Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period

Reinier Cornelis Anthonius Van Linschoten; Nikki Van Leeuwen; Daan Nieboer; Erwin Birnie; Menne Scherpenzeel; Karen Evelyne Verweij; Vincent De Jonge; Jan Antonius Hazelzet; C. Janneke Van Der Woude; Rachel Louise West; Desirée Van Noord

doi:10.1136/bmjopen-2021-050539

Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period

Reinier Cornelis Anthonius Van Linschoten^*, Nikki Van Leeuwen, Daan Nieboer, Erwin Birnie, Menne Scherpenzeel, Karen Evelyne Verweij, Vincent De Jonge, Jan Antonius Hazelzet, C. Janneke Van Der Woude, Rachel Louise West, Desirée Van Noord

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Introduction Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. Methods and analysis IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. Ethics and dissemination The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. Trial registration number NL8276.

Original language	English
Article number	e050539
Journal	BMJ Open
Volume	12
Issue number	1
DOIs	https://doi.org/10.1136/bmjopen-2021-050539
Publication status	Published - 12 Jan 2022

Bibliographical note

Funding Information:
Funding This study is funded partly by the Research and Development Foundation (grant number: N/A) of the Franciscus Gasthuis & Vlietland, the Franciscus Research Foundation (grant number: N/A), AbbVie, Falk, Ferring, Janssen, MSD, Pfizer and Takeda. This study is sponsored by Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.

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© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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Value-based care pathway for inflammatory bowel disease, a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline periodFinal published version, 398 KBLicence: CC BY-NC

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Van Linschoten, R. C. A., Van Leeuwen, N., Nieboer, D., Birnie, E., Scherpenzeel, M., Verweij, K. E., De Jonge, V., Hazelzet, J. A., Van Der Woude, C. J., West, R. L., & Van Noord, D. (2022). Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. BMJ Open, 12(1), Article e050539. https://doi.org/10.1136/bmjopen-2021-050539

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abstract = "Introduction Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. Methods and analysis IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. Ethics and dissemination The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. Trial registration number NL8276.",

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note = "Funding Information: Funding This study is funded partly by the Research and Development Foundation (grant number: N/A) of the Franciscus Gasthuis & Vlietland, the Franciscus Research Foundation (grant number: N/A), AbbVie, Falk, Ferring, Janssen, MSD, Pfizer and Takeda. This study is sponsored by Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands. Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

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Van Linschoten, RCA , Van Leeuwen, N , Nieboer, D, Birnie, E, Scherpenzeel, M, Verweij, KE, De Jonge, V, Hazelzet, JA, Van Der Woude, CJ, West, RL & Van Noord, D 2022, 'Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period', BMJ Open, vol. 12, no. 1, e050539. https://doi.org/10.1136/bmjopen-2021-050539

Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. / Van Linschoten, Reinier Cornelis Anthonius ; Van Leeuwen, Nikki ; Nieboer, Daan et al.
In: BMJ Open, Vol. 12, No. 1, e050539, 12.01.2022.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Value-based care pathway for inflammatory bowel disease

T2 - A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period

AU - Van Linschoten, Reinier Cornelis Anthonius

AU - Van Leeuwen, Nikki

AU - Nieboer, Daan

AU - Birnie, Erwin

AU - Scherpenzeel, Menne

AU - Verweij, Karen Evelyne

AU - De Jonge, Vincent

AU - Hazelzet, Jan Antonius

AU - Van Der Woude, C. Janneke

AU - West, Rachel Louise

AU - Van Noord, Desirée

N1 - Funding Information: Funding This study is funded partly by the Research and Development Foundation (grant number: N/A) of the Franciscus Gasthuis & Vlietland, the Franciscus Research Foundation (grant number: N/A), AbbVie, Falk, Ferring, Janssen, MSD, Pfizer and Takeda. This study is sponsored by Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands. Publisher Copyright: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2022/1/12

Y1 - 2022/1/12

N2 - Introduction Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. Methods and analysis IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. Ethics and dissemination The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. Trial registration number NL8276.

AB - Introduction Biologics are effective for the treatment of inflammatory bowel disease (IBD). However, unwarranted variation in processes and outcomes has been reported in the treatment of IBD. A care pathway for the treatment of IBD has the potential to reduce practice variation and improve outcomes. This study aims to compare the effect of a uniform care pathway for the treatment of patients with IBD with biologics to the current situation. Methods and analysis IBD Value is a longitudinal multicentre non-randomised parallel cluster trial with a baseline period. The study takes place in eight centres in the Netherlands. The baseline period will run for 12 months, after which the care pathway will be implemented in 6 of the 8 participating hospitals during the implementation phase of 3 months. Hereafter, the effect of the care pathway will be assessed for 12 months. Total study period is 27 months. The primary outcome is the effect of the care pathway on disease control (IBD-Control questionnaire). Secondary outcomes are the effect of the care pathway on the other outcomes of the International Consortium of Health Outcomes Measurement IBD standard set, health-related generic quality of life, patient experiences and degree of variation; cost effectiveness of the care pathway; and the variation between hospitals in the aforementioned outcomes in the baseline period. Outcomes will be measured every 6 months. The study started on 1 December 2020 and a minimum of 200 patients will be included. Ethics and dissemination The study was deemed not to be subject to Dutch law (WMO; Medical Research Involving Human Subjects Act) by the Medical Ethics Committee of the Erasmus MC, the Netherlands (registration number: MEC-2020-075) and a waiver was provided. Results will be disseminated through peer-reviewed journals and presented at (inter)national conferences. Trial registration number NL8276.

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Value-based care pathway for inflammatory bowel disease: A protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period

Abstract

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