Shared Decision Making in Paediatric Inflammatory Bowel Disease

NCT05689892 | Unknown

• 1 other identifier: 12069
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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. 2.to adapt and assess the acceptability of DA in a Canadian academic center.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; IBD

Keywords

decisional conflict; shared decision making; SDM; decisional regret; biologics; biologic therapy; pediatric IBD; pIBD

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

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.

Interventions

Decision Coach Sessions OTHER

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.

Also known as: DC sessions

Intervention group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• patient over age 18
• non-English speakers
• acute medical instability or any known major mental illness in parent or adolescent patient

Sponsors & Collaborators

• London Health Sciences Centre: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Related Publications (24)

• 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.

  PMID: 30642716 RESULT

• Briss 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.

  PMID: 14700715 RESULT

• Boland 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.

  PMID: 30658670 RESULT

• Lipstein 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.

  PMID: 27749390 RESULT

• O'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.

  PMID: 10487995 RESULT

• Shay 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.

  PMID: 25351843 RESULT

• Gravel 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.

  PMID: 16899124 RESULT

• Stacey 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.

  PMID: 22505617 RESULT

• Lemberg 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.

  PMID: 25039307 RESULT

• Kappelman 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.

  PMID: 22926499 RESULT

• Schildkraut 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.

  PMID: 22532319 RESULT

• Silva 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.

  PMID: 28070181 RESULT

• Walters 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.

  PMID: 24162032 RESULT

• Forrest 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.

  PMID: 24935993 RESULT

• Hoentjen 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.

  PMID: 19418577 RESULT

• Dulai PS, Thompson KD, Blunt HB, Dubinsky MC, Siegel CA. Risks of serious infection or lymphoma with anti-tumor necrosis factor therapy for pediatric inflammatory bowel disease: a systematic review. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1443-51; quiz e88-9. doi: 10.1016/j.cgh.2014.01.021. Epub 2014 Jan 22.

  PMID: 24462626 RESULT

• Rosh JR, Turner D, Griffiths A, Cohen SA, Jacobstein D, Adedokun OJ, Padgett L, Terry NA, O'Brien C, Hyams JS. Ustekinumab in Paediatric Patients with Moderately to Severely Active Crohn's Disease: Pharmacokinetics, Safety, and Efficacy Results from UniStar, a Phase 1 Study. J Crohns Colitis. 2021 Nov 8;15(11):1931-1942. doi: 10.1093/ecco-jcc/jjab089.

  PMID: 34037715 RESULT

• Ledder O, Assa A, Levine A, Escher JC, de Ridder L, Ruemmele F, Shah N, Shaoul R, Wolters VM, Rodrigues A, Uhlig HH, Posovszky C, Kolho KL, Jakobsen C, Cohen S, Shouval DS, de Meij T, Martin-de-Carpi J, Richmond L, Bronsky J, Friedman M, Turner D. Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN. J Crohns Colitis. 2017 Oct 1;11(10):1230-1237. doi: 10.1093/ecco-jcc/jjx082.

  PMID: 28605483 RESULT

• Grossi V, Lerer T, Griffiths A, LeLeiko N, Cabrera J, Otley A, Rick J, Mack D, Bousvaros A, Rosh J, Grossman A, Saeed S, Kay M, Boyle B, Oliva-Hemker M, Keljo D, Pfefferkorn M, Faubion W, Kappelman MD, Sudel B, Markowitz J, Hyams JS. Concomitant Use of Immunomodulators Affects the Durability of Infliximab Therapy in Children With Crohn's Disease. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1748-56. doi: 10.1016/j.cgh.2015.04.010. Epub 2015 Apr 21.

  PMID: 25911120 RESULT

• De Bie CI, Hummel TZ, Kindermann A, Kokke FT, Damen GM, Kneepkens CM, Van Rheenen PF, Schweizer JJ, Hoekstra JH, Norbruis OF, Tjon A Ten WE, Vreugdenhil AC, Deckers-Kocken JM, Gijsbers CF, Escher JC, De Ridder L. The duration of effect of infliximab maintenance treatment in paediatric Crohn's disease is limited. Aliment Pharmacol Ther. 2011 Jan;33(2):243-50. doi: 10.1111/j.1365-2036.2010.04507.x. Epub 2010 Nov 14.

  PMID: 21083595 RESULT

• Schuler CL, Dodds C, Hommel KA, Ittenbach RF, Denson LA, Lipstein EA. Shared decision making in IBD: A novel approach to trial consent and timing. Contemp Clin Trials Commun. 2019 Sep 8;16:100447. doi: 10.1016/j.conctc.2019.100447. eCollection 2019 Dec.

  PMID: 31538130 RESULT

• Legare F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010 Aug;56(8):e308-14.

  PMID: 20705870 RESULT

• Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26.

  PMID: 19560303 RESULT

• Feenstra B, Lawson ML, Harrison D, Boland L, Stacey D. Decision coaching using the Ottawa family decision guide with parents and their children: a field testing study. BMC Med Inform Decis Mak. 2015 Feb 7;15:5. doi: 10.1186/s12911-014-0126-2.

  PMID: 25889602 RESULT

Related Links

• Ottawa Family Decision Guide © 2012 Lawson, Saarimaki, Kryworuchko, Boland, Feenstra, Stacey. Children's Hospital of Eastern Ontario Family Decision Services
• O'Connor AM. User Manual - Decisional Conflict Scale (16 item question format). Ottawa: Ottawa Hospital Research Institute; © 1993 \[updated 2012\]. 16 p.
• Graham ID, O'Connor AM. Preparation for Decision Making Scale; 2005
• O'Connor AM. User Manual - Decision Regret Scale. Ottawa: Ottawa Hospital Research Institute; © 1996 \[modified 2003\]. 3 p.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Eileen Crowley

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Crowley

CONTACT

519-685-8500; eileen.crowley@lhsc.on.ca

Nidhi Suthar

CONTACT

519-685-8500; nidhirashmikant.suthar@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Assistant Professor

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 19, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share