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Use of On-Line Medical Command to Randomize Patients in a Prehospital Research Study

Published online by Cambridge University Press:  28 June 2012

Bartholomew J. Tortella ,
Robert F. Lavery ,
Mark Quadrel ,
Ronald P. Cody  and
Greg Heyt
Bartholomew J. Tortella*
Affiliation:
New Jersey Trauma and EMS Research Center, UMDNJ-University Hospital, Department of Surgery, Section of Trauma and EMS UMDNJ-New Jersey Medical School, Newark, New Jersey
Robert F. Lavery
Affiliation:
New Jersey Trauma and EMS Research Center, UMDNJ-University Hospital, Department of Surgery, Section of Trauma and EMS
Mark Quadrel
Affiliation:
Department of Medicine, Newark, New Jersey
Ronald P. Cody
Affiliation:
Department of Environmental and Community Medicine, The Robert Wood Johnson Medical School, Piscataway, New Jersey
Greg Heyt
Affiliation:
UMDNJ-New Jersey Medical School, Newark, New Jersey
*
University Hospital, Rm. J-200, 150 Bergen St., Newark, NJ 07103-2406USA
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Abstract

Objective:

To describe the efficiency of using on-line medical command (OLMC) to conduct a prospective, randomized clinical trial addressing safety and patient enrollment.

Design, Setting, and Participants:

Prospective design using OLMC to randomize adult asthmatics into one of three treatment groups. After verifying inclusion and exclusion criteria, OLMC physicians removed a covering label on study sheets and ordered the treatment specified underneath the label that had been assigned in a random sequence.

Results:

A total of 204 patients were seen with dyspnea and wheezing during the three-month study. Of these, 68 (33%) were excluded from the study. Of the 136 (67%) patients who were eligible for study, 87 were enrolled (enrollment efficiency 64%), with 79 fully evaluable (evaluable efficiency 91%). The study safety was 100% because no enrolled patients met any exclusion criteria.

Conclusions:

The design was random and prospective, with patient entry blinded, using paramedics to enroll patients and OLMC physicians as gatekeepers, thus ensuring appropriate patient eligibility and study-arm assignment. Use of OLMC physicians to perform prospective randomized studies is safe and efficient, and results in a high yield of evaluable patients.

Keywords

emergency medical serviceson-line medical controlparamedicsprehospital careresearch design
Type
Brief Report
Information
Prehospital and Disaster Medicine , Volume 11 , Issue 1 , March 1996 , pp. 55 - 59
Copyright
Copyright © World Association for Disaster and Emergency Medicine 1996

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Footnotes

*Presented at the Research Forum, 12th Annual EMS Today Meeting, 1994, in Seattle, Washington.

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