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

NCT ID: NCT02703831

Last Updated: 2016-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2023-05-31

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).

Conditions

Scoliosis, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Dual attending

Two attending spine surgeons during the critical portions of the surgery

Group Type: ACTIVE_COMPARATOR

Dual attending

Intervention Type: PROCEDURE

Two attending spine surgeons perform surgery

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.

Group Type: PLACEBO_COMPARATOR

Single Attending

Intervention Type: PROCEDURE

One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.

Interventions

Dual attending

Two attending spine surgeons perform surgery

Intervention Type: PROCEDURE

Single Attending

One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norton Leatherman Spine Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven D Glassman, MD

Role: PRINCIPAL_INVESTIGATOR

Norton Leatherman Spine Center

Locations

Norton Leatherman Spine Center

Louisville, Kentucky, United States

Countries

United States

Central Contacts

Leah Y Carreon, MD, MSc

Role: CONTACT

leah.carreon@nortonhealthcare.org

5025847525 ext. 4139

Kelly R Bratcher, RN

Role: CONTACT

kelly.bratcher2@nortonhealthcare.org

5025847525

Other Identifiers

16-N0036

Identifier Type: -

Identifier Source: org_study_id