Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoarthritis Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee |
Behavioral: Patient decision aid and referral onward. Behavioral: Patient education and referral onward |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care? |
- Total wait time for surgery [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
- Surgery rates determined by the proportion of patients who proceed to surgery within 2 years [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
- Decision quality, the extent to which patients decisions are informed and values-based [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
- Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs) [ Time Frame: September 2010 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 340 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | January 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Patient decision aid and referral onward
|
Behavioral: Patient decision aid and referral onward.
Patients will receive i) Patient education:usual take home education brochure from recruiting hospital 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:an interactive form used by patients after the DVD to elicit their knowledge, values, preferred option, and perceptions of the decision making process. iv) Referred onward to the surgeon with their preferences for surgery using a standardized report of their clinical findings plus decisional data (knowledge, values, preference). Other Name: non applicable
|
|
Active Comparator: 2
Patient education and referral onward
|
Behavioral: Patient education and referral onward
Patients will receive i) the usual take-home educational brochure available at the recruiting hospital describing preparation for surgery after the decision is made, recovery after surgery, and discharge plans. ii) Referral onward to surgeon with a standardized report of clinical findings only Other Name: non applicable
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Canada, Ontario | |
| The Ottawa Hospital | |
| Ottawa, Ontario, Canada, K1Y 1J7 | |
| Queensway Carleton Hospital | |
| Ottawa, Ontario, Canada, K2H 8P4 | |
| Principal Investigator: | Dawn Stacey, RN PhD | Ottawa Hospital Research Institute |
More Information
Publications:
| Responsible Party: | Dr Dawn Stacey, University of Ottawa School of Nursing |
| ClinicalTrials.gov Identifier: | NCT00911638 History of Changes |
| Other Study ID Numbers: | OHRI-2006724, FIMDM Research Grant 0099-1 |
| Study First Received: | May 29, 2009 |
| Last Updated: | March 15, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
Patient decision aids Patient preferences Osteoarthritis Joint replacement Waiting times |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013