NCT05219786

Brief Summary

After the recent publication of the CODA Trial comparing antibiotics and surgery for acute appendicitis, the investigators developed a comprehensive decision support tool. This tool will help patients understand the risks and benefits of each treatment and make a treatment decision. This study is an online randomized field test comparing the decision support tool to a control infographic and assessing it's affect on decisional outcomes, such as decisional conflict.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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 6, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

Same day

First QC Date

November 8, 2021

Last Update Submit

January 20, 2022

Conditions

Appendicitis Acute

Keywords

decision supportdecision aiddecisional conflict

Outcome Measures

Primary Outcomes (1)

  • Decisional Conflict Pre vs. Post Intervention

    Assessed using the validated decisional conflict scale comparing only participants in the intervention arm before and after viewing the decision support tool.

    At time of enrollment

Secondary Outcomes (3)

  • Decisional Conflict Between Arms

    At time of enrollment

  • Acceptability

    At time of enrollment

  • Trust and Accuracy of Information

    At time of enrollment

Study Arms (2)

Decision Support Tool

EXPERIMENTAL

In this arm study participants saw a decision support tool consisting of a video and a interactive decision aid (www.appyornot.org).

Behavioral: Appendicitis Decision Support Tool

Infographic

ACTIVE COMPARATOR

Participant saw a static infographic providing information about the two treatments for appendicitis.

Behavioral: Control Infographic

Interventions

Appendicitis Decision Support ToolBEHAVIORAL

Viewing of a decision support tool.

Decision Support Tool
Control InfographicBEHAVIORAL

Viewing of a standardized infographic

Infographic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Workers on Amazons Mechanical Turk Platform with an approval rating of 95% or higher
  • Workers on Amazons Mechanical Turk Platform who live in the United States
  • Workers on Amazons Mechanical Turn Platform who have not previously had appendicitis

You may not qualify if:

  • Employees or relatives of employees of the University of Washington

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

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.

    PMID: 33017106RESULT

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • David R Flum, MD, MPH

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 8, 2021

First Posted

February 2, 2022

Study Start

October 6, 2021

Primary Completion

October 6, 2021

Study Completion

October 6, 2021

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)