A Trial to Establish Realistic Patient Expectations of Total Knee Replacement
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patient e-Learning educational tool
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis focused on measuring Primary Total Knee Arthroplasty, Patient Expectations, Patient Satisfaction, Patient Education, e-Learning
Eligibility Criteria
Inclusion Criteria:
- 20-90 years of age
- diagnosis of primary or secondary osteoarthritis of the knee
- scheduled for primary total knee replacement by Joint Replacement Institute orthopaedic surgeons at University Hospital, London Health Sciences Centre
- access to a computer (to log on to the web-based e-learning intervention)
Exclusion Criteria:
- unable to read written English or understand spoken English
- unable to provide informed consent
- diagnosis of rheumatoid arthritis
- scheduled for knee revision, patellar resurfacing, hemiarthroplasty of the knee, unicompartmental (unicondylar) knee arthroplasty or high tibial osteotomy, or knee surgery due to a tumor or trauma
- unable to access a computer (to log on to the web-based e-learning intervention)
Sites / Locations
- London Health Sciences Centre, University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Patient e-Learning educational tool
Arm Description
Patient receives the standard of care.
Patient receives the standard of care and access to patient e-Learning educational tool.
Outcomes
Primary Outcome Measures
Patient Expectations
Patient Expectations will be measured with four distinct domains using single questions related to pain; ability to perform activities of daily living (ADL); ability to participate in sports and global recovery from surgery. Responses are given using a 0 to four scale, with 0 assigned for a not applicable response option: 1= no, I do not expect surgery to help with my pain/ADL/etc., 2= yes, but just a little, 3= yes, somewhat, 4= yes, a lot.
Secondary Outcome Measures
Patient Satisfaction
Patient Satisfaction will be measured using the Patient Acceptable Symptom State Question (PASS). This question will be, "Considering all the activities you do during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" The response options to this question are simply 'yes' or 'no'.
Full Information
NCT ID
NCT01732562
First Posted
November 7, 2012
Last Updated
August 8, 2016
Sponsor
Lawson Health Research Institute
Collaborators
Canadian Orthopaedic Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01732562
Brief Title
A Trial to Establish Realistic Patient Expectations of Total Knee Replacement
Official Title
A Randomized Controlled Trial to Establish Realistic Patient Expectations of Total Knee Arthroplasty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Canadian Orthopaedic Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients from the Joint Replacement Institute scheduled to undergo primary total knee replacement surgery (TKR) will be invited to participate at the Pre Admission Clinic (PAC), University Hospital, London Health Sciences Centre. Baseline questionnaires of preoperative measures and demographic information and a cost analysis will be explored at the PAC for each patient. Patients will be randomized with the treatment group receiving access to a web-based, e-learning intervention. Postoperatively all patients will be asked to complete questionnaires at 6 weeks, 3 months and 1 year after their TKR surgery.
Objectives
The first primary objective is to compare the effect of two methods of providing patient education on expectations of surgical outcome in total knee replacement (TKR) patients.
The second objective is to compare the effect of two methods of providing patient education on satisfaction with surgical outcome in TKR patients.
The intervention of interest is an e-learning education program that spans both the preoperative and postoperative time period. The control condition will be the current method of patient education provided at the hospital study site.
Hypothesis: Objective One
More change in patient expectations will occur between preoperative and one year postoperative in the e-learning educational intervention group.
Hypothesis: Objective Two
More change in patient satisfaction will occur between preoperative and one year postoperative in the e-learning educational intervention group.
Detailed Description
This will be a single centre prospective experimental study, involving seven orthopaedic surgeons and their patients undergoing total knee replacement (TKR). A consecutive sample of elective primary TKR patients will be invited to participate from London Health Sciences Centre, University Hospital, London, Ontario, Canada. Additionally, patient hospital charts will be accessed to establish the concordance between co-morbidities recorded in patient history and self-report measures of co-morbidities.
