Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery

Osteoarthritis Clinical Trial

Official title:

Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911638
• Other study ID #: OHRI-2006724
• Secondary ID: FIMDM Research G
• Status: Completed
• Phase: N/A
• Start date: May 2008
• Est. completion date: May 2017

Study information

• Verified date: September 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This was not indicated as required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: May 2017
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Behavioral:
• Patient decision aid
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).
• Usual care
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

Locations

Country	Name	City	State
Canada	Queensway Carleton Hospital	Ottawa	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (10)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Dartmouth-Hitchcock Medical Center, Feinberg School of Medicine, Northwestern University, Foundation for Informed Medical Decision Making, Northwestern University, Queensway Carleton Hospital, The Ottawa Hospital, University of Chicago, University of Ottawa, University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — 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 Feb 24;15:54. doi: 10.1186/1471-2474-15-54. — View 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. Osteo — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total wait time for surgery		September 2010
Secondary	Surgery rates determined by the proportion of patients who proceed to surgery within 2 years		January 2012
Secondary	Decision quality, the extent to which patients decisions are informed and values-based		September 2010
Secondary	Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)	This phase was delayed to have 5 years of follow-up data on all participants	December 2017