- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887414
TRIAD Appendicitis Decision-making Surveys (TRIAD)
Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Baldwin Park, California, United States, 90027
- Kaiser Permanente Baldwin Park
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Los Angeles, California, United States, 90027
- Kaiser Permanente Los Angeles
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Riverside, California, United States, 92555
- Kaiser Permanente Riverside
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Georgia
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Atlanta, Georgia, United States, 30305
- Grady Health System / Morehouse School of Medicine
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medicine
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Michigan Medicine- University of Michigan
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Atrium Health
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Texas
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Houston, Texas, United States, 77026
- Lyndon B Johnson- Harris Health
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Houston, Texas, United States, 77026
- The University of Texas Health Science Center at Houston
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Lubbock, Texas, United States, 79430
- Texas Tech University
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Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Seattle, Washington, United States, 98133
- Northwest Hospital and Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Surgery
Patients who chose to receive surgery as treatment for their appendicitis.
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Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.
Measure Ottawa Decisional Regret after 30 days.
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Antibiotics
Patients who chose to receive antibiotics as treatment for their appendicitis.
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Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.
Measure Ottawa Decisional Regret after 30 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ottawa Decisional Conflict Scale
Time Frame: 3 years
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Ottawa Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty; and effective decision making
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3 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Giana Davidson, MD, MPH, University of Washington
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00016171
- DI-2021C3-24262 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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