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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Kaiser Permanente
Fred Hutchinson Cancer Research Center
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00697047
First received: June 11, 2008
Last updated: May 25, 2016
Last verified: May 2016
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Automated Mailing
Behavioral: Automated Mailing Plus Assisted
Behavioral: Auto Plus Assisted Plus Navigation

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:
  • Short-term adherence to CRC screening [ Time Frame: From randomization to the end of 2 years ] [ Designated as safety issue: No ]
    To compare CRC screening adherence by randomization arm: Any screening during years 1 or 2; (b) Screening coverage during both years 1 and 2.

  • Long-term adherence to CRC screening [ Time Frame: From randomization to the end of 9 years ] [ Designated as safety issue: No ]
    To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).


Secondary Outcome Measures:
  • Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3 [ Time Frame: From year 3 to the end of 9 years ] [ Designated as safety issue: No ]
    To compare adherence to CRC screening, among those randomized to receive continued interventions compared to stopped interventions: a) during year 3; b) over the 7 years of follow-up from re-randomization at year 3 through the end of year 9.

  • Impact of SOS interventions on outcomes and CRC-related costs [ Time Frame: From randomization to the end of 9 years ] [ Designated as safety issue: No ]
    To compare by randomization arm the impact of SOS interventions on long-term outcomes (advanced adenomas and CRC by stage), costs, and cost-effectiveness.


Enrollment: 4653
Study Start Date: July 2008
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1- Usual Care
Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.
Experimental: 2 - Automated Mailing
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.
Behavioral: Automated Mailing
Usual Care plus Automated mailing
Experimental: 3 - Automated Mailing Plus Assisted
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).
Behavioral: Automated Mailing Plus Assisted
If not screened after automated mailing, MA assists with screening.
Experimental: 4 - Auto Plus Assisted Plus Navigation
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.
Behavioral: Auto Plus Assisted Plus Navigation
If not screened after automated mailing and assistance by MA, RN begins navigation.

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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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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
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Beverly B Green, MD, MPH Group Health Cooperative
  More Information

Publications:

Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00697047     History of Changes
Other Study ID Numbers: 5RO1CA121125 
Study First Received: June 11, 2008
Last Updated: May 25, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Yes, a de-identified data set will be available and shared upon request.

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic 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 August 25, 2016