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

Primary Purpose

Knee Osteoarthritis, Total Knee Arthroplasty

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Baseline and Follow-up Surveys
Patient Reported Outcome Measure informed Decision Aid
Pamphlet
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Edmonton Bone and Joint Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Non Treatment Group

Arm Description

Conventional information

Outcomes

Primary Outcome Measures

Decision quality
Hip and Knee Decision Quality Instrument (HK-DQI)

Secondary Outcome Measures

Quality of life (generic)
Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
Quality of life (condition-specific)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Depression
The Patient Health Questionnaire (PHQ-9)
Knowledge about total knee arthroplasty surgery
HK-DQI
Values
HK-DQI
Decisional conflict
Decisional Conflict Scale (SURE)
Treatment Preference
Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure
Preference for involvement in decision making
Control Preferences Scale (CPS)
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.
Patient-reported shared decision-making
CollaboRATE
Decisional regret
Decision Regret Scale
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'
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.
Surgical consult
Electronic Medical Records (EMR)
Surgery
EMR
Concordance
HK-DQI

Full Information

First Posted
July 27, 2017
Last Updated
April 24, 2020
Sponsor
University of Calgary
Collaborators
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03240913
Brief Title
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty
Official Title
A PROMs Based Educational Tool (PROM-DA) for Patients Considering Total Knee Arthroplasty: Development and a Pilot Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
March 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Total Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Title
Non Treatment Group
Arm Type
Placebo Comparator
Arm Description
Conventional information
Intervention Type
Behavioral
Intervention Name(s)
Baseline and Follow-up Surveys
Intervention Description
(completed online)
Intervention Type
Other
Intervention Name(s)
Patient Reported Outcome Measure informed Decision Aid
Intervention Description
(PROM-DA)
Intervention Type
Other
Intervention Name(s)
Pamphlet
Intervention Description
(usual care)
Primary Outcome Measure Information:
Title
Decision quality
Description
Hip and Knee Decision Quality Instrument (HK-DQI)
Time Frame
40 to 52 weeks after baseline
Secondary Outcome Measure Information:
Title
Quality of life (generic)
Description
Euroqol Five Dimensions Questionnaire (EQ-5D-5L)
Time Frame
40 to 52 weeks after baseline
Title
Quality of life (condition-specific)
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
40 to 52 weeks after baseline
Title
Depression
Description
The Patient Health Questionnaire (PHQ-9)
Time Frame
40 to 52 weeks after baseline
Title
Knowledge about total knee arthroplasty surgery
Description
HK-DQI
Time Frame
Baseline
Title
Values
Description
HK-DQI
Time Frame
Baseline
Title
Decisional conflict
Description
Decisional Conflict Scale (SURE)
Time Frame
Baseline
Title
Treatment Preference
Description
Single item question: Do you feel the potential benefits of knee replacement surgery outweigh the potential surgical risks? Yes No Unsure
Time Frame
Baseline
Title
Preference for involvement in decision making
Description
Control Preferences Scale (CPS)
Time Frame
Baseline
Title
Willingness to have surgery
Description
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.
Time Frame
Baseline
Title
Patient-reported shared decision-making
Description
CollaboRATE
Time Frame
3 to 6 weeks after baseline
Title
Decisional regret
Description
Decision Regret Scale
Time Frame
40 to 52 weeks after baseline
Title
Satisfaction with knee replacement surgery
Description
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'
Time Frame
40 to 52 weeks after baseline
Title
Expectations
Description
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.
Time Frame
40 to 52 weeks after baseline
Title
Surgical consult
Description
Electronic Medical Records (EMR)
Time Frame
1 to 4 weeks after baseline
Title
Surgery
Description
EMR
Time Frame
27 to 30 weeks after baseline
Title
Concordance
Description
HK-DQI
Time Frame
40 to 52 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Edmonton Bone and Joint Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5E 5R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30797238
Citation
Bansback N, Trenaman L, MacDonald KV, Hawker G, Johnson JA, Stacey D, Marshall DA. An individualized patient-reported outcome measure (PROM) based patient decision aid and surgeon report for patients considering total knee arthroplasty: protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2019 Feb 23;20(1):89. doi: 10.1186/s12891-019-2434-2.
Results Reference
derived

Learn more about this trial

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

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