Online Field Test of an Appendicitis Decision Support Tool

Appendicitis Acute Clinical Trial

Official title:

Online Field Test of an Appendicitis Decision Support Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05219786
• Other study ID #: STUDY00012210
• Status: Completed
• Phase: N/A
• Start date: October 6, 2021
• Est. completion date: October 6, 2021

Study information

• Verified date: January 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Behavioral:
• Appendicitis Decision Support Tool
Viewing of a decision support tool.
• Control Infographic
Viewing of a standardized infographic

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

References & 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, Ayoun — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decisional Conflict Between Arms	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.	At time of enrollment
Secondary	Acceptability	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.	At time of enrollment
Secondary	Trust and Accuracy of Information	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.	At time of enrollment

External Links

•   Decision Support Tool