JMIR Publications

ABSTRACT

Background:

Patients with ulcerative colitis (UC) are often faced with complex treatment decisions. While shared decision making (SDM) is considered important, tools to facilitate this are currently lacking in UC. A recent pilot study of a novel web-based decision aid – 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 multicentre, cluster randomized controlled trial involving 22 Australian sites which will assess the clinical efficacy of routine use of myAID (intervention) against usual care (control) for UC patients. Participating sites (clusters) will be randomly allocated in a 1:1 ratio between the two 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 via online questionnaires and faecal calprotectin at baseline, 2 months, 6 months and 12 months. An online 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 to the end of 2019, 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 those patients routinely accessing such decision support intervention versus those who do not, across multiple large IBD centres as well as community-based private practices in Australia. Clinical Trial: Australian New Zealand Clinical Trial Registry (ACTRN12617001246370).