Array of Patient Recruitment Efforts Boost Back Pain Study Participation

Back pain is one of the most common forms of chronic pain affecting adults. People with chronic back pain often take opioids for pain management, but opioids are highly addictive. To address this public health challenge, in 2019 NIH launched the Back Pain Consortium (BACPAC) Research Program, part of the NIH Helping to End Addiction Long-term? (HEAL) Initiative that launched in 2018, a patient-centered effort to address the need for non-addictive, effective and personalized therapies for chronic back pain. Scientists are conducting clinical trials with the hopes of finding new non-opioid treatments. Yet for clinical trials to be effective, the studies must include diverse patient populations and robust patient engagement. Many factors—including distrust, accessibility, cultural differences, and pandemic-related restrictions—can negatively impact patient recruitment and engagement. BACPAC researchers were able to devise new ways to overcome barriers to study recruitment.

Pandemic Challenges and Solutions

In early 2020 when the COVID-19 pandemic hit the United States, many researchers were forced to pause their clinical trial recruitment efforts. Investigators for the BACPAC Research Program were no exception.

BACPAC researchers at Cedars-Sinai in Los Angeles turned to electronic tools to overcome COVID-related patient recruitment and clinical trial challenges. With fewer people going to their doctor’s office for in-person visits, the researchers used artificial intelligence (AI)-powered software to help identify prospective study participants.

The software scans electronic health records (EHR), but in a new way. A typical EHR search focuses on terms found in specific fields, such as the problem list or diagnosis. The investigators used the natural language processing cohort builder to search the language in the clinical notes for references to back pain.

“Back pain is very prevalent, and doctors might not always list it in the problem list or ascribe it a specific diagnosis. We weren’t capturing all the patients with chronic low back pain by doing searches the old way,” explained Lindsey Ross, M.D., a Cedars-Sinai investigator who was part of a BACPAC study involving the use of virtual reality (VR) headsets to help manage chronic pain.

After identifying patients with low back pain, the investigators took it a step further and used the cohort builder to find Black and Hispanic patients and improve clinical trial diversity. Patients found eligible for the study were then screened and consented via email and phone. This process worked well in general, but it presented challenges for some underserved and underrepresented populations.

“Email and phone sounded great in theory, but we found that some of our patients especially the elderly and many of our Hispanic patients didn’t use email as readily,” explained Ross.

To help overcome this challenge, the investigators placed paper forms and drop boxes in clinics where the patients typically went for care. This strategy allowed patients to ask their clinicians questions and get assistance filling out the forms while they were at the clinic for an appointment. Once the forms were complete, they could be placed in the drop box. By adapting to the needs of these patients and providing information in their own environment, investigators were able to recruit individuals who may not have participated if electronic submission was their only option.

Working with principal investigator Dr. Brennan Spiegel, Ross and the team developed and employed a study design that limited in-person contact. The VR headsets and a wristband device were shipped to participants and tracked via an online system. The scientists then used online surveys to capture patient-reported outcomes, and they used web-based platforms to monitor survey responses remotely.

Pandemic Challenges and Solutions

In early 2020 when the COVID-19 pandemic hit the United States, many researchers were forced to pause their clinical trial recruitment efforts. Investigators for the BACPAC Research Program were no exception.

BACPAC researchers at Cedars-Sinai in Los Angeles turned to electronic tools to overcome COVID-related patient recruitment and clinical trial challenges. With fewer people going to their doctor’s office for in-person visits, the researchers used artificial intelligence (AI)-powered software to help identify prospective study participants.

The software scans electronic health records (EHR), but in a new way. A typical EHR search focuses on terms found in specific fields, such as the problem list or diagnosis. The investigators used the natural language processing cohort builder to search the language in the clinical notes for references to back pain.

“Back pain is very prevalent, and doctors might not always list it in the problem list or ascribe it a specific diagnosis. We weren’t capturing all the patients with chronic low back pain by doing searches the old way,” explained Lindsey Ross, M.D., a Cedars-Sinai investigator who was part of a BACPAC study involving the use of virtual reality (VR) headsets to help manage chronic pain.

After identifying patients with low back pain, the investigators took it a step further and used the cohort builder to find Black and Hispanic patients and improve clinical trial diversity. Patients found eligible for the study were then screened and consented via email and phone. This process worked well in general, but it presented challenges for some underserved and underrepresented populations.

“Email and phone sounded great in theory, but we found that some of our patients especially the elderly and many of our Hispanic patients didn’t use email as readily,” explained Ross.

To help overcome this challenge, the investigators placed paper forms and drop boxes in clinics where the patients typically went for care. This strategy allowed patients to ask their clinicians questions and get assistance filling out the forms while they were at the clinic for an appointment. Once the forms were complete, they could be placed in the drop box. By adapting to the needs of these patients and providing information in their own environment, investigators were able to recruit individuals who may not have participated if electronic submission was their only option.

Working with principal investigator Dr. Brennan Spiegel, Ross and the team developed and employed a study design that limited in-person contact. The VR headsets and a wristband device were shipped to participants and tracked via an online system. The scientists then used online surveys to capture patient-reported outcomes, and they used web-based platforms to monitor survey responses remotely.

Boosting Patient Engagement Efforts

The team at Cedars-Sinai also employed strategies to enhance participant engagement. They found that regular email reminders or phone calls, and incentives like gift cards motivated participants to complete surveys about their experiences. Providing participants with phone numbers and email addresses to contact support staff directly also enhanced patient engagement, they found.

“We had a full and dedicated team that was constantly on the phone to make sure we stayed engaged with patients,” said Ross. “We wanted to be sure it wasn’t just, ‘Here’s an email. Here are the materials. Go.’”

Ross also noted that for many study participants, VR was a new and unfamiliar technology. To address this gap, the investigators developed videos demonstrating how to use the VR headsets. When dealing with complicated healthcare technology, patients may find how-to videos more beneficial than pamphlets with written instructions.

These BACPAC researchers used a variety of methods to overcome barriers to clinical trial recruitment during the pandemic. But these same strategies have the potential for more widespread application. Future studies that use specific strategies to enhance patient diversity and attract participants who may be reluctant to join a trial could be a step in the right direction for more personalized chronic pain management.

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This work was supported through funding via HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies (UH3-AR076573-03S1)