Evaluating a Shared Decision Making Program for Crohn's Disease

Agency for Healthcare Research and Quality (AHRQ), University of Pittsburgh, MOUNT SINAI HOSPITAL, Cedars-Sinai Medical Center, University of Maryland, Brigham and Women's Hospital, Thomas Jefferson University, University of Chicago, Atlanta Gastroenterology Associates, Long Island Clinical Research Associates, Center for Digestive and Liver Diseases, Charlotte Gastroenterology and Hepatology, Minnesota Gastroenterology, Ohio Gi and Liver Institute, Winthrop University Hospital

Specific Aim: Study the impact of the Crohn's Disease Shared Decision Making Program on patients' treatment choice, persistence with chosen therapy, decision quality, cost of care, and outcomes Hypothesis: The Crohn's Disease Shared Decision Making Program will help patients understand which treatments are right for them and will lead to a higher acceptance of appropriate therapy, improved persistence with chosen therapy, lower costs and improved clinical outcomes. To accomplish this aim, Investigators will perform a randomized controlled trial to: Determine how the shared decision making program influences patients' choice of therapy Evaluate how the shared decision making program affects persistence with chosen therapy Determine how the shared decision making program affects decision quality Determine how the shared decision making program influences cost of care and clinical outcomes Expected Outcome and Impact: Investigators expect that this program will influence patients' choice of therapy, persistence with their preferred therapy, and lead to improved clinical outcomes. Investigators believe that this product can be successfully operationalized in the clinic to establish a new paradigm of how providers can communicate personalized treatment options to patients across a broad range of diseases.

Patients will have access to an educational decision making program and a risk prediction model, this web based program will be sent subjects in the intervention arm upon enrollment, they can access the program as many times as they wish.

Subjects enrolled at sites participating as control arms will access the same web-based surveys as the intervention group, and receive the same contacts from the study coordinator as the subjects enrolled at intervention sites.

This study is cluster randomized by study-site, Subjects enrolled at intervention sites will access an educational program and risk prediction tool. Their decisions about treatments will be compared to subjects that did not view the educational program or risk prediction tool.

i. Decisional conflict (validated scale) ii. Decision consistent with patient values (i.e., patient receiving the treatment that they want) iii. Trust in physician

Inclusion Criteria: Clinical diagnosis of Crohn's Disease based on standard clinical, radiographic, endoscopic, and histologic criteria Age 18 or older Fluent, English Speaking A candidate to receive immunomodulators or anti-TNF therapy based on their providers recommendation not currently taking immunomodulators (6-mercapropurine, azathioprine, methotrexate) or anti-TNF agents (infliximab, adalimumab, certolizumab pegol) Exclusion Criteria: Participant in a pilot study/focus group for development of Crohn's Shared Decision Making Program Currently taking any medication that is contraindicated to take together with an immunomodulator or anti-TNF agent Known intolerance to either immunomodulators or anti-TNF agents Lack of accessibility to e-mail for follow-up surveys

Zisman-Ilani Y, Thompson KD, Siegel LS, Mackenzie T, Crate DJ, Korzenik JR, Melmed GY, Kozuch P, Sands BE, Rubin DT, Regueiro MD, Cross R, Wolf DC, Hanson JS, Schwartz RM, Vrabie R, Kreines MD, Scherer T, Dubinsky MC, Siegel CA. Crohn's disease shared decision making intervention leads to more patients choosing combination therapy: a cluster randomised controlled trial. Aliment Pharmacol Ther. 2023 Jan;57(2):205-214. doi: 10.1111/apt.17286. Epub 2022 Nov 14.