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

Not Applicable

Completed

• Conditions: Knee Osteoarthritis; Total Knee Arthroplasty
• Interventions: Behavioral: Baseline and Follow-up Surveys; Other: Pamphlet; Other: Patient Reported Outcome Measure informed Decision Aid

• Registration Number: NCT03240913
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-01
• Study First Posted: 2017-08-07
• Primary Completion: 2018-10-18
• Study Completion: 2020-03-03
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Baseline and Follow-up Surveys	-
Non Treatment Group	Baseline and Follow-up Surveys	Conventional information
Non Treatment Group	Pamphlet	Conventional information
Treatment Group	Patient Reported Outcome Measure informed Decision Aid	-

Primary Outcome Measures

Name	Time	Method
Decision quality	40 to 52 weeks after baseline	Hip and Knee Decision Quality Instrument (HK-DQI)

Secondary Outcome Measures

Name	Time	Method
Concordance	40 to 52 weeks after baseline	HK-DQI
Surgery	27 to 30 weeks after baseline	EMR
Depression	40 to 52 weeks after baseline	The Patient Health Questionnaire (PHQ-9)
Decisional regret	40 to 52 weeks after baseline	Decision Regret Scale
Quality of life (condition-specific)	40 to 52 weeks after baseline	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Quality of life (generic)	40 to 52 weeks after baseline	Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
Values	Baseline	HK-DQI
Knowledge about total knee arthroplasty surgery	Baseline	HK-DQI
Willingness to have surgery	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.
Expectations	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.
Surgical consult	1 to 4 weeks after baseline	Electronic Medical Records (EMR)
Decisional conflict	Baseline	Decisional Conflict Scale (SURE)
Preference for involvement in decision making	Baseline	Control Preferences Scale (CPS)
Satisfaction with knee replacement surgery	40 to 52 weeks after baseline	Three item questionnaire: 1. Overall, how satisfied are you with the results of your knee replacement surgery?; 2. 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?; 3. 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'
Treatment Preference	Baseline	Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks?; Yes No Unsure
Patient-reported shared decision-making	3 to 6 weeks after baseline	CollaboRATE

Trial Locations

Locations (1)

Edmonton Bone and Joint Centre; 🇨🇦 Edmonton, Alberta, Canada