DEVELOPMENT AND PILOT OF FOUR DECISION AIDS FOR IMPLANTABLE CARDIOVERTER-DEFIBRILLATORS IN DIFFERENT MEDIA FORMATS
Methods: Tool development followed the Ottawa Decision Support Framework and the International Patient Decision Aid Standards. Prior qualitative and survey assessments directed the initial content. Decision aids (DAs) were iteratively modified using feedback from 28 patient interviews; three patient focus groups; patient stakeholders; local research groups; and a national panel of 14 experts in decision science and/or cardiovascular disease. The pilot trial was conducted at three clinics across Denver, Colorado. To test feasibility, recruitment strategies differed by site: 1) chart review of ICD referrals; 2) chart review of electrophysiologists’ (EP) schedules; and 3) clinic staff identification of eligible patients. Intervention patients were mailed the four DAs before discussing ICD therapy with the EP. Patients were interviewed at baseline, one month after meeting with the EP, and three months after enrollment. Primary outcomes were acceptability and feasibility; secondary outcomes included ICD-specific knowledge, decision quality, values concordance, decision conflict, and decision regret.
Results: Twenty-one eligible patients enrolled; 15 were randomized to the intervention and six to the control (usual care). 67% found the DAs to be unbiased, 22% thought they were biased toward ICDs, and 11% thought they were biased toward not getting an ICD. Furthermore, 89% found the DAs helpful and 100% would recommend them to others. The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than using chart review. Intervention patients did not have significantly greater knowledge about ICDs (M=14.00, SD=2.62) than controls (M=11.60, SD=3.13, t13=1.57, ns). Intervention patients had increased concordance between their decision and end-of-life values (71% concordant vs. 29%, p=0.06). Intervention patients did not have significantly different levels of decision conflict (M=17.81, SD=14.97) than controls (M=24.38, SD=25.35, t13=0.64, ns) or decision regret (M=21.88, SD=16.24, M=16.00, SD=19.12, respectively, t11=0.59, ns).
Conclusions: Patients felt the DAs provided helpful, balanced information that they would recommend to other patients. Furthermore, utilizing clinic staff is an efficacious way to get decision aids to patients. The impact of the DAs on the secondary outcomes will be tested in a future, adequately powered trial.