Appendicitis Choice of Treatment Study

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT04968782
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Actual Duration (Months): 7.2
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Appendicitis	Other: Patients with acute appendicitis

Study Design

• Study Type: Observational
• Actual Enrollment: 23 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Appendicitis Choice of Treatment Study
• Actual Study Start Date: Jul 12, 2021
• Actual Primary Completion Date: Feb 16, 2022
• Actual Study Completion Date: Feb 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with acute appendicitis	Other: Patients with acute appendicitis; No intervention, single survey

Outcome Measures

Primary Outcome Measures

1. Decisional conflict [Time of survey (2 days-2 weeks after treatment for acute appendicitis)]

   Validated evaluation of decision making

Secondary Outcome Measures

1. Preparation for decision making [Time of survey (2 days-2 weeks after treatment for acute appendicitis)]

   Validated measure for patient subject preparedness to make a treatment decision

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington	Seattle	Washington	United States	98105

Sponsors and Collaborators

• University of Washington

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Decisional Conflict Scale

Publications

None provided.

• Responsible Party: David Flum, Director Surgical Outcomes Research Center, University of Washington
• ClinicalTrials.gov Identifier: NCT04968782
• Other Study ID Numbers: STUDY00013390
• First Posted: Jul 20, 2021
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Flum, Director Surgical Outcomes Research Center, University of Washington: Decision Making; Decisional Conflict
• Additional relevant MeSH terms: Appendicitis

Study Results

No Results Posted as of Mar 23, 2022