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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,200
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?
Stichting Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
RECRUITINGStichting Meander Medisch Centrum
Amersfoort, Netherlands
RECRUITINGStichting OLVG
Amsterdam, Netherlands
RECRUITINGGelre Ziekenhuis
Apeldoorn, Netherlands
RECRUITINGStichting Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
RECRUITINGGroene Hart Ziekenhuis
Gouda, Netherlands
RECRUITINGUniversitair Medisch Centrum Groningen
Groningen, Netherlands
RECRUITINGZuyderland Medisch Centrum
Heerlen, Netherlands
RECRUITINGMaastricht Universitair Medisch Centrum
Maastricht, Netherlands
RECRUITINGStichting Nijmeegs Interconfessioneel Ziekenhuis Canisius Wilhelmina
Nijmegen, Netherlands
RECRUITING...and 4 more locations
Serious Adverse Events (SAEs)
Serious adverse events (SAEs), defined as: 1. Grade 3 or more on the Clavien Dindo classification following surgical intervention, or 2. non-operative SAEs will be graded accordingly i.e., events necessitating hospital admission, surgical intervention, single or multi-organ failure, or death.
Time frame: 6 months
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Patients' desired outcome
Patients' desired outcome will be assessed using the Outcome Prioritization Tool (OPT) at baseline (pre-operative assessment).
Time frame: baseline
Survival
Survival at 30 days, 6 months, and 1 year postoperatively
Time frame: 30 days, 6 months, and 1 year postoperatively
Adverse events
Adverse events at 30 days, 6 months, and 1 year postoperatively
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: baseline
Metabolic Equivalent of Task (MET)
Reflecting the amount of energy used by the body during physical activity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline
Number of sMDT discussions per site
Number of sMDT discussions per site
Time frame: through study completion, 3 years
Rutger J. Spruit, MD
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