Effects of Preoperative Multidisciplinary Team Meetings for High-risk, Adult, Noncardiac Surgical Patients — PREPARATION  

Postoperative Complications Clinical Trial

Official title: Is a Preoperative Multidisciplinary Team Meeting (Cost) Effective in Optimizing Noncardiac Surgical Patient Management: The PREPARATION Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Comorbidities and Coexisting Conditions
• Cost-Benefit Analysis
• Interdisciplinary Communication
• Noncardiac Surgery
• Patient Care Team
• Postoperative Complications
• Preoperative Care
• Surgical Procedures, Operative

• NCT number: NCT05703230
• Study type: Interventional
• Source: Rijnstate Hospital
• Contact: Romijn M. Boerlage, MD
• Phone: +3188 005 8833
• Email: preparation@rijnstate.nl
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Completion date: October 31, 2025