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Completed

NCT Number: NCT05411939

Investigating the Impact of a Shared Decision-Making Tool

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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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Medicine Multispecialty, Guilford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared decision-making tool

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

Other

Short video that describes knee osteoarthritis and possible treatment options.

Standard of care

Other

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

Primary outcomes

  1. 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

  1. Change in Impact of SDMT on patient understanding

    Time frame: Baseline, Immediately after intervention, and Week 4

    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).

  2. Change in Impact of SDMT on decision-making

    Time frame: Baseline, Immediately after intervention, and Week 4

    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).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Investigating the Impact of a Shared Decision-Making Tool on Patient Attitudes and Behaviors Regarding Treatment for Knee Osteoarthritis

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2022
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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