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Pre-operativeNCT05305053

Practice Variation in Preoperative Multidisciplinary Team Discussions

An observational study of Pre-operative and High-risk Patient, run by Rijnstate Hospital at 9 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Preoperative multidisciplinary team (MDT)discussions are recommended by national and international guidelines. However, no guidance is given on how to organise and execute an MDT discussion. The objective of this study is to describe the methods used for preoperative MDT discussion executed in the Netherlands. Read more about this study

Who is it for?
Ages 16 to 100 years
Conditions the study is for
Pre-operative, High-risk Patient, Frailty
What is being tested?
preoperative MDT discussion
How many people
225 participants
Where
9 sitesNetherlands
Study dates
1 Apr 2022to 1 Jun 2024
Phase
Observational
Are there results?
None posted in the registry

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 16 to 100 years
  • All sexes
  • Child, Adult, Older adult

Study population: All high risk noncardiac surgical patients selected for a preoperative MDT discussion.

Who may be able to join

  • All patients selected for a Multidisciplinary Team discussion

Who cannot join

  • No implicit consent given for scientific research

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Netherlands9 sites
  • Amsterdam University Medical Centre location VU

    Amsterdam, South Holland, 1081HV

  • Rijnstate Hospital

    Arnhem, Gelderland, 6800 TA

  • Gelderse Vallei

    Ede, Gelderland, 6716RP

  • Catharina Ziekenhuis

    Eindhoven, North Brabant

  • MC Leeuwarden

    Leeuwarden, Provincie Friesland

  • LUMC

    Leiden, South Holland

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3079DZ

  • Franciscus Gasthuis

    Rotterdam, South Holland

  • UMCU

    Utrecht

Other trials in Netherlands

About this study

Official title: Practice Variation in Preoperative Multidisciplinary Team Discussions for High-risk Noncardiac Surgical Patients in the Netherlands: A Multicenter Prospective Observational Study.

Preoperative multidisciplinary team (MDT)discussions are recommended by national and international guidelines. However, no guidance is given on how to organise and execute an MDT discussion. The objective of this study is to describe the methods used for preoperative MDT discussion executed in the Netherlands.

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 surgery increases. Surgical treatment is often the optimal treatment to improve survival, but it is important for high-risk patients, to balance the potential benefits of treatment against the risk of potential permanent loss of functional capacity and quality of life. Multidisciplinary Team (MDT) meetings may be a sophisticated solution to discuss the harm-benefit ratio between different caregivers. There are currently no randomized studies comparing preoperative MDT meetings for high-risk non-cardiac surgery patients with no preoperative MDTs. In observational studies, the preoperative MDT altered medical treatment and management in more than 80% of patients, including 13-36% of patients who, after MDT, did not undergo the planned surgical procedure.(1, 2) The implementation of a preoperative MDT for frail patients scheduled for colorectal surgery was associated with a statistically nonsignificant reduction in severe postoperative complications from 33% to 22% of patients or up to 25% changes in care management.(1, 3) In a retrospective study Sroka found that for 36% of the discussed, high-risk cancer patients the case was risk prohibitive. The retrospective study by Vernooij et al. showed that only 27% of discussed patients received care as planned.(4) In cancer care, extensive experience exists with MDT meetings also known as tumor boards. The introduction of MDTs has impacted patient treatment in oncology. However, these tumor boards may be hindered by an excessive caseload and time pressure(5) which may limit a positive effect of MDT meetings on patient outcome.(6) A preoperative MDT may therefore complement these tumor boards since only the high-risk cases are selected for discussion and medical consultants are invited based specifically on the patients' comorbidities.

Several international guidelines have recommended MDT discussions for high-risk patients but they are not widely implemented yet. (7-9) Not executing preoperative MDT meetings may be a consequence of the fact that objective evidence for the value of the preoperative MDT meetings for high-risk, noncardiac patients is practically nonexistent. Also, no guidance exists on how best to organize an MDT meeting. Sroka proposes a protocol for the identification and multidisciplinary discussion of predefined high-risk patients.(2) In the current multicenter observational study in the Netherlands, the aim is to document how preoperative MDT meetings for high-risk non-cardiac surgery patients are executed. For the hospitals where MDT meetings are executed, considerable practice variation between hospitals may exist concerning performing and organizing MDT meetings. The practice variation may exist regarding patient selection, MDT meeting organization and attendance, MDT discussions, decisions made and, lastly, regarding nonsurgical management.

The first objective of this study is to describe the practice variation in executing preoperative MDT meetings in the presence of an anesthesiologist. The research question is: How much and what kind of variation exists in execution of preoperative MDT meetings for high-risk non-cardiac surgical patients. Secondary objectives are: what is the frequency of care management changes ordered by an MDT discussion; how do these changes affect outcome of the patients measured by the frequency of Serious adverse events; 30 day, 3 months and 12 months mortality postoperatively or post MDT discussion; calculated risks; differences in high-risk patient identification and the relation between calculated risks and outcome.

Being tested
preoperative MDT discussion
Keywords
high-risk;, preoperative risk prediction, perioperative mortality, Multidisciplinary Team meeting
Medical subject headings
Frailty

What participants receive

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

  • preoperative MDT discussionOther

    high-risk patients are subjected to an MDT discussion among care providers

Study groups in NCT05305053
Study groupRoleWhat they receive
high-risk noncardiac surgery patients for preoperative Multidisciplinary Team (MDT) discussionobservation of MDT in 11 hospitals
Receives: Other: preoperative MDT discussion

What is being measured

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

  1. Attendance of the MDT

    number of carers present at meeting

    Measured: 1-4-2022 untill 1-10-2022

  2. Decisions made in MDT

    number of decisions made

    Measured: 01-04-2022 untill 01-010-2022

  3. 12 months postoperative mortality or post MDT

    number of patients that died within 12 months postoperative or 12 months post MDT

    Measured: 01-04-2022 untill 01-10-2024

Secondary outcomes (3)
  1. 30 day postoperative mortality or post MDT

    number of patients that died within 30 days

    Measured: 01-04-2022 untill 01-10-2022

  2. Serious adverse events at 12 months postoperative or post MDT

    number of serious adverse events per patient at 12 months postoperative or 12 months post MDT classified by the Clavien Dindo Classification

    Measured: 01-04-2022 untill 01-10-2024

  3. Hospital admissions at 12 months postoperative or post MDT

    number of hospital admissions per patient at 12 months postoperative or 12 months post MDT

    Measured: 01-04-2022 untill 01-10-2024

Timeline

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

  1. First posted31 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Jun 2024
  4. Study completion1 Jun 2024

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305053
Sponsor's protocol ID
2021-1952
Status last verified
Jun 2024
First submitted
18 Jan 2022
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pre-operative and High-risk Patient, run by Rijnstate Hospital at 9 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Attendance of the MDT (time frame: 1-4-2022 untill 1-10-2022). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Jun 2024.

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