Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2022-10-01
2025-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Surgery
Patients who chose to receive surgery as treatment for their appendicitis.
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.
Antibiotics
Patients who chose to receive antibiotics as treatment for their appendicitis.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Washington
OTHER
Responsible Party
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Giana Davidson
Associate Professor: School of Medicine
Principal Investigators
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Giana Davidson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Kaiser Permanente Baldwin Park
Baldwin Park, California, United States
Kaiser Permanente Los Angeles
Los Angeles, California, United States
Kaiser Permanente Riverside
Riverside, California, United States
Grady Health System / Morehouse School of Medicine
Atlanta, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Boston Medical Center
Boston, Massachusetts, United States
Michigan Medicine- University of Michigan
Ann Arbor, Michigan, United States
Columbia University Medical Center
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Lyndon B Johnson- Harris Health
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Tech University
Lubbock, Texas, 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, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Link to Decision Support Tool and Patient Survey
Other Identifiers
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DI-2021C3-24262
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00016171
Identifier Type: -
Identifier Source: org_study_id
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