DOP068 Crohn’s disease decision aid leads to more patients choosing combination therapy in a cluster randomised controlled trial

Abstract

Background and Aim: Data support the use of early intensive therapy with a combination of an anti-tumor necrosis factor agent and an immunomodulator (IM) for the highest chance of achieving steroid free remission in patients with Crohn's disease. However, this approach is used infrequently, likely related to a combination of reasons including patient and provider concerns about adverse events associated with these drugs, and the inability to stratify patients with low versus high risk of developing complications of their disease. To address these challenges, a decision aid including an online program reviewing benefits and risks of treatment options combined with a personalized risk prediction tool (PROSPECT) for Crohn's disease was developed. The aim of this study was to determine the influence of this decision aid on the proportion of patients choosing combination therapy for treatment of their Crohn's disease. Method(s): Patients with Crohn's disease were prospectively recruited from 16 GI practices across the US (8 academic, 8 community based). To meet inclusion criteria, all patients had to be within 15 years of diagnosis, without any current or prior disease complications, not currently on IMs or biologics but considered a candidate for these treatments by their provider. This study was a cluster randomized trial stratified by practice type, with 8 practices in the intervention arm (received Decision Aid) and 8 practices in the control arm (standard of care). Result(s): A total of 202 patients were recruited over a 3-year period, approximately 2:1 in favor of intervention (133) versus control (69). Demographics were similar between groups (Table 1), with more women in the control group and slightly shorter disease duration in the intervention group. For the primary outcome, 25% of patients in the intervention group chose combination therapy as compared to 5% in the control group (p=0.002). In the intervention group, 1% of patients chose no therapy directed at Crohn's disease versus 17.5% in the control group (p<0.001). There was lower decision conflict in the intervention group (31.4 v 33.9, p=0.04). For those who responded that they did not receive their preferred treatment, 85% in the control group as compared to 60% in the intervention group (p=0.11) indicated that they are still concerned about side effects of medications. For the intervention group, patients consistently reported that the PROSPECT tool (87%) and Crohn's disease online program (98%) increased understanding of their disease. Conclusion(s): The Crohn's disease decision aid consisting of the online program and PROSPECT tool led to a significantly higher proportion of patients selecting combination therapy for treatment, lower decision conflict amongst participants, and increased understanding of their disease. [Table Presented]Copyright © 2018 AGA Institute. All rights reserved.