Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Surgery Patients who chose to receive surgery as treatment for their appendicitis.
  • 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.
Antibiotics Patients who chose to receive antibiotics as treatment for their appendicitis.
  • 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.

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Sabrina Sanchez, MD
sabrina.sanchez@bmc.org

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

Sara DePaoli
206-543-8624
sdepaoli@uw.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.