Decision Tool for Arthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Inability to give English consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2310 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment for any one of 11 musculoskeletal conditions: hip arthritis, knee arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus. This study aims to understand how multiple treatment variables, including pain, rehabilitation time, cost, and choice of surgical versus non-surgical intervention, impact patients' decision-making processes and ultimate choice of treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Since this is an observational study, it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the Decision Tool for Arthritis treatment?

Research shows that decision aids, like the one developed for osteoarthritis, help patients make informed choices by considering their personal preferences and predicting outcomes based on individual characteristics. This approach has been effective in improving decision-making for knee and hip arthritis treatments. ^{1 2 3 4 5}

Is the Decision Tool for Arthritis treatment generally safe for humans?

The safety of arthritis treatments, including those evaluated under different names, often involves risks of adverse events (unwanted side effects). These treatments have been studied for conditions like rheumatoid arthritis, and while they can be effective, they may also cause side effects that need to be carefully considered. ^{6 7 8 9 10}

How does the Decision Tool for Arthritis treatment differ from other treatments for arthritis?

The Decision Tool for Arthritis is unique because it focuses on shared decision-making, helping patients understand the risks and benefits of different treatment options for arthritis. This approach involves using decision aids, which are tools that help patients align their personal preferences with available treatments, potentially leading to more personalized and satisfactory treatment choices. ^{3 11 12 13 14}

Research Team

Richard C. Mather III, MD, MBA

Principal Investigator

Duke University

Eligibility Criteria

This trial is for individuals aged 18-85 with various musculoskeletal conditions like hip or knee arthritis, fractures, and tendon ruptures. Specific age ranges apply to different conditions. Parents of children aged 8-18 can participate for certain juvenile conditions.

Inclusion Criteria

I am between 18 and 65 years old with a hip labral tear.

My age matches the trial's requirement for my condition.

I am between 50 and 80 years old with hip arthritis.

Exclusion Criteria

Inability to read, understand and give effective English consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Questionnaire Validation

Participants complete questionnaires to validate a statistical model for determining treatment preferences

3-5 years

Follow-up

Participants are monitored for changes in treatment preferences and decision-making processes

3-5 years

Treatment Details

Interventions

• Decision tool
• Standard treatment information

Trial Overview The study tests a decision tool against standard treatment information to see how patients choose treatments based on factors like pain, recovery time, cost, and surgical vs non-surgical options.

Participant Groups

Group I: Decision tool Experimental Treatment 1 Intervention

A "decision tool" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus.

Group II: Standard treatment information Active Control 1 Intervention

"Standard treatment information" will be provided to participants who currently or previously have had one of the following 12 musculoskeletal conditions: hip arthritis, knee arthritis, ankle arthritis, hip labral tears and femoroacetabular impingement (FAI), osteochondritis dissecans, Achilles tendon rupture, patellofemoral dislocation, distal radius fracture, and fractures of the hip, ankle, tibia, and proximal humerus.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Current treatments for rheumatoid arthritis (RA) can lead to a significant burden of adverse events (AEs), with serious AEs being low in individuals at risk for RA, but nonserious AEs are often not consistently reported.

For effective prevention of RA in high-risk patients, it is crucial to quantify the benefits and harms of treatments accurately and consider patient preferences, especially regarding serious AEs like infections and malignancies that may not reverse after stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events Associated With Medications in the Treatment and Prevention of Rheumatoid Arthritis. Costello, R., David, T., Jani, M.[2020]

A systematic review of 93 randomized controlled trials involving 31,023 patients revealed a total of 21,498 adverse events (AEs), with 58% of these AEs being suitable for self-reporting by patients, highlighting the importance of patient perspectives in understanding treatment harms.

The study found a lack of systematic reporting on the severity of AEs, with only 9% of trials providing discernible severity grading, indicating a need for standardized frameworks to improve harm reporting in rheumatology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. Berthelsen, DB., Woodworth, TG., Goel, N., et al.[2021]

In a study of 143 patients with rheumatoid arthritis (RA) and osteoarthritis (OA), 35.7% experienced adverse drug events (ADEs), highlighting the commonality of these events in patients taking medications for these conditions.

Most ADEs were linked to disease-modifying anti-rheumatic drugs (59.4%) and non-steroidal anti-inflammatory drugs (14.5%), with 44.1% of the ADEs deemed preventable, indicating a need for better monitoring and management of drug safety in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. Tragulpiankit, P., Chulavatnatol, S., Rerkpattanapipat, T., et al.[2012]

A study of 100 rheumatoid arthritis patients revealed that many are hesitant to accept the risks of adverse effects from arthritis medications, with 45% unwilling to accept the risk of major toxicity.

Patients who had previously experienced adverse effects were more willing to accept risks associated with cosmetic changes, temporary discomfort, and major toxicity, indicating that past experiences can influence their risk tolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unwillingness of rheumatoid arthritis patients to risk adverse effects. Fraenkel, L., Bogardus, S., Concato, J., et al.[2019]

A survey involving 944 rheumatoid arthritis patients identified that the most important treatment attributes are the route of administration and dosing frequency (38%), followed closely by serious side effects (33%).

The results indicate a strong potential for developing a shared decision-making tool that aligns with patient preferences, showing good stability and reliability in treatment attribute importance among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Interactive Tool to Support Shared Decision-Making in Rheumatoid Arthritis: Treatment Attribute Preference. Curtis, JR., Ford, K., Fiore, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Stakeholder engagement in methodological research: Development of a clinical decision support tool. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Patients and clinicians have different perspectives on outcomes in arthritis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The development and utility of a multicriteria patient decision aid for people contemplating treatment for osteoarthritis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Viewpoint on Time Series and Interrupted Time Series Optimum Modeling for Predicting Arthritic Disease Outcomes. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Translating clinical and patient-reported data to tailored shared decision reports with predictive analytics for knee and hip arthritis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events Associated With Medications in the Treatment and Prevention of Rheumatoid Arthritis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in rheumatoid arthritis and osteoarthritis ambulatory patients. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Refining drug safety in rheumatology. [2012]

10. England pubmed.ncbi.nlm.nih.gov

Unwillingness of rheumatoid arthritis patients to risk adverse effects. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Two Distinct Shared Decision-Making Aids for Hip and Knee Osteoarthritis in an Ethnically Diverse Patient Population. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Development of an Interactive Tool to Support Shared Decision-Making in Rheumatoid Arthritis: Treatment Attribute Preference. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Shared decision making in patients with osteoarthritis of the hip and knee: results of a randomized controlled trial. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The Impact Of Decision Aids On Adults Considering Hip Or Knee Surgery. [2023]