(1474) Finding Solutions to Patient Enrollment Challenges in Clinical Trials in Ill Oncological Patients

Introduction: Conducting interventional studies in oncological critical care units (ICU) presents challenges due to the unstable condition of patients and the dynamics of their care environment. Enrolling patients in these settings is difficult as it requires a lot of cooperation. Here we evaluate some of the most common challenges and recommendations from a group of research coordinators working in an ICU of an oncologic hospital.

Methods: A focal group was done with research coordinators of the ICU department to inquire about the challenges that made enrollment of patients difficult in their studies in the last year. The discussion focused first on a multiple-choice question about the causes including refusal from patients, lack of support from clinical staff, and complicated consent processes. In the second part, we asked open-ended questions to learn about the recommendations implemented. The answers to the first question were categorized and dichotomized into yes or no to calculate the mean. The recommendations of the second question were summarized.

Results: The answers were analyzed, and we found that 71% of research coordinators determined that the main challenge is patient refusal, while 43% also indicated that lack of support from clinical staff is a significant challenge. Among the recommendations, the most mentioned was to reframe the approach when presenting the study to patients, review their medical history situation, choose an appropriate time that is not stressful, and check if they have participated in other clinical trials before. For lack of staff support, it was suggested to improve communication with clinical teams, organize meetings with clinical leaders and the PI, make active efforts to make the clinical staff feel part of the research team, and minimize requests to clinical staff so that they do not feel that the study is an additional burden.

Conclusions: Enrolling patients in ICUs for interventional studies in oncology hospitals is challenging, but these can be managed through strategic communication, education, and relationship-building. By prioritizing these elements, researchers can enhance cooperation among the healthcare team and increase patient family participation, ultimately contributing to the success of interventional studies in these sensitive environments.