Clinical trial NCT02703831: Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery:
Official title: Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery: A Cost-effectiveness Study Using Activity-based Costing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Scoliosis, Unspecified
Keywords: adult spine deformity
time-driven activity-based costing
three-column posterior osteotomy
Lead sponsor: Norton Leatherman Spine Center
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Hospitalization cost
timeFrame: 12 months
Secondary outcomes:
measure: Pain scales
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Oswestry Low Back Pain Disability Questionnaire
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Short Form 6D
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: EurQOL 5d
timeFrame: 6, 12, 24, 36, 48 and 60 months
measure: Readmissions
timeFrame: 90 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
Study officials:
affiliation: Norton Leatherman Spine Center
name: Steven D Glassman, MD
role: PRINCIPAL_INVESTIGATOR
References: