Clinical trial NCT01732562: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Primary Total Knee Arthroplasty
Patient Expectations
Patient Satisfaction
Patient Education
e-Learning
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian Orthopaedic Foundation
First posted: 2012-11-26
Enrollment: 416
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Patient Expectations
timeFrame: 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 outcomes:
measure: Patient Satisfaction
timeFrame: 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 outcomes:
measure: Knee Society Score: Pre-Op
timeFrame: 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.
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 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.
measure: Short Form-12 (SF-12) Health Survey
timeFrame: 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.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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.
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 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.
measure: Self-Administered Comorbidity Questionnaire (SCQ)
timeFrame: Baseline measure taken the Pre-Admission Clinic (PAC) visit only.
measure: University of California at Los Angeles (UCLA) Activity Score
timeFrame: 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.
measure: Social Role Participation Questionnaire (SRPQ)
timeFrame: 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.
Locations:
city: London
country: Canada
facility: London Health Sciences Centre, University hospital
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Bert M Chesworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.