EPIDAS: a randomised controlled clinical trial to assess the efficacy of the transmission of therapeutic information

Article type
Authors
Boissel J, Haugh M, Cucherat M, Brun C, Gauthier E
Abstract
Introduction: Several trials have shown that there is a discrepancy between prescribers behaviour and results from clinical trials. The reasons for this gap are probably manifold, but access to pertinent information is almost certainly one important reason.

Objective: To assess the efficacy of the transmission of therapeutic information to general practitioners.

Methods: At least 2000 French general practitioners will be enrolled in a randomised controlled trial with a factorial design. Therapeutic information for a restricted number of pathologies (depression, stomach ulcers, cystitis, menopausal hormone replacement therapy) will be collected and synthesised by invited expert committees. This information will then be translated into a message, which will be a format more readily assimilated by the prescriptors. These messages will be transmitted using a paper form (regular bulletin) or by a free-phone (or fax) service for a three-month period. The physicians (in geographical clusters of about 10) will be allocated to receive the bulletin, to have access to the free-phone service, to have both, or to have neither, giving 4 cells. In addition, half the physicians in each group will attend a half-day seminar on the concepts used in therapeutic information, giving a total of 8 cells. To assess the efficacy of the transmission, the physicians will pass a knowledge test, reply to a series of simulated cases, and collect their prescriptions for a week before and after the 3-month intervention. The primary analysis will assess the change in the percentage of replies for the simulated cases judged to be conform with the information transmitted. The secondary analysis will assess this change for the prescriptions that concern the pathologies chosen for the trial. Two pilot studies will be completed in May - June 1996. The first will assess the seminar on therapeutic information, and the second will assess the acceptability of the forms to be used for the data collection (i.e. multiple-choice test, simulated cases prescriptions, and prescriptions using a trial-specific prescription form).