Same-Day Discharge Protocol for Total Joint Replacement

(PTClearSHoT Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Age 90+, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

210 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the same-day discharge protocol for total joint replacement treatment?

Research shows that same-day discharge after total joint replacement is feasible and safe for up to 75% of patients, although it may have a higher complication rate compared to fast-track discharge. Proper patient selection is crucial to ensure safety and effectiveness. ^{1 2 3 4 5}

Is same-day discharge after total joint replacement generally safe?

Same-day discharge after total joint replacement can be safe for carefully selected patients, but it may have higher complication rates compared to other discharge methods. Safety is more established in healthier patients, and a team-based approach is important for effective care. ^{1 2 6 7 8}

What makes the same-day discharge protocol for total joint replacement unique?

The same-day discharge protocol for total joint replacement is unique because it allows patients to go home on the same day as their surgery, thanks to advances in anesthesia, physical therapy, and surgical techniques. This approach is designed to be safe and cost-effective for selected patients, although it may have higher complication rates compared to fast-track inpatient procedures. ^{2 3 4 7 9}

What is the purpose of this trial?

Conventionally, physical therapy (PT) clearance is sought before total joint arthroplasty (TJA) discharge. However, PT staffing limitations may preclude same-day discharge in patients having surgery late in the day. Failed same-day discharge in eligible TJA patients results in unnecessary hospital bed occupancy, which increases costs, limits operating room throughput for patients requiring inpatient admission, and introduces risks associated with longer length-of-stay. In collaboration with an institutional PT department, the investigators developed a protocol for discharging same-day TJA patients without postoperative PT clearance. Immediately preoperatively, PT administers gait training. Patients are then discharged home after ambulating with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization. This allows for the maximum number of patients discharged home, including the last patient of the day, PT staffing limitations notwithstanding. Single-institution pilot data demonstrates no increased risk of falls, emergency room (ER) visits, or readmissions with this process. The investigators propose a prospective, controlled, multicenter study to expand on pilot data. The study aim is to assess safety of day-of-surgery preoperative PT and postoperative ambulation with PACU nursing before TJA discharge. The primary endpoint is postoperative falls, while secondary endpoints include 90-day ER visits, 90-day hospital readmissions, patient-reported outcome measures, and patient satisfaction scores.

Eligibility Criteria

This trial is for adults over 18 who are having a total hip or knee replacement and can go home the same day. They need someone to stay with them at home for a week after surgery and must be medically okay to leave the hospital after waking up from anesthesia.

Inclusion Criteria

I am scheduled for my first hip or knee replacement surgery.

I can go home the same day as my surgery and have someone to stay with me for a week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Physical Therapy

Participants receive gait and stair training from physical therapy prior to total joint arthroplasty

1 day

1 visit (in-person)

Postoperative Ambulation

Participants ambulate with post-anesthesia care unit (PACU) nurses trained by PT on postoperative mobilization before home discharge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of postoperative falls, ER visits, and readmissions

90 days

Treatment Details

Interventions

• Conventional postoperative physical therapy clearance
• Novel same-day discharge protocol after total joint arthroplasty

Trial Overview The study tests if patients can safely skip post-surgery physical therapy before going home on the same day of joint replacement surgery. Instead, they get walking training before surgery and help from nurses trained in moving patients right after.

Participant Groups

Group I: Preoperative Physical Therapy, Postoperative Ambulation with Nursing Experimental Treatment 1 Intervention

Patients will receive gait/stair training from physical therapy prior to total joint arthroplasty, then ambulate with nursing postoperatively prior to home discharge

Group II: Conventional Postoperative Physical Therapy Clearance Active Control 1 Intervention

Patients will be evaluated and cleared by physical therapy after total joint replacement surgery prior to home discharge

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Rothman Institute Orthopaedics

Collaborator

Trials

127

Recruited

22,600+

Findings from Research

In a study of 1491 patients undergoing same-day discharge (SDD) total joint arthroplasty, 93% were successfully discharged on the same day, while 7% required a longer hospital stay, often due to factors like being non-married or having higher ASA class (III).

Patients who failed to be discharged the same day (FTL) did not experience worse outcomes compared to those who were successfully discharged, as both groups had similar rates of readmissions, revisions, and patient-reported outcomes, indicating that FTL does not predict adverse results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Failure to Meet Same-Day Discharge is Not a Predictor of Adverse Outcomes. Singh, V., Nduaguba, AM., Macaulay, W., et al.[2022]

A systematic review of 14 studies involving 222,766 cases found that same-day discharge total joint arthroplasty (TJA) has a satisfactory safety profile, with no significant differences in mortality or readmission rates compared to inpatient TJA.

