- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04900181
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty
Analysis of the Cost-Effectiveness of Same-day Discharge Surgery for Primary Total Hip Arthroplasty: A Pragmatic Randomized Controlled Study
Total hip arthroplasty (THA) causes a great medical burden globally, and the same-day discharge (SDD) method has previously been considered to be cost saving. However, a standard cost-effectiveness analysis (CEA) in a randomized controlled trial (RCT) is needed to evaluated the benefits of SDD when performing THA from the perspective of both economic and clinical outcomes. So the objective is to evaluate the cost-effectiveness of SDD for hip replacement.
This was a single center, pragmatic RCT with a 6-month follow up. Eighty-four participants who met the inclusion criteria were randomized to either the SDD group or the inpatient group (42 per group). Outcomes were assessed by an independent orthopedist who was not in the surgical team, using the Oxford Hip Score (OHS), EuroQol 5D (EQ-5D) and 36-Item Short-From Health Survey (SF-36) scores at the baseline and the 6-month follow up. All interviews were conducted face to face. All the cost information was collected both from payment receipts and insurance reimbursement records.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hongtao Tian, doctor
- Phone Number: 18627171618
- Email: tianhongtao@vip.163.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Wuhan Union Hospital
-
Contact:
- Hongtao Tian, doctor
- Phone Number: 18627171618
- Email: tianhongtao@vip.163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- undergoing unilateral primary THA
- having the ability to understand the relevant treatment process
- aged between 18 and 75 years
- a body mass index (BMI) ≤ 40 kg/m2
- hemoglobin ≥ 12g/dL
- American Society of Anesthesiologists (ASA) physical status classification of I or II
- no ongoing infection or blood coagulation disorders
Exclusion Criteria:
- with a history of coronary artery disease
- chronic obstructive pulmonary disease
- arrhythmias
- untreated obstructive sleep apnea
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: the same-day discharge surgery
Patients in the the same-day discharge surgery group were admitted to hospital, operated and discharged within 24 hour
|
the same-day discharge surgery is the procedure in which the patient is admitted, operated and discharged within 24 hours.
|
|
No Intervention: inpatient surgery
Patients in inpatient surgery follow routine procedures and do not need to be discharged on the same day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the Oxford Hip Score
Time Frame: six months
|
the Oxford Hip Score consists of 12 questions reflecting the different aspects of hip function.
Each question was scored from 0 to 4, with 4 representing the best outcome or least symptoms
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the quality-adjusted life years
Time Frame: six months
|
the quality-adjusted life years was calculated as the outcome in cost utility analysis, as proposed by the CHEERS and CEA guidelines.
The values of QALYs were estimated by EQ-5D .
The EQ-5D was administered at baseline and at the 6-month follow-up.
The EQ-5D is divided into five aspects (mobility, self-care, usual activities, discomfort, depression) to evaluate patients' health state, and each consists of three levels.
The score for the EQ-5D ranges from -0.59 to 1.00, with a higher score indicating a better quality of life.
|
six months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hongtao Tian, doctor, Wuhan Union Hospital, China
Publications and helpful links
General Publications
- Kurtz SM, Ong KL, Lau E, Bozic KJ. Impact of the economic downturn on total joint replacement demand in the United States: updated projections to 2021. J Bone Joint Surg Am. 2014 Apr 16;96(8):624-30. doi: 10.2106/JBJS.M.00285.
- Molloy IB, Martin BI, Moschetti WE, Jevsevar DS. Effects of the Length of Stay on the Cost of Total Knee and Total Hip Arthroplasty from 2002 to 2013. J Bone Joint Surg Am. 2017 Mar 1;99(5):402-407. doi: 10.2106/JBJS.16.00019.
- Navathe AS, Troxel AB, Liao JM, Nan N, Zhu J, Zhong W, Emanuel EJ. Cost of Joint Replacement Using Bundled Payment Models. JAMA Intern Med. 2017 Feb 1;177(2):214-222. doi: 10.1001/jamainternmed.2016.8263.
- Doran JP, Zabinski SJ. Bundled payment initiatives for Medicare and non-Medicare total joint arthroplasty patients at a community hospital: bundles in the real world. J Arthroplasty. 2015 Mar;30(3):353-5. doi: 10.1016/j.arth.2015.01.035. Epub 2015 Jan 23.
- Zeng JQ. The pilot results of 47 148 cases of BJ-DRGs-based payment in China. Int J Health Plann Manage. 2019 Oct;34(4):1386-1398. doi: 10.1002/hpm.2818. Epub 2019 Jul 8.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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