Investigating the Impact of a Shared Decision-Making Tool on Patient Attitudes and Behaviors Regarding Treatment for Knee Osteoarthritis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 105
- Locations
- 3
- Primary Endpoint
- Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Control
Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Intervention: Video (Other)
Control
Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Intervention: Standard of Care (Other)
Shared Decision-Making Tool
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: Shared Decision-Making Tool (Other)
Shared Decision-Making Tool
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: Video (Other)
Shared Decision-Making Tool
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: Standard of Care (Other)
Outcomes
Primary Outcomes
Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis
Time Frame: Baseline, Immediately after intervention, and Week 4
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 Outcomes
- Change in Impact of SDMT on decision-making(Baseline, Immediately after intervention, and Week 4)
- Change in Impact of SDMT on patient understanding(Baseline, Immediately after intervention, and Week 4)