Extending acute trials to remote populations: a pilot study during interhospital helicopter transfer.
OBJECTIVE
Methods to increase recruitment into acute stroke trials are needed. The purposes of this study were to evaluate the safety and acceptability of initiating acute stroke trials during early helicopter evacuation and to test an intervention to facilitate informed consent.


METHODS
A randomized, controlled trial was done with patients with acute stroke who were transferred by helicopter to the University of Iowa Hospitals and Clinics from February 2007 to January 2008. The intervention to be evaluated was the use of fax and a telephone call to the patient/surrogate ahead of helicopter arrival at the outside emergency department. The aim was to improve the rate of subsequent consent (primary outcome) for a pilot trial of a potentially beneficial, low-risk medical intervention (ranitidine) to prevent aspiration pneumonitis. Consenting eligible patients received the infusion during the flight to University of Iowa Hospitals and Clinics.


RESULTS
One hundred patients were enrolled. Consent rate was 54% in the intervention group and 50% in the control group (P=0.69). However, the consent rate was higher (69%) when prearrival communications between the coinvestigator and potential subjects were successful (P=0.04). This approach resulted in an average gain of 59 minutes as compared with initiating recruitment on arrival to University of Iowa Hospitals and Clinics.


CONCLUSIONS
Enrollment into stroke intervention trials is feasible during helicopter transportation from a community hospital emergency department to a tertiary stroke center. This underused resource may improve trial efficiency by enabling and expediting participation of remote populations currently excluded from research. Consent rates might be further improved by communication strategies that are more successful in reaching patients at outside emergency departments.
Leira
Enrique C
EC
Department of Neurology, Carver College of Medicine, Iowa City, Iowa, USA. enrique-leira@uiowa.edu
Ahmed
Azeemuddin
A
Lamb
Diane L
DL
Olalde
Heena M
HM
Callison
R Charles
RC
Torner
James C
JC
Adams
Harold P
HP
D000208:Acute Disease; D017732:Air Ambulances; D000863:Antacids / Q000627:therapeutic use; D003142:Communication; D004632:Emergency Medical Services; D006635:Histamine H2 Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007258:Informed Consent; D007484:Iowa; D010865:Pilot Projects; D011015:Pneumonia, Aspiration / Q000517:prevention & control; D011899:Ranitidine / Q000009:adverse effects / Q000627:therapeutic use; D012107:Research Design; D020521:Stroke / Q000628:therapy*; D016896:Treatment Outcome
D000863:Antacids; D006635:Histamine H2 Antagonists; D011899:Ranitidine