Osteoarthritis Clinical Trial
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?
Verified date | February 2015 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 142 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | The Ottawa Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute | The Ottawa Hospital, University of Ottawa, University of Toronto |
Canada,
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. — View 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 Fe — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of participant recruitment, intervention provision, and data collection; sample size needed to detect differences in the rates of unnecessary referral | April 2009 | No | |
Secondary | Decision quality | June 2008 | No | |
Secondary | Satisfaction with preparation for decision making | June 2008 | No | |
Secondary | Proportion of unnecessary surgical referrals | April 2009 | No |
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