Clinical trial NCT05703230: Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients
Official title: Is a Preoperative Multidisciplinary Team Meeting (Cost) Effective in Optimizing Noncardiac Surgical Patient Management: The PREPARATION Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interdisciplinary Communication
Postoperative Complications
Noncardiac Surgery
Surgical Procedures, Operative
Preoperative Care
Patient Care Team
Cost-Benefit Analysis
Comorbidities and Coexisting Conditions
Keywords: multidisciplinary team meeting
preoperative
high risk surgical patients
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Amsterdam UMC
name: University of Twente
name: University Medical Center Groningen
name: Maastricht University Medical Center
name: Leiden University Medical Center
First posted: 2023-01-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: cross-sectional stepped wedge cluster randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

The main questions to answer are:

* 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Serious Adverse Events (SAEs)
timeFrame: 6 months
Secondary outcomes:
measure: Disability status
timeFrame: 12 months
measure: Patient experienced quality of life
timeFrame: 12 months
measure: Regret of decision
timeFrame: 12 months
measure: Societal costs measured by a patient cost questionnaire
timeFrame: 12 months
measure: Hospital costs as a component of societal costs
timeFrame: 12 months
measure: Quality-adjusted life years as a component of societal costs
timeFrame: 12 months
measure: Patients' desired outcome
timeFrame: baseline
measure: Survival
timeFrame: 30 days, 6 months, and 1 year postoperatively
measure: Adverse events
timeFrame: 30 days, 6 months, and 1 year postoperatively
measure: Surgical Outcome Risk Tool (SORT)
timeFrame: baseline
measure: Revised Cardiac Risk Index for Pre-Operative Risk (RCRI)
timeFrame: baseline
measure: American College of Surgeons Surgical Risk Calculator (ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program))
timeFrame: baseline
measure: Clinical Frailty Scale (CFS)
timeFrame: baseline
measure: Metabolic Equivalent of Task (MET)
timeFrame: baseline
measure: The number of alterations in perioperative management decided by the sMDT.
timeFrame: baseline
measure: The nature of alterations in perioperative management decided by the sMDT.
timeFrame: baseline
measure: The number of different medical specialties invited to participate in the sMDT meeting
timeFrame: baseline
measure: The number of different medical specialties present during the sMDT meeting
timeFrame: baseline
measure: The function of attending professionals at the sMDT meeting.
timeFrame: baseline
measure: Number of sMDT discussions per site
timeFrame: through study completion, 3 years
Other outcomes:
measure: Performance of sMDTs using an MDT-Meeting Observational Tool (MDT-MOT)
timeFrame: 6 months
measure: Facilitators and barriers to organize preoperative sMDT meetings
timeFrame: 6 months
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Stichting Jeroen Bosch Ziekenhuis
city: Amersfoort
country: Netherlands
facility: Stichting Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Stichting OLVG
city: Apeldoorn
country: Netherlands
facility: Gelre Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Stichting Albert Schweitzer Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Maastricht
country: Netherlands
facility: Maastricht Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina
city: Roosendaal
country: Netherlands
facility: Stichting Bravis Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Stichting Protestants Christelijk Ziekenhuis Ikazia
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
Study officials:
affiliation: Rijnstate Hospital
name: Nick J. Koning, MD PhD DESA
role: PRINCIPAL_INVESTIGATOR
affiliation: Rijnstate Hospital
name: Jacqueline E. Vernooij, MD, MA
role: STUDY_DIRECTOR
References: