NCT04968782

Brief Summary

A longitudinal observational/survey study evaluating patient centered decision making in the choice of treatment for acute appendicitis. Survey evaluates patients experience with decision making and the types of decision support they receive.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

July 8, 2021

Last Update Submit

March 21, 2022

Conditions

Acute Appendicitis

Keywords

Decision MakingDecisional Conflict

Outcome Measures

Primary Outcomes (1)

  • Decisional conflict

    Validated evaluation of decision making

    Time of survey (2 days-2 weeks after treatment for acute appendicitis)

Secondary Outcomes (1)

  • Preparation for decision making

    Time of survey (2 days-2 weeks after treatment for acute appendicitis)

Study Arms (1)

Patients with acute appendicitis

Other: Patients with acute appendicitis

Interventions

Patients with acute appendicitisOTHER

No intervention, single survey

Patients with acute appendicitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department with acute appendicitis who are considered to be candidates for operative or nonoperative management by the treating clinical team. Patients can ultimately have undergone either treatment.

You may qualify if:

  • English Speaking
  • Diagnosed with acute appendicitis
  • Considered by the treating clinical team to be eligible for treatment with surgery or with non operative treatment (antibiotics)
  • Access to an internet connected device capable of taking the survey

You may not qualify if:

  • Patients who do not make their own medical decisions
  • Patients who are not felt to be candidates for a decision between operative and nonoperative treatment by the treating clinical team
  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • David R Flum, MD, MPH

    University of Washington

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Surgical Outcomes Research Center

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 20, 2021

Study Start

July 12, 2021

Primary Completion

February 16, 2022

Study Completion

February 16, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations

US(1)