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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 418

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Ronald Reagan
    • Sylmar, California, United States, 91342
      • Olive View - UCLA Medical Center
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Health
  • Oregon
    • Portland, Oregon, United States, 97210
      • Legacy Health
  • Washington
    • Mount Vernon, Washington, United States, 98274
      • Skagit Regional Health
    • Renton, Washington, United States, 98055
      • Valley Medical Center
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98133
      • Northwest Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL)	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.	3 months - 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who report non-clinical factors as reason for deciding to have surgery	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.	3 months - 4 years

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Study Director: Giana Davidson, MD, MPH, University of Washington

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (ACTUAL): January 1, 2021
• Study Completion (ACTUAL): April 1, 2022

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (ESTIMATE): May 18, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Diverticular Diseases; Diverticulitis
• Other Study ID Numbers: STUDY00003708; 1R01DK103915-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO