Inflammatory Bowel DiseasesSDM-IBDNCT05689892
Shared Decision Making in Paediatric Inflammatory Bowel Disease
A study testing Decision Coach Sessions in people with Inflammatory Bowel Diseases and Crohn Disease, run by London Health Sciences Centre.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Decision Coach Sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- patient over age 18
- non-English speakers
- acute medical instability or any known major mental illness in parent or adolescent patient
Trial locations and contacts
No sites are listed yet.
About this study
Official 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:
Read more
- 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.
Read the 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:
- SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) questionnaire and 16 item Decisional Conflict Scale pre/post SDM intervention,
- Preparation for Decision Making Scale: acceptability and effect of DA following the intervention,
- Decision Coach Questionnaire: acceptability of the DC session post intervention,
- 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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, IBD
- Being tested
- Decision Coach Sessions
- Keywords
- decisional conflict, shared decision making, SDM, decisional regret, biologics, biologic therapy, pediatric IBD, pIBD
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Coach SessionsOther
Also called DC 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Decision Coach Sessions |
| Comparator group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: baseline (before SDM intervention), immediately after the final SDM session
Secondary outcomes (1)
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.
Measured: baseline (before SDM intervention), 6-12 months after the final SDM session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study startJan 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Responsible party
- Principal investigator, Eileen Crowley, London Health Sciences Centre
- Investigators
- Eileen Crowley, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689892
- Sponsor's protocol ID
- 12069
- Acronym
- SDM-IBD
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siyam T, Shahid A, Perram M, Zuna I, Haque F, Archundia-Herrera MC, Vohra S, Olson K. A scoping review of interventions to promote the adoption of shared decision-making (SDM) among health care professionals in clinical practice. Patient Educ Couns. 2019 Jun;102(6):1057-1066. doi: 10.1016/j.pec.2019.01.001. Epub 2019 Jan 3.
PubMed 30642716Briss P, Rimer B, Reilley B, Coates RC, Lee NC, Mullen P, Corso P, Hutchinson AB, Hiatt R, Kerner J, George P, White C, Gandhi N, Saraiya M, Breslow R, Isham G, Teutsch SM, Hinman AR, Lawrence R; Task Force on Community Preventive Services. Promoting informed decisions about cancer screening in communities and healthcare systems. Am J Prev Med. 2004 Jan;26(1):67-80. doi: 10.1016/j.amepre.2003.09.012.
PubMed 14700715Boland L, Graham ID, Legare F, Lewis K, Jull J, Shephard A, Lawson ML, Davis A, Yameogo A, Stacey D. Barriers and facilitators of pediatric shared decision-making: a systematic review. Implement Sci. 2019 Jan 18;14(1):7. doi: 10.1186/s13012-018-0851-5.
PubMed 30658670Lipstein EA, Lovell DJ, Denson LA, Kim SC, Spencer C, Ittenbach RF, Britto MT. High Levels of Decisional Conflict and Decision Regret When Making Decisions About Biologics. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e176-e181. doi: 10.1097/MPG.0000000000001425.
PubMed 27749390O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. doi: 10.1136/bmj.319.7212.731.
PubMed 10487995Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making. 2015 Jan;35(1):114-31. doi: 10.1177/0272989X14551638. Epub 2014 Oct 28.
PubMed 25351843Gravel K, Legare F, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals' perceptions. Implement Sci. 2006 Aug 9;1:16. doi: 10.1186/1748-5908-1-16.
PubMed 16899124Stacey D, Kryworuchko J, Bennett C, Murray MA, Mullan S, Legare F. Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. Med Decis Making. 2012 May-Jun;32(3):E22-33. doi: 10.1177/0272989X12443311. Epub 2012 Apr 13.
PubMed 22505617Lemberg DA, Day AS. Crohn disease and ulcerative colitis in children: an update for 2014. J Paediatr Child Health. 2015 Mar;51(3):266-70. doi: 10.1111/jpc.12685. Epub 2014 Jul 15.
