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

Rijnstate Hospital

Status

Enrolling

Conditions

Postoperative Complications

Surgical Procedures, Operative

Interdisciplinary Communication

Cost-Benefit Analysis

Preoperative Care

Noncardiac Surgery

Comorbidities and Coexisting Conditions

Patient Care Team

Treatments

Other: Structured preoperative multidisciplinary team meeting

Study type

Interventional

Funder types

Other

Identifiers

NCT05703230

2021-1983

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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