A Trial to Establish Realistic Patient Expectations of Total Knee Replacement

Osteoarthritis Clinical Trial

Official title:

A Randomized Controlled Trial to Establish Realistic Patient Expectations of Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732562
• Other study ID #: 103027
• Status: Completed
• Phase: N/A
• First received: November 7, 2012
• Last updated: August 8, 2016
• Start date: April 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• Patient e-Learning educational tool
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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University hospital	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian Orthopaedic Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee Society Score: Pre-Op		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.	No
Other	Knee Injury and Osteoarthritis Outcome Score (KOOS)		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.	No
Other	Short Form-12 (SF-12) Health Survey		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.	No
Other	Hospital Anxiety and Depression Scale (HADS)		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.	No
Other	Pain Catastrophizing Scale (PCS)		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.	No
Other	Self-Administered Comorbidity Questionnaire (SCQ)		Baseline measure taken the Pre-Admission Clinic (PAC) visit only.	No
Other	University of California at Los Angeles (UCLA) Activity Score		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.	No
Other	Social Role Participation Questionnaire (SRPQ)		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.	No
Primary	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.	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.	No
Secondary	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'.	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.	No