Investigating the Impact of a Shared Decision-Making Tool
Primary Purpose
Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Decision-Making Tool
Video
Standard of Care
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- age 45-64
- mild to moderate knee pain consistent with a diagnosis of osteoarthritis
Exclusion Criteria:
- known inflammatory disease diagnosis (ex. Lupus, Sjogren, or rheumatoid arthritis, prior knee replacement, acute knee trauma)
- BMI over 45
- persons from vulnerable populations
Sites / Locations
- Yale Medicine MultispecialtyRecruiting
- Yale Ortho MilfordRecruiting
- Yale OrthoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control
Shared Decision-Making Tool
Arm Description
Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Patients in the treatment arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon that includes discussion of the shared decision-making tool.
Outcomes
Primary Outcome Measures
Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis
The primary objective is to assess the impact of the shared decision-making tool on a patient's decision to seek treatment for knee osteoarthritis. This will be assessed using a survey with a 5-point scale that asks several questions about a patient's willingness to pursue specific treatment options (1 = not at all willing, 5 = completely willing). The change over time is assessed to see if the intervention changes the patient's willingness to consider different treatment options. To assess change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Secondary Outcome Measures
Change in Impact of SDMT on patient understanding
This outcome is assessed using survey questions with a 5-point scale response option (1 = do not understand disease progression, 5 = completely understand disease progression). One survey question asks how well participants understand their disease progression. This is assessed over time to see if the SDMT impacts patient understanding. To assess change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Change in Impact of SDMT on decision-making
This outcome is assessed through a survey question with a 5-point scale response option (1 = did not impact, 5 = completely impacted). This question asks specifically how the discussion (either standard of care or SDMT) impacts the participants decision to pursue treatment. To assess the change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05411939
Brief Title
Investigating the Impact of a Shared Decision-Making Tool
Official Title
Investigating the Impact of a Shared Decision-Making Tool on Patient Attitudes and Behaviors Regarding Treatment for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
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 purpose of this research study is to learn more about how the use of a Shared Decision-Making Tool (SDMT) will impact a patient's decision-making to pursue treatment for knee osteoarthritis.
Detailed Description
The main purpose of this study is to determine the impact of the SDMT on patient decision- making regarding various treatment modalities for knee osteoarthritis. If the SDMT is found to be beneficial, it can be implemented to help engage patients in their care and support more efficient implementation of treatment suggestions. This subsequently will improve patient's quality of life. Getting patients who have not taken advantage of preventive care or healthy lifestyles to change is paramount to making the medical experience in America more equal for all its citizens and reducing total societal costs. Building provider-patient communication tools that resonate with all stakeholders should inform patients as they work to make health decisions that reflect their individual beliefs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized control trial in which participants will be assigned to one of two arms. Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon. Patients in the treatment arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon that includes discussion of the SDMT. All patients will complete pre- and post-visit surveys designed to measure the severity of their knee osteoarthritis and their willingness to proceed with different treatment modalities.
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Other
Arm Description
Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Arm Title
Shared Decision-Making Tool
Arm Type
Experimental
Arm Description
Patients in the treatment arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon that includes discussion of the shared decision-making tool.
Intervention Type
Other
Intervention Name(s)
Shared Decision-Making Tool
Intervention Description
The Shared Decision-Making Tool (SDMT) is designed to provide a personalized, patient- centered framework for clinical discussions regarding treatment options for knee osteoarthritis. The tool functions through patient input of information such as pain severity and current symptoms, alongside other demographic information such as age, race, and comorbidities, to offer a series of outcomes to better illustrate how the patient's specific disease presentation will progress. Ultimately, using the SDMT may impact patient behavior if patients change their treatment preferences after utilizing the tool. This can empower them to seek additional support over time and maintain communication with their orthopedist to ensure they are on a healthier path.
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
Short video that describes knee osteoarthritis and possible treatment options.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care counseling for a patient presenting with knee osteoarthritis.
Primary Outcome Measure Information:
Title
Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis
Description
The primary objective is to assess the impact of the shared decision-making tool on a patient's decision to seek treatment for knee osteoarthritis. This will be assessed using a survey with a 5-point scale that asks several questions about a patient's willingness to pursue specific treatment options (1 = not at all willing, 5 = completely willing). The change over time is assessed to see if the intervention changes the patient's willingness to consider different treatment options. To assess change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Time Frame
Baseline, Immediately after intervention, and Week 4
Secondary Outcome Measure Information:
Title
Change in Impact of SDMT on patient understanding
Description
This outcome is assessed using survey questions with a 5-point scale response option (1 = do not understand disease progression, 5 = completely understand disease progression). One survey question asks how well participants understand their disease progression. This is assessed over time to see if the SDMT impacts patient understanding. To assess change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Time Frame
Baseline, Immediately after intervention, and Week 4
Title
Change in Impact of SDMT on decision-making
Description
This outcome is assessed through a survey question with a 5-point scale response option (1 = did not impact, 5 = completely impacted). This question asks specifically how the discussion (either standard of care or SDMT) impacts the participants decision to pursue treatment. To assess the change a baseline survey, a survey immediately after the intervention, and survey 4 weeks later will be collected. Change = (Week 4 - Baseline) and Change = (Immediately after intervention - Baseline) and Change = (Week 4 - Immediately after intervention).
Time Frame
Baseline, Immediately after intervention, and Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 45-64
mild to moderate knee pain consistent with a diagnosis of osteoarthritis
Exclusion Criteria:
known inflammatory disease diagnosis (ex. Lupus, Sjogren, or rheumatoid arthritis, prior knee replacement, acute knee trauma)
BMI over 45
persons from vulnerable populations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel H Wiznia, MD
Phone
203-785-7132
Email
daniel.wiznia@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Chloe C Dlott, BS
Phone
831-345-3961
Email
chloe.dlott@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel H Wiznia, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Medicine Multispecialty
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel H Wiznia, MD
Phone
203-785-7132
Email
daniel.wiznia@yale.edu
Facility Name
Yale Ortho Milford
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel H Wiznia, MD
Phone
203-785-7132
Email
daniel.wiznia@yale.edu
Facility Name
Yale Ortho
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel H Wiznia, MD
Phone
203-785-7132
Email
daniel.wiznia@yale.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified patient data will be available to other researchers who assist study preparation for publication.
IPD Sharing Time Frame
De-identified data will be kept for 5 years after the data is collected.
IPD Sharing Access Criteria
Researchers involved in the project will discuss access with the principal investigator.
Citations:
PubMed Identifier
29939661
Citation
Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/
Results Reference
background
PubMed Identifier
33756532
Citation
Johnson CB. A Personalized Shared Decision-Making Tool for Osteoarthritis Management of the Knee. Orthop Nurs. 2021 Mar-Apr 01;40(2):64-70. doi: 10.1097/NOR.0000000000000739.
Results Reference
background
PubMed Identifier
33560326
Citation
Katz JN, Arant KR, Loeser RF. Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review. JAMA. 2021 Feb 9;325(6):568-578. doi: 10.1001/jama.2020.22171.
Results Reference
background
PubMed Identifier
31430386
Citation
Marcelin JR, Siraj DS, Victor R, Kotadia S, Maldonado YA. The Impact of Unconscious Bias in Healthcare: How to Recognize and Mitigate It. J Infect Dis. 2019 Aug 20;220(220 Suppl 2):S62-S73. doi: 10.1093/infdis/jiz214.
Results Reference
background
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Investigating the Impact of a Shared Decision-Making Tool
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