Increasing clinical recruitment rate to a single-site observational study: a quality improvement study.

Objective: Clinical recruitment encompasses a significant challenge in multidisciplinary research, often acting as a bottleneck to timely completion due to slower-than-expected patient enrolment rates. Addressing this, enhanced communication within clinical departments is crucial. A quality improvement (QI) study was initiated in the Mater Misericordiae University Hospital (MMUH) to increase the slow recruitment rate of cancer-associated thrombosis patients to the EXPECT Study.

Methods: Process and stakeholder mapping as well as Plan Do Study Act (PDSA) cycles highlighted effective initiatives to increase recruitment rates to the study. The PDSA cycle 1 aimed at increasing clinical communication and study education through implementation of work package-1, which included engaging a clinical project sponsor to drive recruitment and increasing study awareness through educational talks/informative materials. The PDSA cycle 2 aimed to increase process efficiency and paired sample acquisition through implementation of work package-2, which included holding weekly QI meetings, building a strong multidisciplinary QI team and mapping the recruitment process. These efforts aimed to increase recruitment from one to four patients enrolled per month, with recruitment progress tracked with a run/bar chart over a 2 year period.

Results: The communication/education work package-1 initiatives increased the recruitment rate from one to two patients per month, with target enrolment met or exceeded 33% of the QI-project duration. Recruitment numbers nearly doubled in roughly half the timeframe, from 10 patients enrolled in the first 16 months to 18 patients enrolled in the 9 months of the QI study. Furthermore, a greater than threefold statistically significant increase in paired sample acquisition from 20% to 66% was documented following the execution of the second PDSA cycle, aimed at improving process efficiency.

Conclusions: This QI study highlights the need for a highly engaged study team, specifically the clinical project sponsor driving recruitment from a medical front-line perspective as well as a highly efficient recruitment process.