Colorectal Cancer Clinical Trial
Official title:
Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties
The goal of the study is to conduct a randomized clinical trial to test several office-based strategies for improving colon cancer screening among individuals who are regular patients at 16 family practice physician offices in the state of Iowa. These offices are members of the Iowa Research Network (IRENE), a rural practice-based research network. The interventions to be tested are increasing in intensity from the usual care provided in the office, to physician chart reminders, mailed educational materials to patients, a fecal immunochemical test with postage-paid return envelope, and a telephone call designed to determine attitudes and barriers to screening, and to motivate subjects to get screened. Our main research questions are: 1)do attitudes toward CRC screening change after providing educational materials about CRC screening? 2)do mailed educational materials and a FIT, with or without a telephone reminder, result in increased rates of CRC testing with the FIT?
Colorectal cancer is the second leading cause of cancer death in the U.S. yet approximately
half of eligible adults are not up-to-date with colon cancer screening and the rates of
screening are lower among those with lower incomes and who lack insurance. A physician's
recommendation for screening has consistently been show to be one of the most powerful
predictors of CRC screening. Relatively few studies of CRC screening have been conducted in
primary care. Disparities in CRC screening rates are seen in low socioeconomic and rural
individuals who often lack resources and access to screening. Most intervention studies have
been conducted in managed care settings, community health centers, Veteran's Administration
or academic practices. Few studies have looked at interventions in rural medical practices.
This research will address screening issues for rural patients and those residing in
communities designated as medically underserved. The interventions tested in the study will
focus on two key areas: educating the patient about the importance of screening, and
reminding the physician about the need to discuss screening during the patient's visit.
The original goal of the study was to enroll 1500 unscreened patients aged 52 to 79 years
from 16 family physician practices located in poor, rural Iowa counties. This study will
test a combination of patient and physician reminder strategies designed to ensure that the
patient is educated about CRC screening and receives a recommendation for CRC screening from
their physician. The main outcome is colorectal cancer screening by any of the accepted
methods. Rates of screening will be compared across intervention groups. We will also
determine how much the interventions cost per person screened.
Patients due for screening within each practice (based on their self-report) (never screened
or not up to date with screening) will be randomized to one of four groups that will receive
office reminder system strategies of increasing intensity: 1) Usual care, 2) Physician chart
reminder alone, 3) Physician chart reminder plus multifaceted mailed patient education,
including a postage paid fecal immunochemical test, a reminder magnet, and returnable CRC
screening test preference sheet, or 4) Physician chart reminder + multifaceted mailed
patient education/FIT/magnet/preference sheet + telephone reminder to encourage screening
and address barriers.
Our central hypothesis is that providing offices with one or more CRC screening support
systems based on the Chronic Care Model will significantly increase CRC screening rates in
comparison with usual care, and that such interventions will be cost-effective and accepted
in practice.
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