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Completed

NCT Number: NCT03240913

A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty

The primary objectives of this study are to: 1) develop an educational tool known as the Patient Reported Outcome Measure informed Decision Aid (PROM-DA) that will describe the options for patients considering total knee arthroplasty (TKA) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the PROM-DA improves patients decision quality; 3) determine the feasibility of a larger trial to test the PROM-DA in multiple sites and more patients.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Total Knee Arthroplasty

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edmonton Bone and Joint Centre

Edmonton, Alberta, T5E 5R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (age≥30) patients with knee osteoarthritis (OA)
  • Have an appointment with a surgeon for consultation about Total Knee Arthroplasty at the Edmonton Bone and Joint Centre
  • Understands, speaks and reads English; and
  • Able to provide informed consent.

Exclusion criteria

  • Individuals who have had prior total knee arthroplasty
  • Physician-diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Fibromyalgia, or Gout.

Treatment and study plan

Baseline and Follow-up Surveys

Behavioral

(completed online)

Patient Reported Outcome Measure informed Decision Aid

Other

(PROM-DA)

Pamphlet

Other

(usual care)

Primary outcomes

  1. Decision quality

    Time frame: 40 to 52 weeks after baseline

    Hip and Knee Decision Quality Instrument (HK-DQI)

Secondary outcomes

  1. Quality of life (generic)

    Time frame: 40 to 52 weeks after baseline

    Euroqol Five Dimensions Questionnaire (EQ-5D-5L)

  2. Quality of life (condition-specific)

    Time frame: 40 to 52 weeks after baseline

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  3. Depression

    Time frame: 40 to 52 weeks after baseline

    The Patient Health Questionnaire (PHQ-9)

  4. Knowledge about total knee arthroplasty surgery

    Time frame: Baseline

    HK-DQI

  5. Values

    Time frame: Baseline

    HK-DQI

  6. Decisional conflict

    Time frame: Baseline

    Decisional Conflict Scale (SURE)

  7. Treatment Preference

    Time frame: Baseline

    Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks?

    Yes No Unsure

  8. Preference for involvement in decision making

    Time frame: Baseline

    Control Preferences Scale (CPS)

  9. Willingness to have surgery

    Time frame: Baseline

    Single item question: Based on your current understanding of the risks and benefits of knee replacement surgery of your knee arthritis, what is your current preference between having joint replacement surgery or non-surgical treatments?

    I would definitely consider having knee joint replacement surgery now. I would probably consider having knee joint replacement surgery now. I am not sure. I would probably not consider having knee joint replacement surgery now. I would definitely not consider having knee joint replacement surgery now.

  10. Patient-reported shared decision-making

    Time frame: 3 to 6 weeks after baseline

    CollaboRATE

  11. Decisional regret

    Time frame: 40 to 52 weeks after baseline

    Decision Regret Scale

  12. Satisfaction with knee replacement surgery

    Time frame: 40 to 52 weeks after baseline

    Three item questionnaire:

    • Overall, how satisfied are you with the results of your knee replacement surgery?
    • How satisfied are you with your knee replacement surgery for reducing your pain when walking on a flat surface? Going up or down stairs? Sitting or lying down?
    • How satisfied are you with your most recent knee replacement surgery for improving your ability to perform five functions: Going up stairs? Getting in/out of a car or on/off a bus? Rising from bed? Lying in bed? Performing light domestic duties?

    Responses from 'very dissatisfied' to ' very satisfied'

  13. Expectations

    Time frame: 40 to 52 weeks after baseline

    Single item question from Bourne et al. 2010. Clin Orthop Relat Res. related to whether expectations were met; not met; or whether they had no expectations.

  14. Surgical consult

    Time frame: 1 to 4 weeks after baseline

    Electronic Medical Records (EMR)

  15. Surgery

    Time frame: 27 to 30 weeks after baseline

    EMR

  16. Concordance

    Time frame: 40 to 52 weeks after baseline

    HK-DQI

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • University of British Columbia

Registry information

Official study title

A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Aug 7, 2017
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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