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出境医 / 临床实验 / Appendicitis Choice of Treatment Study

Appendicitis Choice of Treatment Study

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
Acute Appendicitis Other: Patients with acute appendicitis

Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Appendicitis Choice of Treatment Study
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022
Arms and Interventions
Group/Cohort Intervention/treatment
Patients with acute appendicitis Other: Patients with acute appendicitis
No intervention, single survey
Outcome Measures
Primary Outcome Measures :
  1. Decisional conflict [ Time Frame: 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 Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
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
Contacts and Locations

Contacts
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Contact: Joshua Rosen, MD, MHS 206-616-6577 jerosen@uw.edu
Contact: Shalynn Howard, MA shahow@uw.edu

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Joshua E Rosen, MD, MHS    206-314-1787    jerosen@uw.edu   
Contact: Shalynn R Howard, MA    206-221-1321    shahow@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
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Study Director: David R Flum, MD, MPH University of Washington
Tracking Information
First Submitted Date July 8, 2021
First Posted Date July 20, 2021
Last Update Posted Date November 10, 2021
Actual Study Start Date July 12, 2021
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2021) 		Decisional conflict [ Time Frame: Time of survey (2 days-2 weeks after treatment for acute appendicitis) ]
Validated evaluation of decision making
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2021) 		Preparation for decision making [ Time Frame: Time of survey (2 days-2 weeks after treatment for acute appendicitis) ]
Validated measure for patient subject preparedness to make a treatment decision
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Appendicitis Choice of Treatment Study
Official Title Appendicitis Choice of Treatment Study
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Acute Appendicitis
Intervention Other: Patients with acute appendicitis
No intervention, single survey
Study Groups/Cohorts Patients with acute appendicitis
Intervention: Other: Patients with acute appendicitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 8, 2021) 		40
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Joshua Rosen, MD, MHS 206-616-6577 jerosen@uw.edu
Contact: Shalynn Howard, MA shahow@uw.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04968782
Other Study ID Numbers STUDY00013390
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party David Flum, University of Washington
Study Sponsor University of Washington
Collaborators Not Provided
Investigators
Study Director: David R Flum, MD, MPH University of Washington
PRS Account University of Washington
Verification Date November 2021