Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up
NCT ID: NCT00697047
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4653 participants
INTERVENTIONAL
2008-07-31
2019-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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1- Usual Care
Usual Care (UC) includes an annual birthday letter with information on overdue screening tests including CRC screening.
No interventions assigned to this group
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.
Automated Mailing
Usual Care plus Automated mailing
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).
Automated Mailing Plus Assisted
If not screened after automated mailing, MA assists with screening.
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.
Auto Plus Assisted Plus Navigation
If not screened after automated mailing and assistance by MA, RN begins navigation.
Interventions
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Automated Mailing
Usual Care plus Automated mailing
Automated Mailing Plus Assisted
If not screened after automated mailing, MA assists with screening.
Auto Plus Assisted Plus Navigation
If not screened after automated mailing and assistance by MA, RN begins navigation.
Eligibility Criteria
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Inclusion Criteria
* Continuously enrolled in Group Health Cooperative (GHC) for 24 months
* Expected to continue to be enrolled at GHC for 24 months.
Exclusion Criteria
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident.
50 Years
73 Years
ALL
No
Sponsors
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Fred Hutchinson Cancer Center
OTHER
The University of Texas Health Science Center, Houston
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Beverly B Green, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Locations
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Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Countries
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References
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Meenan RT, Anderson ML, Chubak J, Vernon SW, Fuller S, Wang CY, Green BB. An economic evaluation of colorectal cancer screening in primary care practice. Am J Prev Med. 2015 Jun;48(6):714-21. doi: 10.1016/j.amepre.2014.12.016.
Green BB, Anderson ML, Wang CY, Vernon SW, Chubak J, Meenan RT, Fuller S. Results of nurse navigator follow-up after positive colorectal cancer screening test: a randomized trial. J Am Board Fam Med. 2014 Nov-Dec;27(6):789-95. doi: 10.3122/jabfm.2014.06.140125.
Green BB, Wang CY, Horner K, Catz S, Meenan RT, Vernon SW, Carrell D, Chubak J, Ko C, Laing S, Bogart A. Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants. Contemp Clin Trials. 2010 Nov;31(6):589-603. doi: 10.1016/j.cct.2010.07.012. Epub 2010 Jul 30.
Green BB, Bogart A, Chubak J, Vernon SW, Morales LS, Meenan RT, Laing SS, Fuller S, Ko C, Wang CY. Nonparticipation in a population-based trial to increase colorectal cancer screening. Am J Prev Med. 2012 Apr;42(4):390-7. doi: 10.1016/j.amepre.2011.11.014.
Green BB, Wang CY, Anderson ML, Chubak J, Meenan RT, Vernon SW, Fuller S. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann Intern Med. 2013 Mar 5;158(5 Pt 1):301-11. doi: 10.7326/0003-4819-158-5-201303050-00002.
Wang CY, de Dieu Tapsoba J, Anderson ML, Vernon SW, Chubak J, Fuller S, Green BB. Time to screening in the systems of support to increase colorectal cancer screening trial. Cancer Epidemiol Biomarkers Prev. 2014 Aug;23(8):1683-8. doi: 10.1158/1055-9965.EPI-14-0270. Epub 2014 Jun 2.
Murphy CC, Vernon SW, Haddock NM, Anderson ML, Chubak J, Green BB. Longitudinal predictors of colorectal cancer screening among participants in a randomized controlled trial. Prev Med. 2014 Sep;66:123-30. doi: 10.1016/j.ypmed.2014.06.013. Epub 2014 Jun 15.
Green BB, Anderson ML, Chubak J, Fuller S, Meenan RT, Vernon SW. Impact of continued mailed fecal tests in the patient-centered medical home: Year 3 of the Systems of Support to Increase Colon Cancer Screening and Follow-Up randomized trial. Cancer. 2016 Jan 15;122(2):312-21. doi: 10.1002/cncr.29734. Epub 2015 Oct 21.
Green BB, Anderson ML, Chubak J, Baldwin LM, Tuzzio L, Catz S, Cole A, Vernon SW. Colorectal Cancer Screening Rates Increased after Exposure to the Patient-Centered Medical Home (PCMH). J Am Board Fam Med. 2016 Mar-Apr;29(2):191-200. doi: 10.3122/jabfm.2016.02.150290.
Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Meenan RT, Vernon SW. A Centralized Program with Stepped Support Increases Adherence to Colorectal Cancer Screening Over 9 Years: a Randomized Trial. J Gen Intern Med. 2022 Apr;37(5):1073-1080. doi: 10.1007/s11606-021-06922-2. Epub 2021 May 28.
Green BB, Anderson ML, Cook AJ, Chubak J, Fuller S, Kimbel KJ, Kullgren JT, Meenan RT, Vernon SW. Financial Incentives to Increase Colorectal Cancer Screening Uptake and Decrease Disparities: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jul 3;2(7):e196570. doi: 10.1001/jamanetworkopen.2019.6570.
Green BB, BlueSpruce J, Tuzzio L, Vernon SW, Aubree Shay L, Catz SL. Reasons for never and intermittent completion of colorectal cancer screening after receiving multiple rounds of mailed fecal tests. BMC Public Health. 2017 May 30;17(1):531. doi: 10.1186/s12889-017-4458-6.
Other Identifiers
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