Trials / Unknown
UnknownNCT05887414
TRIAD Appendicitis Decision-making Surveys
Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
While appendectomy has been the main treatment of appendicitis for over 100 years, recent European studies found that, at least among highly selected patients, antibiotics alone can be an effective alternative. Surgeons and patients alike have a difficult time deciding if surgery or antibiotics are the best choice to treat appendicitis. The goal of the TRIAD is to evaluate the patients who are a part of the TRIAD implementation program and assess satisfaction and decisional regret for patients with appendicitis. This information will be used to inform the design of decision-support interventions to help patients improve their ability to make an informed decision in-line with their preferences and values.
Detailed description
TRIAD Patient Surveys is a cross-sectional survey design that will lead to more informed decision making and better outcomes related to antibiotics for appendicitis. TRIAD was developed from questions raised by the University of Washington CODA Trial that addressed many of the methodological issues in the European studies and included diverse, adult patients (n=1552) with almost all types of presentations of appendicitis. TRIAD surveys will be carried out in clinics and hospitals across the United States. Patients who are diagnosed with appendicitis will be recruited for study participation regardless of which treatment (appendectomy or antibiotics) they receive. Investigators invite patients to participate in a survey designed to identify awareness of treatment options and levels of decisional conflict (measured with the Ottawa Decisional Conflict Score \[DCS\]). Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent at 30 days. By implementing the TRIAD surveys, researchers hope to obtain a better understanding of patients' perspectives, knowledge, and decision-making processes regarding the choice between appendectomy and antibiotic treatment for appendicitis. This data can contribute to more informed decision-making and potentially improve outcomes related to antibiotic use for this condition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Baseline | Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis. |
| OTHER | 30 Day Follow Up | Measure Ottawa Decisional Regret after 30 days. |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2024-10-01
- Completion
- 2025-10-01
- First posted
- 2023-06-02
- Last updated
- 2023-06-18
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05887414. Inclusion in this directory is not an endorsement.