Increasing Recruitment Rates in an Inpatient Clinical Research Study Using Quality Improvement Methods

Abstract

Objective One important benefit of successful patient recruitment is increased generalizability of findings. We sought to optimize enrollment of children admitted with asthma as part of a population-based, prospective, observational cohort study with the goal of enrolling at least 60% of all eligible and staffed patients. Methods Quality improvement methods were used to improve cohort recruitment. Weekly meetings with study staff and study leadership were held to plan and discuss how to maximize recruitment rates. Significant initial variability in recruitment success prompted the team to use small-scale tests of change to increase recruitment numbers. A number of tests were trialed, focusing primarily on reducing patient refusals and improving recruitment process efficiency. Recruitment rates were calculated by dividing eligible by enrolled patients and displayed using annotated Shewhart control charts. Control charts were used to illustrate week-to-week variability while also enabling differentiation of common-cause and special-cause variation. Results The study enrolled 774 patients, representing 54% of all eligible and 59% of those eligible for whom staff were available to enroll. Our mean weekly recruitment rate increased from 55% during the first 3 months of the study to a statistically significant sustained rate of 61%. This was sustained given numerous obstacles, such as departing and hiring of staff and adding a second recruitment location. Conclusions Implementing quality improvement methods within a larger research study led to an increase in the rate of recruitment as well as the stability in recruitment rates from week-to-week.

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