Study protocol

Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol

Jamie C Brehaut^1,2 , Alison Lott⁵ , Dean A Fergusson^1,2 , Kaveh G Shojania⁶ , Jonathan Kimmelman⁴ and Raphael Saginur^1,3

¹  Ottawa Health Research Institute, Ottawa Hospital, Civic Campus, 1053 Carling Avenue, Ottawa, Ontario, K1Y 4E9, Canada

²  Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada

³  Research Ethics Board, The Ottawa Hospital, Civic Campus, Civic Parkdale Clinic, Suite 470, 737 Parkdale Avenue, Ottawa, Ontario, K1Y 1J8, Canada

⁴  Biomedical Ethics Unit, McGill University, 3647 Peel Street, Montreal, Quebec, H3A 1X1, Canada

⁵  Canadian Institutes of Health Research (CIHR), 160 Elgin Street, Address Locator 4809A Ottawa, Ontario, K1A 0W9, Canada

⁶  Sunnybrook Health Sciences Centre, Rm. D470, 2075, Bayview Ave., Toronto, Ontario, M4N 3M5, Canada

author email corresponding author email

Implementation Science 2008, 3:38doi:10.1186/1748-5908-3-38

Published:	23 July 2008

Abstract

Background

Evidence shows that the standard process for obtaining informed consent in clinical trials can be inadequate, with study participants frequently not understanding even basic information fundamental to giving informed consent. Patient decision aids are effective decision support tools originally designed to help patients make difficult treatment or screening decisions. We propose that incorporating decision aids into the informed consent process will improve the extent to which participants make decisions that are informed and consistent with their preferences. A mixed methods study will test this proposal.

Methods

Phase one of this project will involve assessment of a stratified random sample of 50 consent documents from recently completed investigator-initiated clinical trials, according to existing standards for supporting good decision making. Phase two will involve interviews of a purposive sample of 50 trial participants (10 participants from each of five different clinical areas) about their experience of the informed consent process, and how it could be improved. In phase three, we will convert consent forms for two completed clinical trials into decision aids and pilot test these new tools using a user-centered design approach, an iterative development process commonly employed in computer usability literature. In phase four, we will conduct a pilot observational study comparing the new tools to standard consent forms, with potential recruits to two hypothetical clinical trials. Outcomes will include knowledge of key aspects of the decision, knowledge of the probabilities of different outcomes, decisional conflict, the hypothetical participation decision, and qualitative impressions of the experience.

Discussion

This work will provide initial evidence about whether a patient decision aid can improve the informed consent process. The larger goal of this work is to examine whether study recruitment can be improved from (barely) informed consent based on disclosure-oriented documents, towards a process of high-quality participant decision-making.