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

March 20, 2024 updated by: Rijnstate Hospital

Is a Preoperative Multidisciplinary Team Meeting (Cost) Effective in Optimizing Noncardiac Surgical Patient Management: The PREPARATION Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Rutger J. Spruit, MD

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5223GZ
      • Amersfoort, Netherlands, 3817TZ
      • Amsterdam, Netherlands, 1091
        • Recruiting
        • Stichting OLVG
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jasper Kal, MD, PhD
      • Apeldoorn, Netherlands, 7334DZ
      • Dordrecht, Netherlands, 3318AT
        • Recruiting
        • Stichting Albert Schweitzer Ziekenhuis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anika Filius, MD, PhD
        • Sub-Investigator:
          • Minke C Kortekaas, MD
      • Gouda, Netherlands, 2803HH
      • Groningen, Netherlands, 9713GZ
        • Recruiting
        • Universitair Medisch Centrum Groningen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michel Struys, MD, PhD
        • Sub-Investigator:
          • Barbara L van Leeuwen, MD, PhD
      • Heerlen, Netherlands, 6419PC
        • Recruiting
        • Zuyderland Medisch Centrum
        • Contact:
        • Principal Investigator:
          • Zjuul Segers, MD
      • Maastricht, Netherlands, 6229HX
        • Recruiting
        • Maastricht Universitair Medisch Centrum
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dianne de Korte-de Boer, MSc, Phd
        • Sub-Investigator:
          • Dominique Schoester, MD
      • Nijmegen, Netherlands, 6532SZ
        • Recruiting
        • Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Hagenaars, MD
      • Roosendaal, Netherlands, 4708AE
        • Recruiting
        • Stichting Bravis Ziekenhuis
        • Contact:
        • Principal Investigator:
          • Taco van den Ende, MD
      • Rotterdam, Netherlands, 3083AN
      • Veldhoven, Netherlands, 5504DB
        • Recruiting
        • Maxima Medisch Centrum
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esther Dias, MD
      • Zaandam, Netherlands, 1502DV
        • Recruiting
        • Zaans Medisch Centrum
        • Contact:
        • Principal Investigator:
          • Michel Timmerman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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-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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Preoperative care as usual
Patients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting)
Active Comparator: Structured preoperative multidisciplinary team meeting
Patients are discussed preoperatively in a structured preoperative multidisciplinary team meeting
Other: 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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs)
Time Frame: 6 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability status
Time Frame: 12 months
The disability status of the patient, measured by the 12-item WHO disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 results in a metric ranging from 0 to 100 ( where 0 = no disability; 100 = full disability).
12 months
Patient experienced quality of life
Time Frame: 12 months
Quality of life of the patient assessed by the abbreviated World Health Organization Quality of Life (WHOQOL BREF). The WHOQOL BREF results in a percentage of 0 to 100. The higher the percentage (to 100), the better the quality of life of the participant.
12 months
Regret of decision
Time Frame: 12 months

Patients regret of decision measured by a modification of the Decision Regret Scale at 3, 6 and 12 months and qualitative interviews with several patients at 6 months.

