Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 63 |
| Updated: | 3/30/2019 |
| Start Date: | September 1, 2019 |
| End Date: | August 2020 |
| Contact: | Lisa Quirk |
| Email: | lisa.quirk@utsouthwestern.edu |
| Phone: | 214-648-9703 |
Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System
This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach
intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice
of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening
colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program
(which does not offer an explicit choice of screening modality). The trial will be conducted
in a racially and socioeconomically diverse cohort of patients served by an integrated safety
net delivery system that has a "FIT first" population health screening strategy. All patients
will also have access to whatever CRC screening is recommended through usual visit-based
care.
intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice
of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening
colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program
(which does not offer an explicit choice of screening modality). The trial will be conducted
in a racially and socioeconomically diverse cohort of patients served by an integrated safety
net delivery system that has a "FIT first" population health screening strategy. All patients
will also have access to whatever CRC screening is recommended through usual visit-based
care.
Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death
can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54
CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with
screening compared to usual care. Investigators are now conducting a comparative
effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or
colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based
outreach (which does not offer an explicit choice of screening modality (n=8,000.)
Randomization will be stratified based on whether or not patients completed a FIT within the
prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy
educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit
and return mailer with prepaid postage, d) telephone reminder calls including one-on-one
education, and e) centralized patient navigation for follow-up of abnormal screening results,
and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm
will receive the same materials described above; however, the educational letter will explain
and offer the additional choice of screening by colonoscopy (instead of completing the mailed
FIT kit). The mailing will include a low health literacy one-page option grid outlining the
pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred
but instead emphasize that both are good choices, and the patient should choose the screening
option that seems right for them. Patients choosing colonoscopy will be provided a telephone
number to schedule the procedure. During scheduling, patients will be triaged by study staff
with a structured history and physical form to "direct access" colonoscopy or a
pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit
using the return envelope with prepaid postage.
can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54
CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with
screening compared to usual care. Investigators are now conducting a comparative
effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or
colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based
outreach (which does not offer an explicit choice of screening modality (n=8,000.)
Randomization will be stratified based on whether or not patients completed a FIT within the
prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy
educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit
and return mailer with prepaid postage, d) telephone reminder calls including one-on-one
education, and e) centralized patient navigation for follow-up of abnormal screening results,
and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm
will receive the same materials described above; however, the educational letter will explain
and offer the additional choice of screening by colonoscopy (instead of completing the mailed
FIT kit). The mailing will include a low health literacy one-page option grid outlining the
pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred
but instead emphasize that both are good choices, and the patient should choose the screening
option that seems right for them. Patients choosing colonoscopy will be provided a telephone
number to schedule the procedure. During scheduling, patients will be triaged by study staff
with a structured history and physical form to "direct access" colonoscopy or a
pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit
using the return envelope with prepaid postage.
Inclusion Criteria:
- Males and females
- Age 50-63 years
- Seen at least one time at a Parkland primary care clinic within one year prior to
randomization
- Participants in Parkland's medical assistance program for the uninsured (Parkland
Financial Assistance)
- All races and ethnicities
Exclusion Criteria:
- Up-to-date with CRC screening, defined by:
1. Colonoscopy in the last 10 years
2. Sigmoidoscopy in the last 5 years
- Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps
- Address or phone number not on file
- Incarcerated
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