Are Community Health Workers The Key to Promoting Diversity in Clinical Trial Enrollment?

In the United States, a growing number of independent local pharmacies are recruiting community health workers (CHW) to join their teams, a peer-to-peer liason that has a nonclinical role within the local pharmacy, said Tripp Logan, III, PharmD, chief operating officer at Seguridad, Inc, in Charleston, Missouri.

As experts of their neighborhood, CHWs are extremely knowledgeable about health care and social services in the “local ecosystem” of the community and help patients access these services.

“CHWs are the patient-facing person helping patients to navigate [the health care system],” Logan said in an interview with Pharmacy Times. “We need that access point and you need the person in the community that's connected to the community.”

With services that include screening patients, helping patients attain doctors’ referrals, and addressing patient barriers to care (largely food insecurity or medication access), the scope of the CHW is already large, Logan said.

But there is another service that community pharmacies and CHWs can provide to patients (especially those who are not close to large academic medical centers), which is to get patients access and enrollment into clinical trials, said Gerald Finken, RPh, MS, CEO of RxE2 Inc, in Fargo, North Dakota, in an interview with Pharmacy Times.

“This is a real solution to a real problem,” according to Finken. “You can bring clinical trials into [the community pharmacy] to provide additional health care options for patients.”

Clinical trials have been grappling with recruiting diverse populations for years now, and underrepresentation is a near-constant struggle in the space, he explains. A commonly cited reason for underrepresentation is mistrust in the clinical trial system, but the issue extends beyond general mistrust, especially from minority ethnic and racial populations, explained Finken.

On the one hand, some patients of diverse backgrounds are not covered for the cost of screenings and other services that are necessary to participate in the trial, according to Finken said.

“You're asking somebody who doesn't have the means [to] cover the costs,” Finken said.

Requesting that patients cover their own transportation, meals, daycare, and other costs is already a big ask, but asking them to cover the actual health care costs associated with the trial is a bridge too far, Finken explained.

Another point of contention for organizations and institutions trying to enroll diverse patients in their clinical trials relates to abating patient fears. This extends beyond general mistrust and manifests from small unknowns, like “Where do I park?” and “Who am I supposed to see?,” to large what-ifs and anxieties, like “Who's going to address my personal needs?” Finken said.

For these reasons, the community pharmacy might just be the ideal place to get diverse patients to enroll in clinical trials. For one, the community pharmacy is the most accessible health care professional to their local communities, Finken said.

The racial and ethnic makeup of the local community is also reflected in the people who frequent the community pharmacy, according to results from the RxE2-sponsored 8-week Pilot Project on Collection of Patient Race and Ethnicity Data. During this project, investigators confirmed that the racial and ethnic makeup of the populations who frequent the community pharmacy reflect the makeup of people who live in the surrounding area, marking the community pharmacy as a destination that can accurately recruit diverse patients.¹

But even so, the process of getting the patients who come to the local pharmacy interested and actively participating in enrolling in a clinical trial is a different issue, which is where the CHW can step up to the plate, according to Finken.

The CHWs can better address patient what-ifs and unmet needs than people at clinical trial sites because their work is largely centered around building relationships with people. And if more CHWs were positioned at the pharmacy, they would likely have more interactions with patients who are coming to the pharmacy anyways to pick up prescriptions, Finken said.

To that end, patients will also see the CHW at the pharmacy more often than they would see a researcher at a clinical trial site. This not only invites the opportunity to build a relationship with the patient, but it facilitates a level of comfort that supports open and honest communication that can promote better clinical outcomes, Finken explains. For instance, If the CHW gives the patient the space to discuss feelings and hesitations, the CHW is better able to appease concerns and promote good decision making as it relates to the trial, Finken said.

“There's not a budget at the clinical site for the counseling of the patient,” Finken said. “This ability to have a conversation for all the subjective information has an impact.”

As CHWs foster this counseling and communication, it also helps to raise the engagement of the patient as a clinical trial participant. Patients in trials are prone to recall bias—especially when there is a lot of time between treatments—but going to the pharmacy in the interim and checking in with the CHW can trigger recall about data that will eventually be collected by clinical trial researchers, Finken said.

Unfortunately, providers (and even sometimes pharmacists) can intimidate some patients— despite this not being the pharmacist's intent, which can trigger health-related anxiety in a “white coat syndrome” fashion, Logan said. “[But] you know who it doesn't happen to near as much? A CHW, because that is just your person,” Logan said.

Since this health care-related intimidation can be more pronounced in the clinical trial setting, it could be worth having a CHW that is a peer to patients and helps them to achieve stepping-stones in the clinical trial, Logan explained.

There is even an economic incentive for community pharmacies to participate in clinical trial enrollment. Right now, community pharmacies are in a financial crisis, so working with clinical trial sites can boost revenue, diversify, expand pharmacy services, and promote relationships, the latter point being something that the community pharmacy is already successful at, Logan adds.

CHWs can be outsourced, but Logan thinks that pharmacy technicians are a great resource for cross-training as a CHW because they already mediate the community and pharmacy worlds. More than 500 technicians have already received training as a CHW, and there are many more who are receiving accreditation because there is such high demand.

“This [growth] isn't an anomaly,” Logan said. “There's a workforce that is sitting back ready to do this type of work.”

Ultimately, recruiting diverse patients from those who visit the community pharmacy can be a powerful tool to bolster health care research and increase engagement with the system, and the CHW could be a key player in this equation. “When you have a CHW with a pharmacist, just right there, it is 1+1= 5,” Logan concludes.

REFERENCE

1. Hunter E. The Community Pharmacy Can Leverage Trust To Improve Health Equity Outcomes. Pharmacy Times. News Release. October 10, 2023. Accessed on March 14, 2024. https://www.pharmacytimes.com/view/the-community-pharmacy-can-leverage-trust-to-improve-health-equity-outcomes