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Completed

NCT Number: NCT05887414

TRIAD Appendicitis Decision-making Surveys

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaiser Permanente Baldwin Park, Baldwin Park, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baseline

Other

Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.

30 Day Follow Up

Other

Measure Ottawa Decisional Regret after 30 days.

Primary outcomes

  1. Ottawa Decisional Conflict Scale

    Time frame: 3 years

    Ottawa Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty; and effective decision making

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys

Acronym: TRIAD

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 2, 2023
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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