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Knee osteoarthritis is a common condition that can cause pain, stiffness, and difficulty with daily activities. Many patients interpret these symptoms as signs of ongoing joint damage, which can influence their expectations and decisions about treatment.
This randomized controlled trial compares three approaches used during a routine orthopedic visit: a health aid, a decision aid, and usual care. The health aid is designed to improve patients' understanding of knee osteoarthritis by addressing common misconceptions and helping patients develop a more accurate and less distressing understanding of their condition. The decision aid provides structured information about treatment options. In the usual care group, patients receive standard clinical consultation without additional educational materials.
The main goal of the study is to evaluate differences in patients' understanding of knee osteoarthritis immediately after the clinic visit. Secondary outcomes include patients' interest in additional care options such as imaging, physical therapy, injections, and surgery, as well as measures of trust in the clinician and care experience.
The results of this study may help improve how information is communicated to patients with knee osteoarthritis and guide future approaches to patient education and shared decision-making.
Knee osteoarthritis is a highly prevalent musculoskeletal condition and a leading cause of pain and disability in adults. Patients often interpret symptoms such as pain, stiffness, and functional limitation as evidence of progressive structural damage or "wear and tear." These interpretations may contribute to distress, increased demand for imaging or invasive treatments, and misalignment between patient expectations and evidence-based care.
Traditional decision aids are designed to support shared decision-making by presenting information about treatment options and potential outcomes. However, these tools primarily assume that patients make rational decisions based on accurate information. Emerging evidence from cognitive psychology suggests that decision-making is also influenced by automatic, intuitive processes, prior beliefs, emotional responses, and cognitive biases. As a result, providing information alone may not be sufficient to meaningfully shift misconceptions or improve alignment between patient values and treatment choices.
This randomized controlled trial evaluates the impact of a novel "health aid" compared with a standard decision aid and usual care in patients presenting for an initial consultation for knee osteoarthritis. The health aid is designed not only to provide information but also to address common misconceptions about knee osteoarthritis, reduce unnecessary fear related to symptoms, and support a more adaptive understanding of aging-related joint changes. In contrast, the decision aid focuses on presenting structured information about available treatment options.
Participants will be randomized in a 1:1:1 ratio to receive either the health aid, the decision aid, or usual care during their clinic visit. The intervention is delivered immediately after diagnosis is established, and patients complete outcome assessments immediately following the visit.
The primary outcome is post-visit understanding of knee osteoarthritis, measured using a misconception questionnaire. Secondary outcomes include patient-reported interest in subsequent healthcare utilization (including imaging, physical therapy, injections, and surgery), as well as measures of trust and care experience (TRECS).
The study aims to determine whether addressing cognitive and perceptual aspects of illness understanding through a health aid leads to improved patient understanding and potentially influences downstream healthcare preferences compared with traditional decision support tools and usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (Control) | No Intervention | Standard clinical visit without additional educational material | |
| Health Aid | Other | Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit |
|
| Decision Aid | Other | Patients review a decision aid describing treatment options for knee osteoarthritis during the visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Aid | Other | Patients review a health aid addressing misconceptions about knee osteoarthritis during the visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-visit misconception score | Difference in post-visit misconception scores among patients with knee osteoarthritis randomized to a health aid, decision aid, or usual care group. Scores range from 0 to 16, with higher scores indicating a more accurate understanding of knee osteoarthritis. | Measured once, immediately following consultation with the musculoskeletal specialist |
| Measure | Description | Time Frame |
|---|---|---|
| Interest in return visit | Rated from 0 (I definitely will not schedule a return visit) to 10 (I definitely will schedule a return visit). | Measured once, immediately following consultation with the musculoskeletal specialist |
| Interest in an imaging test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Ring, MD, PhD | Contact | 6177929848 | David.ring@austin.utexas.edu | |
| Nadia Azib | Contact | Nadia.azib@austin.utexas.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Ring, MD, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas At Austin | Austin | Texas | 78712 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30031600 | Background | Wilkens SC, Ring D, Teunis T, Lee SP, Chen NC. Decision Aid for Trapeziometacarpal Arthritis: A Randomized Controlled Trial. J Hand Surg Am. 2019 Mar;44(3):247.e1-247.e9. doi: 10.1016/j.jhsa.2018.06.004. Epub 2018 Jul 18. | |
| 33162270 | Background | Kleiss IIM, Kortlever JTP, Ring D, Vagner GA, Reichel LM. A Randomized Controlled Trial of Decision Aids for Upper-Extremity Conditions. J Hand Surg Am. 2021 Apr;46(4):338.e1-338.e15. doi: 10.1016/j.jhsa.2020.09.003. Epub 2020 Nov 6. |
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Individual participant data will not be shared with other researchers. The study involves patient-reported outcomes collected during clinical encounters, including measures of health perceptions, treatment preferences, and trust. Due to the sensitive nature of these data and the absence of a predefined data-sharing infrastructure or funding mandate for data deposition, individual participant data will not be made publicly available. Aggregate study findings will be reported in peer-reviewed publications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2026 | Jun 21, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Participants will be randomized in a 1:1:1 ratio to one of three parallel groups: health aid, decision aid, or usual care. The intervention is delivered immediately during the clinical encounter after the diagnosis of knee osteoarthritis is established. Participants assigned to the health aid or decision aid groups will review the respective educational material during the visit while the clinician steps out briefly. Participants in the usual care group will receive standard clinical consultation without exposure to additional educational materials. All participants complete post-visit outcome assessments immediately after the encounter.
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| Decision Aid | Other | Patients review a decision aid describing treatment options for knee osteoarthritis during the visit |
|
Rated from 0 (I am definitely not interested in scheduling an imaging test for my condition) to 10 (I am definitely interested in scheduling an imaging test for my condition). |
| Measured once, immediately following consultation with the musculoskeletal specialist |
| Interest in physical therapy referral | Rated from 0 (I am definitely not interested in being referred to a physical therapist) to 10 (I am definitely interested in being referred to a physical therapist). | Measured once, immediately following consultation with the musculoskeletal specialist |
| Interest in steroid injection | Rated from 0 (I am definitely not interested in having a knee steroid injection) to 10 (I am definitely interested in having a knee steroid injection) | Measured once, immediately following consultation with the musculoskeletal specialist |
| Interest in surgery | Rated from 0 (I am definitely not interested in knee replacement surgery) to 10 (I am definitely interested in knee replacement surgery). | Immediately after the clinic visit |
| TRECS score | The Trust and Experience with the Clinician Scale (TRECS-7) is a validated 7-item scale that measures patients' trust in and experience with their clinician during a medical consultation. Designed to minimize ceiling effects, it enables more sensitive detection of variation in patient experience across different clinical interactions (Brinkman et al.). Each of 7 statements is scored from 0-4 (strongly disagree, disagree, neutral, agree, strongly agree), resulting in a total score between 0 and 28. Higher scores indicate greater perceived trust in the clinician. Source: Brinkman N, Looman R, Jayakumar P, Ring D, Choi S. Is It Possible to Develop a Patient-reported Experience Measure With Lower Ceiling Effect? Clin Orthop Relat Res. 2025 Apr 1;483(4):693-703. | Measured once, immediately following consultation with the musculoskeletal specialist |
| D012216 |
| Rheumatic Diseases |