Ulcerative Colitis Clinical Trial
— SDM-IBDOfficial title:
Impact of a Shared Decision Making Intervention in Paediatric Inflammatory Bowel Disease Therapeutic Decision-making
The goal of this mixed-methods prospective cohort study is to assess the impact of shared decision-making (SDM) on newly diagnosed pediatric inflammatory bowel disease (IBD) patients and their families. Patient and familial decisional conflict regarding the choice and course of treatment is shown to be high, especially for the newer class of IBD treatments called biologic agents. SDM intervention comprises of coaching with a decision coach (DC) on all aspects of treatment and care, along with educational decision aids (DA) provided and adapted from Cincinnati Children's Hospital Medical Center. The main aims of this study are: 1. to determine if SDM intervention has an impact on patient and parental decision making in pediatric IBD treatments, mainly by assessing decisional conflict and decision satisfaction/regret. 2. to adapt and assess the acceptability of DA in a Canadian academic center. Participants who have been recommended a new biologic as part of their clinical care for IBD will be recruited to the SDM intervention group. The participants will have DC sessions until a final treatment decision is made, will be given DAs, and will be followed by baseline and post-intervention surveys to assess decisional conflict and satisfaction/regret. The comparator group will include participants who have been recommended and have commenced a new biologic within the last 12 months. Outcome metrics will evaluate the impact on parental and patient decisional conflict following SDM intervention, and decisional satisfaction/regret 6-12 months from therapy start.
Status | Not yet recruiting |
Enrollment | 150 |
Est. completion date | December 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 17 Years |
Eligibility | Inclusion Criteria: - English-speaking substitute decision makers and adolescent patients (age 13-17.99 years) with IBD that are recommended a new biologic therapy. - English-speaking substitute decision makers and adolescent patients (age 13-17.99 years) with IBD that have started a new biologic therapy within the last 6 to 12 months, without SDM intervention. Exclusion Criteria: - patient over age 18 - non-English speakers - acute medical instability or any known major mental illness in parent or adolescent patient |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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London Health Sciences Centre | Children's Hospital Medical Center, Cincinnati |
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline on the16-item Decisional Conflict Scale (DCS) test to immediately after the Shared Decision Making intervention | The Decisional Conflict Scale is a 16-item measure that captures uncertainty in making choices related to health, the factors contributing to this uncertainty, and an individual's self-perceived satisfaction in the decision. The scale ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
A Wilcoxon signed-rank test will be used to measure the change in test score. Mann-Whitney U tests will be used to measure differences between intervention and comparator groups. p-values < 0.05 will be considered statistically significant. Improvements in the test score by an effect size of 0.4 or more will determine the success of the study. |
baseline (before SDM intervention), immediately after the final SDM session | |
Primary | Change from baseline on the 4-item SURE (Sure of myself; Understand Information; Risk-benefit ratio; Encouragement) screening test to immediately after the Shared Decision Making intervention | The SURE Test is a screening test for the Decisional Conflict Scale (DCS) intended for use in everyday clinical practice. It can indicate the probability that a patient experiences clinically significant decisional conflict. Total scores range from 0 (extreme decisional conflict) to 4 (no decisional conflict).
A Wilcoxon signed-rank test will be used to measure the change in test score. Mann-Whitney U tests will be used to measure differences between intervention and comparator groups. p-values < 0.05 will be considered statistically significant. An improvement of 4-point test score will determine the success of the study. |
baseline (before SDM intervention), immediately after the final SDM session | |
Primary | Change from baseline on the Decision Coach Questionnaire to immediately after the Shared Decision Making intervention | The Decision Coach Questionnaire is a validated SDM questionnaire to assess the acceptability and effect of decision coaching and decision aids.
A Wilcoxon signed-rank test will be used to measure the change in test score. Mann-Whitney U tests will be used to measure differences between intervention and comparator groups. p-values < 0.05 will be considered statistically significant. An improvement of the mean Preparation for Decision Making score being above 3.8 (or 70) will determine the success of the study. |
baseline (before SDM intervention), immediately after the final SDM session | |
Secondary | Reduced decisional regret at 6-12 months after therapy start in the intervention group | The DRS is a five-item, self-report scale to evaluate decisional regret. Items are scored on five-point Likert scales, ranging from 1 to 5. The overall score ranges from 0 (no regrets) to 100 (maximum regrets). Lower the score, lesser is the self-reported decisional regret.
A Wilcoxon signed-rank test will be used. p-values < 0.05 will be considered statistically significant. The success of the study will be determined by a change in mean Decisional Regret Score in the intervention group by 11 points after 6-12 months of therapy initiation. |
baseline (before SDM intervention), 6-12 months after the final SDM session |
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