The trial was conducted at 7 practices across the US. The P3P and UC groups are compared over time in regard to patients’ literacy DC scale (DCS) at baseline and 1 month. The DCS’s scale was measured by total score (TS) and 4 sub-scales. The groups were carefully balanced to reflect factors that have been previously shown to influence DC - age, education, partner status, working status, income, race, D’Amico risk level, information resources. etc.
392 patients were randomized into two groups with comparable DCS. 198 patients were in the P3P group and 194 patients in UC group. 309 patients returned in 1 month. In multi-variate analysis, P3P slightly reduced TS conflict at 1 month vs. baseline. DC was significantly reduced and attributed to the patient being better informed.
Key conclusions were: 1) P3P was demonstrated to be superior to UC in informing men as to localized prostate cancer options; 2) patients with lowest risk (and probably more options to consider) are more uncertain; 3) men with partners or low income are more likely to be conflicted; and 4) considerable variation by geographic site.
As patient advocates, we are delighted to see rigorous research that measures the patient experience and possible improvements. In this study, decisional conflict was the focus. This research can lead to improved protocols that reduce conflict, enhance satisfaction, and lower decision remorse/blame. With possibly more study and protocol changes as needed, we would hope to ultimately see better shared treatment decisions, outcomes and long-term satisfaction.
Study Funding: NIH 5R01NR009692
Presented by: Donna Berry, PhD, RN, FAAN; Harvard Medical School
Written by: John Fortin, Retired Healthcare Actuary, Fellow in the Society of Actuaries, and Patient-Advocate; and Henry Oat, Clinical Trial Patient Coordinator at Desert Medical Imaging, Prostate Cancer Support Group Leader, and Patient-Advocate
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA