- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05305053
Practice Variation in Preoperative Multidisciplinary Team Discussions
Practice Variation in Preoperative Multidisciplinary Team Discussions for High-risk Noncardiac Surgical Patients in the Netherlands: A Multicenter Prospective Observational Study.
Study Overview
Status
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 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 mortality postoperatively or post MDT discussion; calculated risks; differences in high-risk patient identification and the relation between calculated risks and outcome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Jacqueline Elisabeth M Vernooij
- Phone Number: +31653898910
- Email: jvernooij@rijnstate.nl
Study Contact Backup
- Name: Nick Koning
- Phone Number: +31637308320
- Email: nkoning@rijnstate.nl
Study Locations
-
-
-
Utrecht, Netherlands
- UMCU
-
-
Friesland
-
Leeuwarden, Friesland, Netherlands
- MC Leeuwarden
-
-
Gelderland
-
Arnhem, Gelderland, Netherlands, 6800 TA
- Rijnstate Hospital
-
Ede, Gelderland, Netherlands, 6716RP
- Gelderse Vallei
-
-
Noord Brabant
-
Eindhoven, Noord Brabant, Netherlands
- Catharina Ziekenhuis
-
-
Zuid Holland
-
Amsterdam, Zuid Holland, Netherlands, 1081HV
- Amsterdam University Medical Centre location VU
-
Leiden, Zuid Holland, Netherlands
- LUMC
-
Rotterdam, Zuid Holland, Netherlands, 3079DZ
- Maasstad Ziekenhuis
-
Rotterdam, Zuid Holland, Netherlands
- Franciscus Gasthuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
* All patients selected for a Multidisciplinary Team discussion
Exclusion Criteria:
* No implicit consent given for scientific research
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
high-risk noncardiac surgery patients for preoperative Multidisciplinary Team (MDT) discussion
observation of MDT in 11 hospitals
|
high-risk patients are subjected to an MDT discussion among care providers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attendance of the MDT
Time Frame: 1-4-2022 untill 1-10-2022
|
number of carers present at meeting
|
1-4-2022 untill 1-10-2022
|
Decisions made in MDT
Time Frame: 01-04-2022 untill 01-010-2022
|
number of decisions made
|
01-04-2022 untill 01-010-2022
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30 day postoperative mortality or post MDT
Time Frame: 01-04-2022 untill 01-10-2022
|
number of patients that died within 30 days
|
01-04-2022 untill 01-10-2022
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacqueline M Vernooij, MD, Rijnstate
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-1952
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
Instituto Tecnologico y de Estudios Superiores...Not yet recruiting
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
Longeveron Inc.CompletedAging FrailtyUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Xijing HospitalUnknownFrailty SyndromeChina
-
Region ZealandUniversity of Southern DenmarkActive, not recruitingFrailty SyndromeDenmark
-
Neurological Associates of West Los AngelesEnrolling by invitation
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
Clinical Trials on preoperative MDT discussion
-
Peking University People's HospitalPeking UniversityRecruitingColorectal Neoplasms | OrganoidsChina
-
MicroDose Therapeutx, IncCompletedRespiratory Syncytial Virus Infections | Drug SafetyUnited States
-
MicroDose Therapeutx, IncCompleted
-
Medtronic Spinal and BiologicsWithdrawnPost-operation PainUnited States
-
MicroDose Therapeutx, IncCompletedDrug SafetyUnited States
-
Medtronic Spinal and BiologicsCompletedSciatica | Lumbosacral RadiculopathyUnited States
-
University of California, MercedCompletedParents of Children Ages 10 to 17 Years OldUnited States
-
Centers for Disease Control and PreventionCompletedHIV InfectionsUnited States
-
Medtronic CardiovascularCompletedAortic Valve StenosisJapan
-
Medtronic CardiovascularCompletedAortic Valve StenosisJapan