TY - JOUR
T1 - Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery
T2 - the PREPARATION study—a multicenter stepped-wedge cluster randomized trial
AU - Vernooij, Jacqueline E. M.
AU - Boerlage, Romijn M.
AU - Doggen, Carine J. M.
AU - Preckel, Benedikt
AU - Dirksen, Carmen D.
AU - van Leeuwen, Barbara L.
AU - Spruit, Rutger J.
AU - Festen, Suzanne
AU - van der Wal-Huisman, Hanneke
AU - van Basten, Jean P.
AU - Kalkman, Cor J.
AU - Koning, Nick J.
N1 - Funding Information: For this multicenter study, financial support is granted by The Netherlands Organization for Health Research and Development (ZonMW) regarding the program “Healthcare Evaluation & Appropriate Use” (file number: 10330032010003). Funding Information: We would like to thank Dr. Jan Smook and Maria Toren, our patient representatives, all involved physicians, nurses, research coordinators, and managers of each participating hospital for their contribution to the development and implementation of the study protocol. We would like to thank Lian Roovers for the assistance in the randomization procedure. Also, we would like to thank professor Karla Hemming, PhD, for her help with the design of the study. The PREPARATION study investigators Koene van der Sloot, MD; Esther M. Dias, MD; Jasper E. Kal, MD, PhD; Marjolein C.O. van den Nieuwenhuyzen, MD, PhD; Manuela di Biase, MD; Martin Hagenaars, MD, PhD; Bies Oedairadjsingh, MD; Taco van den Ende, MD; Michel Timmerman, MD; Zjuul Segers, MD; Dominique H.P.A.M. Schoester, MD; Kristy M.J. Vons, MD; A. Filius, MD, PhD; Wim van Harten, MD, PhD; Rudolf W. Poolman, MD, PhD; Michel M.P.J. Reijnen, MD, PhD; Peter G. Noordzij, MD, PhD: Barbara C. van Munster; MD, PhD. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events. Methods/design: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months. Discussion: PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice. Trial registration: ClinicalTrials.gov NCT05703230. Registered on 11/09/2022.
AB - Background: As a result of increased life expectancy and improved care for patients suffering from chronic disease, the number of patients with multimorbidity requiring surgical intervention is increasing. For complex surgical patients, it is essential to balance the potential benefits of surgical treatment against the risk of permanent loss of functional capacity and quality of life due to complications. European and US guidelines on perioperative care recommend preoperative multidisciplinary team (MDT) discussions for high-risk noncardiac surgical patients. However, the evidence underlying benefits from preoperative MDT meetings with all relevant perioperative specialties present is limited. The current study aims to investigate the effect of implementation of preoperative MDT discussions for high-risk patients undergoing noncardiac surgery on serious adverse events. Methods/design: PREPARATION is a stepped-wedge cluster randomized trial in 14 Dutch hospitals without currently established preoperative MDT meeting. The intervention, preoperative MDT meetings, will be implemented sequentially with seven blocks of 2 hospitals switching from control (preoperative screening as usual) to the intervention every 3 months. Each hospital will be randomized to one of seven blocks. We aim to include 1200 patients. The primary outcome is the incidence of serious adverse events at 6 months. Secondary outcomes include (cost)effectiveness, functional outcome, and quality of life for up to 12 months. Discussion: PREPARATION is the first study to assess the effectiveness of a preoperative MDT meeting for high-risk noncardiac surgical patients in the presence of an anesthesiologist. If the results suggest that preoperative MDT discussions for high-risk patients are (cost)-effective, the current study facilitates implementation of preoperative MDT meetings in clinical practice. Trial registration: ClinicalTrials.gov NCT05703230. Registered on 11/09/2022.
KW - Complications
KW - Cost-effectiveness
KW - Costs
KW - Frailty
KW - Health technology assessment
KW - High-risk
KW - Mortality
KW - Patient’s preferences
KW - Preoperative multidisciplinary team
KW - Quality of life
KW - Risk tools
KW - Serious adverse events
KW - Stepped-wedge randomized cluster design
UR - http://www.scopus.com/inward/record.url?scp=85173858926&partnerID=8YFLogxK
U2 - https://doi.org/10.1186/s13063-023-07685-3
DO - https://doi.org/10.1186/s13063-023-07685-3
M3 - Article
C2 - 37821994
SN - 1745-6215
VL - 24
JO - Trials
JF - Trials
IS - 1
M1 - 660
ER -