None listed
Conditions
Brief summary
This is a multicentre non-randomized clinical trial looking to examine the benefit of implementing a decision aid named Pregnancy IBD Decision Aid (PIDA). Access to dedicated pre-conception counselling sessions within both metropolitan, regional and rural Australia and Canada however can be limited, given the restricted number of specialised ‘pregnancy in IBD’ clinics. A decision aid, to be utilised in conjunction with outpatient clinical appointments, may provide a method by which to overcome such limitations in access. Each site will have study outcomes collected over a six month period during the implementation of the current standard of care of preconception counselling; in the following six months the intervention (PIDA) will precede this standard of care. Sites will comprise a combination of tertiary centres with dedicated pregnancy in IBD Clinics, in addition to non-tertiary centres which provide non-specialised IBD care. An improvement in the quality of the decision-making process as measured by the Decisional Conflict Scale will be the primary outcome variable. The secondary outcome variables are: 1. Quality of decision-making process (as assessed by PrepDM scale questionnaire) 2. Quality of decision comprising knowledge and congruence of values (as assessed by CCPKnow; SWD questionnaires)
Interventions
Delivery of a web based decision aid relating to pregnancy related issues in inflammatory bowel disease (IBD) 1 week prior to the consultation with their usual gastroenterologist.
Web based education tool (approximately 10 minutes anticipated to complete) that allows users to input their condition and circumstances to generate information relevant to them in relation to fertility and pregnancy in the context of inflammatory bowel disease.
Target population: Preconception patients
The first h
Delivery of a web based decision aid relating to pregnancy related issues in inflammatory bowel disease (IBD) 1 week prior to the consultation with their usual gastroenterologist. Web based education tool (approximately 10 minutes anticipated to complete) that allows users to input their condition and circumstances to generate information relevant to them in relation to fertility and pregnancy in the context of inflammatory bowel disease. Target population: Preconception patients The first half of the study will allocate all patients to the control arm and the subsequent half of the study (once 60 controls recruited), to the interventional arm. This is aimed as preventing any influence of the decision aid on the treating gastroenterologist and their interactions with participants from the control arm. No specific measure to monitor adherence - self reported only.
Sponsors
Sydney South West Local Health District (SWSLHD)
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Female gender 18 to 45 years of age (reproductive age group) Confirmed diagnosis of ulcerative colitis, Crohn’s disease or IBD-indeterminate Preconception Interest in considering issues surrounding pregnancy
Exclusion criteria
Post partum (within 6 months) Inability to speak or read English sufficiently to complete surveys or use decision aid
Outcome results
None listed