Involving Primary Care Patients and Their Physicians in Pragmatic Clinical Trials: High-Tech Interactive Tools Aid Study Recruitment
By Shelley Norden Barnes
Researchers at the University of Alabama at Birmingham Deep South Musculoskeletal Center for Education and Research on Therapeutics (UAB-CERT) are investigating novel ways to recruit patients for large-scale clinical trials and to make those trials accessible to primary care physicians and their patients. In a study recently published in Patient Preference and Adherence the UAB-CERT team assessed the feasibility of using physician offices and novel, high-tech, interactive tools to screen patients with osteoporosis for a hypothetical pragmatic clinical trial. Their findings are now paving the way for future studies of these tools in the informed consent and randomization processes.
Traditional vs. Pragmatic Trials: More Patients, More Impact
"Our CERT was looking at ways to use pragmatic clinical trials to engage a larger study group and make the outcomes more generalizable in our osteoporosis research," says Amy Mudano, M.P.H., the lead author of the UAB-CERT study. "The question was how to conduct a clinical trial in a doctor’s office using an easy screening tool so primary care physicians do not need to spend hours a day enrolling patients in a traditional clinical trial."
Traditional randomized clinical trials (RCTs) have long been the domain of academic medical centers, which limits access by physicians and patients in primary care practices and community settings. In addition to being time consuming, RCTs have restrictive inclusion and exclusion criteria that often result in small sample sizes. Consequently, the findings of these trials may not be generalizable to a broader patient base. As effectiveness studies have become the new standard in clinical investigation, researchers need to recruit a greater number and range of patients, particularly in primary care settings.
According to Mudano, pragmatic clinical trials fit the bill in nearly every way. They assess the comparative effectiveness of different treatments in real-world settings and measure clinically relevant outcomes that are potentially more applicable to the general population than those of RCTs. They also have broader inclusion criteria that allow recruitment of a larger, more diverse population.
"We would like to bring more clinical research out into the field and involve primary care and family physicians. This change in setting gives patients who typically don’t get to take part in clinical research trials the opportunity to do so. That’s the idea behind a pragmatic clinical trial," Mudano states. "We want to have fewer inclusion/exclusion criteria so more people can participate."
Until now, the main obstacle to conducting pragmatic clinical trials has been inefficient patient enrollment procedures that are particularly challenging for community and rural clinicians who have limited time and research experience. To overcome this obstacle, the UAB-CERT team decided to test different technologies to recruit and enroll patients. Wanting to involve family physicians, they engaged the help of 10 physician offices within the Alabama Practice-Based Research Network and the American Academy of Family Physicians National Research Network.
"We wanted to go beyond the pen-and-paper method and use an automated tool that could identify and enroll potential study participants in real time during a regular physician office visit. This was the first step," says Mudano.
Recruiting With High-Tech Tools
The team decided to evaluate two tools—a tablet computer that patients use to "write" answers to survey questions and a smartphone with access to an automated interactive voice response system that allows patients to answer survey questions verbally or enter them with the keypad. Both tools were programmed with eligibility and screening questions targeted to women aged 65 years and older who were being screened for an osteoporosis study.
"This feasibility pilot study looked at two issues," Mudano explains. "First, would patients in a waiting room be willing to use a tablet computer or a smartphone to determine their eligibility to participate in a clinical study? And if they were willing to undergo screening, which screening method did they prefer?"
Mudano continues, "Instead of responding verbally to screening questions in the waiting room with other patients present, the patients were able to go through the questions very quickly by clicking their answers on the tablet computer," Mudano states. "There was a learning curve in using the touch screen, but very few patients had any issues with the tablet computer. All of them were able to complete the questions." Conversely, many patients had trouble using the smartphone, because they had difficulty hearing the automated voice. They became frustrated and did not complete the screening process. Mudano credits the preference of the tablet computer over the interactive voice response system to both ease of use and novelty.
Easing the Way to Physician Buy-In
Although the UAB-CERT pilot study confirmed the feasibility of waiting room screening, implementing this recruitment process hinges on some logistical factors—for example, ensuring that wireless Internet connections are available in all participating physicians’ offices and that all physicians and staff are actively involved.
"We had some issues with Internet connectivity, especially in rural areas, and had to provide wireless capabilities," notes Mudano. "There also was a shift in the cultural paradigm, in that patients don’t have to complete all the study enrollment forms by hand, but rather learn to use a tablet technology. Now that many physicians’ offices are implementing electronic medical records, it may be a good time to introduce these study recruitment technologies."
Another possible obstacle is motivating practice-based physicians to participate in clinical trials. Many of these physicians have little to no experience in conducting clinical trials and may not consider their offices suitable study sites.
"We wanted to make the recruitment process as easy as possible and not interrupt their work flow so they would be more willing to incorporate it into their daily practice," says Mudano. "We got feedback from all the groups involved, because we wanted to be clear that the pilot study was easy to do and that the next phase of our investigation would be just as simple." Most often, the front-office staff helped facilitate the process.
For the next phase of their study, the UAB-CERT team is working with Mytrus Inc. to test a tablet computer as a platform for completing an online informed consent form that uses animation to explain a hypothetical study and includes intermittent quizzes that test how well the patient understands the study procedures.
Mudano AS, Gary LC, Oliveira AL, et al. Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size. Patient Prefer Adherence. 2013 Jun 14;7:517-23. PMID: 23807841.
The Centers for Education and Research on Therapeutics (CERTs) are a nationwide network of six research centers and a coordinating center that receive core financial support from the Agency for Healthcare Research and Quality. The CERTs conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products; increase awareness of the benefits and risks of therapeutics; and improve quality while cutting the costs of health care.