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Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery:

2016年3月8日 更新者:Norton Leatherman Spine Center

Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery: A Cost-effectiveness Study Using Activity-based Costing

Two recent studies showed that having two attending spine surgeons performing complex adult spine deformity surgery instead of one, decreased complications, unplanned surgeries within 30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein thrombosis and post-operative neurologic complications [Sethi]. However, both studies were retrospective and did not evaluate any cost-savings associated with having two spine surgeons instead of one performing complex spine deformity surgery.

Most cost-effectiveness studies have used traditional accounting (TA) methods to determine costs. A few cost-effectiveness studies have used time-driven activity-based costing (TDABC) [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery.

Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce downstream costs compared to a single spine attending for complex spine surgeries using traditional accounting methods; and (2) to demonstrate an application of the TDABC method to evaluate the operating room phase during complex adult spinal deformity surgery and compare it to traditional accounting methods (TA).

研究概览

详细说明

Two recent studies showed that having two attending spine surgeons performing complex adult spine deformity surgery instead of one, decreased complications, unplanned surgeries within 30-days [Ames], 90-day readmissions, wound infection, pulmonary embolism/deep vein thrombosis and post-operative neurologic complications [Sethi]. However, both studies were retrospective and did not evaluate any cost-savings associated with having two spine surgeons instead of one performing complex spine deformity surgery. With increasing scrutiny on the efficient use of health care dollars, it would be important to determine if there are any downstream cost savings to justify paying the surgeon fees of two spine attendings for these complex and high cost cases.

Most cost-effectiveness studies have used traditional accounting (TA) methods to determine costs. TA uses allocated expenses from the general ledger and payroll activity codes. These codes are derived from billable items and procedures entered into accounting software. Costs of services are grouped by cost types, across units of service.

A few cost-effectiveness studies have used time-driven activity-based costing (TDABC) [Kaplan] in medicine [Au, Balakrishnan] and none in spine surgery. TDABC allows for detailed identification of costs during all phases of a patient's care cycle. While TDABC has been used in other industries, its use has been described only a few times in health care and rarely in the operative setting [Balakrishnan]. This may be due to the large amount of manpower necessary to collect TDABC data.

Objectives: The objectives of the study are (1) to determine if dual spine attendings reduce downstream costs compared to a single spine attending for complex spine surgeries using traditional accounting methods; and (2) to demonstrate an application of the TDABC method to evaluate the operating room phase during complex adult spinal deformity surgery and compare it to traditional accounting methods (TA).

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Norton Leatherman Spine Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

25年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Patients scheduled for a complex spine adult deformity surgery.

    1. instrumented posterior fusion from the thoracic spine into the pelvis, S1 or iliac wings;
    2. and/or any three-column posterior osteotomy, either a pedicle subtraction osteotomy or a vertebral column resection.
  2. Is at least 25 years of age inclusive at time of surgery.
  3. Is willing and able to comply with the study plan and sign the Patient Informed Consent Form

Exclusion Criteria:

  1. Has presence of active malignancy.
  2. Has overt or active bacterial infection, either local or systemic.
  3. Is mentally incompetent.
  4. Is a prisoner.
  5. Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse.
  6. Is pregnant or plan to be pregnant during the course of the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Dual attending
Two attending spine surgeons during the critical portions of the surgery
Two attending spine surgeons perform surgery
安慰剂比较:Single attending
One spine attending and an assistant during the critical portions of the surgery, The assistant can be a spine fellow, a resident or a physician's assistant.
One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Hospitalization cost
大体时间:12 months
Total medical costs including index surgery and re-admissions over 5 years
12 months

次要结果测量

结果测量
措施说明
大体时间
Pain scales
大体时间:6, 12, 24, 36, 48 and 60 months
Pain scales for back and leg pain (0 to 10)
6, 12, 24, 36, 48 and 60 months
Oswestry Low Back Pain Disability Questionnaire
大体时间:6, 12, 24, 36, 48 and 60 months
Low back disability
6, 12, 24, 36, 48 and 60 months
Short Form 6D
大体时间:6, 12, 24, 36, 48 and 60 months
Utility measure
6, 12, 24, 36, 48 and 60 months
EurQOL 5d
大体时间:6, 12, 24, 36, 48 and 60 months
Utility measure
6, 12, 24, 36, 48 and 60 months
Readmissions
大体时间:90 days
Number of readmissions 90 days after surgery
90 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Steven D Glassman, MD、Norton Leatherman Spine Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年5月1日

初级完成 (预期的)

2018年5月1日

研究完成 (预期的)

2023年5月1日

研究注册日期

首次提交

2016年3月3日

首先提交符合 QC 标准的

2016年3月8日

首次发布 (估计)

2016年3月9日

研究记录更新

最后更新发布 (估计)

2016年3月9日

上次提交的符合 QC 标准的更新

2016年3月8日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

There is no plan to share individual level data.

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Dual attending的临床试验

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