(This article is part 1 of a 2-part series – Read Part 2)
We had an overwhelming response to our February webinar on the topic of workload planning and work effort management. As a follow up, here are answers to some of the most popular questions.
Q: Can you explain more about the basics of a time and motion study and how it is used to track work effort?
A: In a nutshell, the time and motion study involves the following steps:
- Prospective documentation of time spent on specified tasks
- Collect data over predefined period of time (e.g., 1 week or 1 month)
- The staff members (e.g., study coordinators) stop every 15 minutes to record their tasks
- Determine time spent per task (intensity) and frequency of tasks performed (volume). For example:
- Task time (intensity): Obtain, process and ship blood samples = 30 minutes
- Frequency (volume): Number of samples managed per week = 10
- Total time = 10 X 30 minutes = 300 minutes or 5 hours per week
To get a rough estimate of the number of staff needed you would then take the total amount of time for ALL tasks ÷ 40 hours = Number of coordinators needed.
The use of standardized tools to capture data and training the personnel on their use is critical to obtaining valid results.
Q: Is there a more efficient way to track resources than coordinators writing down what they are doing every 15 minutes?
A: Whether it’s more efficient or not, the more statistically accurate way to document work effort is to have an independent observer do the tracking and observation through a work sampling study. This eliminates the inherent biases of self-reported data and enables the workers to do their tasks without interruption. However, this is naturally more expensive to do.
The good news about a time and motion study is that this is a limited effort – perhaps one to two weeks. This could be repeated yearly or as work activities change but isn’t something that needs to be done continuously throughout the year. Making the investment to establish benchmark estimates for the core tasks your staff does can yield significant returns on that investment, but it does take a commitment to “biting the bullet” and doing the work of documenting work effort.
Q: Isn’t it better to do this time and motion study or work effort planning prior to the CTA/Budget?
A: That’s correct. That’s why it’s important to make an investment in documenting the average time per task for the most common types of study related activities. Then, when the budgets are being developed you can simply take the schedule of events and multiply the frequency of direct protocol related activities by the average duration to come up with the time allocation for these tasks. If it’s a moderately complex trial, you then add the average time estimate for all associated indirect protocol activities to come up with the true work effort involved in conducting that particular trial. This goes a long way to provide the documentation necessary for budget negotiations and workload allocation.
Q: Can you provide a list of the main tasks that you may include in a worksheet to track work effort?
In the webinar we discussed the fact that different organizations categorize the tasks differently. You can review the references provided in the webinar for additional detail. As a starting point, I’m an advocate of breaking tasks into 3 main buckets:
- Direct protocol related activities: These are the tasks that are directly involved in the implementation of a trial such as obtaining informed consent, processing labs, performing procedures, entering data in the eCRF system, and so forth. Think of these tasks as those that match the protocol schedule of events.
- Indirect protocol related activities: These are all the peripheral tasks surrounding the protocol such as developing the budget, preparing IRB submissions, developing job aids, conducting staff in-services to train staff on the protocol, attending monitoring visits, and the like.
- Non-protocol related activities: These tasks would involve participating in staff meetings, attending continuing education conferences, conducting job performance reviews, and anything that doesn’t directly involve study implementation.
You can get as detailed as you like when developing the checklist of tasks, and some of the examples provided in the references may be a helpful start. When you are just getting started it may be helpful to keep the “buckets” relatively high level so that you don’t get bogged down in the details. You can always fine tune and add granularity over time. The key is to just get started with something reasonable and that will be minimally burdensome for the staff to complete.
Beyond capturing the general tasks it’s often very helpful to indicate which protocol specifically these tasks were associated with. Once all tasks per protocol are determined, the protocols can further be categorized as simple, moderate, or more complex. This way you can establish average benchmark data to be correlated with protocol complexity. For example, a simple protocol may only involve 3 hours of data entry, whereas a more complex protocol may require 10 hours. Or, a moderately complex trial may require 2 hours to obtain consent per patient, whereas a more complex trial may require 6 hours. This enables you to really estimate work effort and associated costs based on the complexity of the trial.