Preoperative team meetings for high-risk surgical patients

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

This study is testing if special team meetings before surgery can help high-risk patients avoid serious complications and improve their recovery compared to regular care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rijnstate Hospital (other)
• Locations: 14 sites ('s-Hertogenbosch and 13 other locations)
• Trial ID: NCT05703230 on ClinicalTrials.gov

What this trial studies

This multicenter trial evaluates the effectiveness of structured preoperative multidisciplinary team (sMDT) meetings for high-risk noncardiac surgical patients. The study aims to determine if these meetings can reduce serious postoperative complications and improve patient outcomes, including quality of life and functional status, compared to standard care. Participants will be involved in discussions about their treatment plans, and their progress will be assessed through questionnaires over a six-month period. The trial includes 14 participating centers and focuses on optimizing perioperative management for complex patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a high American Society of Anesthesiology Physical Status score and Clinical Frailty Scale score, scheduled for elective or semi-elective noncardiac surgery.

Not a fit: Patients requiring emergency surgery or those for whom a similar preoperative team meeting already exists at their hospital may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve the overall quality of life for high-risk surgical patients.

How similar studies have performed: While the concept of preoperative multidisciplinary team meetings is recommended in guidelines, this study is novel in its systematic evaluation of their effectiveness in high-risk noncardiac surgical patients.

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

Where this trial is running

's-Hertogenbosch and 13 other locations

• Stichting Jeroen Bosch Ziekenhuis — 's-Hertogenbosch, Netherlands (RECRUITING)
• Stichting Meander Medisch Centrum — Amersfoort, Netherlands (RECRUITING)
• Stichting OLVG — Amsterdam, Netherlands (RECRUITING)
• Gelre Ziekenhuis — Apeldoorn, Netherlands (RECRUITING)
• Stichting Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (RECRUITING)
• Groene Hart Ziekenhuis — Gouda, Netherlands (RECRUITING)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands (RECRUITING)
• Zuyderland Medisch Centrum — Heerlen, Netherlands (RECRUITING)
• Maastricht Universitair Medisch Centrum — Maastricht, Netherlands (RECRUITING)
• Stichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina — Nijmegen, Netherlands (RECRUITING)
• Stichting Bravis Ziekenhuis — Roosendaal, Netherlands (RECRUITING)
• Stichting Protestants Christelijk Ziekenhuis Ikazia — Rotterdam, Netherlands (RECRUITING)
• Maxima Medisch Centrum — Veldhoven, Netherlands (RECRUITING)
• Zaans Medisch Centrum — Zaandam, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Nick J. Koning, MD PhD DESA — Rijnstate Hospital
• Study coordinator: Romijn M. Boerlage, MD

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