Systems of Support to Increase Colon Cancer Screening and Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,653
- 试验地点
- 2
- 主要终点
- Short-term adherence to CRC screening
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Known high risk for CRC
- •History of CRC
- •History of inflammatory bowel disease
- •Current anticoagulation therapy
- •Organ failure
- •Serious illness
- •Debilitating disease
- •Nursing home resident.
结局指标
主要结局
Short-term adherence to CRC screening
时间窗: From randomization to the end of 2 years
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
时间窗: From randomization to the end of 9 years
To compare the proportion of time participants are adherent to CRC screening long-term (initial randomization to the end of year 9).
次要结局
- Short and long-term adherence to CRC screening for those eligible for re-randomization in year 3(From year 3 to the end of 9 years)
- Impact of SOS interventions on outcomes and CRC-related costs(From randomization to the end of 9 years)