Clinical trial NCT02584998: Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Official title: Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Pennsylvania
First posted: 2015-10-23
Enrollment: 782
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The main study aim is to develop, implement and disseminate a pilot population-based mailed FIT outreach screening program in the Philadelphia VA Medical Center that does not rely on having an office visit, by conducting a proof-of-concept 3-arm parallel-design pragmatic randomized trial to (1) Compare the effects of usual care (UC), screening invitation + reminder (invitation-reminder), or screening invitation + mailed FIT kit + reminder (mailed-FIT); (2) Explore whether the FIT completion rate varies by age or race/ethnicity; and (3) Explore barriers to use of mailed outreach screening for Veterans.

Detailed description: This study seeks to establish the foundation to systematically study and improve the delivery and effectiveness of colorectal cancer (CRC) screening in the VA by developing, implementing and disseminating a pilot mailed-FIT screening outreach program that does not rely on having a clinical office visit. The investigators specifically address the need to identify and remediate potential failures to identify and offer screening to eligible Veterans through multilevel interventions. The investigators will also create electronic data linkages to, in future studies, enable evaluation of FIT performance characteristics and help close critical evidence gaps for optimizing screening among Veterans. As this is a pilot study, the focus is to assess feasibility of a population-based screening outreach approach through the development, implementation and dissemination of a mailed FIT outreach program in the Philadelphia VA Medical Center that does not rely on having an office visit.

Eligibility criteria: Inclusion Criteria:

* The pragmatic trial will include Veterans in southeastern Pennsylvania and Southern New Jersey who, during the funding year
* 50 to 75 years old
* Have received care at the Philadelphia VA Medical Center in the 18-48 months prior to selection for the study but who have not been seen by primary care in the past 18 months prior to selection
* Due for screening
* Are asymptomatic for CRC
* This includes the period during which 3-sample testing was being regularly used at the Philadelphia VA Medical Center

Exclusion Criteria:

* Have any known gastrointestinal symptoms such as:

  * bleeding
  * unexplained weight loss
  * change in bowel habits
  * family history of CRC
  * inflammatory bowel disease (IBD)
  * colectomy using International Classification of Disease (9th and 10th edition) diagnostic code or by self-report.
* The investigators will also exclude Veterans:

  * with evidence of prior colonoscopy within 10 years
  * sigmoidoscopy within 5 years
  * fecal occult blood test (FOBT)/FIT in the same calendar year
* The information used to exclude patients will be derived from the electronic queries or chart audits.

Primary outcomes:
measure: The Number of Participants Who Completed the Mailed FIT Test Screening Within 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: The Number of Participants Who Received Any Colorectal Cancer Screening Test in the 6-month Period After Enrollment Into the Study.
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: E. Carter Paulson, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldshore MA, Mehta SJ, Fletcher W, Tzanis G, Doubeni CA, Paulson EC. An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care. Am J Prev Med. 2020 Jul;59(1):41-48. doi: 10.1016/j.amepre.2020.02.014.