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Inpatient vs Outpatient Total Knee Replacement

Primary Purpose

Osteoarthritis, Knee

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Outpatient
Inpatient
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis, Knee focused on measuring Cost, Total Knee Replacement, Outpatient Surgery, Satisfaction, Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anaesthesiologists (ASA) score equal to or less than 3
  • Have the ability to read and understand English (printed instructions are provided in English only)
  • Live within a 60 minute driving distance of University Hospital (UH)
  • Home / cell phone access
  • An adult to accompany patient home post-operatively
  • Sufficient caregiver support
  • Caregivers: identified as the main caregiver for the participant in the immediate postoperative period (can be family or friend)

Exclusion Criteria:

  • Patient has significant pain management issues
  • Patient / family history of anesthesia related complication(s) (e.g., malignant hyperthermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea)
  • Obesity that significantly impacts the patient's ability to mobilize
  • Anaphylaxis to penicillin
  • Significant psycho / social issues that would prevent the patient from managing at home safely
  • Cognitive issues that preclude the ability to understand instructions
  • Lack of an appropriate social network that can observe the patient post-operatively
  • Caregivers: inability to speak/read English as questionnaires are only available in English

Sites / Locations

  • London Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Outpatient

Inpatient

Arm Description

Patients in the outpatient group (same day discharge following TKA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Patients in the inpatient group (following day discharge following TKA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).

Outcomes

Primary Outcome Measures

Indirect and direct costs of treatment
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Rate of early complications and adverse events
fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Standardized measure of health outcome (EQ-5D)
utility score measured on a scale of 0 (death) to 1 (perfect health)

Secondary Outcome Measures

Patient satisfaction questionnaire
patient satisfaction with care pre-, peri- and postoperative
Western Ontario McMaster Osteoarthritis Index (WOMAC)
functional outcome measured on a total scale of 0 (better function) to 100 (worse function) and made up of subscales for pain, stiffness and function
Knee Society Score
functional outcome measured on a scale of 0 (worse function) to 100 (best function)
Veterans Rand 12
quality of life measured on a scale of 0 (worse) to 100 (better) using norm-based scoring
Pain Numeric Rating Scale
pain measured on a scale from 0 (no pain) to 10 (worst pain imaginable)
Oxford Knee Score
level of function, activities of daily living, effects of pain over preceding four weeks measured with 12 questions each on a 5 point likert scale.

Full Information

First Posted
January 10, 2020
Last Updated
October 5, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04228731
Brief Title
Inpatient vs Outpatient Total Knee Replacement
Official Title
Cost and Patient Satisfaction Associated With Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
December 22, 2024 (Anticipated)
Study Completion Date
December 22, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a prospective cohort study comparing standard inpatient (overnight hospital stay) total knee arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be recruited. This study will compare patient satisfaction and costs from the perspectives of the Ministry of Health, the institution, society and the patient.
Detailed Description
Osteoarthritis (OA) is a leading cause of disability and reduced quality of life, presenting a substantial, growing burden to patients and the healthcare system (1). Total knee arthroplasty (TKA) is an established, effective interventions for advanced OA. The prevalence of knee OA is rapidly increasing, resulting in a rising demand for care. The number of procedures is expected to grow by 48%, by 2020 in the US (2). Currently, TKA along with total hip arthroplasty (THA), have a significant impact on healthcare budgets, costing approximately $1.2 billion in annual spending in Canada (3). These staggering numbers highlight the critical need to improve care delivery. A significant proportion of the overall cost of joint replacement results from the inpatient hospital stay following the procedure. Historically, the standard procedure following TKA required an inpatient hospital stay of two and a half to three weeks, however the introduction of less invasive surgical techniques, improved medical and analgesia management and comprehensive rehabilitation have enabled shorter inpatient stays. Today, the median inpatient stay following TKA is three days in Canada (3). A desire for greater autonomy by the patients as well as patients wanting early mobilization to accelerate recovery and return to activities has led some clinicians to consider an outpatient arthroplasty program. The proposed benefits of outpatient arthroplasty include similar patient outcomes with significantly lower hospital costs, and improved patient satisfaction, independence, and autonomy, however there is a lack of high-quality evidence comparing clinical outcomes of outpatient to inpatient arthroplasty models of care. A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day major complications or readmissions among patients with a zero to two-day hospital stay compared to those discharged on day three or four postoperative (4). Small cohort studies (5-8) suggest lower costs for outpatients and improved patient satisfaction but have inherent biases; limited to carefully selected patients in privatized health systems. It is estimated that up to 20% of the overall cost of joint replacement can be attributed to the inpatient stay in hospital at our institution (9). By discharging patients as outpatients, it could be possible to save 20% of the overall costs of joint replacement. Although these preliminary calculations are encouraging, it is not sufficient to effect change solely to achieve cost control, without consideration of safety, effectiveness and patient satisfaction. Further, it is unknown whether the financial savings will be outweighed by additional postoperative costs, increased readmissions or decreased quality of care. A full economic evaluation that simultaneously evaluates cost and effectiveness is crucial prior to implementation. The lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this study is to evaluate outpatient care pathways for TKA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient TKA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Cost, Total Knee Replacement, Outpatient Surgery, Satisfaction, Arthroplasty

