(This article is part 2 of a 2-part series – Read Part 1)
We had an overwhelming response to our January 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: How do you track time when your job involves constant interruptions? Phone calls from subjects, monitors, investigators, etc.
This can be a challenge during that concerted period of time (one or two weeks) when you are performing a time and motion study. But that’s actually the value of doing the study. We sometimes over or underestimate the amount of time that is spent on those indirect protocol-related activities that often get “lost in the shuffle” when estimating budgets and workload. The key is after every 15 minutes to take a few moments to categorize the tasks. For example, perhaps 12 minutes were spent on patient calls and 3 minutes on monitor calls. Over the course of the day you can see how all that adds up. This gives you a much clearer picture of the true work effort involved in conducting a trial, above and beyond just assigning duration to the more obvious activities in the protocol schedule of events.
Q: Doesn’t work effort management depend on the type of trial (e.g., drug or device, IV versus oral drugs, etc.)?
Most definitely. In addition to categorizing the tasks by specific protocol and protocol complexity, another great suggestion is to categorize by type of trial. So you could imagine a matrix where a given task, such as obtaining PK samples, could range from 0 minutes to several hours for a given type of trial (a device trial may have zero and a Phase I, IV drug trial may have several hours for a given visit). This enables you to establish benchmark averages that can be applied to workload planning and budgeting for future similar trials.
Q: How would you suggest we do a workload estimate for a coordinator who only has acute care trials when they never know when a patient will present (e.g., an Emergency Dept. coordinator with multiple trials – you never know when a potentially eligible patient will come in)? It is difficult to do this – today there may be no one, tomorrow there are 5.
As discussed in the webinar, it’s one thing to know how many hours are associated with a given task and to add up all the tasks to determine the total hours and associated staff functions needed for a protocol. But the real challenge of workload planning is to determine an accurate estimate of both the number of patients to be screened, as well as the flow of patients over time. In the acute care setting, the flow of patients can be much more unpredictable. Going back to past study metrics may be one place to start. If you look at the enrollment logs for the past 3 years, you might see certain patterns or trends for a given type of study. For example, you may note that there are more patients admitted for heart attacks in the months of March and June, and that on average these months have 8 patients, whereas other months average only three. Or, you could look at Emergency Department or hospital admission rates for certain types of conditions each week over the course of a year to get some type of estimate for what the flow and volume of patients might be. This would at least point you in a direction of estimating the number of staff needed. However, for cases that really can’t be predicted, you may need to have some “flex” or on-call staff to cover the ebbs and flows.
Q: Who would be responsible for setting up the functional organizational chart? The coordinator, the manager, or both?
In creating the functional organizational chart, the coordinator assigned to the project may have a better sense of the details of the study and the specific functional roles required. The coordinator could then set up the basic template. The manager, if that function is available within the organization or clinical research department, might then play a role of assigning specific individuals to the task as they may have a better idea of which staff have capacity and are currently available to support the various activities. For more complex trials involving multiple departments, the manager could then liaise with other functional area heads to determine adequate resources, as well as named individuals in the other departments, to secure their commitment to the study.
Q: Are there features within Forte that can assist with workload planning?
Absolutely. That’s the beauty of the CTMS system. You can simplify the aggregation of all of the data by utilizing an electronic interface to do some of the tedious work of documenting work effort. Forte offers two systems, based on the needs of the research organization. For academic medical centers and cancer centers, they offer OnCore eClinical, and for investigator sites and research groups, there’s Allegro CTMS. Both systems provide the means to track work effort, thereby, eliminating the need to track this important information manually or with paper-based processes.