Clinical trial NCT05411939: Investigating the Impact of a Shared Decision-Making Tool
Official title: Investigating the Impact of a Shared Decision-Making Tool on Patient Attitudes and Behaviors Regarding Treatment for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 105
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis
timeFrame: Baseline, Immediately after intervention, and Week 4
Secondary outcomes:
measure: Change in Impact of SDMT on patient understanding
timeFrame: Baseline, Immediately after intervention, and Week 4
measure: Change in Impact of SDMT on decision-making
timeFrame: Baseline, Immediately after intervention, and Week 4
Other outcomes:
Locations:
city: Guilford
country: United States
facility: Yale Medicine Multispecialty
state: Connecticut
city: Milford
country: United States
facility: Yale Ortho Milford
state: Connecticut
city: New Haven
country: United States
facility: Yale Ortho
state: Connecticut
Study officials:
affiliation: Yale University
name: Daniel H Wiznia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
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.
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.
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.