Systems of Support to Increase Colon Cancer Screening and Follow-up
Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up A. Specific Aims
There is strong evidence that colorectal cancer screening (CRCS) decreases colorectal cancer
(CRC) mortality and reduces colorectal cancer incidence. Despite the efficacy of screening,
40-60% of eligible adults are not screened at recommended intervals, and many have never had
any type of CRCS. Screening failures occur not only from lack of screening but also from
breakdowns in follow-up of positive tests, which obviates the benefits of screening.
Strategies for improving the uptake of CRCS typically focus on either patients or health
care providers, without describing the infrastructure changes, or systems of support (SOS),
that are required to implement and sustain these changes.
We propose a two-part study using the Chronic Care Model to organize SOS. We will identify a
cohort of Group Health patients aged 50 -73 years who have not had a colonoscopy (CS) in 10
years, a flexible sigmoidoscopy (FS) in 5 years, or a fecal occult blood test (FOBT) in 10
months.
Part One:
Subjects will be randomized to receive one of four interventions of stepwise increasing
intensity of support.
1. Usual care (UC).
2. Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT
cards, and a reminder card).
3. Assisted (UC + automated + a medical assistant) to document screening intent and
assists patients via the resources already supplied or sending requests to the
patient's physician.
4. Care management (UC + automated + assisted + cancer screening nurse support) who
counsels patient and assists with this screening plan (assessing procedural risk, and
ordering tests).
Part Two: Patients with a positive FOBT or a positive FS (CS needed) will be randomized to
one of two follow-up intervention arms: A. Usual care (which at Group Health includes a
registry and physician alerts) or B. Care Management (UC + cancer screening nurse who
manages care after a positive test). Our study hypotheses are that increasing levels of SOS
will result in increasing CRCS rates, and care management by cancer screening nurses will
increase follow-up rates after a positive test.
The primary specific aims are:
1. To compare the effectiveness of each intervention condition on increasing CRCS rates.
2. To compare the effectiveness of each intervention condition on follow-up after a
positive screening test.
The secondary aims are:
3. To assess the effects of each intervention condition on participants' cognitive,
affective, and social factors related to CRCS adherence and satisfaction with medical
services
4. To compare utilization, costs, and incremental cost-effectiveness of each intervention
condition.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Colorectal cancer screening rates (as defined by both the NCQA HEDIS measure and the American Cancer Society), and follow-up rates after a positive screening test.
Baseline, 12 mo f/u, 24 mo f/u, and 6mo after positive screening test
Yes
Beverly B Green, MD, MPH
Principal Investigator
Group Health Cooperative
United States: Institutional Review Board
5RO1CA121125
NCT00697047
July 2008
May 2013
Name | Location |
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Group Health Research Institute | Seattle, Washington 98101 |