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

September 6, 2018 updated by: Ottawa Hospital Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was not indicated as required.

Study Type

Interventional

Enrollment (Actual)

343

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K2H 8P4
        • Queensway Carleton Hospital
      • Ottawa, Ontario, Canada, K1Y 1J7
        • The Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1: Patient decision aid
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
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).

Other Names:
  • non applicable
Behavioral: 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

Other Names:
  • non applicable
ACTIVE_COMPARATOR: 2: Usual care
Usual patient educational resources for patients undergoing hip or knee replacement surgery.
Behavioral: 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

Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total wait time for surgery
Time Frame: September 2010
September 2010

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

Northwestern University
University of Chicago
Dartmouth-Hitchcock Medical Center
University of Toronto
The Ottawa Hospital
University of Ottawa
Northwestern University Feinberg School of Medicine
Foundation for Informed Medical Decision Making
Queensway Carleton Hospital

Investigators

  • Principal Investigator: Dawn Stacey, RN PhD, Ottawa Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

May 29, 2009

First Posted (ESTIMATE)

June 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHRI-2006724
  • FIMDM Research Grant 0099-1 (OTHER_GRANT: FIMDM Research Grant 0099-1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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