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DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory (DEBUT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776787
Recruitment Status : Recruiting
First Posted : May 18, 2016
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
David Flum, University of Washington

Brief Summary:
Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients' lives.

Condition or disease
Diverticulitis

Detailed Description:

This study will examine both clinical and non-clinical reasons for pursuing surgery, taking into account previously unexplored areas in surgical decision-making including the comprehensive impact of this disease, as well as factors that impact a surgeon's willingness to recommend surgery. Ultimately, this patient-centered research approach will help us understand the impact of treatment decisions on a patient's quality of life, work, and clinical symptoms, and will ultimately help to inform our recommendations for the treatment of patients with diverticulitis.

The DEBUT study was developed from questions raised by our Washington State Surgical Collaborative, (SCOAP Colon and Rectal Surgery Work Group) and will be carried out in clinics and hospitals across Washington State, Oregon, and California. The investigators invite patients to participate in research activities designed to identify the impact of diverticulitis and treatment options, in order to better understand the outcomes that matter most to patients. Patients who are considering surgery or who have received treatment for their diverticulitis will be recruited for study participation. Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent quarterly for up to four years. These surveys will examine quality of life, overall health, and clinical symptoms to understand what drives patients and surgeons to an operation, as well as how that decision impacts quality of life and recurrent events in patients that choose to have surgery compared to those that do not have surgery. Participating surgeons will complete surveys that examine their indications for surgery and surgical outcomes.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory
Study Start Date : March 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Patients with diverticulitis
Surgeons
Surgeons who perform elective colon resections



Primary Outcome Measures :
  1. Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL) [ Time Frame: 3 months - 4 years ]
    Patient-reported burden of disease (diverticulitis symptoms and quality of life, as measured by the Diverticulitis Quality of Life scale (DV-QOL)) will be measured over time among patients that do and do not undergo elective colon resection.


Secondary Outcome Measures :
  1. Number of patients who report non-clinical factors as reason for deciding to have surgery [ Time Frame: 3 months - 4 years ]
    Patient-reported factors (clinical and non-clinical) for deciding to have elective colon surgery, or deciding to have medical management for diverticulitis will be analyzed across surgical and non-surgical patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with confirmed diagnoses of diverticulitis will be recruited from emergency rooms (first time episodes), GI clinics, and surgical clinics across the Pacific Northwest and California.
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of diverticulitis
  • Patients 18 years of age or older
  • Patients who are able to consent to participate in research

Exclusion Criteria:

  • Patients that have had prior colon resection surgery
  • Patients that do not make their own medical decisions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776787


Contacts
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Contact: Erin Carney, BA 206-685-9770 ecarney@uw.edu
Contact: Giana Davidson, MD, MPH 206-543-9559 ghd@uw.edu

Locations
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United States, California
UCLA Ronald Reagan Recruiting
Los Angeles, California, United States, 90095
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Olive View - UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Contact: Anusha Krishnadasan    747-210-3115    idnet@ucla.edu   
Principal Investigator: David Talan, MD         
United States, New York
NYU Langone Health Recruiting
Brooklyn, New York, United States, 11220
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Principal Investigator: Patricia Ayoung-Chee, MD         
United States, Oregon
Legacy Health Recruiting
Portland, Oregon, United States, 97210
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
United States, Washington
Skagit Regional Health Recruiting
Mount Vernon, Washington, United States, 98274
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Valley Medical Center Recruiting
Renton, Washington, United States, 98055
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Contact: Dione Froman    425-228-3440    dione_froman@valleymed.org   
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Principal Investigator: David R Flum, MD         
Northwest Hospital and Medical Center Recruiting
Seattle, Washington, United States, 98133
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Principal Investigator: David R Flum, MD         
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Ellie Brewer, MPH    206-221-1321    ebrewer@uw.edu   
Principal Investigator: David R Flum, MD, MPH         
Sponsors and Collaborators
University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Study Director: Giana Davidson, MD, MPH University of Washington

Additional Information:
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Responsible Party: David Flum, Director, Surgical Outcomes Research Center, University of Washington
ClinicalTrials.gov Identifier: NCT02776787    
Other Study ID Numbers: 50836
1R01DK103915-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases