Objective To test whether patient decision aids may be more effective than standard consent forms for informing the decision to participate in a clinical trial.

Rationale The standard process for obtaining informed consent for clinical trials can leave participants with a poor understanding of the trial, and regretting a decision to participate. Patient decision aids are known to improve the quality of decision-making in a variety of contexts, notably during patient screening and treatment decisions. In this pilot study, we test the notion that use of decision aid techniques can improve the decision-making process among individuals making hypothetical decisions about whether to participate in a clinical trial.

Methods We recruited 84 hypothetical decision-makers (visitors to an emergency department; 21 per group) to participate in a 2 x 2 factorial design experiment. Two types of decision support (consent form [CF], decision aid [DA]) were varied for two recently-completed clinical trials (a thrombosis treatment trial, trial comparing treatments for C-difficile). Existing CFs were converted to DA format using a recent template developed in accordance with International Patient Decision Aids Standards (IPDAS) specifications. Participants were randomly assigned to a condition and told to imagine that they had the relevant condition and were being asked to participate in a clinical trial. After reviewing the materials, participants immediately completed a short survey. Outcome measures included knowledge of the key points of the decision, satisfaction with the materials, decision conflict, and a hypothetical decision about participation in the clinical trial.

Results Immediately after reading the materials, a test of knowledge of key points of the decision showed no difference between DA and CF (F (1,81) = 0.007, ns.). Participants actually rated satisfaction with the materials as higher for CFs vs. DAs (F (1,81) = 4.89, p = .03). Participants reported less decision conflict (F (1,81) = 4.27, p = .04) after a DA, and DA groups were marginally more likely say they would participate in the trial (48.7% vs. 39.5%, p = .06). Trial topic effects and interactions were generally non-significant.

Conclusions These pilot data suggest that incorporating DAs into the informed consent process may benefit potential participants, but future work must determine what components of DAs are useful in this context and must involve decision-makers in real trial settings.