Investigating the Impact of a Shared Decision-Making Tool

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411939
• Other study ID #: 2000032637
• Secondary ID: No NIH funding
• Status: Completed
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: September 20, 2023

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: September 20, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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.
• Video
Short video that describes knee osteoarthritis and possible treatment options.
• Standard of Care
Standard of care counseling for a patient presenting with knee osteoarthritis.

Locations

Country	Name	City	State
United States	Yale Medicine Multispecialty	Guilford	Connecticut
United States	Yale Ortho Milford	Milford	Connecticut
United States	Yale Ortho	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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/ — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Immediately after intervention, and Week 4
Secondary	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).	Baseline, Immediately after intervention, and Week 4
Secondary	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).	Baseline, Immediately after intervention, and Week 4