The OMACS-PIL study: a randomised controlled trial within the OMACS observational study

Area of Science:

• Clinical trial methodology
• Patient recruitment strategies

Background:

• Limited research exists on how patient information leaflet (PIL) appearance affects participant decisions.
• Studies Within A Trial (SWAT) offer an efficient method to investigate such methodological questions.
• A SWAT was embedded within the Outcome Monitoring after Cardiac Surgery (OMACS) cohort study.

Purpose of the Study:

• To determine if the format and color of paper patient information leaflets (PILs) influence participant consent rates.
• To compare the effectiveness of three different PIL formats (enhanced, hybrid, standard) in a real-world clinical trial setting.

Main Methods:

• Potential participants were randomized to receive one of three PIL formats (A: enhanced, B: hybrid, C: standard).
• Consent to the OMACS study was the primary outcome, with consent rates compared across PIL formats.
• Qualitative feedback was gathered from a public and patient involvement (PPI) group.

Main Results:

• Out of 1517 potential participants, 640 (42%) consented to OMACS.
• PIL B (hybrid format) had the highest recruitment rate at 45%, compared to PIL A (40%) and PIL C (41%).
• Consent rates were similar across all formats, with no statistically significant differences observed.

Conclusions:

• Patient information leaflet format did not significantly impact consent rates in this study.
• PIL B, the hybrid format, was preferred by the PPI group and will be used for the remainder of the OMACS study.
• Findings will inform the design of PILs for future research studies.