Subject recruitment in critical care nursing research: a complex task in a complex environment

Area of Science:

• Critical care medicine
• Clinical research methodology
• Nursing studies

Background:

• Subject recruitment in critical care settings presents unique challenges.
• Inadequate recruitment can compromise the statistical power of clinical trials.
• Limited data exists on recruitment barriers specifically within critical care nursing studies.

Purpose of the Study:

• To describe subject recruitment challenges encountered in a funded study conducted in a medical respiratory intensive care unit (ICU).

Main Methods:

• Daily review of all admitted patients to a medical respiratory ICU for study eligibility.
• Documentation of patient demographics, reasons for ineligibility, and consent failures.
• Analysis of enrollment rates, ineligibility factors, and reasons for consent refusal.

Main Results:

• Out of 593 reviewed patients, only 7.1% were enrolled; 77.1% were ineligible, and 15.8% were eligible but not enrolled.
• Key reasons for eligible patients not being enrolled were family unavailability (40%) and unwillingness to consent (27%).
• Families cited high stress levels as a primary reason for not consenting; a higher proportion of Black patients were not enrolled compared to the screened population.

Conclusions:

• Enrolling subjects and obtaining consent in critical care environments is complex due to patient acuity.
• Researchers must anticipate and address issues related to patient condition and family consent processes for successful critical care research.