Investigating the Impact of a Shared Decision-Making Tool

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Video; Other: Shared Decision-Making Tool; Other: Standard of Care

• Registration Number: NCT05411939
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2022-06-06
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Study Start: 2023-04-15
• Primary Completion: 2023-09-20
• Study Completion: 2023-09-20
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Video	Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Control	Standard of Care	Patients in the control arm of the study will watch a short video and then receive standard of care counseling with an orthopaedic surgeon.
Shared Decision-Making Tool	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.
Shared Decision-Making Tool	Video	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.
Shared Decision-Making Tool	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Change in Impact of the shared decision-making tool on a patient's willingness to seek treatment for knee osteoarthritis	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 Outcome Measures

Name	Time	Method
Change in Impact of SDMT on decision-making	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).
Change in Impact of SDMT on patient understanding	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).

Trial Locations

Locations (3)

Yale Medicine Multispecialty; 🇺🇸 Guilford, Connecticut, United States

Yale Ortho Milford; 🇺🇸 Milford, Connecticut, United States

Yale Ortho; 🇺🇸 New Haven, Connecticut, United States