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OsteoarthritisNCT00911638

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

A study testing Patient decision aid in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis
What is being tested?
Patient decision aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
343 participants
Where
2 sitesCanada
Study dates
May 2008to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • The Ottawa Hospital

    Ottawa, Ontario, K1Y 1J7

  • Queensway Carleton Hospital

    Ottawa, Ontario, K2H 8P4

Other trials in Canada

About this study

Official title: 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.

Read the detailed description

This was not indicated as required.

Conditions
Osteoarthritis
Being tested
Patient decision aid, Usual care
Keywords
Patient decision aids, Patient preferences, Osteoarthritis, Joint replacement, Waiting times
Medical subject headings
Osteoarthritis, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient decision aidBehavioural

    Also called non applicable

    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 careBehavioural

    Also called non applicable

    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

Study groups in NCT00911638
Study groupRoleWhat they receive
1: Patient decision aidExperimentalPatient 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
Receives: Behavioral: Patient decision aid; Behavioral: Usual care
2: Usual careActive comparatorUsual patient educational resources for patients undergoing hip or knee replacement surgery.
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total wait time for surgery

    Measured: September 2010

Secondary outcomes (3)

  1. Surgery rates determined by the proportion of patients who proceed to surgery within 2 years

    Measured: January 2012

  2. Decision quality, the extent to which patients decisions are informed and values-based

    Measured: September 2010

  3. 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

    Measured: December 2017

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionJan 2012
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
343 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911638
Sponsor's protocol ID
OHRI-2006724
Other IDs
FIMDM Research Grant 0099-1
Status last verified
Sep 2018
First submitted
29 May 2009
Last updated
10 Sep 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18397937

  • 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.

    PubMed 24564877

  • 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.

    PubMed 21729315

  • 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.

    PubMed 26254238

  • 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.

    PubMed 28624294

  • 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.

    PubMed 32173628

Questions about this trial

What is this clinical trial studying?

A study testing Patient decision aid in people with Osteoarthritis, run by Ottawa Hospital Research Institute at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total wait time for surgery (time frame: September 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00911638, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2018.

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