Comparison of Ways to Prepare Patients for Decisions About Joint Replacement Surgery
Are Patient Decision Aids for Total Joint Replacement Cost-effective and do They Optimize the Surgical Referral Process From Primary Care?
2 other identifiers
interventional
343
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2008
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedSeptember 10, 2018
September 1, 2018
3.7 years
May 29, 2009
September 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total wait time for surgery
September 2010
Secondary Outcomes (3)
Surgery rates determined by the proportion of patients who proceed to surgery within 2 years
January 2012
Decision quality, the extent to which patients decisions are informed and values-based
September 2010
Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)
December 2017
Study Arms (2)
1: Patient decision aid
EXPERIMENTALPatient decision aid focused on treatment options for osteoarthritis of the hip or knee and preference report for surgeons. The patient decision aid used is from the Informed Medical Decisions Foundation
2: Usual care
ACTIVE COMPARATORUsual patient educational resources for patients undergoing hip or knee replacement surgery.
Interventions
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).
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Foundation for Informed Medical Decision Makingcollaborator
- The Ottawa Hospitalcollaborator
- Queensway Carleton Hospitalcollaborator
- University of Ottawacollaborator
- University of Torontocollaborator
- University of Chicagocollaborator
- Northwestern University Feinberg School of Medicinecollaborator
- Northwestern Universitycollaborator
- Dartmouth-Hitchcock Medical Centercollaborator
Study Sites (2)
The Ottawa Hospital
Ottawa, Ontario, K1Y 1J7, Canada
Queensway Carleton Hospital
Ottawa, Ontario, K2H 8P4, Canada
Related Publications (6)
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.
PMID: 18397937BACKGROUNDStacey 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.
PMID: 24564877BACKGROUNDSepucha 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.
PMID: 21729315BACKGROUNDStacey 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.
PMID: 26254238RESULTTrenaman 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.
PMID: 28624294RESULTTrenaman 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.
PMID: 32173628DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dawn Stacey, RN PhD
Ottawa Hospital Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 2, 2009
Study Start
May 1, 2008
Primary Completion
January 1, 2012
Study Completion
May 1, 2017
Last Updated
September 10, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share