The decision regret scale is a 5-item questionnaire, scoring statements 1 (strongly agree) to 5 (strongly disagree). Final scoring consists of reversing the scores of the two negatively phrased items, then taking the mean of the five items. Last, the mean is converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25. A higher score may indicate greater patient regret about their made treatment decisions. The scale was modified by adding a question asking by whom the decision was made. This question is not part of the previously described scoring of the 5-item decision regret scale.
12 months
Societal costs measured by a patient cost questionnaire
Time Frame: 12 months
Societal costs as measured by a cost questionnaire at baseline, 3 and 12 months, including items of the iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) with a recall period of 3 months.
12 months
Hospital costs as a component of societal costs
Time Frame: 12 months
Hospital costs based on electronic medical record (EMR) patient data, as a component of societal costs. Measured at baseline (hospital costs over a period of 3 months prior to preoperative screening) and measured during 12 months follow up.
12 months
Quality-adjusted life years as a component of societal costs
Time Frame: 12 months
Quality-adjusted life years (QALYs) measured by the EQ-5D-5L at baseline, 3 and 12 months, as a component of societal costs.
12 months
Patients' desired outcome
Time Frame: baseline
Patients' desired outcome will be assessed using the Outcome Prioritization Tool (OPT) at baseline (pre-operative assessment).
baseline
Survival
Time Frame: 30 days, 6 months, and 1 year postoperatively
Survival at 30 days, 6 months, and 1 year postoperatively
30 days, 6 months, and 1 year postoperatively
Adverse events
Time Frame: 30 days, 6 months, and 1 year postoperatively
Adverse events at 30 days, 6 months, and 1 year postoperatively
30 days, 6 months, and 1 year postoperatively
Surgical Outcome Risk Tool (SORT)
Time Frame: baseline
Calculating an estimate of the patients' risk of death within 30 days of an operation.
baseline
Revised Cardiac Risk Index for Pre-Operative Risk (RCRI)
Time Frame: baseline
The RCRI estimates patients' risk of cardiac complications after noncardiac surgery. The index is constructed by 6 items. The 6 items are scored yes (+1) or no (0), adding up to a minimum score of 0 and a maximum score of 6. The score is categorised into 4 categories (0, 1, 2, ≥3) and converted to "risk of major cardiac event (95% CI)" defined as death, myocardial infarction, or cardiac arrest at 30 days after noncardiac surgery.
baseline
American College of Surgeons Surgical Risk Calculator (ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program))
Time Frame: baseline
Estimates patients' risk of postoperative complications.
baseline
Clinical Frailty Scale (CFS)
Time Frame: baseline
A judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
baseline
Metabolic Equivalent of Task (MET)
Time Frame: baseline
Reflecting the amount of energy used by the body during physical activity.
baseline
The number of alterations in perioperative management decided by the sMDT.
Time Frame: baseline
The number of alterations in perioperative management decided by the sMDT (19, 20). Examples for alterations are (but not limited to) changes in; type of anaesthesia, type of surgery, planned postoperative intensive care admission, cancellation of surgery, additional medication or diagnostics.
baseline
The nature of alterations in perioperative management decided by the sMDT.
Time Frame: baseline
The nature of alterations in perioperative management decided by the sMDT (19, 20). Examples for alterations are (but not limited to) changes in; type of anaesthesia, type of surgery, planned postoperative intensive care admission, cancellation of surgery, additional medication or diagnostics.
baseline
The number of different medical specialties invited to participate in the sMDT meeting
Time Frame: baseline
The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.
baseline
The number of different medical specialties present during the sMDT meeting
Time Frame: baseline
The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.
baseline
The function of attending professionals at the sMDT meeting.
Time Frame: baseline
The function of attending professionals at the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.
baseline
Number of sMDT discussions per site
Time Frame: through study completion, 3 years
Number of sMDT discussions per site
through study completion, 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of sMDTs using an MDT-Meeting Observational Tool (MDT-MOT)
Time Frame: 6 months
In a subset of patients: Performance of sMDTs using an MDT-Meeting Observational Tool (MDT-MOT).(21) In the MDT-MOT 10 observable teamwork domains are rated on a 5-point rating scale, using descriptive anchors for the extremes and midpoint of the scale. A score of '5' represents optimal effectiveness, calibrated against recommendations within 'The Characteristics of an Effective MDT' (by the National Cancer Action Team). A score of '3' represents effectiveness that exhibits some degree of agreement with the optimum, but not consistently, and a score of '1' represents no or little agreement with the defined optimum. Scores of '2' and '4' are included in the tool but not defined to allow observers the freedom to gradate their assessment.
6 months
Facilitators and barriers to organize preoperative sMDT meetings
Time Frame: 6 months
Facilitators and barriers to organize preoperative sMDT meetings are evaluated using structured interviews with health care professionals from all different medical specialties.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Collaborators

University Medical Center Groningen
Maastricht University Medical Center
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
University of Twente
Amsterdam UMC

Investigators

  • Principal Investigator: Nick J. Koning, MD PhD DESA, Rijnstate hospital
  • Study Director: Jacqueline E. Vernooij, MD, MA, Rijnstate hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-1983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Starting 12 months after publication

IPD Sharing Access Criteria

Data will be made accessible on request after agreement has been received from the entire project group.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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