NCT05703230

Brief Summary

The current multicenter stepped wedge randomized cluster trial study aims to assess whether implementation of preoperative multidisciplinary team (MDT) discussions is (cost)effective for high risk noncardiac surgical patients. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Nov 2022Feb 2027

Study Start

First participant enrolled

November 1, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

November 4, 2022

Last Update Submit

February 23, 2026

Conditions

Interdisciplinary CommunicationPostoperative ComplicationsNoncardiac SurgerySurgical Procedures, OperativePreoperative CarePatient Care TeamCost-Benefit AnalysisComorbidities and Coexisting Conditions

Keywords

multidisciplinary team meetingpreoperativehigh risk surgical patients

Outcome Measures

Primary Outcomes (1)

  • Serious Adverse Events (SAEs)

    Serious adverse events (SAEs), defined as: 1. Grade 3 or more on the Clavien Dindo classification following surgical intervention, or 2. non-operative SAEs will be graded accordingly i.e., events necessitating hospital admission, surgical intervention, single or multi-organ failure, or death.

    6 months

Secondary Outcomes (20)

  • Disability status

    12 months

  • Patient experienced quality of life

    12 months

  • Regret of decision

    12 months

  • Societal costs measured by a patient cost questionnaire

    12 months

  • Hospital costs as a component of societal costs

    12 months

  • +15 more secondary outcomes

Other Outcomes (2)

  • Performance of sMDTs using an MDT-Meeting Observational Tool (MDT-MOT)

    6 months

  • Facilitators and barriers to organize preoperative sMDT meetings

    6 months

Study Arms (2)

Preoperative care as usual

NO INTERVENTION

Patients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting)

Structured preoperative multidisciplinary team meeting

ACTIVE COMPARATOR

Patients are discussed preoperatively in a structured preoperative multidisciplinary team meeting

Other: Structured preoperative multidisciplinary team meeting

Interventions

Structured preoperative multidisciplinary team meetingOTHER

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?

Structured preoperative multidisciplinary team meeting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older; and
  • 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.

You may not qualify if:

  • no informed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Stichting Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223GZ, Netherlands

Location

Stichting Meander Medisch Centrum

Amersfoort, 3817TZ, Netherlands

Location

Stichting OLVG

Amsterdam, 1091, Netherlands

Location

Gelre Ziekenhuis

Apeldoorn, 7334DZ, Netherlands

Location

Stichting Albert Schweitzer Ziekenhuis

Dordrecht, 3318AT, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, 2803HH, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713GZ, Netherlands

Location

Zuyderland Medisch Centrum

Heerlen, 6419PC, Netherlands

Location

Maastricht Universitair Medisch Centrum

Maastricht, 6229HX, Netherlands

Location

Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina

Nijmegen, 6532SZ, Netherlands

Location

Stichting Bravis Ziekenhuis

Roosendaal, 4708AE, Netherlands

Location

Stichting Protestants Christelijk Ziekenhuis Ikazia

Rotterdam, 3083AN, Netherlands

Location

Maxima Medisch Centrum

Veldhoven, 5504DB, Netherlands

Location

Zaans Medisch Centrum

Zaandam, 1502DV, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 37821994BACKGROUND

  • 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.

    PMID: 40480911DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nick J. Koning, MD PhD DESA

    Rijnstate Hospital

    PRINCIPAL INVESTIGATOR

  • Jacqueline E. Vernooij, MD, MA

    Rijnstate Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: cross-sectional stepped wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2022

First Posted

January 27, 2023

Study Start

November 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Data will be made accessible on request after agreement has been received from the entire project group. The principal investigator will communicate data availability with researchers sending the requests.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 12 months after publication
Access Criteria
Data will be made accessible on request after agreement has been received from the entire project group.

Locations

NL(14)