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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Scoliosis, Unspecified
• Intervention / Treatment: Procedure: Dual attending; Procedure: Single Attending

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).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Y Carreon, MD, MSc; Phone Number: 4139 5025847525; Email: leah.carreon@nortonhealthcare.org
• Study Contact Backup: Name: Kelly R Bratcher, RN; Phone Number: 5025847525; Email: kelly.bratcher2@nortonhealthcare.org

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Leatherman Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dual attending; Two attending spine surgeons during the critical portions of the surgery	Procedure: Dual attending; Two attending spine surgeons perform surgery
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization cost	Total medical costs including index surgery and re-admissions over 5 years	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scales	Pain scales for back and leg pain (0 to 10)	6, 12, 24, 36, 48 and 60 months
Oswestry Low Back Pain Disability Questionnaire	Low back disability	6, 12, 24, 36, 48 and 60 months
Short Form 6D	Utility measure	6, 12, 24, 36, 48 and 60 months
EurQOL 5d	Utility measure	6, 12, 24, 36, 48 and 60 months
Readmissions	Number of readmissions 90 days after surgery	90 days

Collaborators and Investigators

• Sponsor: Norton Leatherman Spine Center
• Investigators: Principal Investigator: Steven D Glassman, MD, Norton Leatherman Spine Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 3, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 8, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: adult spine deformity; time-driven activity-based costing; three-column posterior osteotomy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Congenital Abnormalities; Scoliosis
• Other Study ID Numbers: 16-N0036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual level data.