Background/Purpose: The aim of this qualitative research was to identify physician-perceived patient and clinic barriers to patient recruitment in a RA pragmatic trial of anti-TNF biologic vs. non-TNF biologic/Janus-Kinase inhibitor initiation after an inadequate response to methotrexate (MTX-IR).

Methods: Semi-structured telephone interviews were conducted with 26 rheumatologists in March 2019. An exploratory thematic analysis approach was used to analyze the interview data.

Results: Physician perceived patient barriers to the implementation of a RA pragmatic trial.

Two main themes were coded, consistent with the research questions identified and included patient barriers, and clinic barriers (Figure 1). This theme covers three sub-themes: 1) patients’ personal barriers, 2) patients’ treatment-related factors, and 3) trial-related factors (e.g., patient recruitment, side effects, mode of use, etc.). Patients’ personal factors, the largest sub-theme, included insurance status, language barriers, and travel-related factors. Insurance status and plan was the biggest factor thought to influence patients’ medication affordability and thus, trial participation. Seventeen out of 26 (65%) physicians mentioned health insurance as one of the top three patient barriers. The second sub-theme was treatment-related factors, including patients’ medical condition and complexity, comorbidities, treatment, and patient outcomes. The third large sub-theme was trial-related factors, and included patient recruitment, preferences, burden, and side effects (Figure 1).

Physicians perceived clinic barriers interfered with the pragmatic trial enrollment from the clinic or the healthcare system perspective. This theme covered four sub-themes (Figure 1): 1) clinic-related factors, 2) patient-related factors, 3) research personnel, and 4) facilitators (positive factors of the clinic). The clinic-related factors include patient/clinic flow, lack of resources (e.g., patient room, infrastructure, and time), ethics committee approval, competing trial/studies, clinical equipoise, and recent changes to a new health care record system (e.g., EPIC). Among all patient-related factors, insurance was considered as the key clinic barrier by 12 (46%) participants, including 7 participants who thought that insurance was a barrier for both clinic and patients. Research personnel was the third sub-theme under clinic barrier theme, including coordinator efforts and provider engagement.

Conclusion: Our results from the inductive thematic analysis will help researchers understand the key patient and clinic/system factors/barriers that may influence pragmatic RA trial implementation. The themes suggest there are factors that can be modified (e.g., coordinator effort needed, effective patient recruitment during clinic visits, provider engagement) and challenges to overcome (patient insurance status, busy clinic flow, and space issues including limited number of patient rooms). In summary, these themes provide a basis for our and other research teams to develop clinic-centered and patient-centered strategies to implement a pragmatic RA trial.

Figure 1: Patient Barriers and Clinic Barriers

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/identifying-physician-perceived-barriers-to-a-pragmatic-treatment-trial-in-rheumatoid-arthritis/