By Deborah Borfitz 

March 23, 2023 | Consumers are by now accustomed to opting out of everything from unwanted telemarketing calls to text messages about a flash sale at their favorite department store. It is perhaps unsurprising then that they would not object to the idea of an opt-out approach to cold contact about a clinical trial for which they are potentially eligible.   

Happy indeed was the recruitment team at the South Carolina Clinical & Translational Research (SCTR) Institute to have that hunch confirmed by a pair of participant engagement groups (PEGs), according to SCTR Institute Codirector Patrick Flume, M.D. Patients of the Medical University of South Carolina (MUSC) as well as community members and trusted leaders from across the state, have indicated that they’d be willing to be contacted at least every three months about participation opportunities—twice as often as initially proposed. 

The process, referred to as patient outreach recruitment (POR), is intended to increase reach and opportunity for patient participation in research. Hoped-for outcomes include not only improved study enrollment and a greater admix of subjects, says Flume, but timelier completion of trials.  

Benefits of the POR approach are highlighted in an article that published recently in the Journal of Clinical and Translational Science (DOI: 10.1017/cts.2023.21). The paper describes how to stand up the recruitment strategy, communicate the change to patients and the community, and document study team contact and patient research preference. 

The practice is expected to spread to other Clinical and Translational Science Award (CTSA) hubs of the National Institutes of Health. Recruitment managers and coordinators at partner institutions regularly inquire about the novel POR process, reports Tara Pittman, recruitment manager at SCTR’s SUCCESS Center offering a suite of services to investigators. Among the frequently asked questions are management of the cold-contact strategy, sentiments of the institutional review board (IRB), and getting needed approvals from legal or compliance offices. 

Diversity Matters 

The goal with POR is to increase the number of clinical trial participants, especially diverse ones. “It is not so much that you are looking for diversity for diversity’s sake, but ... to make sure you are including a population that represents the group that you intend to treat,” says Flume. 

If a study is investigating a condition that affects everyone in the state but enrolls an entirely white population, it is questionable whether the results extrapolate to people of other cultural backgrounds, he cites as an example. Similarly, if a study is looking at a condition affecting mostly older people but enrolls all younger subjects, it won’t reveal anything about the safety of the therapeutic in targeted end users.      

Factors to be considered might be race, ethnicity, age, socioeconomic status, customs, language, religion, sex, gender, and geographical area. Flume underscores the importance of including both urban and rural populations to ensure study conclusions are more generalizable in the real world.    

The POR opt-out strategy “in and of itself isn’t limiting which populations it targets,” notes Pittman. “In fact, it is kind of removing the barriers to access.” But the ability to contact patients doesn’t necessarily increase their recruitment. 

How people are approached about study opportunities matters, she says. To that end, the SCTR Institute helps investigators tailor their messages for specific populations. Gaining access to them is the necessary first step to ensuring inclusive research.  

Due to the demographics of South Carolina, the POR tactic immediately bumped up investigator access to African American and Hispanic populations—representing nearly 27% and more than 6%, respectively, on state census rolls—heretofore underrepresented in trials. According to the U.S. Food and Drug Administration, African Americans make up only 5% of clinical trial participants while Hispanics account for about 1%. 

The Transition 

With POR, MUSC defaults to permitting cold contact for all patients in the health system excepting those who express an unwillingness to receive such communication. “We want to build a culture of research and not make it something that is different,” says Flume. 

Individuals may choose not to participate in a trial, he continues, perhaps because it’s inconvenient. But it shouldn’t be because they’re skeptical of it or mistakenly believe they’d be guinea pigs. “We have important questions we need to answer ... [as] a research institution, so we want people to be comfortable with that.” 

Historically, MUSC patients could opt into trials via MyChart, the patient portal system of the Epic electronic health record, says Pittman. The approach required that they be using MyChart, and many of them did not. 

Even if they did, it might be sporadically to grab a test result or get appointment reminders, she continues. Despite being eager to participate, they didn’t necessarily know how or want to go into MyChart to fill out a questionnaire asking whether they were willing to be contacted about potential research studies for which they might qualify, or to change those preferences once selected.  

The transition to the opt-out approach has grown the pool of potential participants from just over 51,000 to the 1.7 million composing the entire MUSC patient base. People can use MyChart to opt out of being contacted or make that request when contacted about a particular study, says Pittman. A dedicated research website also walks patients through the steps of logging into MyChart to opt out of research contact. 

Between the launch of POR in January 2021 and last September, about 4,800 patients chose to opt out, which Pittman says is not concerning—especially considering the large number of patients that have already been contacted about research. Patients can change that preference at any point.   

