Clinical trial NCT05887414: TRIAD Appendicitis Decision-making Surveys
Official title: Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Appendicitis
Keywords: Decision Support Tool
Implementation
Antibiotics
Surgery
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2023-06-02
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient 18+ years old or older who has been diagnosed with appendicitis at a participating TRIAD clinical site after anticipated exclusion due to age, medical condition, or radiographic finding.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ottawa Decisional Conflict Scale
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baldwin Park
country: United States
facility: Kaiser Permanente Baldwin Park
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside
state: California
city: Atlanta
country: United States
facility: Grady Health System / Morehouse School of Medicine
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine- University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: Lyndon B Johnson- Harris Health
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University
state: Texas
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital and Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Giana Davidson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Ayoung-Chee P, Chiang W, Rushing A, Steinberg S, Foster CS, Schaetzel SM, Price TP, Mandell KA, Ferrigno L, Salzberg M, DeUgarte DA, Kaji AH, Moran GJ, Saltzman D, Alam HB, Park PK, Kao LS, Thompson CM, Self WH, Yu JT, Wiebusch A, Winchell RJ, Clark S, Krishnadasan A, Fannon E, Lavallee DC, Comstock BA, Bizzell B, Heagerty PJ, Kessler LG, Talan DA. A Randomized Trial Comparing Antibiotics with Appendectomy for Appendicitis. N Engl J Med. 2020 Nov 12;383(20):1907-1919. doi: 10.1056/NEJMoa2014320. Epub 2020 Oct 5.