Efficacy of an intervention to improve communication about randomised clinical trials (RCTS) in cancer

Background: Fewer than 5% of eligible patients worldwide are offered entry into RCTs. Recruitment problems impede introduction of potentially efficacious treatments. To aid communication about RCTs we designed and evaluated a comprehensive training program. The program comprises 4 modules with videotaped scenarios, interactive exercises and a handbook. Video 1 deals with generic issues about RCTs. 3 further videos each contain 2 scenarios dealing with adjuvant trials, those with palliation as the goal and trials where patients have a preference for one treatment arm. Patient characteristics eg the deferential, highly suspicious or overly informed are illustrated throughout. Methods: 101 participants were evaluated. Subjective and objective assessments were made pre (T1) and post (T2) workshop. Participants self-rated their confidence about different aspects of trial discussion. All were videotaped discussing a trial with a simulated patient at T1 and T2: an experienced rater, blinded to time point, viewed these tapes to check for the presence/absence of key information required by Good Clinical Practice(GCP) Guidelines. Simulated patients also assessed the interviews at each time point. Results: Skills of 33 clinicians and 68 research nurses were evaluated. Significant improvements were found on subjective and objective measures of their communication post-workshop. Self-confidence increased significantly across all areas (P<0.0001). Patient simulator ratings revealed a global improvement in discussions about trials (P<0.0001) odds ratio showed significant changes for 13/15 key items Objective analysis of video assessments demonstrated a positive shift with odds ratios showing significant changes for 10/15 GCP items. Conclusions An intensive 1. 5-day program significantly improved the confidence and competence of communication about RCTs. More interventions are needed to promote better understanding about trials and to encourage clinicians to approach more eligible patients.