Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments mailed-fit, screening invitation-reminder
Sponsor Corporal Michael J. Crescenz VA Medical Center
Collaborator University of Pennsylvania
Start date October 2015
End date December 2016
Trial size 783 participants
Trial identifier NCT02584998, PPO 14-369-2 -- 01522

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(No Intervention)
These patients will continue to receive the current practice at the Philadelphia VA Medical Center (VAMC) of offering screening during an office visit. Other interventions will be embedded within this existing program for a pragmatic approach. However, all participants in the trial, including those in usual care (UC), will receive follow-up of test results and navigation to diagnostic colonoscopy for positive FIT results.
(Active Comparator)
Participants will receive UC and also receive an invitation letter with information about CRC testing. The information will include lay-audience description of screening tests and symptoms that should prompt diagnostic work-up. The packet will have instructions to contact the study team if participants believe they are not eligible and to update the contact information on record. The letter will inform participants that a telephone reminder will follow in 4 weeks from invitation letter if screening is not completed. They will also receive notification of test results and navigation to colonoscopy, if needed. For the purposes of this intervention, Week 1 will be the week the invitation letter was sent (time zero).
screening invitation-reminder
These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm
(Active Comparator)
Participants randomized to Mailed-FIT will receive a mailed FIT pre-notification letter (plus a screening invitation) followed by the kit 1 week later. Participants will receive instructions to contact the study team if they believe they are not eligible and to update their contact information. They will be informed that a telephone reminder will follow 4 weeks from notification letter if screening is not completed. Participants who do not return their kit within 4 weeks after their pre-notification letter was mailed will receive a live telephone reminder, followed by 2 additional calls at the end of weeks 5 and 6, if needed. For the purposes of this intervention, Week 1 will be the week the pre-notification letter was sent (time zero).
mailed-fit Fecal Immunochemical Test
The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is ≥100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies.

Primary Outcomes

Measure
The completion rate of FIT within 6 months of the mailing of the screening invitation. Absence of screening completion data in the VA medical record system will be recorded as failure to complete screening.
time frame: 6 months

Secondary Outcomes

Measure
The receipt of any colorectal cancer screening test in the 6-month period after enrollment into the study.
time frame: 6 months

Eligibility Criteria

Male or female participants from 50 years up to 74 years old.

Inclusion Criteria: The pragmatic trial will include veterans in southeastern Pennsylvania and Southern New Jersey who, during the funding year, are 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, are due for screening, and 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, or change in bowel habits, family history of CRC, inflammatory bowel disease (IBD), or 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, and 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.

Additional Information

Official title Reducing Colorectal Cancer Death Through Mailed Outreach Screening
Principal investigator Emily C. Paulson, MD, MSCE
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center.