TY - JOUR
T1 - Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial)
T2 - study protocol for a stepped-wedge cluster-randomized controlled trial
AU - de Rijk, Florence E. M.
AU - van Veldhuisen, Charlotte L.
AU - Besselink, Marc G.
AU - van Hooft, Jeanin E.
AU - van Santvoort, Hjalmar C.
AU - van Geenen, Erwin J. M.
AU - van Werkhoven, Cornelis H.
AU - de Jonge, Pieter Jan F.
AU - Bruno, Marco J.
AU - Dutch Pancreatitis Study Group
AU - Verdonk, Robert C.
N1 - Funding Information: With special thanks to the national and international CP experts who have critically reviewed our evidence-based management algorithm before implementing in clinical practice: Suresh T. Chari (endocrine pancreatic function), Esther Croes (lifestyle modifications), J. Enrique Dominguez-Munoz (treatment of exocrine pancreatic insufficiency), Asbjørn Mohr Drewes (pain management), Eva Grimbergen (nutritional management), Maarten van Kleef (pain management), Matthias Löhr (nutritional management and bone health), Harold J.A. Nijhuis (pain management), Ajith Siriwardena (pain management), and Niek J. de Wit (lifestyle modifications). The authors also thank the clinical centers and local principal investigators (all in the Netherlands): Marie-Paule G.F. Anten (Department of Gastroenterology and Hepatology, Franciscus Gasthuis en Vlietland, Rotterdam, The Netherlands), Abha Bhalla (Department of Gastroenterology and Hepatology, Haga Hospital, The Hague, The Netherlands), Philip R. Bos (Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands), Menno A. Brink (Department of Gastroenterology and Hepatology, Meander MC, Amersfoort, The Netherlands), Wouter L. Curvers (Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands), Brechje C. van Eijck (Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, The Netherlands), Erwin J.M. van Geenen (Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands), Muhammed Hadithi (Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands), Akin Inderson (Department of Gastroenterology and Hepatology, Leids Universitair Medisch Centrum, Leiden, The Netherlands), Liesbeth M. Kager (Department of Gastroenterology and Hepatology, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands), Yolande Keulemans (Department of Gastroenterology and Hepatology, Zuyderland MC, Sittard, The Netherlands), Parweez Koehestanie (Department of Gastroenterology and Hepatology, Bravis Hospital, Roosendaal, The Netherlands), Sjoerd D. Kuiken (Department of Gastroenterology and Hepatology, OLVG, Amsterdam, The Netherlands), Alexander C. Poen (Department of Gastroenterology and Hepatology, Isala, Zwolle, The Netherlands), Rutger Quispel (Department of Gastroenterology and Hepatology, Reinier de Graaf Gasthuis, Delft, The Netherlands), Tessa E.H. Römkens (Departement of Gastroeenterology and Hepatology, Jeroen Bosch Ziekenhuis, ‘s-Hertogenbosch, The Netherlands), Jerome Sint Nicolaas (Department of Gastroenterology and Hepatology, Amphia Ziekenhuis, Breda, The Netherlands), Jan Willem W. A. Straathof (Department of Gastroenterology and Hepatology, Maxima Medisch Centrum, Veldhoven, The Netherlands), Adriaan C.I.T.L. Tan (Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands), Willem J. Thijs (Department of Gastroenterology and Hepatology, Martini Ziekenhuis, Groningen, The Netherlands),Merel Tielemans (Department of Gastroenterology and Hepatology, Bravis Hospital, Roosendaal, The Netherlands), Niels G. Venneman (Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands), Frank P. Vleggaar (Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, The Netherlands), Rogier P. Voermans (Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands), Roy L.J. van Wanrooij (Department of Gastroenterology and Hepatology, Amsterdam UMC, Amsterdam, The Netherlands), and Tessa Verlaan (Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands). Publisher Copyright: © 2023, The Author(s).
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP. Methods: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial. Discussion: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice. Trial registration: ISRCTN, ISRCTN13042622. Registered on 5 September 2020.
AB - Background: Chronic pancreatitis (CP) is an inflammatory disease that may be complicated by abdominal pain, pancreatic dysfunction, nutritional deficiencies, and diminished bone density. Importantly, it is also associated with a substantially impaired quality of life and reduced life expectancy. This may partly be explained by suboptimal treatment, in particular the long-term management of this chronic condition, despite several national and international guidelines. Standardization of care through a structured implementation of guideline recommendations may improve the level of care and lower the complication rate of these patients. Therefore, the aim of the present study is to evaluate to what extent patient education and standardization of care, through the implementation of an evidence-based integrated management algorithm, improve quality of life and reduce pain severity in patients with CP. Methods: The COMBO trial is a nationwide stepped-wedge cluster-randomized controlled trial. In a stepwise manner, 26 centers, clustered in 6 health regions, cross-over from current practice to care according to an evidence-based integrated management algorithm. During the current practice phase, study participants are recruited and followed longitudinally through questionnaires. Individual patients contribute data to both study periods. Co-primary study endpoints consist of quality of life (assessed by the PANQOLI score) and level of pain (assessed by the Izbicki questionnaire). Secondary outcomes include process measure outcomes, clinical outcomes (e.g., pancreatic function, nutritional status, bone health, interventions, medication use), utilization of healthcare resources, (in) direct costs, and the level of social participation. Standard follow-up is 35 months from the start of the trial. Discussion: This is the first stepped-wedge cluster-randomized controlled trial to investigate whether an evidence-based integrated therapeutic approach improves quality of life and pain severity in patients with CP as compared with current practice. Trial registration: ISRCTN, ISRCTN13042622. Registered on 5 September 2020.
KW - COMBO
KW - Chronic pancreatitis
KW - Evidence-based
KW - Integrated care
KW - Management algorithm
KW - Pain severity
KW - Quality of life
KW - Randomized controlled trial
KW - Stepped-wedge
UR - http://www.scopus.com/inward/record.url?scp=85145951856&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-022-07044-8
DO - https://doi.org/10.1186/s13063-022-07044-8
M3 - Article
C2 - 36611202
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 18
ER -