2021-1983

About this trial

Last updated 3 years ago

Study ID

2021-1983

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started 3 years ago

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.

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