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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Patient decision aid
Usual care
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Osteoarthritis focused on measuring Patient decision aids, Patient preferences, Osteoarthritis, Joint replacement, Waiting times

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital
  • Queensway Carleton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: Patient decision aid

2: Usual care

Arm Description

Patient 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

Usual patient educational resources for patients undergoing hip or knee replacement surgery.

Outcomes

Primary Outcome Measures

Total wait time for surgery

Secondary Outcome Measures

Surgery rates determined by the proportion of patients who proceed to surgery within 2 years
Decision quality, the extent to which patients decisions are informed and values-based
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

Full Information

First Posted
May 29, 2009
Last Updated
September 6, 2018
Sponsor
Ottawa Hospital Research Institute
Collaborators
Foundation for Informed Medical Decision Making, The Ottawa Hospital, Queensway Carleton Hospital, University of Ottawa, University of Toronto, University of Chicago, Northwestern University Feinberg School of Medicine, Northwestern University, Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00911638
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Foundation for Informed Medical Decision Making, The Ottawa Hospital, Queensway Carleton Hospital, University of Ottawa, University of Toronto, University of Chicago, Northwestern University Feinberg School of Medicine, Northwestern University, Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Patient decision aids, Patient preferences, Osteoarthritis, Joint replacement, Waiting times

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
343 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Patient decision aid
Arm Type
Experimental
Arm Description
Patient 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
Arm Title
2: Usual care
Arm Type
Active Comparator
Arm Description
Usual patient educational resources for patients undergoing hip or knee replacement surgery.
Intervention Type
Behavioral
Intervention Name(s)
Patient decision aid
Other Intervention Name(s)
non applicable
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Other Intervention Name(s)
non applicable
Intervention Description
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
Primary Outcome Measure Information:
Title
Total wait time for surgery
Time Frame
September 2010
Secondary Outcome Measure Information:
Title
Surgery rates determined by the proportion of patients who proceed to surgery within 2 years
Time Frame
January 2012
Title
Decision quality, the extent to which patients decisions are informed and values-based
Time Frame
September 2010
Title
Cost effectiveness (including estimated effects on quality adjusted life expectancy and costs)
Description
This phase was delayed to have 5 years of follow-up data on all participants
Time Frame
December 2017

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Stacey, RN PhD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 1J7
Country
Canada
Facility Name
Queensway Carleton Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 8P4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18397937
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.
Results Reference
background
PubMed Identifier
24564877
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.
Results Reference
background
PubMed Identifier
21729315
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.
Results Reference
background
PubMed Identifier
26254238
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.
Results Reference
result
PubMed Identifier
28624294
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.
Results Reference
result
PubMed Identifier
32173628
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.
Results Reference
derived

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

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