Ideas by Bridgeable

Reimagining the Informed Consent Form

Our healthcare system is undergoing radical change, moving away from a past where healthcare roles were clearly defined toward a system where patients are increasingly playing a more active role in their own care.

Our healthcare system is undergoing radical change, moving away from a past where healthcare roles were clearly defined toward a system where patients are increasingly playing a more active role in their own care.

While a patient-centered approach to healthcare presents an opportunity for patients to be more engaged than ever before, it comes with its own set of challenges. With more decisions to make and complex information to understand, it can leave patients feeling lost in the system and confused.

In the world of clinical trials, one patient communication stands out for being both exceptionally important and singularly complex—the informed consent form.

Is there a way to reimagine and redesign Informed Consent Forms given this new patient-centric landscape?

That’s the question that Debra Reinhard, Bristol-Myers Squibb (BMS); and Susan Bartlett, Bridgeable will answer in their presentation, “Reimagining the Informed Consent Form”, at the EyeForPharma Patient Summit USA 2017 Conference on November 3rd.

In this talk, Debra and Susan will give an overview of the Universal Patient Language (UPL), a set of resources developed by BMS and Bridgeable using service design capabilities to help communicate with patients about complex topics, and discuss the way BMS and Bridgeable applied the UPL to BMS’s Informed Consent Forms using co-creation.

We sat down with Susan in advance of their presentation to talk about how BMS uses service design methodology to redesign their patient communications.

How did the UPL come about?

The Universal Patient Language (UPL) wasn’t an isolated project. The year before UPL launched, BMS and Bridgeable collaborated on an enterprise-wide strategy with the hope of improving patient experience. The resulting strategic framework provided the ‘how-to guide’ for the UPL: leveraging service design capabilities like co-creation and prototyping to collaborate with a variety of different external partners, including patients.

From the outset, the UPL project was always about building two different things: The UPL itself (a toolkit for creating patient communications), and individual patient communications that applied the UPL. With our focus on making patient communications that addressed real challenges, UPL had a built-in feedback mechanism. Each time we co-created with patients and designed a new patient communication we learned more and fed that learning back into our UPL tools.  

Why is co-creation such a powerful tool in redesigning the informed consent form?

The informed consent form is a single document, but it’s really the output of an incredibly complex ecosystem. Within the pharmaceutical company sponsoring the trial there are a lot of different players—from the individuals developing the protocol to the lawyers reviewing all the elements. Then there are stakeholders from Institutional Review Boards (IRB) who will review the consent and adapt it to the guidelines of their organization. You also have individual sites and the research staff who conduct the trial and ultimately deliver the consent to patients and their caregivers. And of course, informed consent is heavily regulated by the FDA.

Co-creation brings together all of these perspectives to tackle redesigning the informed consent form. By having everyone working together, we can design solutions that meet the diverse needs represented around the table. We make the hard compromises live in co-creation so that we can walk out with prototypes that satisfy many different stakeholder needs and are much more likely to work in the real world. As a bonus, we also prototype ideas for additional ways we can support informed decision-making about clinical trial participation. 

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