Appendicitis Choice of Treatment Study | NCT04968782

Studies
Appendicitis Choice of Treatment Study

NCT04968782

Sponsor

University of Washington

Status

Completed

Last Update Posted

Mar 23, 2022Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Acute Appendicitis

Interventions

Patients with acute appendicitis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2021Actual

Primary Completion Date

Feb 16, 2022Actual

Completion Date

Feb 16, 2022Actual

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2022

Last Update Posted Date

Mar 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Flum, Director Surgical Outcomes Research Center, University of WashingtonPrincipal Investigator

Lead Sponsor

University of WashingtonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute appendicitis			Other: Patients with acute appendicitis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients with acute appendicitis	Other	No intervention, single survey	Patients with acute appendicitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decisional conflict	Validated evaluation of decision making	Time of survey (2 days-2 weeks after treatment for acute appendicitis)

Secondary Outcomes

Measure	Description	Time Frame
Preparation for decision making	Validated measure for patient subject preparedness to make a treatment decision	Time of survey (2 days-2 weeks after treatment for acute appendicitis)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David R Flum, MD, MPH	University of Washington	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Washington		Seattle	Washington	98105	United States

Label	URL
Decisional Conflict Scale	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001064	Appendicitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided