FIT Mailing Protocol-For Cancer Screening Navigation

NCT02934958 | Unknown

• 1 other identifier: GI-0002-1
• Study Type: interventional
• Target: 13,392
• Locations: 1 country
• Sites: 1

Brief Summary

We plan to study whether the impact of offering the choice of a pre-colonoscopy physician visit or direct referral to colonoscopy will increase adherence to colonoscopy relative to usual care in a large fecal immunochemical test (FIT) mailing campaign. We will evaluate two study options, usual care during which patients will be required to have an office visit with wither a PCP or a Gastroenterologist prior to being scheduled for a colonoscopy, or a choice where patients will be given the option of a pre-colonoscopy visit with a gastroenterologist or PCP vs. direct referral for a colonoscopy. In these two options we will examine colonoscopy adherence, adequacy of triage, patient satisfaction, colonoscopy outcomes (no show rate, prep quality, and pain during colonoscopy) and how insurance coverage, gender, race, education or patient understanding of colon cancer screening message during the navigation process might impact outcomes.

Conditions

Colorectal Neoplasms

Keywords

Colon Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Colonoscopy Completion

  One Year

Study Arms (2)

FIT Positive

ACTIVE COMPARATOR

Referral to GI or Primary Care. Patients will be referred to MD for pre-colonoscopy vist.Standard of Care.

Behavioral: Standard of Care

FIT Positive Choice

EXPERIMENTAL

Offered Chioce of Direct referral. Patients will be given a choice to advance to directly having a colonoscopy screening.Colon Cancer Screening Navigation.

Behavioral: Colon Cancer Screening Navigation

Interventions

Colon Cancer Screening Navigation BEHAVIORAL

Patients with FIT Positive results that have been given the choice will be followed and navigated from referral to colonoscopy to assist in obtaining colonoscopy.

FIT Positive Choice

Standard of Care BEHAVIORAL

Patients will be tracked to compare how effective are usual care methods

FIT Positive

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants that have not had a colonoscopy with in 10 years, flexible sigmoidoscopy with in 5 years, or a stool for occult blood with in 1 year.

You may not qualify if:

• History of colon cancer, inflammatory bowel disease or colon polyps.

Sponsors & Collaborators

• Renown Regional Medical Center: lead

Study Sites (1)

Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paul Devereux, PhD, MPH

  Univeristy of Nevada, Reno

  STUDY CHAIR

• John Gray, MD, FACG

  GI Consulatants

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 17, 2016
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

US (1)