Participant Engagement Groups 

MUSC models its PEGs after Vanderbilt Institute for Clinical and Translational Research’s Community Engagement Studios and have used them for a variety of purposes, including input on study protocols and recruitment campaigns, says Pittman. Two PEGs were created for POR to get feedback from patients and community members as well as trusted leaders from across the state, including physicians, church leaders, and educators. 

Members of the first group were patients and community members who provided feedback on who they considered community leaders/champions—i.e., influencers, particularly in the areas of health and healthy choices—who were used to create the second PEG, Pittman explains.  

This first group fielded questions about preferred communication methods and were asked what they need to know in addition to how they’d respond if told they were discovered because of their medical record, says Pittman. The recruitment team wanted to learn how they felt about being approached about research, what would incite or deter their interest, and who would be involved in their decision to participate. 

Community members and champions provided feedback on drafted messages, including digital announcement boards in clinics and vertical banners hung in high-traffic campus areas, she says. They also indicated where they would want to go for more information, which prompted expansion of an existing, general research website to explain what it means to be a patient at MUSC with an opt-out strategy.  

Champions in the community were additionally asked for their impressions, to identify community needs, and express their reservations, says Pittman. They also were asked what resources the SCTR Institute could provide to help “spread the word” about the new recruitment process and to suggest the best media channels to help guide marketing efforts. 

PEG members voiced different preferred method of communication (e.g., phone call versus email or letter), Pittman says. Data being collected by MUSC’s enterprise research clinical trial management system (OnCore) will now be used to identify trends to determine if cold contact ultimately yields enrollment success and greater diversity. With the enrollment information they hope to better understand which populations are most receptive to this recruitment tactic and the impact the type of contact may have, so investigators can make informed decisions about using the POR strategy for their study populations. 

Recruitment Reports 

For researchers, implementation of the opt-out, cold contact process involved a new workflow that expands on MUSC’s existing request process for accessing data for research, says Pittman. The eligibility criteria for their study and clinical indicators of those criteria are used to pull a list of potentially eligible patients from the research data warehouse that filters out patients who don’t want to be contacted about research. 

Following IRB approval, project-specific recruitment reports are accessed by study teams via the Research Electronic Data Capture (REDCap) system. A research contact form is affiliated with each patient, on which study teams are required to document date of contact, she explains. 

Prior to each study, investigators have a required POR consultation with the research preferences manager. Once they are familiar with REDCap, this is primarily to ensure the information delivered to them is what they requested, free of errors, and contains only the necessary data elements, says Pittman.  

When patients on the recruitment report are contacted and express a desire to opt out, investigators immediately record that preference, which then gets pushed to their medical record, she explains. This is also how notifications of patient deaths are documented. Recruitment reports get refreshed to remove these patients, so they don’t appear on future POR reports. 

“The most important part of the training on our end is to ensure they know what that contact form means ... [and] the importance of completing it in live time,” says Pittman. Her team also documents the ways investigators are planning to contact patients to be sure they have the necessary approvals to do so and answers their questions about strategies for reaching out to certain population groups. 

Key Challenges 

How to ensure contacted individuals become more fully engaged in a clinical trial are “still lessons we have to learn,” stresses Flume. As the experience of MUSC’s regional health network has demonstrated, “people don’t like it if we fly in and fly out” and their enthusiasm to participate may diminish if they are not apprised of trial results. 

Logistical challenges in implementing the opt-out recruitment approach are related primarily to reporting and workflow needs, says Pittman. For example, some study teams have complex inclusion/exclusion requirements that require sophisticated querying and additional reporting forms. They may also be contacting thousands of patients at a time and require a unique, automated approach to documenting contact. Setting up the data pull allowing for patient opt-outs to be displayed and refreshed across all existing recruitment reports was also not an easy ask of the in-house Biomedical Informatics Center (BMIC).  

An additional challenge was gaining consensus on how to handle the opt-out policy for pediatric populations, Pittman says. “We had to decide at what age ... you approach the parent versus the child and [whose] opt-out preferences you use.” 

For difficult decisions like these, the guidance of a steering committee has been invaluable, says Pittman. Members include representatives from the university compliance office, IRB, legal counsel, BMIC, Epic Research, and institutional research leadership. An active steering committee is “crucial” to the ongoing success of POR at any institution to work through the inevitable hiccups as the program is established and matures, she adds. 

At MUSC, initial reception to the new recruitment process by researchers has been positive. Early anecdotal reports from two investigators, which is included in the published study, suggest progress is being made in more quickly meeting enrolment targets and that the most diverse recruits are coming from POR methods.