The Importance of Defining the Patient Journey in Decentralized Clinical Trials
One of the key tools in the effective implementation of a Decentralized Clinical Trial is the design of the Patient Journey. In this weeks article, I am going to explain what a ‘Patient Journey’ is, why it is so key in working in a DCT setting and how best to go about preparing them.
Materials that are typically prepared during the planning of a traditional site based clinical trial tend to lack the necessary detail on stakeholder interactions with the patient. Before DCT’s the details of what might happen between the site and the patient was largely down to each investigator. With DCT, the implementation and tools are more intrinsically involved.
At KCR we use the definition of a patient journey in hybrid DCT trials to support the definition of forms, workflow and communications typically as part of a platform implementation, but even with a multi-component DCT solution, the exercise of preparing a patient journey is valuable.
So what is a ‘Patient Journey’
The Patient Journey defines the steps and activities that are performed for or on behalf of the patient through the entire lifecycle of the patient in a clinical trial. The aim of the patient journey is to make clear the steps, conditions and branches that may occur and to present this information in a visual format that facilitates understanding and interaction — e.g. swimlane or story board diagram formats — see example in Figure 1 below.
I personally have a preference towards swimlanes where you define each of the stakeholders down the vertical axis and the patient states across the horizontal axis. Tools such as Lucidcharts and Visio can be used to prepare and collaborate on such flows.
We recognized that the story boarding of the patient journey was not just important from a software configuration basis, it also served to prove out the details of the protocol.
I would like to share some of the methods we employ incase they are of use for sponsors or DCT solution providers in the future.
Building the Patient Journey
Step 0 — Preparation — I would highly recommend the preparation of a stencil that includes shapes that represent the key aspects of your DCT. Tools like Lucidcharts and Visio allow you to create or combine your own visually representative shapes that include connector support and store them in a stencil library. The stencil should also be described in an instructional page that goes with the Patient Journey — see sample in Figure 2.
Step 1 — Gather source materials. Start with a known list of potential stakeholders — ideally these match to roles of users in systems. These are applied down the side of the diagram. Next we do the same for the participant ‘states’ — these are the different states that we wish to recognize a study participant achieving — e.g. Candidate, Screened, etc. These might be the same as Patient Statuses, but might also be a superset.
Step 2 — Draft basic flow — draw a first draft diagram based on known information. It is better to step into a stakeholder meeting with an initially draft rather than starting from blank. Walking through this draft will help engage a multi-stakeholder audience. Walking through this will often result in gaps between identified and filled.
Step 3 — Stakeholder walkthrough — this is where the decision makers and knowledge owners gather round a real or virtual table to walk through the patient journey. Any gaps are filled during the walk through. In my experience, it is not unusual at this stage to pick up changes to the protocol.
Step 4 — (Optional) Wireframe review — this is where the Patient Journey is annotated with screenshots or wireframe samples. For example, you might have a process box that describes the activity in the initial flow. The addition of a representative screenshot helps further visualize the story help an audience understand the information and activities being performed at each step.
The following benefits can be achieved in preparing, sharing and reviewing the Patient Journey;
- Identification of each activity for all stakeholders
- Discover bottlenecks in process
- Determine areas of risk in stakeholder <> participant interactions
- Define conditions to proceed to next step in process
- Assure project team understands & appreciates the whole picture from a patient perspective
- Lock down specifications early leading to earlier configuration and testing of the final solution
Understanding the impact of the various activities and interactions with the patient is fundamental in achieving success in a Decentralized Clinical Trial. Defining the patient journey is one way in helping to achieve this.
KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston, US, Berlin, Germany, and Warsaw, Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.
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