Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients
NCT ID: NCT05703230
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2022-11-01
2025-10-31
Brief Summary
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The main questions to answer are:
* Primary question: Does implementation of preoperative multidisciplinary team discussions for high risk noncardiac surgical patients diminish serious adverse events as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment?
* Secondary questions: Does implementation of preoperative multidisciplinary team discussion for high risk noncardiac surgical patients improve disability, survival, functional outcome, quality of life and cost-effectiveness as compared to care as usual at six months postoperatively or six months after multidisciplinary team discussion in case of nonsurgical treatment?
Participants will be asked to answer questionnaires at baseline, 3, 6,9 and 12 months postoperatively or post MDT discussion.
Patients for whom no structured preoperative multidisciplinary discussion is installed yet (care as usual) will be compared with patients for whom a structured preoperative multidisciplinary discussion is performed (intervention).
The study will be performed in hospitals that have no established preoperative MDT meeting at the start of the study.
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Detailed Description
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This study will assess the efficacy of implementation of a preoperative structured multidisciplinary team (sMDT) meeting to optimize perioperative management for high risk noncardiac surgical patients.
The hypothesis is that implementation of preoperative sMDT meetings for high risk noncardiac surgical patients results in less serious adverse events, is more cost-effective, and improves quality of life and functional outcome at six months, compared to preoperative care as usual (control).
A preoperative structured Multidisciplinary Team (sMDT) meeting for high risk noncardiac surgical patients will be implemented in each participating center (n=14) throughout the study. In the sMDT meeting, patients' treatment plan and alternatives will be discussed by the anesthesiologist, surgical specialist and other relevant consultants or (specialized) nurses.
The primary outcome is Serious adverse events (SAEs) according to the Clavien Dindo classification grade 3 or more, at 6 months following surgery or following the preoperative sMDT meeting in case of nonsurgical management. Secondary outcomes are: functional outcome (12-item WHO Disability Assessment Schedule), survival, quality of life (WHOQOL BREF), patients' regret (including interview at 6 months), societal costs (iMCQ and iPCQ, Electronic Medical Record (EMR) data, EQ5D-5L), alterations in perioperative management and sMDT performance (MDT-MOT), and facilitators and barriers (using structured interviews health care professionals). Most secondary outcomes will be assessed at baseline, 30 days, 3, 6 and 12 months.
Subgroup analyses will take place for e.g. age groups (approximate quintiles), patient sex, size of hospital, intent of surgery, BMI categories (underweight, normal, overweight, obese, ≥super obese), ASA physical status, frailty, MET score, smoking behavior, alcohol use, comorbidity index score, planned postoperative destination, educational attainment, and employment status.
For detailed description, see below.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Preoperative care as usual
Patients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting)
No interventions assigned to this group
Structured preoperative multidisciplinary team meeting
Patients are discussed preoperatively in a structured preoperative multidisciplinary team meeting
Structured preoperative multidisciplinary team meeting
The intervention to be investigated is the introduction of a preoperative structured multidisciplinary team (sMDT) meeting for high risk noncardiac surgical patients, which is attended by at least the treating surgical specialist, an anesthesiologist and another medical consultant with expertise relevant for the patients comorbidities and preferences. In the preoperative sMDT meeting, at least the following questions will be discussed as recommended by the Dutch Perioperative Guideline:
* Is the proposed surgical intervention appropriate care for the patient?
* Is the risk/benefit ratio of the proposed surgical intervention acceptable for the patient?
* Should the patient's condition be optimized before undergoing the proposed surgical intervention?
Interventions
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Structured preoperative multidisciplinary team meeting
The intervention to be investigated is the introduction of a preoperative structured multidisciplinary team (sMDT) meeting for high risk noncardiac surgical patients, which is attended by at least the treating surgical specialist, an anesthesiologist and another medical consultant with expertise relevant for the patients comorbidities and preferences. In the preoperative sMDT meeting, at least the following questions will be discussed as recommended by the Dutch Perioperative Guideline:
* Is the proposed surgical intervention appropriate care for the patient?
* Is the risk/benefit ratio of the proposed surgical intervention acceptable for the patient?
* Should the patient's condition be optimized before undergoing the proposed surgical intervention?
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology Physical Status (ASA-PS) score is 3 or more; and
* Clinical Frailty Scale score is 4 or more; and
* Patient is planned for elective or semi-elective noncardiac surgery; and
* As stated by the Dutch perioperative guideline:
* Doubt by the surgeon or anesthesiologist (or other discipline) regarding harm-benefit ratio of the surgical procedure; or
* Doubt if the correct measures were taken to limit the perioperative risk as much as possible; or
* Doubt if the patient agrees with the surgery or the anesthesiologic treatment and expected risks.
Exclusion Criteria
* unable to communicate with patient (either directly or through third party)
* emergency surgery
* Proposed surgical intervention for which a structured preoperative multidisciplinary team meeting, similar to the current study intervention, already exists in this respective hospital at the start of the study
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Amsterdam UMC
OTHER
University of Twente
OTHER
University Medical Center Groningen
OTHER
Maastricht University Medical Center
OTHER
Leiden University Medical Center
OTHER
Rijnstate Hospital
OTHER
Responsible Party
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Principal Investigators
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Nick J. Koning, MD PhD DESA
Role: PRINCIPAL_INVESTIGATOR
Rijnstate Hospital
Jacqueline E. Vernooij, MD, MA
Role: STUDY_DIRECTOR
Rijnstate Hospital
Locations
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Stichting Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Stichting Meander Medisch Centrum
Amersfoort, , Netherlands
Stichting OLVG
Amsterdam, , Netherlands
Gelre Ziekenhuis
Apeldoorn, , Netherlands
Stichting Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina
Nijmegen, , Netherlands
Stichting Bravis Ziekenhuis
Roosendaal, , Netherlands
Stichting Protestants Christelijk Ziekenhuis Ikazia
Rotterdam, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Zaans Medisch Centrum
Zaandam, , Netherlands
Countries
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Central Contacts
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Rutger J. Spruit, MD
Role: CONTACT
Facility Contacts
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References
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Vernooij JEM, Hobrink E, Boerlage RM, van Beest P, van de Calseijde S, Holl T, Janssen LMJ, Klinkert L, Marsman M, Nouwen MJ, Wefers Bettink MA, Preckel B, Kalkman CJ, van Leeuwen B, Festen S, Koning NJ. Characteristics and outcome of preoperative multidisciplinary team discussions for high-risk noncardiac surgical patients in the Netherlands: a multicentre prospective observational study. Br J Anaesth. 2025 Aug;135(2):449-458. doi: 10.1016/j.bja.2025.05.004. Epub 2025 Jun 6.
Vernooij JEM, Boerlage RM, Doggen CJM, Preckel B, Dirksen CD, van Leeuwen BL, Spruit RJ, Festen S, van der Wal-Huisman H, van Basten JP, Kalkman CJ, Koning NJ; PREPARATION study investigators. Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study-a multicenter stepped-wedge cluster randomized trial. Trials. 2023 Oct 11;24(1):660. doi: 10.1186/s13063-023-07685-3.
Other Identifiers
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2021-1983
Identifier Type: -
Identifier Source: org_study_id
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