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.
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
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.
- Conditions
- Pre-operative, High-risk Patient, Frailty
- 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 group | Role | What they receive |
|---|---|---|
| high-risk noncardiac surgery patients for preoperative Multidisciplinary Team (MDT) discussion | observation 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.
Attendance of the MDT
number of carers present at meeting
Measured: 1-4-2022 untill 1-10-2022
Decisions made in MDT
number of decisions made
Measured: 01-04-2022 untill 01-010-2022
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)
30 day postoperative mortality or post MDT
number of patients that died within 30 days
Measured: 01-04-2022 untill 01-10-2022
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
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.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-operativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Vernooij, Rijnstate Hospital
- Investigators
- Jacqueline M Vernooij, MD, Principal investigator, Rijnstate
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Variation in Preoperative Multidisciplinary Team Discussions for High-risk Noncardiac Surgical Patients in the Netherlands: A Multicenter Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05305053
- Acronym / sponsor ID
- 2021-1952
- Conditions
- Pre-operative, High-risk Patient, Frailty
- Keywords
- high-risk;, preoperative risk prediction, perioperative mortality, Multidisciplinary Team meeting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-risk noncardiac surgery patients for preoperative Multidisciplinary Team (MDT) discussion | – | Other: preoperative MDT discussionobservation of MDT in 11 hospitals |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All high risk noncardiac surgical patients selected for a preoperative MDT discussion.
Key inclusion criteria (1 listed)
- All patients selected for a Multidisciplinary Team discussion
Key exclusion criteria (1 listed)
- No implicit consent given for scientific research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preoperative MDT discussionhigh-risk patients are subjected to an MDT discussion among care providers | Other | high-risk noncardiac surgery patients for preoperative Multidisciplinary Team (MDT) discussion |
Primary outcome
Attendance of the MDT
Time frame: 1-4-2022 untill 1-10-2022
number of carers present at meeting
Decisions made in MDT
Time frame: 01-04-2022 untill 01-010-2022
number of decisions made
12 months postoperative mortality or post MDT
Time frame: 01-04-2022 untill 01-10-2024
number of patients that died within 12 months postoperative or 12 months post MDT
3 secondary outcomes
30 day postoperative mortality or post MDT
Time frame: 01-04-2022 untill 01-10-2022
Serious adverse events at 12 months postoperative or post MDT
Time frame: 01-04-2022 untill 01-10-2024
Hospital admissions at 12 months postoperative or post MDT
Time frame: 01-04-2022 untill 01-10-2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Related trials for Pre-operative
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
RecruitingPhase 2/3
Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer
Renal Pelvis and Ureter Urothelial Carcinoma
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline M Vernooij, MD principal investigator
Rijnstate
9 sites in 1 country: see every site and its status.
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.