- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05219786
Online Field Test of an Appendicitis Decision Support Tool
January 20, 2022 updated by: David Flum, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
194
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria: who live in the United States and who have not previously had appendicitis.
- 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
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
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Viewing of a decision support tool.
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Active Comparator: Infographic
Participant saw a static infographic providing information about the two treatments for appendicitis.
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Viewing of a standardized infographic
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional Conflict Pre vs. Post Intervention
Time Frame: At time of enrollment
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Assessed using the validated decisional conflict scale comparing only participants in the intervention arm before and after viewing the decision support tool.
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At time of enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decisional Conflict Between Arms
Time Frame: At time of enrollment
|
Total score on the validated decisional conflict scale after viewing the intervention support tool or the control infographic.
Scale ranges from 0-100 with higher scores being worse.
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At time of enrollment
|
Acceptability
Time Frame: At time of enrollment
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Between arm comparison of the acceptability of the information presented to the participants rated on a 4 point acceptability scale with higher scores representing higher acceptability.
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At time of enrollment
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Trust and Accuracy of Information
Time Frame: At time of enrollment
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Participants perception of the trustworthiness and accuracy of the information presented to them on a 5 point scale with higher scores representing a higher perceived trustworthiness and perceived accuracy.
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At time of enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: David R Flum, 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.
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 6, 2021
Primary Completion (Actual)
October 6, 2021
Study Completion (Actual)
October 6, 2021
Study Registration Dates
First Submitted
November 8, 2021
First Submitted That Met QC Criteria
January 20, 2022
First Posted (Actual)
February 2, 2022
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 20, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00012210
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Appendicitis Acute
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North Estonia Medical CentreTartu University HospitalRecruitingAcute Appendicitis | Appendicitis Acute | Appendicitis Perforated | Acute Appendicitis With Rupture | Appendicitis; Perforation | Acute Appendicitis Without Peritonitis | Acute Appendicitis With Appendix AbscessEstonia
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Pirogov Russian National Research Medical UniversityCompletedAcute Appendicitis | Acute Appendicitis With Rupture | Acute Appendicitis Without Peritonitis | Acute Appendicitis With PeritonitisRussian Federation
-
HJ23Hospital Universitari Joan XXIII de Tarragona.Not yet recruitingAcute Appendicitis | Appendicitis Perforated | Appendicitis Suppurative
-
Turku University HospitalOulu University Hospital; Kuopio University Hospital; Seinajoki Central Hospital and other collaboratorsNot yet recruitingUncomplicated Acute AppendicitisFinland
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Hospital Universitario Virgen de la ArrixacaUnknownUncomplicated Acute AppendicitisSpain
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Centre Hospitalier Universitaire, AmiensRecruiting
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Tanta UniversityCompletedDiagnosis of Acute Appendicitis in ChildrenEgypt
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A.O. Ospedale Papa Giovanni XXIIIUnknownAcute Appendicitis Without PeritonitisItaly
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Nigde Omer Halisdemir UniversityCompletedAcute Appendicitis | Acute Appendicitis With RuptureTurkey
-
King Abdulaziz UniversityCompletedAppendicitis | Acute Appendicitis | Pathology | Appendicitis (Diagnosis)Saudi Arabia
Clinical Trials on Appendicitis Decision Support Tool
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Duke UniversityNational Cancer Institute (NCI)CompletedDuctal Carcinoma in SituUnited States
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University of California, San FranciscoNational Comprehensive Cancer NetworkCompletedNon-small Cell Lung CancerUnited States
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University of British ColumbiaCanadian Institutes of Health Research (CIHR)RecruitingPregnancy | Preterm Birth | Decision Making, SharedCanada
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University of North Carolina, Chapel HillNorth Carolina Translational and Clinical Sciences InstituteCompletedPremature Birth | Feeding and Eating Disorders of ChildhoodUnited States
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Saint Luke's Health SystemMerck Sharp & Dohme LLCRecruiting
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University of FloridaRecruitingTelemedicine | PediatricsHaiti
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University of MichiganNational Institute of Nursing Research (NINR)Completed
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Massachusetts General HospitalNot yet recruitingSuicide, Attempted | Suicide
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Children's Hospital of PhiladelphiaNational Library of Medicine (NLM)CompletedComprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants (PreemieCDS)PrematurityUnited States
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Northwestern UniversityNot yet recruitingHeart Failure With Reduced Ejection FractionUnited States