Appendicitis AcuteNCT05219786
Online Field Test of an Appendicitis Decision Support Tool
A study testing Appendicitis Decision Support Tool in people with Appendicitis Acute, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Appendicitis Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 6 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Employees or relatives of employees of the University of Washington
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Appendicitis Acute
- Being tested
- Appendicitis Decision Support Tool, Control Infographic
- Keywords
- decision support, decision aid, decisional conflict
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appendicitis Decision Support ToolBehavioural
Viewing of a decision support tool.
Control InfographicBehavioural
Viewing of a standardized infographic
| Study group | Role | What they receive |
|---|---|---|
| Decision Support Tool | Experimental | In this arm study participants saw a decision support tool consisting of a video and a interactive decision aid (www.appyornot.org). Receives: Behavioral: Appendicitis Decision Support Tool |
| Infographic | Active comparator | Participant saw a static infographic providing information about the two treatments for appendicitis. Receives: Behavioral: Control Infographic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of enrollment
Secondary outcomes (3)
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.
Measured: At time of enrollment
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.
Measured: At time of enrollment
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.
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start6 Oct 2021
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David R Flum, MD, MPH, Study director, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219786
- Sponsor's protocol ID
- STUDY00012210
- Status last verified
- Jan 2022
- First submitted
- 8 Nov 2021
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33017106
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Field Test of an Appendicitis Decision Support Tool
- ClinicalTrials.gov ID
- NCT05219786
- Acronym / sponsor ID
- STUDY00012210
- Conditions
- Appendicitis Acute
- Keywords
- decision support, decision aid, decisional conflict
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Patient-Centered Outcomes Research Institute
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Support Tool | Experimental | Behavioral: Appendicitis Decision Support ToolIn this arm study participants saw a decision support tool consisting of a video and a interactive decision aid (www.appyornot.org). |
| Infographic | Active comparator | Behavioral: Control InfographicParticipant saw a static infographic providing information about the two treatments for appendicitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Employees or relatives of employees of the University of Washington
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Appendicitis Decision Support ToolViewing of a decision support tool. | Behavioural | Decision Support Tool |
| Control InfographicViewing of a standardized infographic | Behavioural | Infographic |
Primary outcome
Decisional Conflict Pre vs. Post Intervention
Time frame: 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.
3 secondary outcomes
Decisional Conflict Between Arms
Time frame: At time of enrollment
Acceptability
Time frame: At time of enrollment
Trust and Accuracy of Information
Time frame: At time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Results publication: PubMed 33017106CODA 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.
- Decision Support ToolLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Appendicitis Acute
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
Not yet recruitingPhase 2
Patient Choice Between Antibiotics and Appendectomy in Uncomplicated Appendicitis (FRENCH 47 - ALACARTE)
Acute Appendicitis
Active, not recruitingObservational study
Retrospective Acute Care Appendectomy Study
Acute Appendicitis
Not yet recruiting
Immediate Laparoscopic Appendectomy Versus Interval Laparoscopic Appendectomy for Early Appendicular Mass
Appendicular Mass, Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Flum, MD, MPH study director
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendicitis Decision Support Tool in people with Appendicitis Acute, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict Pre vs. Post Intervention (time frame: At time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05219786, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.