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

Scoliosis, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02703831
• Other study ID #: 16-N0036
• Status: Not yet recruiting
• Phase: N/A
• First received: March 3, 2016
• Last updated: March 8, 2016
• Start date: May 2016
• Est. completion date: May 2023

Study information

• Verified date: March 2016
• Source: Norton Leatherman Spine Center
• Contact: Leah Y Carreon, MD, MSc
• Phone: 5025847525
• Email: leah.carreon[@]nortonhealthcare.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 2023
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Scoliosis
• Scoliosis, Unspecified

Intervention

Procedure:
• Dual attending
Two attending spine surgeons perform surgery
• Single Attending
One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.

Locations

Country	Name	City	State
United States	Norton Leatherman Spine Center	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Norton Leatherman Spine Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization cost	Total medical costs including index surgery and re-admissions over 5 years	12 months	No
Secondary	Pain scales	Pain scales for back and leg pain (0 to 10)	6, 12, 24, 36, 48 and 60 months	No
Secondary	Oswestry Low Back Pain Disability Questionnaire	Low back disability	6, 12, 24, 36, 48 and 60 months	No
Secondary	Short Form 6D	Utility measure	6, 12, 24, 36, 48 and 60 months	No
Secondary	EurQOL 5d	Utility measure	6, 12, 24, 36, 48 and 60 months	No
Secondary	Readmissions	Number of readmissions 90 days after surgery	90 days	No