Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      SOS is a four-arm randomized controlled study of ways to increase screening for colorectal
      cancer. About 40-50% of the people age 50 and older are not up to date on screening. This is
      a very important problem because screening both prevents colorectal cancer and decreases
      colon cancer deaths.

      We are studying 3 different levels of support to help people get screened and follow-up after
      positive screening tests. These involve comparing to usual care stepwise increasing in
      intensity approaches; an automated approach of mailing information and home screening tests,
      this plus phone assistance by a medical assistant, both of these plus phone counseling and
      care management. We will also compare nurse assisted follow-up after a positive screening
      test compared to usual care

      By doing this study we hope to increase colon cancer screening rates, and also follow-up
      rates for positive screening tests.
    

Detailed description: 
      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.
    

Intervention name(s): Automated Mailing; Automated Mailing Plus Assisted; Auto Plus Assisted Plus Navigation
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Usual Care plus Automated mailing; If not screened after automated mailing, MA assists with screening.; If not screened after automated mailing and assistance by MA, RN begins navigation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Colorectal Neoplasms; Mass Screening; Population Surveillance; Randomized controlled trial; Occult Blood; Colonoscopy; Sigmoidoscopy; Health Behavior; Colorectal Screening