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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240913
• Other study ID #: REB16-0869
• Status: Completed
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: March 3, 2020

Study information

• Verified date: April 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 3, 2020
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Total Knee Arthroplasty

Intervention

Behavioral:
• Baseline and Follow-up Surveys
(completed online)

Other:
• Patient Reported Outcome Measure informed Decision Aid
(PROM-DA)
• Pamphlet
(usual care)

Locations

Country	Name	City	State
Canada	Edmonton Bone and Joint Centre	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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