Impact of a Shared Decision Making Intervention in Paediatric Inflammatory Bowel Disease Therapeutic Decision-making
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- 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
研究概览
简要总结
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:
- 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.
- 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.
详细描述
Rationale Patient and family-centered care has become prevalent in the last few decades, recognizing the pivotal role of patients and their families in the decision-making process. Partnering with the healthcare team improves decision making, reduces uncertainty and conflicts that often accompany complex decisions, potentially leading to better outcomes for the patient and family. This shared decision-making (SDM) employs decision aids (DA) and/or an impartial Decision Coach (DC) as a foundation to help patients be actively involved in their care and ensure the best outcomes.
A group of chronic diseases with complicated prognoses and poorly understood pathophysiology, Inflammatory Bowel Disease (IBD) has shown increasing incidence in children. Long-term therapy is required to maintain remission. About 60% of patients undergo biologic therapy, many needing a change of therapy or surgery due to failed initial induction. The availability of multiple biologic therapies for paediatric IBD (pIBD), each with risks, benefits and side effects, modes of administrations, dosing and insurance coverage issues, frequently overwhelms patients and parents when deciding on initial therapies. Delays in the decision process may also result in further complications and reduced steroid-free remission rates.
This project will investigate the impact of SDM on familial stress, decisional confidence and decisional regret of pIBD patients and their families. Expected outcomes are a change in decisional conflict and regret, leading to improved efficiency and quality of care supporting the need for this approach in all healthcare settings.
Aims and Hypothesis The aim of this pilot study is to evaluate whether an SDM intervention has an impact on patient and parental decision making in pIBD treatments, focusing on the constructs of decisional conflict and decision satisfaction/regret. The secondary aim is to adapt and assess the acceptability of the DA in a Canadian academic center.
The investigators hypothesize that: 1) Parents and adolescent patients will experience reduced conflict post-decision because of the SDM intervention. 2) The SDM intervention will reduce decisional regret 6 months after the treatment decision. 3) The DA will be accepted and have a positive effect on patient and parent preparation for decision making. 4) Patients and parents will be satisfied with the DC session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •patient over age 18
- •non-English speakers
- •acute medical instability or any known major mental illness in parent or adolescent patient
结局指标
主要结局
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
时间窗: baseline (before SDM intervention), immediately after the final SDM session
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.
Change from baseline on the Decision Coach Questionnaire to immediately after the Shared Decision Making intervention
时间窗: baseline (before SDM intervention), immediately after the final SDM session
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.
Change from baseline on the16-item Decisional Conflict Scale (DCS) test to immediately after the Shared Decision Making intervention
时间窗: baseline (before SDM intervention), immediately after the final SDM session
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.
次要结局
- Reduced decisional regret at 6-12 months after therapy start in the intervention group(baseline (before SDM intervention), 6-12 months after the final SDM session)
研究者
Eileen Crowley
Physician, Assistant Professor
London Health Sciences Centre