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Interdisciplinary CommunicationPREPARATIONNCT05703230

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

A study testing Structured preoperative multidisciplinary team meeting in people with Interdisciplinary Communication and Postoperative Complications, run by Rijnstate Hospital at 14 sites in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Structured preoperative multidisciplinary team meeting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
14 sitesNetherlands
Study dates
1 Nov 2022to Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Netherlands14 sites
  • Stichting Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223GZ

  • Stichting Meander Medisch Centrum

    Amersfoort, 3817TZ

  • Stichting OLVG

    Amsterdam, 1091

  • Gelre Ziekenhuis

    Apeldoorn, 7334DZ

  • Stichting Albert Schweitzer Ziekenhuis

    Dordrecht, 3318AT

  • Groene Hart Ziekenhuis

    Gouda, 2803HH

  • Universitair Medisch Centrum Groningen

    Groningen, 9713GZ

  • Zuyderland Medisch Centrum

    Heerlen, 6419PC

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229HX

  • Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina

    Nijmegen, 6532SZ

  • Stichting Bravis Ziekenhuis

    Roosendaal, 4708AE

  • Stichting Protestants Christelijk Ziekenhuis Ikazia

    Rotterdam, 3083AN

  • Maxima Medisch Centrum

    Veldhoven, 5504DB

  • Zaans Medisch Centrum

    Zaandam, 1502DV

Other trials in Netherlands

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Structured preoperative multidisciplinary team meeting
Keywords
multidisciplinary team meeting, preoperative, high risk surgical patients
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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?
Study groups in NCT05703230
Study groupRoleWhat they receive
Preoperative care as usualNo interventionPatients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting)
Structured preoperative multidisciplinary team meetingActive comparatorPatients are discussed preoperatively in a structured preoperative multidisciplinary team meeting
Receives: Other: Structured preoperative multidisciplinary team meeting

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (20)
  1. Disability status

    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).

    Measured: 12 months

  2. Patient experienced quality of life

    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.

    Measured: 12 months

  3. Regret of decision

    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.

    Measured: 12 months

  4. Societal costs measured by a patient cost questionnaire

    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.

    Measured: 12 months

  5. Hospital costs as a component of societal costs

    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.

    Measured: 12 months

  6. Quality-adjusted life years as a component of societal costs

    Quality-adjusted life years (QALYs) measured by the EQ-5D-5L at baseline, 3 and 12 months, as a component of societal costs.

    Measured: 12 months

  7. Patients' desired outcome

    Patients' desired outcome will be assessed using the Outcome Prioritization Tool (OPT) at baseline (pre-operative assessment).

    Measured: baseline

  8. Survival

    Survival at 30 days, 6 months, and 1 year postoperatively

    Measured: 30 days, 6 months, and 1 year postoperatively

  9. Adverse events

    Adverse events at 30 days, 6 months, and 1 year postoperatively

    Measured: 30 days, 6 months, and 1 year postoperatively

  10. Surgical Outcome Risk Tool (SORT)

    Calculating an estimate of the patients' risk of death within 30 days of an operation.

    Measured: baseline

  11. Revised Cardiac Risk Index for Pre-Operative Risk (RCRI)

    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.

    Measured: baseline

  12. American College of Surgeons Surgical Risk Calculator (ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program))

    Estimates patients' risk of postoperative complications.

    Measured: baseline

  13. Clinical Frailty Scale (CFS)

    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).

    Measured: baseline

  14. Metabolic Equivalent of Task (MET)

    Reflecting the amount of energy used by the body during physical activity.

    Measured: baseline

  15. The number of alterations in perioperative management decided by the sMDT.

    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.

    Measured: baseline

  16. The nature of alterations in perioperative management decided by the sMDT.

    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.

    Measured: baseline

  17. The number of different medical specialties invited to participate in the sMDT meeting

    The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.

    Measured: baseline

  18. The number of different medical specialties present during the sMDT meeting

    The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.

    Measured: baseline

  19. The function of attending professionals at the sMDT meeting.

    The function of attending professionals at the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings.

    Measured: baseline

  20. Number of sMDT discussions per site

    Number of sMDT discussions per site

    Measured: through study completion, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 Nov 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Sequential
Model description
cross-sectional stepped wedge cluster randomized trial
Masking
None (open label)
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703230
Sponsor's protocol ID
2021-1983
Acronym
PREPARATION
Status last verified
Feb 2026
First submitted
4 Nov 2022
Last updated
25 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 37821994
  • 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.

    PubMed 40480911

Questions about this trial

What is this clinical trial studying?

A study testing Structured preoperative multidisciplinary team meeting in people with Interdisciplinary Communication and Postoperative Complications, run by Rijnstate Hospital at 14 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (SAEs) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703230, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.

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