跳至主要内容
临床试验/NCT03119532
NCT03119532已完成不适用

Investigating Trends in Compliance With Quality Assurance Metrics

University of Michigan0 个研究点目标入组 672 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
672
主要终点
Number of providers with improved compliance (for all clinical providers) with Anesthesia Quality Measures using an email based provider specific feedback system

研究概览

简要总结

Over 40 million major operative procedures are performed in the US annually and comprise about 40% of healthcare expenditures. Despite decades of research, perioperative mortality and morbidity remain a major healthcare system cost and detriment to long-term quality of life. More than ten percent of patients experience a significant event such as surgical site infection, reoperation, myocardial infarction, pulmonary embolus, or death. Nearly 100,000 patients die after surgery each year. National data demonstrate a 3-fold variation in risk adjusted surgical morbidity and mortality, suggesting many opportunities for improvement in perioperative care.

Anesthesiology care demonstrates wide variation in practice. Sometimes, this variation is appropriate because the anesthesiologist is responding to patient comorbidities or procedure specific events. However, even after controlling for patient specific factors, there is a substantial amount of unexplained variation in fundamental elements of anesthesiology care. The same procedure and patient can be performed using completely different anesthetic techniques, hemodynamic management strategies, and medications. This variation in care can lead to a variation in outcome.

The use of electronic health records (EHR) with detailed preoperative and intraoperative data allows an automated system to be developed to notify clinicians their compliance to both process of care metrics and outcome metrics. The Multicenter Perioperative Outcomes Group (MPOG) quality improvement arm is known as Anesthesiology Performance Improvement Reporting Exchange (ASPIRE). Like other Collaborative Quality Initiatives, the primary goal of ASPIRE is to provide hospitals with risk-adjusted feedback on outcome and process of care variation. In addition, ASPIRE creates an active best-practice sharing environment to enable data to spur action. Recent literature has demonstrated that hospital-level feedback may not be adequate to improve performance and clinical outcomes. In addition to hospital level data and feedback, ASPIRE can disseminate provider-specific electronic feedback that may decrease variation in care known to impact complications and cost.

The primary aim for this research study on ASPIRE's QI program is to determine if the investigators can change behavior as measured by a provider's compliance to specific performance metrics. The investigators believe that the start of individual provider performance feedback reports to ASPIRE members presents a unique opportunity to research the efficacy of these novel tools. The investigators propose to test the hypothesis that monthly provider specific feedback emails on ASPIRE quality metrics over a period of 9 months improves provider compliance as measured by a either a 10% improvement in the Total Performance Score or by moving from below to above the 90% performance threshold in the Total Performance Score Index.

Each provider type (faculty, CRNA, resident/fellow) within a hospital participating in ASPIRE will be individually randomized to either receiving the electronic performance improvement email or not for a total of nine months. No individual at the participating site will see the individualized email compliance reports except for the specific provider. Only an aggregate of the compliance across the entire hospital will be supplied to the chairperson and the quality assurance directors. After the completion of the nine month randomization period, all providers will receive monthly ASPIRE performance improvement emails.

The University of Michigan is the coordinating center but also participating in this research on QI project. De-identified patient data will be pulled in aggregate for each provider using the MPOG database. The provider performance for each measure will then be sent from ASPIRE to the randomized care provider via an email. The chairperson and quality assurance directors will only see aggregate data on compliance rates and can NOT identify individual compliance rates. Each participating site will obtain their own institutional IRB to participate in this study.

详细描述

Anesthesiology care demonstrates wide variation in practice. Sometimes, this variation is appropriate because the anesthesiologist is responding to patient comorbidities or procedure specific events. However, even after controlling for patient specific factors, there is a substantial amount of unexplained variation in fundamental elements of anesthesiology care. The same procedure and patient can be performed using completely different anesthetic techniques, hemodynamic management strategies, and medications. This variation in care can lead to a variation in outcome.

  • Hemodynamic Management: Despite expert opinion that blood pressure should be maintained within 20% of baseline, several studies have demonstrated that more than 40% of patients experience profound hypotension in the operating room, defined as systolic blood pressure of 79 mmHg or below. These blood pressure levels have been demonstrated to be associated with acute kidney injury, myocardial ischemia, and death.
  • Intraoperative ventilation strategies: A recent prospective, randomized trial in major abdominal surgery demonstrated that the use of low intraoperative tidal volumes decreases the risk of postoperative pulmonary complications, including pneumonia and reintubation, by more than 50%, with no additional costs or adverse events. The use of large tidal volumes and failure to administer intraoperative recruitment maneuvers is widespread.
  • Neuromuscular blockade (paralysis): The use of intraoperative neuromuscular blockade for many patients undergoing general anesthesia is necessary to optimize surgical conditions and prevent catastrophic injury due to unintended patient movement. However, several trials have now demonstrated that most patients suffer from residual neuromuscular blockade at the conclusion of surgery, resulting in markedly increased risk of postoperative hypoxia, pneumonia, reintubation, and prolonged recovery room stay.
  • Fluid balance: Although fluid administration strategies have been studied in small prospective trials extensively, basic consensus regarding the definition of "liberal" versus "restrictive" intraoperative fluid administration is absent. Prospective randomized controlled trials of restrictive fluid administration combined with vasopressor administration in major abdominal cases have demonstrated markedly reduced complications and length of stay.
  • Fluid choice: The use of colloid fluid therapy has been demonstrated to increase costs without an improvement in outcomes, yet there are no signs that the use of albumin or synthetic colloids has decreased. In addition, despite overwhelming evidence that discretionary transfusion of red blood cells above a hemoglobin of 10 mg/dl is rarely indicated, recent data demonstrate its continued occurrence in many perioperative patients.

The use of electronic health records (EHR) with detailed preoperative and intraoperative data allows an automated system to be developed to notify clinicians their compliance to both process of care metrics and outcome metrics. The primary goal of ASPIRE is to provide hospitals with confidential risk-adjusted feedback on outcome and process of care variation. In addition, ASPIRE creates an active best-practice sharing environment to enable data to spur action.

Recent literature has demonstrated that hospital-level feedback may not be adequate to improve performance and clinical outcomes. In addition to hospital level data and feedback, ASPIRE can disseminate provider-specific feedback that may decrease variation in care known to impact complications and cost. ASPIRE uses the underlying EHR data integration foundation of the Multicenter Perioperative Outcomes Group to aggregate and analyze process of care and outcome data.

To date, there is no anesthesia standard for quality improvement practice regarding provider-specific feedback. The primary aim of this research study on ASPIRE's QI program is to determine whether provider-specific feedback affects quality improvement performance metrics. The investigators believe that the start of individual provider performance feedback reports to ASPIRE members presents a unique opportunity to evaluate the efficacy of these tools.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Hospitals currently participating in ASPIRE (https://www.aspirecqi.org/)
  • Quality assurance champion and chairperson have decided to participate in this quality assurance project.

排除标准

  • Hospitals not currently participating in ASPIRE

结局指标

主要结局

Number of providers with improved compliance (for all clinical providers) with Anesthesia Quality Measures using an email based provider specific feedback system

时间窗: 9 months

Investigating improved bundle compliance for all providers where all anesthesia care providers at the given institution were randomized to receive emails (attending/residents/CRNAs).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nirav Shah

Assistant Professor

University of Michigan

相似试验