Feasibility and Acceptability of an Internet-based Decision Aid for Ulcerative Colitis Patients
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1 Feasibility and Acceptability of an Internet-based Decision Aid for Ulcerative Colitis Patients Dr Andrew Kim, FRACP PhD Candidate, Ingham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW on behalf of the myaid research team
2 BACKGROUND Shared decision making (SDM) enables and encourages patients to play an active role in the management of their health. 1, 2 This can lead to: More favourable health outcomes Lower demand for health care resources Increased satisfaction with health care experience. 3 Decision aids (DAs) can prepare patients for SDM about specific treatment choices. 4 1 Charles C et al. Soc Sci Med 1997, 2 Gionfriddo, MR et al. Syst Rev 2014, 3 Siegel CA. Inflamm Bowel Dis 2007, 4 Stacey D et al. Cochrane Database Syst Rev 2014.
3 ULCERATIVE COLITIS (UC) Chronic relapsing inflammatory condition involving the large intestine Diarrhoea, rectal bleeding, abdominal pain, weight loss Australian prevalence of 37,500 5 Disproportionately affects young people in their most productive years (15-40 years) Lifelong medical treatment and possibly surgery Unpredictable disease course and complications Reduced quality of life (QoL) Reduced productivity and increased healthcare costs (AUD$3.2 billion/yr) 5 5 PricewaterhouseCoopers 2013
4 TREATMENT FOR UC CAN BE COMPLEX Usually lifelong Often requires more than one drug Each drug has a different risk and benefit profile 5-aminosalicylates (5-ASAs) Immunomodulators Biologic agents Combination therapy Surgery Goals of treatment for physicians and patients may be different 6 6 Vaucher et al. Scand J Gastroenterol 2016
5 myaid myaid (Emmi Solutions) is an internet-based DA specifically designed to help patients with ulcerative colitis in their treatment decisions. Content Informed by survey of 460 UC patients from USA and Australia 7 97% responded that they would like to be at least knowledgeable or have an in-depth understanding about UC and the treatments 87% indicated that they would like to participate in SDM 7 Thompson KD et al. Inflamm Bowel Dis 2016
6 myaid Development Review by Patient focus groups International expert panel (IBD physicians, communitybased gastroenterologists, IBD nurses, psychologists, and colorectal surgeons) SDM and decision aid experts Australianisation Patients and non-medical volunteers IBD physicians IBD nurses
7 Emmi Solutions
8 Emmi Solutions
9 Can use of myaid improve outcomes for UC patients?
10 PILOT STUDY (Nov 15 ~ Feb 16) Aim To assess the feasibility and acceptability of using myaid in clinical practice To inform the cluster randomised clinical trial (RCT) of routine use of myaid vs usual care Inclusion Criteria UC patients >18y who failed* 5-aminosalicylate therapy (5-ASA) needing to make a new decision about their treatment Methods Password-protected link to myaid online (view in clinic or at home) Questionnaires (online or hard copy) completed at baseline and at 2 months 1:1 telephone interviews for feedback on myaid 15 clinicians also invited for 1:1 telephone interviews *Failure includes non-adherence
11 PILOT STUDY Outcome Measures and Consultation Timings Baseline post 1 st consultation Decision consult 2 weeks post decision consult 2 Months post decision consult 6 Months post decision consult 12 Months post decision consult Face to face consult Suggested not required Suggested not required Suggested not required Faecal calprotectin (returned to any SONIC lab or to hospital) Online survey AQoL-8D heiq HLQ Quality of Decision Making HADS Anxiety MMAS-8 UC disease activity (P-SCCAI) Clinical outcomes (Patient Diary) Questionnaires included items to capture: PRIMARY OUTCOMES Health-related quality of life SECONDARY OUTCOMES Empowerment, quality of decision making, anxiety, medication adherence, work productivity and activity impairment, and UC disease outcomes WPAI Implementation & acceptability (Intervention group only)
12 RESULTS N=11 (from Liverpool hospital during Nov 15 ~ Feb 16) ALL patients had: Active disease (mean Simple Clinical Colitis Activity Index 6.5) Reduced quality of life (mean Assessment of Quality of Life-8D 0.68 vs Australian norm 0.86) Productivity impairment (32.7% work & 48% activity impairment due to UC) Trends found at 2 months*: Improved disease activity (mean SCCAI 6.5 vs 4.4) Quality of decision making (Decisional Conflict Scale 39.7 vs 25.4) *Pilot study not powered for statistical significance
13 FEEDBACK Patients (it) helped me to understand my situation now I am more aware of my options I am more confident about my treatment It was spot on, it was perfect. I did not feel overwhelmed by it. But there was enough for me to take away and want to know more. On sharing with family/friends: it can be explained to them in a way I wouldn t be able to myaid was judged as informative, well-presented, and easy to use.
14 FEEDBACK Patients 9/10 able to make a more confident decision about their treatment ALL indicated increased understanding of their options after viewing myaid Most helpful 4/10 surgery 2/10 combination therapy
15 FEEDBACK Clinicians (it) addressed a lot of those secret things that (patients) don t often want to bring up thorough without being over the top pitched at the right pace Clinicians welcomed myaid as a positive addition to their clinical practice. 11/15 indicated that they would like to use myaid routinely in their practice if available.
16 CRCT: Current Status Design A two arm, prospective phase III CRCT comparing outcomes using myaid to usual care 120 patients in each arm Data collected over a 12-month period Setting Consultants practising in public hospitals and private rooms across 18 sites in NSW, SA, Vic, QLD, and WA Randomisation Each site involved will be the cluster randomised to myaid vs usual care Now underway! 56 patients recruited since Feb 17
17 CONCLUSION myaid is an internet-based decision aid tool that encourages SDM in UC patients myaid is highly acceptable and feasible to use with potential to improve clinical outcomes CRCT is currently underway to test routine use of myaid vs usual care
18 A cluster randomised controlled trial of a decision aid for ulcerative colitis patients Enhancing patients quality of life, empowerment, quality of decision making and disease control A Prof Susan J Connor Senior Staff Specialist, Department of Gastroenterology and Hepatology, Liverpool Hospital Prof Afaf Girgis Director, Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, UNSW Prof Jane M Andrews Clinical Professor, Department of Gastroenterology and Hepatology, Royal Adelaide Hospital A Prof Corey Siegel Director, Inflammatory Bowel Disease (IBD) Center, Dartmouth-Hitchcock Medical Center, New Hampshire, United States of America. Mrs Alexandra Sechi IBD Clinical Nurse Consultant, Clinical Trials Coordinator, Department of Gastroenterology and Hepatology, Liverpool Hospital Ms Sasha Ruban Research Assistant, Psycho-Oncology Research Group, Ingham Institute for Applied Medical Research, UNSW Dr Andrew H Kim Gastroenterologist, PhD Candidate, Ingham Institute for Applied Medical Research, UNSW Funding: South Western Sydney Local Health District Mid-Career Grant; Gastroenterological Society of Australia Abbvie IBD Clinical Research Grant, Australian Government Research Training Program Scholarship
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