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. 2020 Jul 10;9(7):e15994.
doi: 10.2196/15994.

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

Andrew H Kim  1   2 , Afaf Girgis  1 , Neda Karimi  1 , Alexandra J Sechi  2 , Joseph Descallar  1 , Jane M Andrews  3   4 , Corey A Siegel  5 , Susan J Connor  1
Affiliations

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

Andrew H Kim et al. JMIR Res Protoc. .

Abstract

Background: 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.

Objective: This paper describes the study protocol of the myAID study to assess the clinical impact of systematic implementation of myAID in routine UC management.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: Australian New Zealand Clinical Trial Registry ACTRN12617001246370 http://anzctr.org.au/Trial/ Registration/TrialReview.aspx?ACTRN=12617001246370.

International registered report identifier (irrid): DERR1-10.2196/15994.

Keywords: decision aid; shared decision making; ulcerative colitis.

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Conflict of interest statement

Conflicts of Interest: AK, AG, NK, and JD have no relevant competing interests. AS has served as a consultant for AbbVie, Janssen, and Pfizer and received travel support from AbbVie, Ferring, Janssen, Orphan, Shire, and Takeda. JA is on advisory boards, has received speakers’ fees and research support, and/or has coordinated education meetings for Abbott, AbbVie, Allergan, Bayer, Celgene, Ferring, Gilead, Janssen, MSD, Pfizer, Shire, and Takeda. All money has been received by her employer to support investigator-initiated research. CS has served as a key advisor to the development of the Ulcerative Colitis Treatment Options program in the United States by Emmi Solutions, Inc; has served as a consultant and is on the advisory boards for AbbVie, Amgen, Celgene, Janssen, Lilly, Pfizer, Prometheus, Salix, Sandoz, Sebela, and Takeda; has received speaker fees from AbbVie, Janssen, Pfizer, and Takeda; has received grant support from AbbVie, Janssen, Pfizer, Takeda, Broad Medical Research Program, Crohn’s and Colitis Foundation of America (CCFA), and AHRQ (1R01HS021747-01); and is the co-chair of the CCFA quality of care program. SC is on advisory boards; has received speaker fees, educational support, and research support; and/or has coordinated education meetings for AbbVie, Celgene, Ferring, Gilead, Janssen, MSD, Orphan/Aspen, Pfizer, and Takeda.

Figures

Figure 1
Figure 1
myAID study flowchart. 5-ASA: 5-aminosalicylates; UC: ulcerative colitis; myAID: my Actively Informed Decision. *Decision consult, if arranged, will be arranged within 2-4 weeks of referral. **Post decision consult (if arranged) or follow-up questionnaire to be completed within 2-4 weeks of referral.
Figure 2
Figure 2
Screenshots of myAID (myAID@2015 Emmi Solutions, LLC). myAID: my Actively Informed Decision.
See this image and copyright information in PMC

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