However, same-day discharge TJA showed a significantly higher rate of overall complications compared to fast-track inpatient TJA, indicating that while it is generally safe, careful monitoring for complications is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day discharge arthroplasty has a higher overall complications rate than fast-track arthroplasty: a systematic review and meta-analysis. Li, M., Luo, R., Zeng, Y., et al.[2022]

Same day discharge after total joint arthroplasty is becoming a viable option for selected patients, potentially reducing hospital stays and associated costs.

The review discusses institutional guidelines for patient selection and contraindications, emphasizing the importance of careful evaluation to ensure safety and minimize complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same Day Discharge After Total Joint Arthroplasty The Future May Be Now. Aggarwal, V., Thakkar, S., Collins, K., et al.[2018]

In a study of 1778 patients who underwent same-day discharge (SDD) total joint arthroplasty (TJA), those enrolled in a formal SDD program had shorter surgical times compared to those who were SDD but not enrolled (87.29 vs 109.39 minutes).

Despite the differences in surgical times, both groups showed no significant differences in discharge outcomes, emergency department visits, readmissions, or joint function scores, suggesting that formal enrollment in an SDD program may not be necessary for achieving successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Formal Same-Day Discharge Total Joint Arthroplasty Program May Not Be Necessary: A Propensity-Matched Cohort Study. Singh, V., Realyvasquez, J., Simcox, T., et al.[2022]

In a study of 1100 consecutive primary total joint arthroplasties (TJAs), 75% of unselected patients achieved same-day discharge (SDD) to home, demonstrating that ambulatory surgery is feasible and safe for most patients without increasing complication risks.

Factors such as being female and undergoing total hip arthroplasty (THA) were associated with a higher likelihood of failing to achieve SDD, indicating that patient characteristics can influence discharge outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-day discharge to home is feasible and safe in up to 75% of unselected total hip and knee arthroplasty. Verdier, N., Boutaud, B., Ragot, P., et al.[2022]

In a study of 5,250 hip and 9,752 knee arthroplasty patients with higher comorbidities, same-day discharge was found to be as safe as inpatient care, showing no increased risk of emergency department visits, readmissions, or complications.

Same-day discharge for knee arthroplasty also demonstrated noninferiority in terms of mortality risk, suggesting that this approach can be safely expanded to higher-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Same-Day Discharge Total Joint Arthroplasty and Risk of 90-Day Adverse Events in Patients with ASA Classification of ≥3. Reddy, NC., Prentice, HA., Paxton, EW., et al.[2023]

Same-day-discharge total joint arthroplasty is safe and does not lead to higher readmission rates in carefully selected patients, thanks to improvements in anesthesia, surgical techniques, and care protocols.

This approach is also cost-effective and is expected to become more common as healthcare focuses on value-driven care, highlighting the importance of a team-based strategy for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team Approach: Same-Day Discharge of Patients Undergoing Total Joint Arthroplasty. Crawford, AM., Chen, AF., Sabeti, A., et al.[2021]

From 2011 to 2016, the rate of same-day discharge (SDD) following total joint arthroplasty (TJA) increased significantly from 0.95% to 20.5%, but about 68% of patients were still discharged directly home, indicating a stable trend in discharge practices.

Patients discharged to alternate care facilities were older, had higher comorbidity scores, and experienced more complications compared to those discharged directly home, highlighting the need for careful consideration of patient disposition in SDD TJA studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Same-Day Discharge Following Total Joint Arthroplasty: Examining Trends, Discharge Dispositions, and Complications Over Time. Clouette, J., Agarwalla, A., Ravi, B., et al.[2020]

A study of 1200 patients undergoing same-day discharge total joint arthroplasty (SDD-TJA) showed that this procedure can be safely performed in community hospitals, with a low 30-day complication rate of only 1.3% for readmissions.

However, the use of general anesthesia was linked to a higher risk of 'failure to launch' (FTL), occurring in 7.1% of patients, suggesting that spinal anesthesia is a safer option for minimizing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Total Joint Arthroplasty Enhanced Recovery Program in a Community Hospital Setting. Adams, CT., O'Connor, CM., Young, JR., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Failure to Meet Same-Day Discharge is Not a Predictor of Adverse Outcomes. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Same-day discharge arthroplasty has a higher overall complications rate than fast-track arthroplasty: a systematic review and meta-analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Same Day Discharge After Total Joint Arthroplasty The Future May Be Now. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Formal Same-Day Discharge Total Joint Arthroplasty Program May Not Be Necessary: A Propensity-Matched Cohort Study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Same-day discharge to home is feasible and safe in up to 75% of unselected total hip and knee arthroplasty. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Association Between Same-Day Discharge Total Joint Arthroplasty and Risk of 90-Day Adverse Events in Patients with ASA Classification of ≥3. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Team Approach: Same-Day Discharge of Patients Undergoing Total Joint Arthroplasty. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Same-Day Discharge Following Total Joint Arthroplasty: Examining Trends, Discharge Dispositions, and Complications Over Time. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Total Joint Arthroplasty Enhanced Recovery Program in a Community Hospital Setting. [2021]