Trial of a Decision Support Intervention for Adolescents and Young Adults With Ulcerative Colitis

Study Overview
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Brief Summary
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A web application decision support tool has been developed for adolescents and young adults (AYAs). The purpose of this pilot trial is to test the web application for adolescent and young adults (AYAs) with Ulcerative Colitis (UC). This research will assess acceptability, feasibility of the decision support intervention for AYA UC patients. Participants will be randomized to usual care or usual care plus the web application prior to an upcoming clinic visit in Gastroenterology. Participants will complete surveys one week after their clinic visit about decision making preferences and, for those in the intervention group, usability and acceptability of the web application.

Detailed Description
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The iBDecide app provides participants with electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications. Participants will be provided instructions over the phone or via email to download the iBDecide app on their personal smartphone approximately two weeks prior to the scheduled clinic visit. When possible they will download the app during the consent call and the research staff member will review features of the app with the participant. For those unable to download it while talking on the phone, a follow-up phone call will be scheduled to review the features. During the consenting phone call or at the clinic visit, a time will be scheduled to collect additional information via a brief telephone survey approximately one week after the clinic visit. Participants will be sent emails and an electronic calendar invitation to confirm their scheduled telephone interview.

Official Title
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iBDecide Pilot Randomized Controlled Trial

Conditions
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Ulcerative Colitis, Pediatric

Intervention / Treatment
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* Other: iBDecide Decision Support Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking patients with Ulcerative Colitis that have an appointment at the CCHMC Gastroenterology clinic 14-25 years of age Treatment decision anticipated during clinic Did not participate in usability testing for the iBDecide App Has a smart phone that can download the iBDecide app Exclusion Criteria: Unable to read or speak English

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iBDecide App Decision-support Arm<br>Participants will download the iBDecide app on their smartphone approximately two weeks prior to the scheduled clinic visit. Approximately one week after the clinic visit, survey data, along with demographic data will be collected from all participants via a brief telephone call. We will collect data on app use between installation and the clinic visit as well as in the 3 months following the clinic visit. | Other: iBDecide Decision Support Application<br>* The iBDecide app provides an electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.<br>|
| No Intervention: Control Arm<br>Control participants will not use the iBDecide app prior to their clinic visit. They will complete a brief telephone survey approximately one week from clinic visit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of intervention | The extent to which this intervention impacts the flow of a clinic appointment, as measured by physician perception of visit length and efficiency. | At clinic visit | 
| Acceptability of intervention | The extent to which patients and physicians feel the intervention is appropriate and useful. This is measured through adaptations of the System Usability Scale and the decision aid acceptability measure. | One week after clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Measure of decisional uncertainty, assessed via Decisional Conflict Scale. | At clinic visit | 
| Perceived Shared Decision making | Degree of shared decision-making the patient and physician each report, measured by the Shared Decision-Making Questionnaire-9 and Shared Decision-making Questionnaire 9-doc. | One week after clinic visit | 
| Decision preference congruence | Extent to which the patients' role in the decision process matched their preferred role, measured via the Control Preference Scale. | One week after clinic visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents and young adults, decision making