Online Field Test of an Appendicitis Decision Support Tool

NCT ID: NCT05219786

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2021-10-06

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Decision Support Tool

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

Group Type EXPERIMENTAL

Appendicitis Decision Support Tool

Intervention Type BEHAVIORAL

Viewing of a decision support tool.

Infographic

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

Group Type ACTIVE_COMPARATOR

Control Infographic

Intervention Type BEHAVIORAL

Viewing of a standardized infographic

Interventions

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Appendicitis Decision Support Tool

Viewing of a decision support tool.

Intervention Type BEHAVIORAL

Control Infographic

Viewing of a standardized infographic

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Employees or relatives of employees of the University of Washington
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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David Flum

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David R Flum, MD, MPH

Role: STUDY_DIRECTOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 33017106 (View on PubMed)

Related Links

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http://www.appyornot.org

Decision Support Tool

Other Identifiers

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STUDY00012210

Identifier Type: -

Identifier Source: org_study_id

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