Extending Acute Trials to Remote Populations

Author:

Leira Enrique C.1,Ahmed Azeemuddin1,Lamb Diane L.1,Olalde Heena M.1,Callison R. Charles1,Torner James C.1,Adams Harold P.1

Affiliation:

1. From the Departments of Neurology (E.C.L., H.M.O., R.C.C., H.P.A.) and Emergency Medicine (A.A., D.L.L.), Carver College of Medicine, Iowa City, Iowa; and the Department of Epidemiology (J.C.T.), College of Public Health, University of Iowa, Iowa City, Iowa.

Abstract

Background and Purpose— 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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