TRIAD Appendicitis Decision-making Surveys

University of Washington

Status: Enrolling

Conditions: Appendicitis

Treatments: Other: 30 Day Follow Up; Other: Baseline

Study type: Observational

Funder types: Other

Identifiers

NCT05887414

DI-2021C3-24262 (Other Grant/Funding Number)

STUDY00016171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient the clinical team feels is appropriate for considering either surgery or antibiotics for their initial appendicitis treatment

Exclusion criteria

• Pregnant patients
• Immunocompromised patients
• Patients with high complication risk of recurrent infections
• Evidence of severe phlegmon or walled off abscess or free air on imaging
• Septic shock
• Diffuse peritonitis
• Patients under 18 years old

Trial design

3,000 participants in 2 patient groups

Surgery

Description:

Patients who chose to receive surgery as treatment for their appendicitis.

Treatment:

Other: Baseline

Other: 30 Day Follow Up

Antibiotics

Description:

Patients who chose to receive antibiotics as treatment for their appendicitis.

Treatment:

Other: Baseline

Other: 30 Day Follow Up