Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05305053
Other study ID # 2021-1952
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date June 1, 2024

Study information

Verified date June 2024
Source Rijnstate Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 225
Est. completion date June 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers
Gender All
Age group 16 Years to 100 Years
Eligibility Inclusion Criteria: * All patients selected for a Multidisciplinary Team discussion Exclusion Criteria: * No implicit consent given for scientific research

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Netherlands Amsterdam University Medical Centre location VU Amsterdam Zuid Holland
Netherlands Rijnstate Hospital Arnhem Gelderland
Netherlands Gelderse Vallei Ede Gelderland
Netherlands Catharina Ziekenhuis Eindhoven Noord Brabant
Netherlands MC Leeuwarden Leeuwarden Friesland
Netherlands LUMC Leiden Zuid Holland
Netherlands Franciscus Gasthuis Rotterdam Zuid Holland
Netherlands Maasstad Ziekenhuis Rotterdam Zuid Holland
Netherlands UMCU Utrecht

Sponsors (1)

Lead Sponsor Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Attendance of the MDT number of carers present at meeting 1-4-2022 untill 1-10-2022
Primary Decisions made in MDT number of decisions made 01-04-2022 untill 01-010-2022
Primary 12 months postoperative mortality or post MDT number of patients that died within 12 months postoperative or 12 months post MDT 01-04-2022 untill 01-10-2024
Secondary 30 day postoperative mortality or post MDT number of patients that died within 30 days 01-04-2022 untill 01-10-2022
Secondary 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 01-04-2022 untill 01-10-2024
Secondary Hospital admissions at 12 months postoperative or post MDT number of hospital admissions per patient at 12 months postoperative or 12 months post MDT 01-04-2022 untill 01-10-2024
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04992286 - Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04061785 - Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women N/A
Completed NCT04140890 - Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT04888884 - Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
Recruiting NCT04145726 - Frailty In Thoracic Surgery for Esophageal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Not yet recruiting NCT06022666 - PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery. N/A
Not yet recruiting NCT04514536 - Evaluation of a Health Monitoring Platform for Elderly in Home Care Context N/A
Completed NCT01126723 - Effects of Tai Chi on Frailty in Elderly Adults N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Enrolling by invitation NCT05047731 - Antihypertensive Deprescribing in Long-term Care N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03824106 - Frailty Rehabilitation Phase 4
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed NCT04087343 - Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults N/A