A Web-Based Decision Aid (myAID) to Enhance Quality of Life, Empowerment, Decision Making, and Disease Control for Patients With Ulcerative Colitis: Protocol for a Cluster Randomized Controlled Trial

Abstract

<jats:sec> <jats:title>Background</jats:title> <jats:p>Patients with ulcerative colitis (UC) often face complex treatment decisions. Although shared decision making (SDM) is considered important, tools to facilitate this are currently lacking for UC. A recent pilot study of a novel Web-based decision aid (DA), my Actively Informed Decision (myAID), has suggested its acceptability and feasibility for informing treatment decisions and facilitating SDM in clinical practice.</jats:p> </jats:sec> <jats:sec> <jats:title>Objective</jats:title> <jats:p>This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>The myAID study is a multicenter, cluster randomized controlled trial (CRCT) involving 22 Australian sites that will assess the clinical efficacy of routine use of myAID (intervention) against usual care without access to myAID (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the 2 arms. Patients making a new treatment decision beyond 5-aminosalicylate agents will be eligible to participate. Patients allocated to the intervention arm will view myAID at the time of recruitment and have free access to it throughout the study period. The effect of the myAID intervention will be assessed using the results of serial Web-based questionnaires and fecal calprotectin at baseline, 2 months, 6 months, and 12 months. A Web-based questionnaire within 2-4 weeks of referral will determine early change in quality of decision making and anxiety (both arms) and intervention acceptability (intervention arm only).</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>Study recruitment and funding began in October 2016, and recruitment will continue through 2020, for a minimum of 300 study participants at baseline at the current projection. The primary outcome will be health-related quality of life (Assessment of Quality of Life-8D), and secondary outcomes will include patient empowerment, quality of decision making, anxiety, work productivity and activity impairment, and disease activity. In addition, we aim to determine the predictors of UC treatment decisions and outcomes and the cost-effectiveness of implementing myAID in routine practice. Feedback obtained about myAID will be used to determine areas for improvement and barriers to its implementation. Completion of data collection and publication of study results are anticipated in 2021.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions</jats:title> <jats:p>myAID is a novel Web-based DA designed to facilitate SDM in UC management. The results of this CRCT will contribute new evidence to the literature in comparing outcomes between patients who routinely access such decision support intervention versus those who do not, across multiple large inflammatory bowel disease centers as well as community-based private practices in Australia.</jats:p> </jats:sec> <jats:sec> <jats:title>Trial Registration</jats:title> <jats:p>Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370</jats:p> </jats:sec> <jats:sec> <jats:title>International Registered Report Identifier (IRRID)</jats:title> <jats:p>DERR1-10.2196/15994</jats:p> </jats:sec>

Letter: expanding the role for decision aids in IBD into pregnancy‐related topics

“…3 Siegel and colleagues have led in this field through their development and validation of electronic decision aids for both ulcerative colitis and Crohn's disease. 1,4 Our multi-national research team has identified a role for a decision aid to guide patients with IBD to navigate decisions in the context of reproduction. This is on the background of a higher rate of voluntary childlessness amongst women with IBD, with contributors of poor knowledge as well as fears surrounding fertility, medications, inheritance, and delivery.…”

DECIDE: Delphi Expert Consensus Statement on Inflammatory Bowel Disease Dysplasia Shared Management Decision-Making

“…Visual decision aids were considered to be important decision-making facilitators by the DECIDE patient stakeholders and the independent decision-making expert in view of the potentially overwhelming amount of technical details about the management options and the risk information that needs to be conveyed. Paper and web-based visual aids have been shown to facilitate confident decision-making in IBD patients choosing between surgical and/or medical options for symptomatic IBD [174][175][176] . None are specifically relevant for dysplasia with asymptomatic colitis and so we have developed a new patient-facing decision aid to help support decision-making, including signposting to patient support groups or charities (Supplementary Appendices 5).…”

Development of a feasible and acceptable digital prehabilitation pathway to improve elective surgical outcomes

“…The work builds on our previous findings that: People on specialist outpatient waitlists actively engage in screening and hospital directed self-management (IBS) ( 11 ) Consumers and their regular doctors already use decision support tools ( 11 , 12 ) Digital technology is a feasible, acceptable and effective mode of facilitating the above ( 13 ). We describe here the codesign and initial user testing of the My PreHab Program , and assess its feasibility, acceptability, and appropriateness for consumers referred for orthopaedic assessment for total hip or knee replacement surgery.…”