Is a Preoperative Multidisciplinary Team Meeting (Cost) Effective in Optimizing Noncardiac Surgical Patient Management: The PREPARATION Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
- 试验地点
- 14
- 主要终点
- Serious Adverse Events (SAEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Preoperative care as usual
Patients undergoing preoperative care as usual, which does not include a structured preoperative multidisciplinary team meeting (no sMDT meeting)
Structured preoperative multidisciplinary team meeting
Patients are discussed preoperatively in a structured preoperative multidisciplinary team meeting
干预措施: Structured preoperative multidisciplinary team meeting (Other)
结局指标
主要结局
Serious Adverse Events (SAEs)
时间窗: 6 months
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.
次要结局
- Hospital costs as a component of societal costs(12 months)
- American College of Surgeons Surgical Risk Calculator (ACS-NSQIP (American College of Surgeons National Surgical Quality Improvement Program))(baseline)
- The number of different medical specialties present during the sMDT meeting(baseline)
- Quality-adjusted life years as a component of societal costs(12 months)
- Patients' desired outcome(baseline)
- Societal costs measured by a patient cost questionnaire(12 months)
- Regret of decision(12 months)
- Disability status(12 months)
- Patient experienced quality of life(12 months)
- Survival(30 days, 6 months, and 1 year postoperatively)
- Adverse events(30 days, 6 months, and 1 year postoperatively)
- The number of different medical specialties invited to participate in the sMDT meeting(baseline)
- Surgical Outcome Risk Tool (SORT)(baseline)
- Revised Cardiac Risk Index for Pre-Operative Risk (RCRI)(baseline)
- Clinical Frailty Scale (CFS)(baseline)
- The number of alterations in perioperative management decided by the sMDT.(baseline)
- Metabolic Equivalent of Task (MET)(baseline)
- The nature of alterations in perioperative management decided by the sMDT.(baseline)
- The function of attending professionals at the sMDT meeting.(baseline)
- Number of sMDT discussions per site(through study completion, 3 years)