Investigating the Impact of a Shared Decision-Making Tool

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-15

Study Completion Date

2023-09-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Video

Intervention Type OTHER

Short video that describes knee osteoarthritis and possible treatment options.

Standard of Care

Intervention Type OTHER

Standard of care counseling for a patient presenting with knee osteoarthritis.

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.

Group Type EXPERIMENTAL

Shared Decision-Making Tool

Intervention Type OTHER

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.

Video

Intervention Type OTHER

Short video that describes knee osteoarthritis and possible treatment options.

Standard of Care

Intervention Type OTHER

Standard of care counseling for a patient presenting with knee osteoarthritis.

Interventions

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Shared Decision-Making Tool

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

Video

Short video that describes knee osteoarthritis and possible treatment options.

Intervention Type OTHER

Standard of Care

Standard of care counseling for a patient presenting with knee osteoarthritis.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes