Factors Influencing Consent Rates in a Sleep Medicine Randomized Control Trial

Abstract

The success and timeliness of clinical research studies depends on the enrollment of eligible participants. Various demographic factors such as race, education level, socioeconomic status, and gender have been found to influence a person’s decision to consent for participation in clinical trials, however, the effect of each of these factors have been found to vary among each study. The purpose of this quality improvement study was to analyze the effect of age and other demographic factors such as gender, race, education level, and insurance type on consent rates in the SAVE CPAP trial, a sleep medicine randomized control trial. We retrospectively reviewed the medical records of 558 patients that had been eligible for SAVE CPAP over a year span. We found that age did not have an effect on consent rate whether it was treated as a categorical or continuous variable, and that the demographic factors that were collected also did not have a statistically significant effect on consent rates. In addition, we collected the reasons why patients did not consent and found that they provide insight on how to remove obstacles that impede consent. Our study also identified that standardizing the consent process across technicians, and changing paperwork delivery may increase patient satisfaction and participation in the SAVE CPAP trial.