Clinical trial NCT02776787: DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory
Official title: DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diverticulitis
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-05-18
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL)
timeFrame: 3 months - 4 years
Secondary outcomes:
measure: Number of patients who report non-clinical factors as reason for deciding to have surgery
timeFrame: 3 months - 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Ronald Reagan
state: California
city: Sylmar
country: United States
facility: Olive View - UCLA Medical Center
state: California
city: Brooklyn
country: United States
facility: NYU Langone Health
state: New York
city: Portland
country: United States
facility: Legacy Health
state: Oregon
city: Mount Vernon
country: United States
facility: Skagit Regional Health
state: Washington
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: Northwest Hospital and Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Giana Davidson, MD, MPH
role: STUDY_DIRECTOR
References: