- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02703831
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).
연구 개요
상세 설명
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).
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Leah Y Carreon, MD, MSc
- 전화번호: 4139 5025847525
- 이메일: leah.carreon@nortonhealthcare.org
연구 연락처 백업
- 이름: Kelly R Bratcher, RN
- 전화번호: 5025847525
- 이메일: kelly.bratcher2@nortonhealthcare.org
연구 장소
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Kentucky
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Louisville, Kentucky, 미국, 40202
- Norton Leatherman Spine Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Dual attending
Two attending spine surgeons during the critical portions of the surgery
|
Two attending spine surgeons perform surgery
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위약 비교기: 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.
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One spine attending and an assistant perform surgery.
The assistant can be a spine fellow, a resident or a physician's assistant.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Hospitalization cost
기간: 12 months
|
Total medical costs including index surgery and re-admissions over 5 years
|
12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Pain scales
기간: 6, 12, 24, 36, 48 and 60 months
|
Pain scales for back and leg pain (0 to 10)
|
6, 12, 24, 36, 48 and 60 months
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Oswestry Low Back Pain Disability Questionnaire
기간: 6, 12, 24, 36, 48 and 60 months
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Low back disability
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6, 12, 24, 36, 48 and 60 months
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Short Form 6D
기간: 6, 12, 24, 36, 48 and 60 months
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Utility measure
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6, 12, 24, 36, 48 and 60 months
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EurQOL 5d
기간: 6, 12, 24, 36, 48 and 60 months
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Utility measure
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6, 12, 24, 36, 48 and 60 months
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Readmissions
기간: 90 days
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Number of readmissions 90 days after surgery
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90 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Steven D Glassman, MD, Norton Leatherman Spine Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 16-N0036
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Dual attending에 대한 임상 시험
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-
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-
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-
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-
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-
Samsung Medical CenterTaewoong Medical Co., Ltd.알려지지 않은
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Mansoura University아직 모집하지 않음