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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Other: Structured preoperative multidisciplinary team meeting


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: cross-sectional stepped wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Preoperative care as usual<br>Patients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting) | |
| Active Comparator: Structured preoperative multidisciplinary team meeting<br>Patients are discussed preoperatively in a structured preoperative multidisciplinary team meeting | Other: Structured preoperative multidisciplinary team meeting<br>* The intervention to be investigated is the introduction of a preoperative structured multidisciplinary team (sMDT) meeting for high risk noncardiac surgical patients, which is attended by at least the treating surgical specialist, an anesthesiologist and another medical consultant with expertise relevant for the patients comorbidities and preferences. In the preoperative sMDT meeting, at least the following questions will be discussed as recommended by the Dutch Perioperative Guideline: Is the proposed surgical intervention appropriate care for the patient? Is the risk/benefit ratio of the proposed surgical intervention acceptable for the patient? Should the patient's condition be optimized before undergoing the proposed surgical intervention?<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events (SAEs) | Serious adverse events (SAEs), defined as: Grade 3 or more on the Clavien Dindo classification following surgical intervention, or non-operative SAEs will be graded accordingly i.e., events necessitating hospital admission, surgical intervention, single or multi-organ failure, or death. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability status | The disability status of the patient, measured by the 12-item WHO disability Assessment Schedule 2.0 (WHODAS 2.0). The WHODAS 2.0 results in a metric ranging from 0 to 100 ( where 0 = no disability; 100 = full disability). | 12 months | 
| Patient experienced quality of life | Quality of life of the patient assessed by the abbreviated World Health Organization Quality of Life (WHOQOL BREF). The WHOQOL BREF results in a percentage of 0 to 100. The higher the percentage (to 100), the better the quality of life of the participant. | 12 months | 
| Regret of decision | Patients regret of decision measured by a modification of the Decision Regret Scale at 3, 6 and 12 months and qualitative interviews with several patients at 6 months. The decision regret scale is a 5-item questionnaire, scoring statements 1 (strongly agree) to 5 (strongly disagree). Final scoring consists of reversing the scores of the two negatively phrased items, then taking the mean of the five items. Last, the mean is converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25. A higher score may indicate greater patient regret about their made treatment decisions. The scale was modified by adding a question asking by whom the decision was made. This question is not part of the previously described scoring of the 5-item decision regret scale. | 12 months | 
| Societal costs measured by a patient cost questionnaire | Societal costs as measured by a cost questionnaire at baseline, 3 and 12 months, including items of the iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire (iMCQ) and iMTA Productivity Cost Questionnaire (iPCQ) with a recall period of 3 months. | 12 months | 
| Hospital costs as a component of societal costs | Hospital costs based on electronic medical record (EMR) patient data, as a component of societal costs. Measured at baseline (hospital costs over a period of 3 months prior to preoperative screening) and measured during 12 months follow up. | 12 months | 
| Quality-adjusted life years as a component of societal costs | Quality-adjusted life years (QALYs) measured by the EQ-5D-5L at baseline, 3 and 12 months, as a component of societal costs. | 12 months | 
| Patients' desired outcome | Patients' desired outcome will be assessed using the Outcome Prioritization Tool (OPT) at baseline (pre-operative assessment). | baseline | 
| Survival | Survival at 30 days, 6 months, and 1 year postoperatively | 30 days, 6 months, and 1 year postoperatively | 
| Adverse events | Adverse events at 30 days, 6 months, and 1 year postoperatively | 30 days, 6 months, and 1 year postoperatively | 
| Surgical Outcome Risk Tool (SORT) | Calculating an estimate of the patients' risk of death within 30 days of an operation. | baseline | 
| Revised Cardiac Risk Index for Pre-Operative Risk (RCRI) | The RCRI estimates patients' risk of cardiac complications after noncardiac surgery. The index is constructed by 6 items. The 6 items are scored yes (+1) or no (0), adding up to a minimum score of 0 and a maximum score of 6. The score is categorised into 4 categories (0, 1, 2, ≥3) and converted to risk of major cardiac event (95% CI) defined as death, myocardial infarction, or cardiac arrest at 30 days after noncardiac surgery. | baseline | 
| American College of Surgeons Surgical Risk Calculator (ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program)) | Estimates patients' risk of postoperative complications. | baseline | 
| Clinical Frailty Scale (CFS) | A judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). | baseline | 
| Metabolic Equivalent of Task (MET) | Reflecting the amount of energy used by the body during physical activity. | baseline | 
| The number of alterations in perioperative management decided by the sMDT. | The number of alterations in perioperative management decided by the sMDT (19, 20). Examples for alterations are (but not limited to) changes in; type of anaesthesia, type of surgery, planned postoperative intensive care admission, cancellation of surgery, additional medication or diagnostics. | baseline | 
| The nature of alterations in perioperative management decided by the sMDT. | The nature of alterations in perioperative management decided by the sMDT (19, 20). Examples for alterations are (but not limited to) changes in; type of anaesthesia, type of surgery, planned postoperative intensive care admission, cancellation of surgery, additional medication or diagnostics. | baseline | 
| The number of different medical specialties invited to participate in the sMDT meeting | The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings. | baseline | 
| The number of different medical specialties present during the sMDT meeting | The number of different medical specialties present during the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings. | baseline | 
| The function of attending professionals at the sMDT meeting. | The function of attending professionals at the sMDT meeting in order to describe the multidisciplinary attendance of the sMDT meetings. | baseline | 
| Number of sMDT discussions per site | Number of sMDT discussions per site | through study completion, 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multidisciplinary team meeting, preoperative, high risk surgical patients