Enrollment Challenges in Critical Care Nursing Research

Area of Science:

• Critical care medicine
• Clinical research methodology
• Nursing research

Background:

• Enrollment in critical care research is frequently hampered by time constraints, the acute nature of critical illness, insufficient research personnel, and difficulties in obtaining legal proxy consent.
• Family dynamics and language barriers further complicate the recruitment process for critically ill patients.

Purpose of the Study:

• To analyze enrollment statistics for a critical care nursing trial.
• To identify barriers encountered during patient recruitment.
• To evaluate strategies implemented to improve enrollment rates in critical care studies.

Main Methods:

• Analysis of two years of recruitment and enrollment data from an oral care intervention trial involving critically ill adults on mechanical ventilation.
• Data collected included patient screening, eligibility, enrollment, declination, and demographic information (sex, race, ethnicity).

Main Results:

• The study aimed for 15.5 patients per month but achieved an average of 13.3 patients per month (86% of target).
• Key strategies included 24/7 study personnel availability, regular communication with clinical staff, and Spanish-language consent forms.
• The primary barrier to enrollment was the unavailability of a legal proxy (88%), while refusal rates varied significantly by race, with Asian or multi-racial patients declining more often (35%).

Conclusions:

• The unavailability of a legal proxy within limited enrollment windows presents a significant obstacle in critical care research.
• Patient consent decisions are influenced by multiple factors, necessitating careful consideration in study design.
• Future clinical study designs should incorporate more conservative enrollment projections.