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Inpatient vs Outpatient Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT03026764
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
University of Western Ontario, Canada
Information provided by (Responsible Party):
Brent Lanting, Lawson Health Research Institute

Brief Summary:
This study is a pragmatic randomized clinical trial comparing standard inpatient total hip arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be randomized to inpatient or same day discharge. The investigators will compare patient costs from the perspective of the Ministry of Health, the institution, society and the patient. The investigators will also record complications, patient satisfaction, functional ability and quality of life.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Outpatient Procedure: Inpatient Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Patient Satisfaction and Costs Associated With Total Hip Arthroplasty
Actual Study Start Date : May 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Outpatient
Patients in the outpatient group (same day discharge following THA) 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).
Procedure: Outpatient
Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total hip arthroplasty

Active Comparator: Inpatient
Patients in the inpatient group (following day discharge following THA) 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).
Procedure: Inpatient
Patients in the inpatient group will be discharged from the hospital the following day after a total hip arthroplasty




Primary Outcome Measures :
  1. Indirect and Direct Costs of Treatment [ Time Frame: 3 months ]
    ER visits, clinician visits, caregiver lost productivity, tests, etc

  2. Early complications and adverse events [ Time Frame: 3 months ]
    falls, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc

  3. Standardized measure of health outcome (EQ-5D) [ Time Frame: 3 months ]
    utility


Secondary Outcome Measures :
  1. Patient Satisfaction Questionnaire [ Time Frame: 3 months ]
  2. Western Ontario McMaster Osteoarthritis Index (WOMAC) [ Time Frame: 3 months ]
    Functional outcome

  3. Harris Hip Score [ Time Frame: 3 months ]
    Functional Outcome

  4. Short Form - 12 [ Time Frame: 3 months ]
    Quality of Life

  5. Pain Numeric Scale Rating [ Time Frame: 3 months ]
    Pain

  6. Caregiver Assistance Scale [ Time Frame: 3 months ]
    Caregiver Confidence



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. American Society of Anaesthesiologists (ASA) score equal to or less than 3
  2. Have the ability to read and understand English (printed instructions are provided in English only)
  3. Live within a 60 minute driving distance of University Hospital (UH)
  4. Home / cell phone access
  5. An adult to accompany patient home post-operatively
  6. Sufficient caregiver support

Exclusion Criteria:

  1. Patient has significant pain management issues
  2. Patient / family history of anesthesia related complication(s) (e.g., malignant hyperthermia, pseudocholinesterase deficiency, airway difficulties, obstructive sleep apnea)
  3. Obesity that significantly impacts the patient's ability to mobilize
  4. Anaphylaxis to penicillin
  5. Significant psycho / social issues that would prevent the patient from managing at home safely
  6. Cognitive issues that preclude the ability to understand instructions
  7. Lack of an appropriate social network that can observe the patient post-operatively
  8. Previous total hip arthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026764


Contacts
Contact: Dianne Bryant, PhD 519661211 ext 83947 dianne.bryant@uwo.ca
Contact: Bryn Zomar, MSc 519-685-8500 ext 32794 bryn.zomar@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A5A5
Contact: Dianne Bryant, PhD    519-661-2111 ext 83947    dianne.bryant@uwo.ca   
Contact: Bryn Zomar, MSc    519-685-8500 ext 32794    bryn.zomar@lhsc.on.ca   
Principal Investigator: Brent Lanting, MD, FRCSC         
Sponsors and Collaborators
Lawson Health Research Institute
University of Western Ontario, Canada
Investigators
Principal Investigator: Brent Lanting, MD, FRCSC London Health Sciences Centre

Publications of Results:

Other Publications:
Responsible Party: Brent Lanting, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03026764     History of Changes
Other Study ID Numbers: 106362
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Brent Lanting, Lawson Health Research Institute:
cost
total hip replacement
outpatient Surgery
satisfaction
arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases