Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
1 Patient decision aid
2 Usual care
Sponsored by
About this trial
This is an interventional health services research trial for Osteoarthritis focused on measuring patient decision aids, patient preferences, osteoarthritis, joint replacement, waiting times
Eligibility Criteria
Inclusion Criteria:
- Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Exclusion Criteria:
- Patients with inflammatory arthritis
- Previous TJA
- Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Sites / Locations
- The Ottawa Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1 Patient decision aid
2 Usual care
Arm Description
Patient decision aid about treatment options for osteoarthritis
Usual patient educational materials
Outcomes
Primary Outcome Measures
Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcome Measures
Decision quality
Satisfaction with preparation for decision making
Proportion of unnecessary surgical referrals
Full Information
NCT ID
NCT00743951
First Posted
July 25, 2007
Last Updated
March 29, 2016
Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital, University of Ottawa, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00743951
Brief Title
Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
Official Title
Feasibility Study: Does Screening Plus Patient Decision Aids Reduce Unnecessary Surgical Referrals for Total Joint Arthroplasty in Practices With Long Waiting Lists for Surgical Consults?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
The Ottawa Hospital, University of Ottawa, University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Ministries of Health consider wait lists for total joint replacement a top priority. Research priorities to manage wait lists indicate the need to establish benchmarks that consider patient preferences. However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indicators for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. When decision aids are used in combination with assessing surgical eligibility, there may be a reduction in unnecessary referrals for surgery either because the patient is ineligible or because the eligible candidates make informed decisions to forgo this option.
The study objective is to pilot test the feasibility of a trial evaluating the effects of patient decision aids on reducing unnecessary surgical referrals for total joint replacement, when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility.
The investigators expect to provide evidence of feasibility (e.g. ease of recruiting patients, delivering the interventions, measuring patient outcomes) and sample size needed for a larger scale study. This study should also provide evidence for planning implementation of the interventions and standardized training across other centers.
Detailed Description
Background:
Current research priorities to manage wait times for total joint arthroplasty (TJA) indicate the need to establish benchmarks that consider patient preferences. Among clinically appropriate candidates for this procedure, patients' preferences for surgery is very low; between 8.5 and 14.9% of clinically ideal candidates were definitely willing to consider TJA.However, patients' preferences for hip or knee replacements are strongly associated with their misperceptions of the indications for, and the risks and benefits of, these procedures. These misperceptions can be corrected with the use of patient decision aids. Therefore, patient decision aids may have a role in ensuring that wait list reforms address under-use of surgical procedures that informed patients need and want, while preventing the over-use of procedures that informed patients do not value. If they were used in combination with screening for surgical eligibility, they might also prevent inappropriate referrals for surgery (i.e., patients who are not clinically eligible or who would not want surgery even if they were clinically eligible).
Objective:
To pilot test the feasibility of a trial evaluating the incremental effects of patient decision aids on reducing unnecessary surgical referrals for TJA, when used in combination with a general practitioner intake clinic that screens patients for surgical eligibility.
Participants & Setting:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited. Excluded are those with inflammatory arthritis, previous TJA, or those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Design:
In this pilot study, patients will be screened for surgical eligibility by a trained general practitioner using a standardized examination of the hip/knee and questionnaire assessing joint symptoms and disability. Eligible patients will be stratified by affected joint (hip/knee) and randomly allocated to either: a) usual education; or b) a patient decision aid which presents balanced evidence-based information on the treatment options, including the risks and benefits. Automated reports will be sent to the surgeon for all patients.
Primary Outcomes:
Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Secondary Outcomes
Proportion of unnecessary surgical referrals.
Decision quality, the extent to which patients' decisions are informed and values-based.
Perception of Preparation for Decision Making.
Timeline and Deliverables:
By the end of this one year study, we will prepare a report and policy brief on the evidence of feasibility to support a larger scale multi-centre trial and a fully implementable set of interventions, with standardized training, to facilitate replication elsewhere.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
patient decision aids, patient preferences, osteoarthritis, joint replacement, waiting times
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Patient decision aid
Arm Type
Experimental
Arm Description
Patient decision aid about treatment options for osteoarthritis
Arm Title
2 Usual care
Arm Type
Active Comparator
Arm Description
Usual patient educational materials
Intervention Type
Behavioral
Intervention Name(s)
1 Patient decision aid
Intervention Description
Patients will receive:
i)patient education booklet ii) a video/DVD PtDA for either hip (Treatment choices for hip osteoarthritis) or knee (Treatment choices for knee osteoarthritis) © Health Dialog 2005.
iii) a personal decision form is an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process.
iv) Referral to the surgeon with a standardized report of their clinical findings plus decisional data (knowledge, values, preference).
Intervention Type
Behavioral
Intervention Name(s)
2 Usual care
Intervention Description
Patient will be given i) education booklet from local hospital which is a standardized teaching booklet given to all patients describing preparation for surgery, recovery after surgery, discharge plans.
ii) Referral to the surgeon with a standardized report of their clinical findings.
Primary Outcome Measure Information:
Title
Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral
Time Frame
April 2009
Secondary Outcome Measure Information:
Title
Decision quality
Time Frame
June 2008
Title
Satisfaction with preparation for decision making
Time Frame
June 2008
Title
Proportion of unnecessary surgical referrals
Time Frame
April 2009
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients referred for surgical consultation for hip or knee osteoarthritis at The Ottawa Hospital will be recruited
Exclusion Criteria:
Patients with inflammatory arthritis
Previous TJA
Those unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Stacey, PHD
Organizational Affiliation
University of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 1J7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18397937
Citation
Stacey D, Hawker G, Dervin G, Tomek I, Cochran N, Tugwell P, O'Connor AM. Management of Chronic Pain: Improving shared decision making in osteoarthritis. BMJ. 2008 Apr 26;336(7650):954-5. doi: 10.1136/bmj.39520.701748.94. Epub 2008 Apr 8.
Results Reference
background
PubMed Identifier
24564877
Citation
Stacey D, Hawker G, Dervin G, Tugwell P, Boland L, Pomey MP, O'Connor AM, Taljaard M. Decision aid for patients considering total knee arthroplasty with preference report for surgeons: a pilot randomized controlled trial. BMC Musculoskelet Disord. 2014 Feb 24;15:54. doi: 10.1186/1471-2474-15-54.
Results Reference
result
Links:
URL
http://www.bmj.com/cgi/content/full/336/7650/954-a?view=long&pmid=18397937
Description
Clinical and Decision Summary tool
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Feasibility Study: Effect of Patient Decision Aids for Total Joint Replacement on Surgical Referrals
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