Improving Clinical Trials Through Conversations
Suzann Johnson, Associate Director of Investigator and Patient Engagement at Janssen, talks about how the company’s HealthCaring Conversations for Clinical Research initiative can improve the clinical trial experience for patients and investigators.
PV: What is Janssen’s HealthCaring Conversations for Clinical Research program?
Johnson: HealthCaring Conversations is an initiative that strives to put the patient at the center of clinical trial conversations. At the heart of the program is a proprietary communications framework, which works as a blueprint, if you will, to outline clear and empathic conversations with patients. We built off work executed by our colleagues at Johnson & Johnson Health and Wellness. We brought in our clinical trial expertise and our site managers and adapted the communication model for the clinical research setting.
The model is based on three pillars: understand, connect, and empower. Within those three pillars, we’ve taken the best of what we know from healthcare in general, health communications, and behavior science to create guidelines for communications with patients about clinical trials.
We piloted the program in North America last year, and we are preparing for a global launch in the fourth quarter of this year. This means that any Janssen clinical trial that starts after October 2019 will automatically have this offering provided as part of the trial.
Trials will now include a digital learning lab, an online skills enhancement module for sites and their staff. This module provides modeled conversations with suggestions on how to respond to the patient. The learning lab has been well received; in fact, 98% of the pilot participants said they would continue to use the concepts moving forward.
PV: How does this framework improve the clinical trial experience for patients?
Johnson: We know from talking with patients there is a general feeling that they do not feel as if they are true partners in the research, and that participating in a trial felt as if it were a clinical process. We have an opportunity to bridge these gaps.
We know that patients really value the relationship with their family doctor and they want to feel understood and they want to be part of a trusted relationship.
They want this same type of relationship with their principal investigator. By providing the HealthCaring framework, we are helping healthcare providers to have better conversations with patients. We know that improving communications can lead to improved trust and also help the patient better understand the clinical trial process, his or her roles, and responsibilities. The patient then becomes a partner in the process and improves the overall experience.
PV: Do investigators want or need this type of communications program?
Johnson: We have run global think tanks with our investigators, and one of the requests was for help with soft skill training around communicating with patients. Our investigators acknowledge that communication around clinical research across the variety of patients they see can be quite complex. At the end of the day we’ve made a commitment to improve patients’ experience with clinical trials. Our tagline is “Better Trials. Made Together." This means we are working with investigators and with patients to improve the trial experience. This is just one of the many efforts that folds into the larger goals for all of Janssen R&D at this point. Everyone is tasked with bringing the concept of better trials together forward as part of their daily job.
PV: What are Janssen’s plans going forward?
Johnson: We want to share this program with the industry. As such, we’re offering a workshop at the Society for Clinical Research Sites Global Summit in October. We will be introducing the model and covering the behavior science behind the program.(PV)
~~~~~~~~~~~~~~~~~~~~~~~~~
About Janssen’s HealthCaring Conversations
HealthCaring Conversations (HC2) was customized for the clinical trial setting, incorporating relevant, appropriate components for the environment into the core clinical research framework.
An extensive literature review was conducted by the J&J Behavior Science team to identify the scientific evidence of clinical trial participation, and to understand the scientific evidence of communication skills training as a potential opportunity to support provider and patient satisfaction with clinical trial conversations. From the literature review, the company learned that there are opportunities across all stakeholders focused on areas such as building trust, using open-ended questions to elicit patients’ views, and enhancing the consent process. The behavior science insights were combined with market insights from commercial and clinical trial partners to develop the clinical research framework and tools used to support it.
The framework is designed to help guide the HCP to engage with the patient in such a way that it taps into that patient’s unique motivation drivers and challenges. This, in turn, is intended to provide the patient with the sense of a more customized or personalized healthcare experience, which may increase the likelihood he or she will follow the guidance/instructions of the site staff.
A site manager and site staff post-pilot feedback survey found:
98% are likely to use or will use the concepts in the HealthCaring Conversation framework going forward.
62% are likely to or will recommend this course to a colleague.
