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临床试验/NCT02703831
NCT02703831Unknown不适用

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

Norton Leatherman Spine Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Hospitalization cost

研究概览

简要总结

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).

详细描述

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).

研究设计

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

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Dual attending

Active Comparator

Two attending spine surgeons during the critical portions of the surgery

干预措施: Dual attending (Procedure)

Single attending

Placebo Comparator

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.

干预措施: Single Attending (Procedure)

结局指标

主要结局

Hospitalization cost

时间窗: 12 months

Total medical costs including index surgery and re-admissions over 5 years

次要结局

  • Short Form 6D(6, 12, 24, 36, 48 and 60 months)
  • Oswestry Low Back Pain Disability Questionnaire(6, 12, 24, 36, 48 and 60 months)
  • Pain scales(6, 12, 24, 36, 48 and 60 months)
  • EurQOL 5d(6, 12, 24, 36, 48 and 60 months)
  • Readmissions(90 days)

研究者

发起方
Norton Leatherman Spine Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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