Online Field Test of an Appendicitis Decision Support Tool

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT05219786
• Collaborator: National Institutes of Health (NIH) (NIH), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 194
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis Acute	Behavioral: Appendicitis Decision Support Tool; Behavioral: Control Infographic	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Online Field Test of an Appendicitis Decision Support Tool
• Actual Study Start Date: Oct 6, 2021
• Actual Primary Completion Date: Oct 6, 2021
• Actual Study Completion Date: Oct 6, 2021

Arms and Interventions

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).	Behavioral: Appendicitis Decision Support Tool; Viewing of a decision support tool.
Active Comparator: Infographic Participant saw a static infographic providing information about the two treatments for appendicitis.	Behavioral: Control Infographic; Viewing of a standardized infographic

Outcome Measures

Primary Outcome Measures

1. Decisional Conflict Pre vs. Post Intervention [At time of enrollment]

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

Secondary Outcome Measures

1. Decisional Conflict Between Arms [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.

2. Acceptability [At time of enrollment]

   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.

3. Trust and Accuracy of Information [At time of enrollment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington
• National Institutes of Health (NIH)
• Patient-Centered Outcomes Research Institute

Investigators

• Study Director: David R Flum, MD, MPH, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Decision Support Tool

Publications

None provided.

• Responsible Party: David Flum, Professor of Surgery, University of Washington
• ClinicalTrials.gov Identifier: NCT05219786
• Other Study ID Numbers: STUDY00012210
• First Posted: Feb 2, 2022
• Last Update Posted: Feb 2, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Flum, Professor of Surgery, University of Washington: decision support; decision aid; decisional conflict
• Additional relevant MeSH terms: Appendicitis

Study Results

No Results Posted as of Feb 2, 2022