Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients

Last updated: March 20, 2024
Sponsor: Rijnstate Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Structured preoperative multidisciplinary team meeting

Clinical Study ID

NCT05703230
2021-1983
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 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-benefitratio of the surgical procedure; or
  • Doubt if the correct measures were taken to limit the perioperative risk as much aspossible; or
  • Doubt if the patient agrees with the surgery or the anesthesiologic treatment andexpected risks.

Exclusion

Exclusion Criteria:

  • no informed consent
  • unable to communicate with patient (either directly or through third party)
  • emergency surgery
  • Proposed surgical intervention for which a structured preoperative multidisciplinaryteam meeting, similar to the current study intervention, already exists in thisrespective hospital at the start of the study

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Structured preoperative multidisciplinary team meeting
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
October 31, 2025

Study Description

Due to the increase in life expectancy and improved care for patients suffering from a chronic disease, the number of complex patients requiring a surgical intervention is increasing. It is important to balance the potential benefits of this 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 all recommend preoperative multidisciplinary team meetings for high-risk noncardiac surgical patients. However, the evidence underlying a benefit of a preoperative MDT meeting is absent and recommendations are based on expert opinion. Moreover, considerable practice variation is currently present.

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.

Connect with a study center

  • Stichting Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223GZ
    Netherlands

    Active - Recruiting

  • Stichting Meander Medisch Centrum

    Amersfoort, 3817TZ
    Netherlands

    Active - Recruiting

  • Stichting OLVG

    Amsterdam, 1091
    Netherlands

    Active - Recruiting

  • Gelre Ziekenhuis

    Apeldoorn, 7334DZ
    Netherlands

    Active - Recruiting

  • Stichting Albert Schweitzer Ziekenhuis

    Dordrecht, 3318AT
    Netherlands

    Active - Recruiting

  • Groene Hart Ziekenhuis

    Gouda, 2803HH
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713GZ
    Netherlands

    Active - Recruiting

  • Zuyderland Medisch Centrum

    Heerlen, 6419PC
    Netherlands

    Active - Recruiting

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229HX
    Netherlands

    Active - Recruiting

  • Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina

    Nijmegen, 6532SZ
    Netherlands

    Active - Recruiting

  • Stichting Bravis Ziekenhuis

    Roosendaal, 4708AE
    Netherlands

    Active - Recruiting

  • Stichting Protestants Christelijk Ziekenhuis Ikazia

    Rotterdam, 3083AN
    Netherlands

    Active - Recruiting

  • Maxima Medisch Centrum

    Veldhoven, 5504DB
    Netherlands

    Active - Recruiting

  • Zaans Medisch Centrum

    Zaandam, 1502DV
    Netherlands

    Active - Recruiting

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