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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a tool designed to assist in making treatment decisions for joint and bone conditions, such as hip or knee arthritis and certain fractures. Researchers aim to understand how factors like pain, recovery time, and cost influence treatment choices. Participants may receive either a new decision tool (a guide to assist in treatment choices) or standard treatment information to compare their effectiveness in aiding treatment decisions. This trial may suit individuals dealing with long-term issues related to hip or knee arthritis or various bone fractures. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance decision-making tools for future patients.

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 prior data suggests that this decision tool is safe for use in determining treatment preferences for musculoskeletal conditions?

Studies have shown that decision tools, like the one in this trial, are generally safe for participants. These tools help people understand their treatment options by presenting information clearly and systematically. Research indicates that decision aids can increase patients' knowledge about their treatment choices and boost their confidence in making decisions. No reports suggest these tools cause harm or side effects, as they primarily provide information rather than medical treatment. Participants can use the decision tool in this study without worrying about safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Tool for arthritis because it offers a personalized approach to managing musculoskeletal conditions. Unlike the standard treatment information, which provides general guidance, this tool helps patients make informed decisions tailored to their specific condition and needs. By empowering patients with customized options and insights, it has the potential to improve outcomes and patient satisfaction in a way that standard treatments may not.

What evidence suggests that this decision tool is effective for determining treatment preferences in musculoskeletal conditions?

This trial will compare a decision tool with standard treatment information for participants with musculoskeletal conditions. Research has shown that decision tools can help individuals with these conditions select better treatments. One study found that a decision aid increased participants' confidence in their treatment choices. Another study showed that these tools enhanced patients' understanding of their options, though they did not significantly alter other outcomes. These tools help patients envision their future with different treatments, making them feel more informed and less stressed about deciding. Overall, decision tools aid in understanding treatment options and boosting confidence in healthcare decisions. ^{1 2 3 4 6}

Who Is on the Research Team?

Richard C. Mather III, MD, MBA

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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

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

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

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

Exclusion Criteria

Inability to read, understand and give effective English consent

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8011510/

A Personalized Shared Decision-Making Tool for ... Using a personalized SDM tool for OA may decrease musculoskeletal health disparities by providing the patient with an illustration of a future state of likely ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7209464/

Do Decision Aids Benefit Patients with Chronic ... Decision aids may improve patients' knowledge about treatment options for chronic musculoskeletal pain but largely did not impact other outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1063458421008116

Effectiveness of a decision aid for patients with knee ... Our results show a significant immediate effect of the PtDA on decisional conflict, objective knowledge and SDMP. Achaval et al., the only randomized trial ...

4. oarsijournal.com oarsijournal.com/article/S1063-4584(21)00811-6/fulltext

Effectiveness of a decision aid for patients with knee ... Outcome measures were the Decisional Conflict Scale (DCS), knowledge of osteoarthritis and arthroplasty, satisfaction with the decision-making ...

5. withpower.com withpower.com/trial/phase-femoracetabular-impingement-1-2016-75b4c

Decision Tool for Arthritis · Info for Participants This study is an observational study to test and validate a questionnaire and statistical model used to determine patient preferences regarding treatment ...

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2776550

Comparison of an Artificial Intelligence–Enabled Patient ... This randomized clinical trial of 129 patients demonstrated statistically significant improvement in decision quality, level of shared decision-making, patient ...