Investigating the Impact of a Shared Decision-Making Tool

NCT05411939 | Completed

• 2 other identifiers: 2000032637No NIH funding
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Impact of SDMT on patient understanding

  Baseline, Immediately after intervention, and Week 4

• Change in Impact of SDMT on decision-making

  Baseline, Immediately after intervention, and Week 4

Study Arms (2)

Control

OTHER

Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.

Other: Video; Other: Standard of Care

Shared Decision-Making Tool

EXPERIMENTAL

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.

Other: Shared Decision-Making Tool; Other: Video; Other: Standard of Care

Interventions

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.

Shared Decision-Making Tool

Video OTHER

Short video that describes knee osteoarthritis and possible treatment options.

Control; Shared Decision-Making Tool

Standard of Care OTHER

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

Control; Shared Decision-Making Tool

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 45-64
• mild to moderate knee pain consistent with a diagnosis of osteoarthritis

You may not qualify if:

• known inflammatory disease diagnosis (ex. Lupus, Sjogren, or rheumatoid arthritis, prior knee replacement, acute knee trauma)
• BMI over 45
• persons from vulnerable populations

Sponsors & Collaborators

• Yale University: lead

Study Sites (3)

Yale Medicine Multispecialty

Guilford, Connecticut, 06437, United States

Location

Yale Ortho Milford

Milford, Connecticut, 06461, United States

Location

Yale Ortho

New Haven, Connecticut, 06519, United States

Location

Related Publications (4)

• Hsu H, Siwiec RM. Knee Osteoarthritis. 2023 Jun 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK507884/

  PMID: 29939661 BACKGROUND

• 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.

  PMID: 33756532 BACKGROUND

• 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.

  PMID: 33560326 BACKGROUND

• 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.

  PMID: 31430386 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Videotape Recording; Standard of Care

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daniel H Wiznia, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: April 15, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be kept for 5 years after the data is collected.
• Access Criteria: Researchers involved in the project will discuss access with the principal investigator.

Locations

US (3)