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Outpatient
Arm Type
Experimental
Arm Description
Patients in the outpatient group (same day discharge following TKA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).
Arm Title
Inpatient
Arm Type
Active Comparator
Arm Description
Patients in the inpatient group (following day discharge following TKA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver).
Intervention Type
Procedure
Intervention Name(s)
Outpatient
Intervention Description
Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty
Intervention Type
Procedure
Intervention Name(s)
Inpatient
Intervention Description
Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty
Primary Outcome Measure Information:
Title
Indirect and direct costs of treatment
Description
ER visits, clinician visits, caregiver lost productivity, tests, etc.
Time Frame
1 Year
Title
Rate of early complications and adverse events
Description
fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.
Time Frame
1 Year
Title
Standardized measure of health outcome (EQ-5D)
Description
utility score measured on a scale of 0 (death) to 1 (perfect health)
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Patient satisfaction questionnaire
Description
patient satisfaction with care pre-, peri- and postoperative
Time Frame
2 Weeks
Title
Western Ontario McMaster Osteoarthritis Index (WOMAC)
Description
functional outcome measured on a total scale of 0 (better function) to 100 (worse function) and made up of subscales for pain, stiffness and function
Time Frame
1 Year
Title
Knee Society Score
Description
functional outcome measured on a scale of 0 (worse function) to 100 (best function)
Time Frame
1 Year
Title
Veterans Rand 12
Description
quality of life measured on a scale of 0 (worse) to 100 (better) using norm-based scoring
Time Frame
1 Year
Title
Pain Numeric Rating Scale
Description
pain measured on a scale from 0 (no pain) to 10 (worst pain imaginable)
Time Frame
1 Year
Title
Oxford Knee Score
Description
level of function, activities of daily living, effects of pain over preceding four weeks measured with 12 questions each on a 5 point likert scale.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Osteoarthritis of the knee Booked for primary unilateral total knee arthroplasty Have the ability to read and understand English (printed instructions are provided in English only) Home / cell phone access Planning to be discharged to home environment Patient has an adult to accompany them home post-operatively Exclusion Criteria: Cognitive issues that preclude the ability to understand instructions or provide informed consent Lack of a social supports at home American Society of Anaesthesiologists (ASA) score equal to or less than 4
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquelyn Marsh, PhD
Phone
519-661-2111
Ext
88844
Email
jmarsh2@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dianne Bryant, PhD
Phone
519-661-2111
Ext
83947
Email
dianne.bryant@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Lanting, MD, FRCSC
Organizational Affiliation
London Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lyndsay Somerville
Phone
5196858500
Email
lyndsay.somerville@lhsc.on.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24740658
Citation
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.
Results Reference
background
PubMed Identifier
27605685
Citation
Sutton JC 3rd, Antoniou J, Epure LM, Huk OL, Zukor DJ, Bergeron SG. Hospital Discharge within 2 Days Following Total Hip or Knee Arthroplasty Does Not Increase Major-Complication and Readmission Rates. J Bone Joint Surg Am. 2016 Sep 7;98(17):1419-28. doi: 10.2106/JBJS.15.01109.
Results Reference
background
PubMed Identifier
25264442
Citation
Aynardi M, Post Z, Ong A, Orozco F, Sukin DC. Outpatient surgery as a means of cost reduction in total hip arthroplasty: a case-control study. HSS J. 2014 Oct;10(3):252-5. doi: 10.1007/s11420-014-9401-0. Epub 2014 Jul 12.
Results Reference
background
PubMed Identifier
15930933
Citation
Bertin KC. Minimally invasive outpatient total hip arthroplasty: a financial analysis. Clin Orthop Relat Res. 2005 Jun;(435):154-63. doi: 10.1097/01.blo.0000157173.22995.cf.
Results Reference
background
PubMed Identifier
23972298
Citation
Lovald ST, Ong KL, Malkani AL, Lau EC, Schmier JK, Kurtz SM, Manley MT. Complications, mortality, and costs for outpatient and short-stay total knee arthroplasty patients in comparison to standard-stay patients. J Arthroplasty. 2014 Mar;29(3):510-5. doi: 10.1016/j.arth.2013.07.020. Epub 2013 Aug 21.
Results Reference
background
PubMed Identifier
19224306
Citation
Kolisek FR, McGrath MS, Jessup NM, Monesmith EA, Mont MA. Comparison of outpatient versus inpatient total knee arthroplasty. Clin Orthop Relat Res. 2009 Jun;467(6):1438-42. doi: 10.1007/s11999-009-0730-0. Epub 2009 Feb 18.
Results Reference
background
PubMed Identifier
26387922
Citation
Petis SM, Howard JL, Lanting BA, Marsh JD, Vasarhelyi EM. In-Hospital Cost Analysis of Total Hip Arthroplasty: Does Surgical Approach Matter? J Arthroplasty. 2016 Jan;31(1):53-8. doi: 10.1016/j.arth.2015.08.034. Epub 2015 Aug 29.
Results Reference
background
Citation
The Arthritis Alliance of Canada, The Impact of Arthritis in Canada: Today and over the next 30 Years, 2011 http://www.arthritisalliance.ca/en/initiativesen/impact-of-arthritis
Results Reference
background
Citation
Canadian Institute for Health Information. Hip and Knee Replacements in Canada, 2017-2018: Canadian Joint Replacement Registry Annual Report. Ottawa, ON: CIHI; 2019.
Results Reference
background

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Inpatient vs Outpatient Total Knee Replacement

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