NCT05887414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

17 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

May 24, 2023

Last Update Submit

June 13, 2023

Conditions

Keywords

Decision Support ToolImplementationAntibioticsSurgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Surgery

Patients who chose to receive surgery as treatment for their appendicitis.

Other: BaselineOther: 30 Day Follow Up

Antibiotics

Patients who chose to receive antibiotics as treatment for their appendicitis.

Other: BaselineOther: 30 Day Follow Up

Interventions

Measure Ottawa Decisional Regret at baseline when patients receive a diagnosis of appendicitis.

AntibioticsSurgery

Measure Ottawa Decisional Regret after 30 days.

AntibioticsSurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Any patient the clinical team feels is appropriate for considering either surgery or antibiotics for their initial appendicitis treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Kaiser Permanente Baldwin Park

Baldwin Park, California, 90027, United States

RECRUITING

Kaiser Permanente Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Kaiser Permanente Riverside

Riverside, California, 92555, United States

NOT YET RECRUITING

Grady Health System / Morehouse School of Medicine

Atlanta, Georgia, 30305, United States

NOT YET RECRUITING

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Michigan Medicine- University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Atrium Health

Charlotte, North Carolina, 28204, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Lyndon B Johnson- Harris Health

Houston, Texas, 77026, United States

NOT YET RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77026, United States

RECRUITING

Texas Tech University

Lubbock, Texas, 79430, United States

NOT YET RECRUITING

Harborview Medical Center

Seattle, Washington, 98104, United States

RECRUITING

Northwest Hospital and Medical Center

Seattle, Washington, 98133, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Related 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, 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.

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

BaseLine dental cement

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Giana Davidson, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara DePaoli

CONTACT

Erin Fannon

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor: School of Medicine

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 2, 2023

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

June 18, 2023

Record last verified: 2023-06

Locations