TRIAD Appendicitis Decision-making Surveys (TRIAD)

June 13, 2023 updated by: Giana Davidson, University of Washington

Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient 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.

Study Overview

Status

Recruiting

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

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Baldwin Park, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Baldwin Park
        • Contact:
        • Principal Investigator:
          • Hong Yoon Plurad, MD
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles
        • Contact:
        • Principal Investigator:
          • Kevin Patel, MD
      • Riverside, California, United States, 92555
        • Not yet recruiting
        • Kaiser Permanente Riverside
        • Contact:
        • Principal Investigator:
          • Tara Wilson, MD
    • Georgia
      • Atlanta, Georgia, United States, 30305
        • Not yet recruiting
        • Grady Health System / Morehouse School of Medicine
        • Contact:
        • Principal Investigator:
          • Patricia Ayoung-Chee, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine
        • Principal Investigator:
          • Michael Shapiro, MD
        • Contact:
        • Principal Investigator:
          • Hasan Alam, MD
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Brett Faine, PharmD, MS
        • Principal Investigator:
          • Dionne Skeete, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Frederick Drake, MD
        • Principal Investigator:
          • Sabrina Sanchez, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Michigan Medicine- University of Michigan
        • Contact:
        • Principal Investigator:
          • Anne Ehlers, MD
        • Principal Investigator:
          • Pauline Park, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Katherine Fischkoff, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Heather Evans, MD
    • Texas
      • Houston, Texas, United States, 77026
        • Not yet recruiting
        • Lyndon B Johnson- Harris Health
        • Contact:
        • Principal Investigator:
          • Lillian Kao, MD
      • Houston, Texas, United States, 77026
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Lillian Kao, MD
        • Contact:
      • Lubbock, Texas, United States, 79430
        • Not yet recruiting
        • Texas Tech University
        • Contact:
        • Principal Investigator:
          • Jayne McCauley, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
        • Principal Investigator:
          • Estell Williams, MD
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Harborview Medical Center
        • Contact:
        • Principal Investigator:
          • Deepika Nehra, MD, MPH
      • Seattle, Washington, United States, 98133
        • Recruiting
        • Northwest Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Rebecca Petersen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Other: Baseline
Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.
Other: 30 Day Follow Up
Measure Ottawa Decisional Regret after 30 days.
Antibiotics
Patients who chose to receive antibiotics as treatment for their appendicitis.
Other: Baseline
Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.
Other: 30 Day Follow Up
Measure Ottawa Decisional Regret after 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Giana Davidson, MD, MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

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

No

Studies a U.S. FDA-regulated device product

No

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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