TRIAD Patient Surveys

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT05887414
Collaborator
Patient-Centered Outcomes Research Institute (Other)
3,000
17
36
176.5
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Baseline
  • Other: 30 Day Follow Up

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 Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Treatment Individualized Appendicitis Decision-Making (TRIAD) Patient Surveys
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Ottawa Decisional Conflict Scale [3 years]

    Ottawa Decisional Conflict Scale (DCS) measures personal perceptions of uncertainty in choosing options; modifiable factors contributing to uncertainty; and effective decision making

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kaiser Permanente Baldwin Park Baldwin Park California United States 90027
2 Kaiser Permanente Los Angeles Los Angeles California United States 90027
3 Kaiser Permanente Riverside Riverside California United States 92555
4 Grady Health System / Morehouse School of Medicine Atlanta Georgia United States 30305
5 Northwestern Medicine Chicago Illinois United States 60611
6 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
7 Boston Medical Center Boston Massachusetts United States 02118
8 Michigan Medicine- University of Michigan Ann Arbor Michigan United States 48109
9 Columbia University Medical Center New York New York United States 10032
10 Atrium Health Charlotte North Carolina United States 28204
11 Medical University of South Carolina Charleston South Carolina United States 29425
12 Lyndon B Johnson- Harris Health Houston Texas United States 77026
13 The University of Texas Health Science Center at Houston Houston Texas United States 77026
14 Texas Tech University Lubbock Texas United States 79430
15 Harborview Medical Center Seattle Washington United States 98104
16 Northwest Hospital and Medical Center Seattle Washington United States 98133
17 University of Washington Medical Center Seattle Washington United States 98195

Sponsors and Collaborators

  • University of Washington
  • Patient-Centered Outcomes Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Giana Davidson, Associate Professor: School of Medicine, University of Washington
ClinicalTrials.gov Identifier:
NCT05887414
Other Study ID Numbers:
  • STUDY00016171
  • DI-2021C3-24262
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giana Davidson, Associate Professor: School of Medicine, University of Washington
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023