A Trial to Establish Realistic Patient Expectations of Total Knee Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Lawson Health Research Institute
Sponsor:
Collaborator:
Canadian Orthopaedic Foundation
Information provided by (Responsible Party):
Bert Chesworth, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01732562
First received: November 7, 2012
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Other: Patient e-Learning educational tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial to Establish Realistic Patient Expectations of Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Patient Expectations [ 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. ] [ Designated as safety issue: No ]
    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 [ 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. ] [ Designated as safety issue: No ]
    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'.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Self-Administered Comorbidity Questionnaire (SCQ) [ Time Frame: Baseline measure taken the Pre-Admission Clinic (PAC) visit only. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 352
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Patient receives the standard of care.
Experimental: Patient e-Learning educational tool
Patient receives the standard of care and access to patient e-Learning educational tool.
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.
Other Name: NewKnees.ca

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

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732562

Contacts
Contact: Sharon E Culliton, PhD (C) 519-636-6456 scullit2@uwo.ca
Contact: Bert M Chesworth, PhD 519-661-2111 ext 88009 bcheswor@uwo.ca

Locations
Canada, Ontario
London Health Sciences Centre, University hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Steven J MacDonald, MD    519-685-8500 ext 33689    Steven.MacDonald@lhsc.on.ca   
Principal Investigator: Sharon E Culliton, PhD (C)         
Sponsors and Collaborators
Lawson Health Research Institute
Canadian Orthopaedic Foundation
Investigators
Principal Investigator: Bert M Chesworth, PhD University of Western Ontario, Canada
  More Information

No publications provided

Responsible Party: Bert Chesworth, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01732562     History of Changes
Other Study ID Numbers: 103027
Study First Received: November 7, 2012
Last Updated: April 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Primary Total Knee Arthroplasty
Patient Expectations
Patient Satisfaction
Patient Education
e-Learning

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

ClinicalTrials.gov processed this record on October 30, 2014