PubMed 25039307Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
PubMed 22926499Schildkraut V, Alex G, Cameron DJ, Hardikar W, Lipschitz B, Oliver MR, Simpson DM, Catto-Smith AG. Sixty-year study of incidence of childhood ulcerative colitis finds eleven-fold increase beginning in 1990s. Inflamm Bowel Dis. 2013 Jan;19(1):1-6. doi: 10.1002/ibd.22997.
PubMed 22532319Silva FA, Rodrigues BL, Ayrizono ML, Leal RF. The Immunological Basis of Inflammatory Bowel Disease. Gastroenterol Res Pract. 2016;2016:2097274. doi: 10.1155/2016/2097274. Epub 2016 Dec 14.
PubMed 28070181Walters TD, Kim MO, Denson LA, Griffiths AM, Dubinsky M, Markowitz J, Baldassano R, Crandall W, Rosh J, Pfefferkorn M, Otley A, Heyman MB, LeLeiko N, Baker S, Guthery SL, Evans J, Ziring D, Kellermayer R, Stephens M, Mack D, Oliva-Hemker M, Patel AS, Kirschner B, Moulton D, Cohen S, Kim S, Liu C, Essers J, Kugathasan S, Hyams JS; PRO-KIIDS Research Group. Increased effectiveness of early therapy with anti-tumor necrosis factor-alpha vs an immunomodulator in children with Crohn's disease. Gastroenterology. 2014 Feb;146(2):383-91. doi: 10.1053/j.gastro.2013.10.027. Epub 2013 Oct 23.
PubMed 24162032Forrest CB, Crandall WV, Bailey LC, Zhang P, Joffe MM, Colletti RB, Adler J, Baron HI, Berman J, del Rosario F, Grossman AB, Hoffenberg EJ, Israel EJ, Kim SC, Lightdale JR, Margolis PA, Marsolo K, Mehta DI, Milov DE, Patel AS, Tung J, Kappelman MD. Effectiveness of anti-TNFalpha for Crohn disease: research in a pediatric learning health system. Pediatrics. 2014 Jul;134(1):37-44. doi: 10.1542/peds.2013-4103. Epub 2014 Jun 16.
PubMed 24935993Hoentjen F, van Bodegraven AA. Safety of anti-tumor necrosis factor therapy in inflammatory bowel disease. World J Gastroenterol. 2009 May 7;15(17):2067-73. doi: 10.3748/wjg.15.2067.
PubMed 19418577
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Shared Decision Making Intervention in Paediatric Inflammatory Bowel Disease Therapeutic Decision-making
- ClinicalTrials.gov ID
- NCT05689892
- Acronym / sponsor ID
- SDM-IBD / 12069
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, IBD
- Keywords
- decisional conflict, shared decision making, SDM, decisional regret, biologics, biologic therapy, pediatric IBD, pIBD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Study start
- Jan 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) questionnaire and 16 item Decisional Conflict Scale pre/post SDM intervention,
- Preparation for Decision Making Scale: acceptability and effect of DA following the intervention,
- Decision Coach Questionnaire: acceptability of the DC session post intervention,
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Decision Coach SessionsParticipants 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. |
| Comparator group | No intervention | –Participants who have been recommended a new biologic therapy within the last 12 months and have commenced treatment will be recruited to this arm. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- patient over age 18
- non-English speakers
- acute medical instability or any known major mental illness in parent or adolescent patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Coach SessionsAlso: DC sessionsParticipants 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 | Intervention group |
Primary outcome
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.
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.
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Results publication: PubMed 30642716Siyam T, Shahid A, Perram M, Zuna I, Haque F, Archundia-Herrera MC, Vohra S, Olson K. A scoping review of interventions to promote the adoption of shared decision-making (SDM) among health care professionals in clinical practice. Patient Educ Couns. 2019 Jun;102(6):1057-1066. doi: 10.1016/j.pec.2019.01.001. Epub 2019 Jan 3.
- Results publication: PubMed 14700715Briss P, Rimer B, Reilley B, Coates RC, Lee NC, Mullen P, Corso P, Hutchinson AB, Hiatt R, Kerner J, George P, White C, Gandhi N, Saraiya M, Breslow R, Isham G, Teutsch SM, Hinman AR, Lawrence R; Task Force on Community Preventive Services. Promoting informed decisions about cancer screening in communities and healthcare systems. Am J Prev Med. 2004 Jan;26(1):67-80. doi: 10.1016/j.amepre.2003.09.012.
