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

Area of Science:

• Clinical research operations
• Quality improvement methodologies
• Patient recruitment strategies

Background:

• Clinical recruitment is a major challenge in multidisciplinary research, often delaying study completion.
• Slow patient enrollment rates necessitate innovative solutions to improve efficiency.
• Enhanced communication within clinical departments is vital for successful clinical trial recruitment.

Purpose of the Study:

• To implement a quality improvement (QI) study at Mater Misericordiae University Hospital (MMUH).
• To increase the slow recruitment rate of cancer-associated thrombosis patients to the EXPECT Study.
• To identify and implement effective strategies for enhancing clinical trial recruitment.

Main Methods:

• Utilized process and stakeholder mapping alongside Plan-Do-Study-Act (PDSA) cycles.
• PDSA Cycle 1 focused on enhancing clinical communication and study education via a clinical project sponsor and awareness initiatives.
• PDSA Cycle 2 concentrated on improving process efficiency and paired sample acquisition through weekly QI meetings and a dedicated QI team.

Main Results:

• Initiatives in the first PDSA cycle increased recruitment from one to two patients per month.
• Patient enrollment nearly doubled within the QI study period compared to the initial phase.
• A statistically significant threefold increase in paired sample acquisition (20% to 66%) was achieved after implementing process efficiency measures.

Conclusions:

• A highly engaged study team, particularly a clinical project sponsor, is crucial for driving recruitment.
• An efficient recruitment process is essential for overcoming enrollment bottlenecks.
• Quality improvement initiatives can significantly enhance clinical trial recruitment rates and efficiency.