Shared Decision Making in Paediatric Inflammatory Bowel Disease (SDM-IBD)

December 8, 2023 updated by: Eileen Crowley, London Health Sciences Centre

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study design and methods This is a mixed methods prospective cohort and case-control pilot study. Recruitment: 75 parents of pIBD patients will be recruited in the intervention and comparator groups each over 2 years' time. New biologic therapy patients will be in the intervention group, those who have been on a biologic within the last 12 months in the comparator group. Patients referred to the SDM program at Children's Hospital, London Health Sciences Centre (LHSC) by the clinicians (Dr. Eileen Crowley, Dr. Dhandapani Ashok, and Dr. Kevin Bax) will be prospectively screened for enrollment and initially approached for the study by the clinicians. Interested patients will be provided letters of information and consent (assent if applicable - in the instance participants are unable to provide consent, since the population includes children and adolescents) by the clinicians or the research team prior to the session(s) with the DC. Participation in the study is voluntary and will not impact the clinical SDM process.

SDM Intervention: Intervention group families will be referred to the DC for independent virtual session(s) to discuss recommended treatment plans facilitated by the Ottawa Family Decision Guide. Multiple meetings may be necessary until a final decision is made. All SDM consults will be done virtually using a secure videoconferencing platform. The Ottawa Family Decision Guide will be used to facilitate the discussion. A DA will be provided to the study participants in the form of information cards containing information about different treatment options in pediatric IBD. This includes administration schedule, side effects, risk of cancer, among others. Sessions with the Decision Coach and the DAs provided will work in tandem to provide the best outcome for the patient and their family. The DA has been developed and provided by the Cincinnati Children's Hospital Medical Center and adapted to the Canadian setting with electronic version by this research group with approval from the authors.

Study procedures: Patient characteristics and clinical outcome data will be collected from medical charts. All information will be deidentified and anonymous, complying with the requirements for the protection of patient privacy and confidentiality. Intervention group participants will complete the baseline survey prior to any consultations. Validated SDM questionnaires will be applied during and post decision visit, as is part of the clinical program, with baseline questionnaires at first visit. Decisional regret will be assessed 6 months after therapy start. The validated questionnaires are:

  1. SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) questionnaire and 16 item Decisional Conflict Scale pre/post SDM intervention,
  2. Preparation for Decision Making Scale: acceptability and effect of DA following the intervention,
  3. Decision Coach Questionnaire: acceptability of the DC session post intervention,
  4. Decisional Regret Scale: distress or remorse after the treatment decision

Statistical analysis: Summary statistics will employ medians and interquartile ranges for continuous variables or means and standard deviations when appropriate. Frequencies with proportions will be used for categorical variables. A Wilcoxon signed-rank test will be used to measure change in decisional conflict pre- and post-intervention. Mann-Whitney U tests will be used to measure differences between intervention and comparator groups. SPSS v.27 (IBM Corp., Armonk, NY, USA) will be used for all analyses, and p-values <0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants who have been diagnosed with IBD and are recommended a new biologic therapy will be recruited to this arm. Participants and their families will be referred to a decision coach (DC), who will provide support in gaining knowledge of treatment and care options. They will also be given decision aids (DA) as outlined in the study description.
Other: Decision Coach Sessions

Participants in the intervention group and their families will be referred to the DC to meet independently and discuss recommended treatment pathways.

Multiple sessions may be necessary until a final decision is reached. All SDM consults will be done virtually using a secure videoconferencing platform. The Ottawa Family Decision Guide will be used to facilitate the discussion. A DA will be provided to the study participants in the form of information cards containing information about different treatment options in pediatric IBD. This includes administration schedule, side effects, risk of cancer, among others. The DA has been developed and provided by the Cincinnati Children's Hospital Medical Center and adapted to the Canadian setting with electronic version by this research group with approval from the authors.

Other Names:
  • DC sessions
No Intervention: Comparator group
Participants who have been recommended a new biologic therapy within the last 12 months and have commenced treatment will be recruited to this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline on the16-item Decisional Conflict Scale (DCS) test to immediately after the Shared Decision Making intervention
Time Frame: 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.
baseline (before SDM intervention), immediately after the final SDM session
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
Time Frame: 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.
baseline (before SDM intervention), immediately after the final SDM session
Change from baseline on the Decision Coach Questionnaire to immediately after the Shared Decision Making intervention
Time Frame: 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.
baseline (before SDM intervention), immediately after the final SDM session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduced decisional regret at 6-12 months after therapy start in the intervention group
Time Frame: baseline (before SDM intervention), 6-12 months after the final SDM session

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre

Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Eileen Crowley, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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