TRIAD Appendicitis Decision-making Surveys

Last updated: June 13, 2023
Sponsor: University of Washington
Overall Status: Active - Recruiting

Phase

N/A

Condition

Appendicitis

Treatment

Baseline

30 Day Follow Up

Clinical Study ID

NCT05887414
STUDY00016171
DI-2021C3-24262
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 3000
Treatment Group(s): 2
Primary Treatment: Baseline
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
October 01, 2025

Study 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.

Connect with a study center

  • Kaiser Permanente Baldwin Park

    Baldwin Park, California 90027
    United States

    Active - Recruiting

  • Kaiser Permanente Los Angeles

    Los Angeles, California 90027
    United States

    Active - Recruiting

  • Kaiser Permanente Riverside

    Riverside, California 92555
    United States

    Site Not Available

  • Grady Health System / Morehouse School of Medicine

    Atlanta, Georgia 30305
    United States

    Site Not Available

  • Northwestern Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • Michigan Medicine- University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Atrium Health

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Lyndon B Johnson- Harris Health

    Houston, Texas 77026
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77026
    United States

    Active - Recruiting

  • Texas Tech University

    Lubbock, Texas 79430
    United States

    Site Not Available

  • Harborview Medical Center

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Northwest Hospital and Medical Center

    Seattle, Washington 98133
    United States

    Active - Recruiting

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Active - Recruiting

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