Janssen Hopes to Improve Communication with Clinical Trial Patients Through New Program
While clinical trials tend to focus on helping patients find new ways to conquer their disease and advance scientific understanding, the patient’s experience isn’t always at the center of the conversation. The patient’s safety and well-being are always central, but sometimes communication isn’t as clear as possible, leaving the patient with questions or suboptimal understanding of the care they’re receiving.
Janssen plans to change that with their new program called “HealthCaring Conversations for Clinical Research: A Science-Based Framework for Patient-Centered Conversations,” which aims to improve the clinical trial experience for both the patient and the investigators. They recently spoke about HealthCaring Conversations at the Clinical Trial Innovation Summit in May.
“HealthCaring Conversations is a blueprint for having an efficient but empathic conversation with a patient,” said Suzann Johnson, Janssen’s associate director of clinical insights and experience. “We’re taking good conversations and making them great by putting the patient at the center of every conversation.”
As the name suggests, this program puts patients at the center of conversations by modeling the simple skills clinical trial researchers need to focus on and effectively communicate with patients. This allows researchers to address the “social contract” of a clinical trial, which is so often under-discussed with the patient.
Based on behavior science and a large literature review performed by Janssen, this communication model combines the best parts of multiple behavior models, effective communication modes, and data on clinical trial participation into one easy-to-use platform. Researchers can use this communication model as a blueprint to guide them through conversations with the patient. This model aims to help the researchers understand, connect and empower their patients by allowing them to determine the unique issues that are important to each patient and effectively address them.
“We want patients to be comfortable navigating clinical research and get the information they need and want,” Johnson added. “There is a misconception that empathy takes more time – it does not take more time to be empathic.”
Patient-centered communication training in healthcare
Putting the patient at the center of conversations should be the goal of every healthcare interaction to ensure the patient’s concerns are being effectively addressed. Effective communication is especially key when the patient has questions or concerns about a disease or procedure. To promote the integration of patient-centered conversations in healthcare, there are some training programs available.
The Communication Skills Pathfinder provides both online and in-person training to healthcare professionals who work with seriously ill patients. They offer on-demand webinars, continuing education, and online short videos as well as an intensive in-person course on how to conduct a positive, patient-centered conversation.
The Communication Skills Pathfinder was developed by three patient-centered organizations: the Center to Advance Palliative Care (CAPC), a national organization for making quality palliative care services more available for people with serious illnesses; VitalTalk, a nonprofit organization that offers communication skills training geared towards clinicians who care for seriously ill patients; and Ariadne Labs, a Boston-based “health system innovation center” that is working to provide solutions to improve health care delivery. Both CAPC and VitalTalk offer communication training and tools for clinicians in addition to the Pathfinder training.
The patient-centered outcomes research trust fund (PCORTF), under the Office of the Assistant Secretary for Planning and Evaluation (ASPE) of the U.S. Department of Health and Human Services (HHS), supports data collection on clinical effectiveness and health outcomes research. While this focuses less on communication, this initiative collects valuable data on patient-centered outcomes in health care and clinical research.
Addressing an unmet need in clinical trials
Patient-centered clinical trials, and healthcare in general, is increasingly being recognized for its importance in medicine. However, there aren’t many widely used specific guidelines or interventions to facilitate effective patient-centered conversations. There is also limited data on patient-centered health care approaches published in the literature, including a review of patient-centered care in randomized controlled trials, quantitative challenges in patient-centered outcomes research, trends and opportunities for patient-centered care in clinical trials, and an overview of the data on patient-centered activities in clinical research.
When Janssen asked what could be improved with clinical trials, clinical research staff requested more training in soft skills and patients identified a communication disconnect between them and the staff.
“Common feedback we received included patients saying, ‘I heard everything the doctor said, but I didn’t understand a word of it,’” Johnson said. “Researchers are skilled, and their hearts are in the right place, but communication is complex and not always perceived correctly.”
The large volume of information communicated to patients in trials paired with their involved and technical nature creates this communication barrier between patients and researchers. By implementing a patient-centered dialogue, researchers and clinicians can rethink communication by prioritizing information, communicating to a patient when they will be most receptive to hearing information, and communicating in an efficient and empathic manner.
Some ways to improve communication skills with patients (and in general) include minimizing jargon, being uncomplicated, being specific, using some repetition to help with understanding, and checking patient understanding. Using task-oriented behaviors (such as active listening responses from patients) and affective behaviors (such as responding empathically and addressing the patient’s main concern) can also greatly increase the patient’s satisfaction with their care.
Focusing on the patient
The HealthCaring Conversations platform mainly involves training via a 20-minute online interactive module that models communication with a patient. The person being trained would choose the best responses during the simulated patient conversation, shaping the conversation to continue based on their responses.
“This program is quick, easy, online, evidence-based and effective,” Johnson said. “It is critical to not only make sure it is effective, but that it is easy for clinical staff to access and incorporate into their busy day.”
This communication model can be used in any patient situation, not just for clinical trials. For example, Johnson & Johnson, Janssen’s parent company, first trained over 10,000 dental professionals to use the HealthCaring Conversations model in their practices. They provided seminar, webinar or digital-based training on behavioral techniques as well as pamphlets, a conversation guide, conversation starters to display in the patient rooms, and an action plan tear pad that the dental professional can give to each patient to help them incorporate the advice given during the appointment to create better habits.
Janssen then modified that conversation platform to optimize it for clinical trial use. The program is brought to clinical trial sites via the site managers, who advocate for their sites to embrace the program. According to Janssen, 98 percent of clinical trial site staff who went through the HealthCaring Conversations training plan to use the communication concepts in their next clinical trial.
Increasing the program’s reach
Currently, HealthCaring Conversations is only being used internally for some Janssen-sponsored clinical trials as a pilot program in North America. Starting this October, it will be offered to all new Janssen trials worldwide on a rolling basis.
The overall goal is to fully integrate this program into clinical trials: “This is something we value in the way we conduct our trials,” Johnson said. “We want to build this platform into the normal workflow of the clinical trial site staff, so that it is sustainable.”
In the longer-term, Janssen plans to roll this platform out to non-Janssen trials. For now, interested site managers of non-Janssen trials are welcome to attend a public workshop at the Society for Clinical Research Sites Global Site Solutions Summit being held October 11-13 in Hollywood, Florida. Hosted by Janssen and other behavioral scientists, this workshop will provide a more generic training on how to communicate with patients, focusing on the research of effective communication and how to apply it.