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

Primary Purpose

Scoliosis, Unspecified

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual attending
Single Attending
Sponsored by
Norton Leatherman Spine Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Scoliosis, Unspecified focused on measuring adult spine deformity, time-driven activity-based costing, three-column posterior osteotomy

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Norton Leatherman Spine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dual attending

Single attending

Arm Description

Two attending spine surgeons during the critical portions of the surgery

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain scales
Pain scales for back and leg pain (0 to 10)
Oswestry Low Back Pain Disability Questionnaire
Low back disability
Short Form 6D
Utility measure
EurQOL 5d
Utility measure
Readmissions
Number of readmissions 90 days after surgery

Full Information

First Posted
March 3, 2016
Last Updated
March 8, 2016
Sponsor
Norton Leatherman Spine Center
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1. Study Identification

Unique Protocol Identification Number
NCT02703831
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norton Leatherman Spine Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scoliosis, Unspecified
Keywords
adult spine deformity, time-driven activity-based costing, three-column posterior osteotomy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual attending
Arm Type
Active Comparator
Arm Description
Two attending spine surgeons during the critical portions of the surgery
Arm Title
Single attending
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Dual attending
Intervention Description
Two attending spine surgeons perform surgery
Intervention Type
Procedure
Intervention Name(s)
Single Attending
Intervention Description
One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.
Primary Outcome Measure Information:
Title
Hospitalization cost
Description
Total medical costs including index surgery and re-admissions over 5 years
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain scales
Description
Pain scales for back and leg pain (0 to 10)
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Oswestry Low Back Pain Disability Questionnaire
Description
Low back disability
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Short Form 6D
Description
Utility measure
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
EurQOL 5d
Description
Utility measure
Time Frame
6, 12, 24, 36, 48 and 60 months
Title
Readmissions
Description
Number of readmissions 90 days after surgery
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Y Carreon, MD, MSc
Phone
5025847525
Ext
4139
Email
leah.carreon@nortonhealthcare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly R Bratcher, RN
Phone
5025847525
Email
kelly.bratcher2@nortonhealthcare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven D Glassman, MD
Organizational Affiliation
Norton Leatherman Spine Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Leatherman Spine Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual level data.

Learn more about this trial

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

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