This project required a very in-depth user interaction analysis.
Our objective was to recruit the physician investigators. After about six months of earnest site recruitment, in which I assisted, using traditional methods, the company allowed me to investigate why investigator recruitment was so slow and why there were errors in the imaging data from sites already enrolled. A number of reasons surfaced. The one I could impact involved a general lack of understanding of the study protocol, imaging charter and imaging manual by the site staff.
I spent six weeks analyzing all the relevant company SOPs, Imaging Charter, product User Manual, Imaging Manual, user created documents and the Study Protocol line by line, eventually creating cards with each step listed individually.
Cards
When the cards were laid out, it was obvious why the site staff was so confused. On top of staff compartmentalization, aimed at keeping study costs down, the steps and requirements simply were not in agreement. In addition, the steps required of the site were extremely time consuming, difficult and required two people present, but only one was budgeted for and recommended.
Unfortunately, the nature of clinical trials does not permit easy revision of these documents.
The sponsor did not have the budget to pay for the staffing required. Using the information I discovered, I created a complex timeline that would fit on a clip-board for the study staff to use while dosing and imaging a patient, reducing dosing errors.
The other items to overcome required a deeper market analysis and revisions to the imaging charter and study protocol. Both had been submitted to the FDA so revisions were not possible.
Cards outlining steps required during image acquisition, stacked in groups with related tasks. The step is titled, per the primary document, on the top. A description, if not obvious from the title, is located on the body of the card. On the bottom left, the document (D) the step was mentioned in is printed. My goal was to find more than one document for each step. That didn't always happen.
Cards outlining steps required per company SOPs, stacked in groups with related tasks. The step is titled, per the primary step, on the top. A description, if not obvious from the title, is located on the body of the card. On the bottom left, the Standard Operating procedure (SOP) the step was outlined in is documented for reference. The individual responsible for each step is abbreviated on the upper left. PM- Project Manager, IC- Imaging coordinator, IS- Imaging Specialist, Imaging Designate.
Draft #1
Because it was easier to understand, I started with the Imaging Manual and outlined the steps that needed to occur. The Imaging Manual is an optional user-manual, guiding their actions. It allows those individuals collecting the images to focus their resources on image scanning and collection and not on the entire study Protocol, which is often several hundred pages long.
Originally created in Excel, because the Microsoft Suite is the usual health care professional's choice, I began to see it did not let me present the information in a useful manner. Yes the steps were present, but it wasn't obvious which steps needed to be continued during other steps.
On the right you can see where I came up with the idea of dragging down a "bar" to encompass tasks that were done during another item.
Draft #2
Originally, I started using green to represent patient actions and blue for the site staff. They are colors used frequently in medicine. The orange is the client color and the purple is my employer color.
The two right columns show my first digital use of the "bars" dropping down. In the left column you begin to see the impact of comparing the document I began the process with, the Imaging Manual, to the Protocol and Imaging Charter. The space reflects more time and alternating of tasks between the patient being scanned and the imaging tech. The Protocol and Imaging Charter are considered more "official" because they are submitted to the FDA.
Draft #3
In the next iteration, many of the patient actions were re-assigned to the site staff, because they are responsible for directing and observing the patient to ensure compliance.
The dop "bars" became thinner, giving more room for simpler steps and fewer acronyms. Times were added to the bars.
Final Document
The document was reviewed by more people directly involved in the study and a few changes were made. The scientists chose which document was "more correct." Additionally, it was decided certain information, such as frame rate, was "standard" for that type of medical image and not necessary for this document.
The background was made lighter because imaging is typically done in a darker room to calm the patient. In addition, reducing the contrast of the background image made the document more legible.
