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.
KW - health economics
KW - health policy
KW - inflammatory bowel disease
KW - organisation of health services
U2 - 10.1136/bmjopen-2021-050539
DO - 10.1136/bmjopen-2021-050539
M3 - Article
C2 - 35022169
AN - SCOPUS:85123566686
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
M1 - e050539
ER -