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Online Field Test of an Appendicitis Decision Support Tool

Primary Purpose

Appendicitis Acute

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Appendicitis Decision Support Tool
Control Infographic
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Appendicitis Acute focused on measuring decision support, decision aid, decisional conflict

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision Support Tool

Infographic

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 8, 2021
Last Updated
January 20, 2022
Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05219786
Brief Title
Online Field Test of an Appendicitis Decision Support Tool
Official Title
Online Field Test of an Appendicitis Decision Support Tool
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
October 6, 2021 (Actual)
Study Completion Date
October 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
decision support, decision aid, decisional conflict

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision Support Tool
Arm Type
Experimental
Arm Description
In this arm study participants saw a decision support tool consisting of a video and a interactive decision aid (www.appyornot.org).
Arm Title
Infographic
Arm Type
Active Comparator
Arm Description
Participant saw a static infographic providing information about the two treatments for appendicitis.
Intervention Type
Behavioral
Intervention Name(s)
Appendicitis Decision Support Tool
Intervention Description
Viewing of a decision support tool.
Intervention Type
Behavioral
Intervention Name(s)
Control Infographic
Intervention Description
Viewing of a standardized infographic
Primary Outcome Measure Information:
Title
Decisional Conflict Pre vs. Post Intervention
Description
Assessed using the validated decisional conflict scale comparing only participants in the intervention arm before and after viewing the decision support tool.
Time Frame
At time of enrollment
Secondary Outcome Measure Information:
Title
Decisional Conflict Between Arms
Description
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.
Time Frame
At time of enrollment
Title
Acceptability
Description
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.
Time Frame
At time of enrollment
Title
Trust and Accuracy of Information
Description
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.
Time Frame
At time of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Flum, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33017106
Citation
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.
Results Reference
result
Links:
URL
http://www.appyornot.org
Description
Decision Support Tool

Learn more about this trial

Online Field Test of an Appendicitis Decision Support Tool

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