Enrollment Challenges in Critical Care Nursing Research

Abstract

Background Enrollment challenges for critical care research are common. Contributing factors include short enrollment windows, the crisis nature of critical illness, lack of research staff, unavailable legal proxy, family dynamics, and language barriers. Objective To describe enrollment statistics for an ongoing critical care nursing trial, barriers to recruitment, and strategies to enhance enrollment. Methods Two years’ worth of recruitment and enrollment data from an oral care intervention trial in critically ill adults receiving mechanical ventilation at 1 hospital were analyzed. Recruitment logs include number of patients screened, eligible, enrolled, and declined and patients’ sex, race, and ethnicity. Results Target enrollment (15.5 patients per month) was based on experience and historical data. Strategies implemented to promote enrollment included providing study personnel at least 18 hours per day for 7 days per week, regular rounds, communication with direct care staff, and Spanish consent processes. In 2 years, 6963 patients were screened; 1551 (22%) were eligible. Consent was sought from 366 (24% of eligible patients). Enrollment averaged 13.3 patients per month (86% of projected target). The main factor impeding enrollment was unavailability of a legal proxy to provide consent (88%). The refusal rates of white (11%), black (13%), and Hispanic (16%) patients did not differ significantly. However, those classified as Asian or as more than 1 race declined significantly more often (35%) than did white or black patients (P=.02). Conclusions Unavailability of a legal proxy within a short enrollment window was the major challenge to enrollment. Various factors influenced consent decisions. Clinical study design requires more conservative estimates.

Impact of deep oropharyngeal suctioning on microaspiration, ventilator events, and clinical outcomes: A randomized clinical trial

“…During the 3‐year data collection, 11,125 patients were assessed for eligibility; 2,283 met inclusion criteria; and 513 were enrolled and randomized to groups. Most of those eligible and not enrolled were secondary to inability to obtain consent during the short enrolment window (Sole et al, ). Demographic data for those eligible versus those consented were no different with one exception.…”

“…Demographic data for those eligible versus those consented were no different with one exception. Proxies of participants of Asian descent had a higher rate of decline (Sole et al, ).…”

“…Preliminary study findings showed that a catheter specifically designed to reach the oropharynx was the most effective device for secretion removal, especially in the posterior oropharynx (Sole, Penoyer, Bennett, & Bertrand, 2010). In a small sample, the number of patients with a tracheal specimen positive for α-amylase decreased when deep oropharyngeal suctioning was implemented in a 4-hr period (Sole et al, 2012).…”

“…Data validation features were used in REDCap™ to facilitate accurate data entry and data were audited regularly for accuracy. TA B L E 1 Demographics variable analysis to inability to obtain consent during the short enrolment window (Sole et al, 2017). Demographic data for those eligible versus those consented were no different with one exception.…”

“…aspiration, aspiration biomarker, mechanical ventilation, nursing, pneumonia, ventilator associated events, α-amylase Filloux et al, 2013;Qu et al, 2018;Samanta et al, 2018;Sole et al, 2012;Tripathi, Mirant-Borde, & Lee, 2011;Weiss, Moazed, DiBardino, Swaroop, & Wunderink, 2013).…”