisting their workloads were at maximum capacity. Oncology Solutions proposed to evaluate the staff’s responsibilities to specifically determine if:
- The RNs’ workloads were in fact at maximum capacity
- The tasks currently being completed by RNs were value added vs. non value added for an RN
- The organizational structure was conducive for a collaborative, team-oriented environment
In the clinical research department, RNs were expected to identify and screen patients for trial eligibility; educate, consent, and enroll patients in studies; and document and manage patients for their assigned physicians. Embedded in these responsibilities were numerous administrative tasks that did not require an RN for completion. Ultimately an RN should be providing assessment of and education to the patient and their family/caregiver(s) and workup to the level of their licensure.
Oncology Solutions created task categories based on interview feedback and data. The following table displays the average amount of time spent on each activity per nurse.
|Task Categories||Average Time Spent Per Day (in hours)|
|Tumor Conference, MDC, MD Office Visits||0.9|
|Patient Assessment and Monitoring||0.6|
Operational Definition and Measurement
As previously stated, Lean Six Sigma is a data-driven methodology used to reduce defects and ensure the correct source of those defects is improved. Defects in this project were defined as “hours spent daily on non-value-added tasks” and were measured by adding the total hours spent on these tasks as reported by the research nurses. Non-value-added tasks are defined as any time a registered nurse is not functioning to the height of his/her license and is completing non-nursing-specific tasks.
The following tools were utilized during the assessment:
- Staff job function forms
- Daily time logs completed by staff
- Staff observation and interviews
- Review of department organizational chart
- Pareto Chart
- Fishbone Diagram
Task and time documentation completed by the clinical research staff, observation, and individual interviews were used to identify value-added vs non-value-added tasks. Oncology Solutions’ staff paired up to conduct two-on-one interviews, with one person asking questions and one person taking notes and/or tracking time. Example interview questions included:
- What are your specific job responsibilities and the amount of time spent on this task?
- What are the barriers that interfere with your job? What do you do about the barriers?
- Are there additional resources to help you with your job? I.e., individuals in the MD offices, documentation tools, EMR, etc.
- Are you completing extra steps that could be eliminated from your job?
Value-added (RN functions) and non-value-added (non-RN functions) tasks were identified during this interview process and the table below lists examples of job functions for nurses and clerical staff, respectively.
|RN Clinical Trial Functions
|Non-RN Clinical Trial Functions
(Non Value Added)
|Clinical education||Faxing documents|
|Physical assessments||Providing regulatory information to the sponsors|
|Providing oversight for staff screening and consenting patients||Completing regulatory submission, data queries, collection submission, follow up, and tracking data|
|Policy/Procedure review||Preparing submission document(s)|
|Evaluating new protocols||Data entry/data collection (if not too high level)|
|Preparing staff for audits||Submitting follow-up information as specified by protocol|
|Meeting with Principle Investigators (PI) to discuss opening new trials||Assisting clinical staff with all labs, pathology, and radiation summaries|
|IRB oversight of documents submitted for review||IRB prep/closure documents|
|Performance improvement projects (monthly chart reviews)||Maintaining study records, coordinating labs or imaging|
Task and Time Allocation
Oncology Solutions’ data analysis revealed nurses spent only 20% (1.5 hours) of their daily time on value-added tasks. In the chart below, the average time spent on non-value-added and value-added activities are displayed by task category.
The Pareto Principle is when 80% of the consequences of a problem are associated with 20% of its cause. For this cancer center, this translated to 80% of the defects (hours spent daily on non-value-added tasks) were associated with 20% of the task categories.
In order to see if the Pareto Principle was in effect, Oncology Solutions created a Pareto Chart. This bar chart showed the frequency of defects by non-value-added task category in descending order. A second y-axis placed to the right of the chart displays cumulative percentages of defects.
By charting the non-value-added tasks, it was evident that three main task categories caused over 80% of the defects. The top non-value-added tasks as outlined in the Pareto Chart were screening, documentation in the EMR/CREDIT systems, and administrative functions. The tasks and time in the chart below represent the average time spent per day on each non-value-added task by all RN staff.
In addition to a Pareto Chart, Oncology Solutions created a Fishbone Diagram based on interview feedback. These diagrams are also called “cause-and-effect diagrams” or “Ishikawa Diagrams” and provide a visual tool for categorizing potential sources of a problem in order to identify its root causes.
To construct the diagram, Oncology Solutions started by stating the problem in the form of a question: “Why are non-value-added tasks being completed by an RN?” This question becomes the head and spine of the fishbone from which other “bones” are created. Clinical research is a service-oriented industry and therefore we used the nationally recognized “4 Ps” (People, Policies, Plant/Technology, and Process) to form the side bones. Next, common themes communicated during interviews were attached as root causes to each branch explaining why that branch was a potential source of the problem. These causes formed the basis for our project recommendations.
Click here to view the fishbone diagram.
Recommendations and Outcomes
Based on Oncology Solution’s recommendations regarding staff structure, duplicative documentation, and ensuring nurses are completing only value-added activities, the cancer center implemented a number of items that has greatly increased their efficiency and ability to meet accrual goals.
Implemented items include:
- Hiring a paid student, who works 12–15 hours per week and assists with administrative duties and updating the clinical trial menu and website for patients and physicians
- Transitioning one of the regulatory staff to a study coordinator role, who has the training to screen and consent patients on non-treatment trials, increasing the center’s ability to accrue patients
- Consolidating the three separate CREDIT systems into two to reduce duplication of efforts
- Increasing staff training to demonstrate proficiency in using the required EMR/CREDIT systems
Clinical trials are one of the pillars of a successful cancer program and play a critical role in advancing cancer care. Trials provide the promise and potential of translating research gains into improved treatment options for patients. However, as this case study proves, clinical trials can be a tremendous amount of work and it is paramount to have the program reaching its highest potential with the ultimate goal of increasing patient participation in clinical trials.