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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kaiser Permanente
Fred Hutchinson Cancer Research Center
Information provided by:
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00697047
First received: June 11, 2008
Last updated: August 15, 2012
Last verified: August 2012
  Purpose

SOS is a four-arm randomized controlled study of ways to increase screening for colonrectal 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.


Condition Intervention
Colorectal Cancer Screening
Behavioral: Usual care plus automated mailing
Behavioral: Usual care, automated mailing plus phone assistance by a medical assistant
Behavioral: Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Systems of Support to Increase Colon Cancer Screening and Follow-up

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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. [ Time Frame: Baseline, 12 mo f/u, 24 mo f/u, and 6mo after positive screening test ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cognitive, affective, and social factors related to CRCS, satisfaction with medical services, utilization and costs. [ Time Frame: Baseline, 24 mo f/u, and 6mo after positive screening test ] [ Designated as safety issue: No ]

Estimated Enrollment: 6200
Study Start Date: July 2008
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual Care
Experimental: 2
Usual care plus automated mailing
Behavioral: Usual care plus automated mailing
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)
Experimental: 3
Usual care, automated mailing plus phone assistance by a medical assistant who helps patients clarify screening intent and refers care (such as ordering a screening colonoscopy) back to the patient's physician.
Behavioral: Usual care, automated mailing plus phone assistance by a medical assistant
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)
Experimental: 4
Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening (assesses risks related to screening tests, counsels and assists patient in making a screening choice, and arranges the screening plan).
Behavioral: Usual care, automated mailing, phone assistance by a medical assistant, who refers care to a registered nurse who provides care management for screening
Part 2 - patients with positive stool test or flexible sigmoidoscopy are randomized to receive usual care or nurse care management (registered nurse)

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.
  Eligibility

Ages Eligible for Study:   50 Years to 73 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Not up to date on CRCS
  • Continuously enrolled in 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697047

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Kaiser Permanente
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Beverly B Green, MD, MPH Group Health Cooperative
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beverly B. Green, MD, MPH (Principal Investigator), Group Health Research Institute
ClinicalTrials.gov Identifier: NCT00697047     History of Changes
Other Study ID Numbers: 5RO1CA121125, CFDA: 93.393, OC: 414E, PCC:4KHE
Study First Received: June 11, 2008
Last Updated: August 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Colorectal Neoplasms
Mass Screening
Population Surveillance
Randomized controlled trial
Occult Blood
Colonoscopy
Sigmoidoscopy
Health Behavior

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014