Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM) is an NIH Pragmatic Trials Collaboratory Trial integrating a group-based mindfulness stress reduction program into primary care settings for patients with chronic low back pain. The research team, led by Dr. Natalia Morone, enrolled 451 participants across 3 healthcare systems. Participants were randomized to a telehealth-delivered group-based mindfulness intervention arm or a usual care arm.

To amplify patient and other partner voices, the research team received an NIH supplemental award to support a community advisory board; determine partner perspectives on recruitment, retention, implementation, and dissemination; and document patient perspectives on living with chronic low back pain and on their participation in research studies (Figure). Morone shared that the supplement allowed the team to significantly expand the scope and quality of patient engagement. “There was no comparison of what we were able to do once we received the supplement,” she said.

Figure. Summary of OPTIMUM Partner Engagement Activities

While the engagement efforts included a variety of partners, patient engagement was a focus. The study team engaged more than 60 patient partners. Activities included a community advisory board, focus groups, and individual patient interviews.

Table. OPTIMUM Partner Engagement Methods

Dr. Isabel Roth, who led OPTIMUM’s engagement activities, reflected on the lessons learned from the research team’s experience engaging with patient partners.

What Went Well: Factors That Promoted Successful Patient Engagement

Several factors contributed to OPTIMUM’s success with patient engagement:

Skilled Staff to Support Engagement

• The team hired an experienced community engagement expert who had expertise in community-based participatory research. Just as trials invest in data analysts or study coordinators, engagement experts must be budgeted for.
• The team hired bilingual research staff who spoke Spanish and could converse with patients and translate materials. Bilingual staff were prioritized and compensated for their valuable skill.
• The team trained facilitators for its focus groups and community advisory board, which Roth said can be just as important as training patient partners.

Patient-Centered Practices

• Cultural humility was at the core of the team’s work.

“It was very important for our team to be respectful, to be kind, and to be open to what people had to say,” Morone said. “People know when they are being treated respectfully. They told us in the interviews how much they appreciated that.”

• The team used an ethnographic approach to engage with partners, which was important in contextualizing information and establishing trust.
• The team prioritized clear communication and keeping promises. This was critical to developing and maintaining trust. Whenever possible, Roth said, provide updates to patient partners on how their feedback is implemented.
• The team scheduled the intervention and focus groups based on insight from partners. For example, the intervention took place during evening hours at the request of participants.
• The team used focus groups to glean key insights. They found focus groups to be powerful because patients wanted to share among other patients with similar experiences.
• Many patient partners were impacted by the social determinants of health. Paying patient partners was critical and showed respect.
• The team recognized the intersectionality among patient partners. Patient partners may represent different identities and perspectives, such as patient advocates, medical experts, clinicians, and others.
• The team invested time and resources to train patient partners before they participated in engagement activities to ensure they were equipped and comfortable to participate fully. Training resources used are outlined in the Table.

Table. Training Resources Used with Patient Partners

Process for Rapidly Implementing Feedback

• The team used the Stanford Lightning Report Method as a model to quickly aggregate and distribute feedback from the focus groups and Community Advisory Board to study sites. These rapid turnarounds were essential because recruitment was ongoing. “Waiting six months for a formal qualitative analysis didn’t make sense in our case. We needed the main points quickly,” Roth said.

Challenges and Barriers Encountered

Challenges experienced by the OPTIMUM team during patient engagement activities included:

• Like many multisite PCTs, OPTIMUM had a large research team, many of whom had never met in person. Keeping the team connected was an ongoing challenge.
• All patient engagement took place virtually, and some patient partners encountered technological barriers and literacy challenges.
• The team reflected that they could have improved in their dissemination of follow-up materials like the lightning reports back to the community advisory board and focus groups.
• The team faced serious challenges related to timely payment of patient partners. With regulatory differences across the different academic health systems and understaffing in a budget office, payment was distributed later than intended. For some lower-income patient partners, the delay became distressing and degraded trust. Roth recommended being transparent about the situation and working hard to avoid future delays; also, expect and budget time for unexpected “regulatory hoops.”

Additional Recommendations

Morone and Roth shared additional guidance. While not specifically pertinent to OPTIMUM experiences, these recommendations are relevant to engaging with patient partners in PCTs.

• Engage patient partners as early as possible in the research process. Patient partner perspectives and insights can also generate future research questions.
• Include and prioritize patient engagement in PCT proposals so that the funding is guaranteed from the beginning, even when patient engagement is not required.
• Ask how patient partners wish to be acknowledged for their valuable insight, and follow through with their requests.
• To promote feasibility of more patient engagement in PCTs, create standing community advisory boards with patient partners whose expertise could be used across trials. Established relationships and trust hold immense value. This strategy could promote ongoing and more sustainable patient engagement.

Closing Thoughts: Patient Partner Perspectives Especially Relevant to PCTs

In the context of PCTs that span multiple, diverse health systems, patient engagement can be even more critical, Roth said. By nature, PCTs focus on real-world settings in which patients interact with clinical care. Engaging patient partners and tailoring trials based on their insight can be even more beneficial to understanding results and generating knowledge than in other clinical trials.

“They are telling us how to do this in a more patient-centered way,” Roth said. “We have more flexibility in pragmatic trials to make things more like the real world.”