Abstract
BackgroundAdverse drug events could often be prevented. One of their main causes is that patients rarely know how to detect them. Another cause is inadequate communication between patients and physicians. If patients were to be effectively trained in detecting and reporting adverse drug events, this should help to prevent their occurrence and subsequent complications. Our purpose is to present the protocol of the InPAct trial, which aims to evaluate an interactive program that encourages patients to report adverse drug events in primary care.Methods/designWe will conduct a cluster randomised controlled stepped wedge trial, with eight clusters of 10 general practitioners each. The physicians will suggest to all of their antihypertensive-treated patients that they take part in this study. The InPAct program will be implemented in the clusters in random order along five successive three-month periods. Two new clusters will be trained in implementing the program at each step. The program features: an interactive patient booklet including informative paragraphs, several care plans and adverse drug event report forms; and standardised training of physicians in how to present the booklet to the patient. The primary outcome will be the reporting of adverse drug events by patients to their physician within three months. We assume that the number of patients reporting at least one adverse drug event will increase from 3% before program implementation to 7.5% afterward (coefficient of variation = 0.5, α = 0.05, β = 0.2), which means that 1,200 patients must be included. The effect of the intervention on the main outcome will be quantified and tested using a mixed logistic model to integrate cluster and time effects.DiscussionOur choice of a stepped wedge design is particularly appropriate for evaluating the implementation of a patient safety program within the constraints of general practice. We describe the InPAct intervention, which is an original program that is intended to improve communication between patients and physicians. Indeed, none of the previously published intervention studies has combined a patient education program and a patient reporting system for adverse drug events with the aim of improving patient safety in primary care.Trial registrationThis study is registered in ClinicalTrials.gov NCT01610817.
Highlights
Adverse drug events could often be prevented
The aim of this study is to evaluate how effectively the Information for Participating Actively (InPAct) program encourages patient-general practitioner (GP) interaction and improves patientinitiated Adverse drug event (ADE) reporting
The implementation of the InPAct program may increase ADE reporting by patients in general practice
Summary
Adverse drug events could often be prevented One of their main causes is that patients rarely know how to detect them. If patients were to be effectively trained in detecting and reporting adverse drug events, this should help to prevent their occurrence and subsequent complications. According to a recent report of the Canadian Patient Safety Institute, the management of adverse drug events (ADEs) in primary medical care is a public health priority [1]. A lack of information and communication between patients and health care professionals has been identified as an underlying factor favouring the occurrence of ADEs [4,5]. A significant proportion of ADEs and associated complications could be prevented if risk situations were detected earlier and if patients were better informed about participating in their own medical care and about reporting ADEs [6]. The proportion of patients experiencing at least one ADE within the first three months following the prescription of an antihypertensive has been estimated at 12.6% [2]
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