High-quality research possible in busy specialty practice

By David Bronstein

PHOENIX—Using a research tool known as pragmatic study design, investigators at Vanderbilt Specialty Pharmacy identified a large cohort of patients who were nonadherent to their medications and developed several targeted interventions that significantly improved compliance.

But it was the value of the methodology, as much as the study results, that Autumn Zuckerman, PharmD, BCPS, AAHIVP, CSP, the director of Health Outcomes and Research at Vanderbilt Specialty Pharmacy, in Nashville, Tenn., emphasized. “Contrary to a controlled clinical trial, pragmatic studies must fit into normal workflow and allow for variation in practice,” Dr. Zuckerman said during a Specialty Pearls session at the 2022 ASHP Summer Meetings and Exhibition. “This is important for those of us integrating research into practice, because it takes into account the challenges, intricacies and behaviors of patients and clinicians in a nonclinical trial setting.”

The Vanderbilt team, led by specialty pharmacist Amanda Kibbons, PharmD, considered this research approach “about three years ago, when we wanted to evaluate our adherence rates and any opportunities to improve them,” Dr. Zuckerman said. Their initial investigations showed they had more than 1,000 patients with a proportion of days covered (PDC) of less than 80%, versus a baseline overall rate of 95%.

So, the next question was how to identify the key drivers of nonadherence in that cohort, as well as strategies to address them, in a way that worked with the demanding schedule of pharmacists tasked with performing the prospective research.

One key piece of this puzzle was to engage with a health information technology partner within the medical center to build a connection between the pharmacy software system and Vanderbilt’s Research Electronic Data Capture (REDCap) system.

“REDCap is actually external to our electronic health record, but it allowed us to efficiently perform randomization and collect patient and intervention data,” Dr. Zuckerman said. “We then developed a daily report of patients who met our inclusion criteria, which was securely transferred to a server. An API [Application Programming Interface] was built between the server and REDCap, such that we had automatic importing of the data into REDCap each evening.”

When the pharmacist who was assigned to the research project had dedicated time to devote to it, “she would review the newly imported patients for reasons for nonadherence,” Dr. Zuckerman explained. “If they had no appropriate gaps in treatment, she would randomize them within REDCap.”

But the effort wasn’t only about numbers: “We also engaged patients in the process by asking them about the main medication adherence barriers they were facing,” she emphasized.

The prospective study that emerged focused on patients who had more than four fills of the same specialty medication in the previous 12 months and a PDC of less than 90%. A total of 439 patients were included in the final analysis, with an even split between patients given usual care and those who received pharmacist interventions to address key drivers of medication noncompliance.

The most common interventions were related to memory (27% of all reasons for nonadherence), which included setting up memory aids on patients phones or sending pill boxes. Additionally, for patients who were unreachable to schedule a refill (20%), the pharmacist attempted to contact them via phone, patient portal, and finally mail, Dr. Zuckerman noted.

“Our primary outcome was PDC at eight months, post-enrollment,” she said. “We found that at that time point, intervention patients were 1.8 times more likely to have a higher PDC than usual care, illustrating the effectiveness of the interventions.”

Diving a bit deeper into the data, median PDC at six months was 0.95 versus 0.90 for patients in the intervention and usual care arms, respectively (P=0.003); at eight months, 0.94 versus 0.88 (P<0.001); and at 12 months, 0.93 versus 0.87 (P<0.001).

The pragmatic study design approach taken by the Vanderbilt team allowed for several invaluable tweaks, Dr. Zuckerman noted. For example, “we found that reviewing patients when they showed up on the nonadherence report was burdensome and required significant manpower,” she said. “So, we enlisted an additional floater pharmacist to help with patient review.”

As for when to consider employing a pragmatic study design in clinical practice, “if you’re planning to develop a new service or change services, maybe this is how you assess its effectiveness,” Dr. Zuckerman said. She also stressed the benefits of involving your IT department in the process. “By all means, engage health IT and your research experts. They are likely at your institution, so the good news is that you don’t have to necessarily reinvent the wheel.” Finally, when doing any type of research, it’s important not to lose sight of the importance of providing high-quality care amid all of the data crunching, Dr. Zuckerman noted. “We certainly don’t want to reduce the care we’re providing,” she said. “Rather, we want to optimize it by identifying an add-on service or a better method for providing patient care.”

“There is so much about this study design that excites me,” commented JoAnn Stubbings, BSPharm, MHCA, a clinical associate professor emerita in the Department of Pharmacy Practice, University of Illinois Chicago College of Pharmacy, and one of the founding members of UIC’s Specialty Pharmacy program. “The interface between the pharmacy software system and REDCap was innovative and efficient.”

Dr. Stubbings, a member of the advisory board for Pharmacy Practice News and Specialty Pharmacy Continuum, also lauded the research approach taken by the Vanderbilt team. “I like the prospective study design with a control group and the PDC measures taken after a reasonable time—four months for baseline and eight months for intervention,” she said. “The Vanderbilt group demonstrated that monitoring adherence and targeted interventions such as memory aids can significantly improve adherence in the long run. We can all put these findings into action to improve patient outcomes.”

Vanderbilt’s health information technology partner helped build a connection between Vanderbilt’s pharmacy software and its Research Electronic Data Capture (REDCap) system.

PharmD, BCPS, AAHIVP, CSP The sources reported no relevant financial disclosures.

Making the most of opportunities to manage costs and increase revenue is core to our consulting. We help you improve fi nancial performance across your organization.

• Comprehensive Strategic Assessments • 340B Program Solutions • Specialty Pharmacy Programs • Revenue Cycle and Drug Reimbursement

Strategies • Supply Chain Strategies • Drug Diversion Programs • Drug Compounding Excellence

Transforming healthcare through pharmacy.TM