Scoliosis, UnspecifiedNCT02703831
Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery:
A study testing Dual attending and Single Attending in people with Scoliosis, Unspecified, run by Norton Leatherman Spine Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Scoliosis, Unspecified
- What is being tested?
- Dual attending and Single Attending
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
About this study
Official title: 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).
Read the 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
- Being tested
- Dual attending, Single Attending
- Keywords
- adult spine deformity, time-driven activity-based costing, three-column posterior osteotomy
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual attendingProcedure or surgery
Two attending spine surgeons perform surgery
Single AttendingProcedure or surgery
One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.
| Study group | Role | What they receive |
|---|---|---|
| Dual attending | Active comparator | Two attending spine surgeons during the critical portions of the surgery Receives: Procedure: Dual attending |
| Single attending | Placebo comparator | 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. Receives: Procedure: Single Attending |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization cost
Total medical costs including index surgery and re-admissions over 5 years
Measured: 12 months
Secondary outcomes (5)
Pain scales
Pain scales for back and leg pain (0 to 10)
Measured: 6, 12, 24, 36, 48 and 60 months
Oswestry Low Back Pain Disability Questionnaire
Low back disability
Measured: 6, 12, 24, 36, 48 and 60 months
Short Form 6D
Utility measure
Measured: 6, 12, 24, 36, 48 and 60 months
EurQOL 5d
Utility measure
Measured: 6, 12, 24, 36, 48 and 60 months
Readmissions
Number of readmissions 90 days after surgery
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norton Leatherman Spine Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D Glassman, MD, Principal investigator, Norton Leatherman Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703831
- Sponsor's protocol ID
- 16-N0036
- Status last verified
- Mar 2016
- First submitted
- 3 Mar 2016
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to share individual level data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Versus Dual Spine Attending Surgeons in Complex Adult Deformity Surgery: A Cost-effectiveness Study Using Activity-based Costing
- ClinicalTrials.gov ID
- NCT02703831
- Acronym / sponsor ID
- 16-N0036
- Conditions
- Scoliosis, Unspecified
- Keywords
- adult spine deformity, time-driven activity-based costing, three-column posterior osteotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Norton Leatherman Spine CenterUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual attending | Active comparator | Procedure: Dual attendingTwo attending spine surgeons during the critical portions of the surgery |
| Single attending | Placebo comparator | Procedure: Single AttendingOne 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for a complex spine adult deformity surgery.
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual attendingTwo attending spine surgeons perform surgery | Procedure or surgery | Dual attending |
| Single AttendingOne spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant. | Procedure or surgery | Single attending |
Primary outcome
Hospitalization cost
Time frame: 12 months
Total medical costs including index surgery and re-admissions over 5 years
5 secondary outcomes
Pain scales
Time frame: 6, 12, 24, 36, 48 and 60 months
Oswestry Low Back Pain Disability Questionnaire
Time frame: 6, 12, 24, 36, 48 and 60 months
Short Form 6D
Time frame: 6, 12, 24, 36, 48 and 60 months
EurQOL 5d
Time frame: 6, 12, 24, 36, 48 and 60 months
Readmissions
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
- Individual participant dataSharing planned: No. There is no plan to share individual level data.
Related trials for Scoliosis, Unspecified
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven D Glassman, MD principal investigator
Norton Leatherman Spine Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual attending and Single Attending in people with Scoliosis, Unspecified, run by Norton Leatherman Spine Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leah Y Carreon, MD, MSc (5025847525 ext. 4139, leah.carreon@nortonhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization cost (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2016.