- Results publication: PubMed 30658670Boland L, Graham ID, Legare F, Lewis K, Jull J, Shephard A, Lawson ML, Davis A, Yameogo A, Stacey D. Barriers and facilitators of pediatric shared decision-making: a systematic review. Implement Sci. 2019 Jan 18;14(1):7. doi: 10.1186/s13012-018-0851-5.
- Results publication: PubMed 27749390Lipstein EA, Lovell DJ, Denson LA, Kim SC, Spencer C, Ittenbach RF, Britto MT. High Levels of Decisional Conflict and Decision Regret When Making Decisions About Biologics. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):e176-e181. doi: 10.1097/MPG.0000000000001425.
- Results publication: PubMed 10487995O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing health treatment or screening decisions: systematic review. BMJ. 1999 Sep 18;319(7212):731-4. doi: 10.1136/bmj.319.7212.731.
- Results publication: PubMed 25351843Shay LA, Lafata JE. Where is the evidence? A systematic review of shared decision making and patient outcomes. Med Decis Making. 2015 Jan;35(1):114-31. doi: 10.1177/0272989X14551638. Epub 2014 Oct 28.
- Results publication: PubMed 16899124Gravel K, Legare F, Graham ID. Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals' perceptions. Implement Sci. 2006 Aug 9;1:16. doi: 10.1186/1748-5908-1-16.
- Results publication: PubMed 22505617Stacey D, Kryworuchko J, Bennett C, Murray MA, Mullan S, Legare F. Decision coaching to prepare patients for making health decisions: a systematic review of decision coaching in trials of patient decision AIDS. Med Decis Making. 2012 May-Jun;32(3):E22-33. doi: 10.1177/0272989X12443311. Epub 2012 Apr 13.
- Results publication: PubMed 25039307Lemberg DA, Day AS. Crohn disease and ulcerative colitis in children: an update for 2014. J Paediatr Child Health. 2015 Mar;51(3):266-70. doi: 10.1111/jpc.12685. Epub 2014 Jul 15.
- Results publication: PubMed 22926499Kappelman MD, Moore KR, Allen JK, Cook SF. Recent trends in the prevalence of Crohn's disease and ulcerative colitis in a commercially insured US population. Dig Dis Sci. 2013 Feb;58(2):519-25. doi: 10.1007/s10620-012-2371-5. Epub 2012 Aug 29.
- Results publication: PubMed 22532319Schildkraut V, Alex G, Cameron DJ, Hardikar W, Lipschitz B, Oliver MR, Simpson DM, Catto-Smith AG. Sixty-year study of incidence of childhood ulcerative colitis finds eleven-fold increase beginning in 1990s. Inflamm Bowel Dis. 2013 Jan;19(1):1-6. doi: 10.1002/ibd.22997.
- Results publication: PubMed 28070181Silva FA, Rodrigues BL, Ayrizono ML, Leal RF. The Immunological Basis of Inflammatory Bowel Disease. Gastroenterol Res Pract. 2016;2016:2097274. doi: 10.1155/2016/2097274. Epub 2016 Dec 14.
- Ottawa Family Decision Guide © 2012 Lawson, Saarimaki, Kryworuchko, Boland, Feenstra, Stacey. Children's Hospital of Eastern Ontario Family Decision ServicesLink provided by the sponsor.
- O'Connor AM. User Manual - Decisional Conflict Scale (16 item question format). Ottawa: Ottawa Hospital Research Institute; © 1993 \[updated 2012\]. 16 p.Link provided by the sponsor.
- Graham ID, O'Connor AM. Preparation for Decision Making Scale; 2005Link provided by the sponsor.
- O'Connor AM. User Manual - Decision Regret Scale. Ottawa: Ottawa Hospital Research Institute; © 1996 \[modified 2003\]. 3 p.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Crowley principal investigator
London Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Decision Coach Sessions in people with Inflammatory Bowel Diseases and Crohn Disease, run by London Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen Crowley (519-685-8500 ext. 58177, eileen.crowley@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05689892, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.