Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up

Kaiser Permanente

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Auto Plus Assisted Plus Navigation; Behavioral: Automated Mailing Plus Assisted; Behavioral: Automated Mailing

Study type: Interventional

Funder types: Other

Identifiers

NCT00697047

5R01CA121125

Details and patient eligibility

About

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.

Full 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.

Usual care (UC). Automated (UC+ mailed information, access to a cancer screening hotline, mailed FOBT cards, and a reminder card). 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. 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:

To compare the effectiveness of each intervention condition on increasing CRCS rates.

To compare the effectiveness of each intervention condition on follow-up after a positive screening test.

The secondary aims are:

To assess the effects of each intervention condition on participants' cognitive, affective, and social factors related to CRCS adherence and satisfaction with medical services To compare utilization, costs, and incremental cost-effectiveness of each intervention condition.

Enrollment: 4,653 patients

Sex: All

Ages: 50 to 73 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Not up to date on CRCS
• Continuously enrolled in Group Health Cooperative (GHC) for 24 months
• Expected to continue to be enrolled at GHC for 24 months.

Exclusion criteria

• Known high risk for CRC
• History of CRC
• History of inflammatory bowel disease
• Current anticoagulation therapy
• Organ failure
• Serious illness
• Debilitating disease
• Dementia
• Nursing home resident.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,653 participants in 4 patient groups

1- Usual Care

No Intervention group

Description:

Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.

2 - Automated Mailing

Experimental group

Description:

Usual care plus automated mailing. Mailing 1 is a pamphlet about screening choices and number to call for colonoscopy. Mailing 2 is a FIT kit if not requesting colonoscopy. Mailing 3 is a Reminder letter.

Treatment:

Behavioral: Automated Mailing

3 - Automated Mailing Plus Assisted

Experimental group

Description:

Usual care, automated mailing plus, if screening is still not completed, phone assistance by a medical assistant (MA) who asks about patients screening intent, and provides brief assistance to complete this (e.g. sends another fecal test, assists with provider order for a colonoscopy).

Treatment:

Behavioral: Automated Mailing Plus Assisted

4 - Auto Plus Assisted Plus Navigation

Experimental group

Description:

Usual care, automated mailing, phone assistance by a medical assistant, plus navigation by a registered nurse (RN) if still not screened. Navigators are trained to use motivational interviewing techniques. They assess CRC and procedure risk, facilitate screening choice, address barriers, and provide follow-up until screening is completed.

Treatment:

Behavioral: Auto Plus Assisted Plus Navigation