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A protocol for a randomized controlled trial investigating the safety and cost-effectiveness of outpatient total hip
Bryn O Zomar1,2, Jacquelyn D Marsh1,2, Brent A Lanting2,3,4
1Faculty of Health Sciences, University of Western Ontario, London, ON, Canada.
Insights
Outpatient total hip arthroplasty (THA) offers potential cost savings. This trial compares same-day discharge to inpatient stays, evaluating safety and cost-effectiveness for this evolving surgical care model.
Area of Science:
- Orthopedic Surgery
- Health Economics
- Patient Outcomes
Background:
- Total hip arthroplasty (THA) costs are significantly impacted by inpatient stays.
- Shifting to outpatient THA could offer substantial cost savings.
- High-quality evidence for outpatient THA effectiveness is lacking.
Purpose of the Study:
- To evaluate outpatient care pathways for THA.
- To compare serious adverse event rates between outpatient and inpatient THA.
- To estimate the cost-effectiveness of outpatient THA.
Main Methods:
- Prospective, randomized controlled trial with blinding.
- Patients randomized to same-day discharge (outpatient) or standard inpatient stay.
- Primary outcome: serious adverse events at 30 days; secondary outcomes: patient-reported outcomes and costs.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This is the first blinded, adequately powered randomized trial on outpatient THA.
- The study prospectively performs a full economic evaluation of outpatient THA.
- Results could provide clinical evidence for the role of outpatient THA.
Background:
A significant proportion of the overall cost of total hip arthroplasty (THA) results from the inpatient hospital stay following the procedure. Considering the substantial and increasing number of these procedures performed annually, shifting to an outpatient model of care where the patient is discharged home the same day as their surgery represents a potential for significant cost savings. The potential significant impact of an outpatient care model on constrained healthcare budgets and lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this prospective, randomized controlled trial is to evaluate outpatient care pathways for THA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient THA.
Methods:
We will include patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight. Consenting patients will be randomized to be discharged on the same day as surgery, as outpatients, or as inpatients according to standard of care (minimum of one night in hospital) using a modified Zelen consent model. The primary outcome measure is the incidence of serious adverse events at 30 days postoperative. Participants and their caregivers will complete secondary outcomes measures at each follow-up visit including patient-reported outcome measures and self-reported cost questionnaires.
Discussion:
This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation. It is also the first adequately powered trial to prospectively assess the safety of outpatient THA. Successful completion of this study could have the potential to provide clinical evidence for the role of outpatient THA in current practice.
Trial Registration:
This study was retrospectively registered on ClinicalTrials.gov ( NCT03026764 ) on March 9th, 2016.