Recruitment for a hospital-based pragmatic clinical trial using volunteer nurses and students.
Recruitment of subjects is critical to the success of any clinical trial, but achieving this goal can be a challenging endeavor. Volunteer nurse and student enrollers are potentially an important source of recruiters for hospital-based trials; however, little is known of either the efficacy or cost of these types of enrollers. We assessed volunteer clinical nurses and health science students in their rates of enrolling family members in a hospital-based, pragmatic clinical trial of cardiopulmonary resuscitation education, and their ability to achieve target recruitment goals. We hypothesized that students would have a higher enrollment rate and are more cost-effective compared to nurses.



Volunteer nurses and student enrollers were recruited from eight institutions. Participating nurses were primarily bedside nurses or nurse educators while students were pre-medical, pre-nursing, and pre-health students at local universities. We recorded the frequency of enrollees recruited into the clinical trial by each enroller. Enrollers' impressions of recruitment were assessed using mixed-methods surveys. Cost was estimated based on enrollment data. Overall enrollment data were analyzed using descriptive statistics and generalized estimating equations.



From February 2012 to November 2014, 260 hospital personnel (167 nurses and 93 students) enrolled 1493 cardiac patients' family members, achieving target recruitment goals. Of those recruited, 822 (55%) were by nurses, while 671 (45%) were by students. Overall, students enrolled 5.44 (95% confidence interval (CI): 2.88, 10.27) more subjects per month than nurses (p < 0.01). After consenting to participate in recruitment, students had a 2.85 (95% CI: 1.09, 7.43) increased chance of enrolling at least one family member (p = 0.03). Among those who enrolled at least one subject, nurses enrolled a mean of 0.51(95% CI: 0.42, 0.59) subjects monthly, while students enrolled 1.63 (95% CI: 1.37, 1.90) per month (p < 0.01). Of 198 surveyed hospital personnel (127 nurses, 71 students), 168/198 (85%) felt confident conducting enrollment. The variable cost per enrollee recruited was $25.38 per subject for nurses and $23.30 per subject for students.



Overall, volunteer students enrolled more subjects per month at a lower cost than nurses. This work suggests that recruitment goals for a pragmatic clinical trial can be successfully obtained using both nurses and students.
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA Audrey.blewer@uphs.upenn.edu.
Audrey L
AL
Blewer
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
Jiaqi
J
Li
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA.
Daniel J
DJ
Ikeda
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.
Marion
M
Leary
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA.
David G
DG
Buckler
School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.
Barbara
B
Riegel
Department of Health Care Policy, Harvard Medical School, Boston, MA, USA.
Sunita
S
Desai
Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.
Peter W
PW
Groeneveld
Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.
Mary E
ME
Putt
Department of Emergency Medicine and Center for Resuscitation Science, University of Pennsylvania, Philadelphia, PA, USA.
Benjamin S
BS
Abella
D000293:Adolescent; D000328:Adult; D016887:Cardiopulmonary Resuscitation / Q000193:education*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009726:Nurses / Q000706:statistics & numerical data*; D018579:Patient Selection; D064792:Pragmatic Clinical Trials as Topic; D013336:Students, Health Occupations / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D014838:Volunteers / Q000706:statistics & numerical data; D055815:Young Adult
Pragmatic clinical trial; cost of enrollers; enrollment or recruitment; nurse and student enrollers