TRIAD Appendicitis Decision-making Surveys

Appendicitis Clinical Trial

— TRIAD  

Official title:

Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05887414
• Other study ID #: STUDY00016171
• Secondary ID: DI-2021C3-24262
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: Sara DePaoli
• Phone: 206-543-8624
• Email: sdepaoli[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Baseline
Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.
• 30 Day Follow Up
Measure Ottawa Decisional Regret after 30 days.

Locations

Country	Name	City	State
United States	Michigan Medicine- University of Michigan	Ann Arbor	Michigan
United States	Grady Health System / Morehouse School of Medicine	Atlanta	Georgia
United States	Kaiser Permanente Baldwin Park	Baldwin Park	California
United States	Boston Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	Northwestern Medicine	Chicago	Illinois
United States	Lyndon B Johnson- Harris Health	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Kaiser Permanente Los Angeles	Los Angeles	California
United States	Texas Tech University	Lubbock	Texas
United States	Columbia University Medical Center	New York	New York
United States	Kaiser Permanente Riverside	Riverside	California
United States	Harborview Medical Center	Seattle	Washington
United States	Northwest Hospital and Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

CODA Collaborative; Flum DR, Davidson GH, Monsell SE, Shapiro NI, Odom SR, Sanchez SE, Drake FT, Fischkoff K, Johnson J, Patton JH, Evans H, Cuschieri J, Sabbatini AK, Faine BA, Skeete DA, Liang MK, Sohn V, McGrane K, Kutcher ME, Chung B, Carter DW, Ayoun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ottawa Decisional Conflict Scale	Ottawa Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty; and effective decision making	3 years

External Links

•   Link to Decision Support Tool and Patient Survey
•   University of Washington Be Certain Website