Clinical trial NCT00911638: Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery
Official title: Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Patient decision aids
Patient preferences
Osteoarthritis
Joint replacement
Waiting times
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
name: The Ottawa Hospital
name: Queensway Carleton Hospital
name: University of Ottawa
name: University of Toronto
name: University of Chicago
name: Northwestern University Feinberg School of Medicine
name: Northwestern University
name: Dartmouth-Hitchcock Medical Center
First posted: 2009-06-02
Enrollment: 343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 primary study objective is to evaluate the effect of patient decision aids (PtDAs) on total wait times (wait times for surgical consultation, plus wait times for surgery) when used in combination with a general practitioner run clinic to screen patients with hip or knee osteoarthritis for surgical eligibility. Major secondary objectives include determining (a) the effect of PtDAs on surgery rates within two years, (b) the effect of PtDAs on decision quality, and (c) cost-effectiveness of PtDAs for total joint arthroplasty.

Detailed description: This was not indicated as required.

Eligibility criteria: Inclusion Criteria:

* Patients referred for surgical consultation for hip or knee osteoarthritis
* WOMAC and HKPT scores indicate that pain and functional criteria are rated as moderate or severe, or there is radiographic evidence of joint damage

Exclusion Criteria:

* Patients with inflammatory arthritis
* Patients who have had previous TJA
* Patients unable to understand video/DVD decision aids due to deafness, blindness, cognitive impairment, or language barrier

Primary outcomes:
measure: Total wait time for surgery
timeFrame: September 2010
Secondary outcomes:
measure: Surgery rates determined by the proportion of patients who proceed to surgery within 2 years
timeFrame: January 2012
measure: Decision quality, the extent to which patients decisions are informed and values-based
timeFrame: September 2010
measure: Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)
timeFrame: December 2017
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Queensway Carleton Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Dawn Stacey, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: Sepucha KR, Stacey D, Clay CF, Chang Y, Cosenza C, Dervin G, Dorrwachter J, Feibelmann S, Katz JN, Kearing SA, Malchau H, Taljaard M, Tomek I, Tugwell P, Levin CA. Decision quality instrument for treatment of hip and knee osteoarthritis: a psychometric evaluation. BMC Musculoskelet Disord. 2011 Jul 5;12:149. doi: 10.1186/1471-2474-12-149.
citation: Stacey D, Taljaard M, Dervin G, Tugwell P, O'Connor AM, Pomey MP, Boland L, Beach S, Meltzer D, Hawker G. Impact of patient decision aids on appropriate and timely access to hip or knee arthroplasty for osteoarthritis: a randomized controlled trial. Osteoarthritis Cartilage. 2016 Jan;24(1):99-107. doi: 10.1016/j.joca.2015.07.024. Epub 2015 Aug 4.
citation: Trenaman L, Stacey D, Bryan S, Taljaard M, Hawker G, Dervin G, Tugwell P, Bansback N. Decision aids for patients considering total joint replacement: a cost-effectiveness analysis alongside a randomised controlled trial. Osteoarthritis Cartilage. 2017 Oct;25(10):1615-1622. doi: 10.1016/j.joca.2017.05.022. Epub 2017 Jun 15.
citation: Trenaman L, Stacey D, Bryan S, Payne K, Hawker G, Bansback N. Long-term effect of patient decision aids on use of joint replacement and health care costs. Osteoarthritis Cartilage. 2020 Jun;28(6):819-823. doi: 10.1016/j.joca.2020.01.019. Epub 2020 Mar 12.