DECISION AIDS NEAR THE END-OF-LIFE, A PILOT RANDOMIZED CONTROLLED TRIAL AND QUALITATIVE EXIT INTERVIEWS

Purpose: Patients nearing the end of their lives face an array of difficult decisions.  This pilot study was designed to assess the feasibility and acceptability of a novel decision aid (DA) applied to patients on a hospital-based palliative care (PC) service.

Methods: We conducted a pilot randomized controlled trial of the Looking Ahead: choices for medical care when you’re seriously ill DA (booklet and DVD) developed by the Foundation for Informed Medical Decision Making.  All adult, English-speaking patients (or their decision makers in the case of patient incapacity) on the hospital PC consult service were potentially eligible.  Patients were not approached if they were in isolation, did not speak English, or if the physicians felt they were not appropriate due to issues such as family conflict or active death.  Patients in both study arms received standard PC consultation.  Participants in the intervention arm also received a copy of the DA.  Participants were interviewed at baseline (prior to viewing the DA) and again after the PC consult and after viewing the DA.  Primary outcomes included decision conflict and knowledge of advance directives measured by six true/false questions developed by the investigators.  Participants in the intervention arm also completed a qualitative exit interview designed to evaluate the DA’s acceptability.

Results: Of 237 patients or decision makers seen between November 2009 and May 2010, 136 (57%) were approached and 51(22%) agreed to participate in the trial.  Ten did not complete the second interview due to death or decline.  Decision conflict decreased and knowledge of advance directives increased in both the intervention and control groups.  These changes were not statistically significant but this feasibility trial lacked the power to assert ‘no difference.’  Exit interviews of the intervention participants indicated that the DA was acceptable, unbiased, and helpful although they wished they would have had it earlier.  A strong theme was that participants felt the DA was empowering: “The one thing that the [DA] did for me is to validate the course of action we took...” 

Conclusions: A randomized trial of a DA on a hospital based PC service was both feasible and acceptable.  Future trials of this DA should be performed on patients earlier in their illness and should include additional outcome measures such as self-efficacy and confidence.