Interested patients will be randomized into one of two groups. Group 1 (intervention) will receive the e-learning educational intervention in addition to the current method of patient education. It will commence at the pre-admission clinic and continue to the study end-point of 1-year postoperative. Group 2 (control) will receive the current, existing method utilized by each of the seven orthopaedic surgeons for their patient education. At pre-admission, patients are provided a 31 page hard copy of My Guide to Total Knee Joint Replacement (Revised January, 2008) and they are made aware of an electronic copy of this document available at the following website: http://www.jointreplacementinstitute.com/patients.html
The assumption is that patients can and will read this document to educate themselves about their TKR surgery. The interactive e-learning patient education intervention extends beyond simple accessibility to information and includes interactive features. The intervention spans surgery and rehabilitation aftercare with patients undergoing TKR. Measurements will take place at pre-admission before any preoperative education takes place and at 6 weeks, 3 months and 1 year after TKR surgery. Patients will have the option of completing questionnaires online using Empower or hard copy sent by mail. They will also receive reminders by email or phone about completing the questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Primary Total Knee Arthroplasty, Patient Expectations, Patient Satisfaction, Patient Education, e-Learning
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
416 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patient receives the standard of care.
Arm Title
Patient e-Learning educational tool
Arm Type
Experimental
Arm Description
Patient receives the standard of care and access to patient e-Learning educational tool.
Intervention Type
Other
Intervention Name(s)
Patient e-Learning educational tool
Other Intervention Name(s)
NewKnees.ca
Intervention Description
Web based site with videos of TKR surgical animation, demonstrations of exercises and activities following surgery and conversations with surgeons, physiotherapist, occupational therapist and patients.
Primary Outcome Measure Information:
Title
Patient Expectations
Description
Patient Expectations will be measured with four distinct domains using single questions related to pain; ability to perform activities of daily living (ADL); ability to participate in sports and global recovery from surgery. Responses are given using a 0 to four scale, with 0 assigned for a not applicable response option: 1= no, I do not expect surgery to help with my pain/ADL/etc., 2= yes, but just a little, 3= yes, somewhat, 4= yes, a lot.
Time Frame
Change in Patient Expectations from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient Satisfaction will be measured using the Patient Acceptable Symptom State Question (PASS). This question will be, "Considering all the activities you do during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?" The response options to this question are simply 'yes' or 'no'.
Time Frame
Change in Patient Satisfaction from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Other Pre-specified Outcome Measures:
Title
Knee Society Score: Pre-Op
Time Frame
Change in Knee Society Score: Pre-Op from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Change in KOOS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Short Form-12 (SF-12) Health Survey
Time Frame
Change in SF-12 from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Change in HADS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Pain Catastrophizing Scale (PCS)
Time Frame
Change in PCS from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Self-Administered Comorbidity Questionnaire (SCQ)
Time Frame
Baseline measure taken the Pre-Admission Clinic (PAC) visit only.
Title
University of California at Los Angeles (UCLA) Activity Score
Time Frame
Change in UCLA Activity Score from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
Title
Social Role Participation Questionnaire (SRPQ)
Time Frame
Change in SRPQ from the Pre-Admission Clinic (PAC) visit (about 4 weeks before surgery) to 6 weeks postoperative, PAC visit to 3 months postoperative, and PAC visit to 1 year postoperative.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-90 years of age
diagnosis of primary or secondary osteoarthritis of the knee
scheduled for primary total knee replacement by Joint Replacement Institute orthopaedic surgeons at University Hospital, London Health Sciences Centre
access to a computer (to log on to the web-based e-learning intervention)
Exclusion Criteria:
unable to read written English or understand spoken English
unable to provide informed consent
diagnosis of rheumatoid arthritis
scheduled for knee revision, patellar resurfacing, hemiarthroplasty of the knee, unicompartmental (unicondylar) knee arthroplasty or high tibial osteotomy, or knee surgery due to a tumor or trauma
unable to access a computer (to log on to the web-based e-learning intervention)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bert M Chesworth, PhD
Organizational Affiliation
The University of Western Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre, University hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29555496
Citation
Culliton SE, Bryant DM, MacDonald SJ, Hibbert KM, Chesworth BM. Effect of an e-Learning Tool on Expectations and Satisfaction Following Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. 2018 Jul;33(7):2153-2158. doi: 10.1016/j.arth.2018.02.040. Epub 2018 Feb 17.
Results Reference
derived
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A Trial to Establish Realistic Patient Expectations of Total Knee Replacement
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