Helping Women Stay Up-To-Date With Cancer Screening By Using a Prevention Care Manager or Usual Care
New York Prevention Care Manager Project / Medicaid Managed Care Organization Version
RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments.
PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Develop and evaluate an enhanced telephone support intervention (Prevention Care Manager [PCM]) to promote colorectal, cervical, and breast cancer screening more widely among women enrolled in a Medicaid Managed Care Organization (MMCO).
- Explore the impact of patient, Community/Migrant Health Center (C/MHC), and MMCO characteristics on cancer screening status and the impact of the intervention.
- Evaluate the impact of the enhanced PCM intervention upon colorectal, breast, and cervical cancer screening rates.
Secondary
- Compare the status of women who are up-to-date (UTD) on CRC screening versus the UTD status of cervical cancer and breast cancer screening.
OUTLINE: This is a randomized, controlled study. The study is conducted in 2 parts.
Part 1 (barrier interview and pilot testing): Patients are stratified according to primary language and whether or not they have had an outpatient visit in the past year.
- Barrier interview: Patients undergo a 15-30 minute interview to determine barriers they face preventing them from receiving recommended cancer screenings and healthcare, as well as facilitators which have encouraged them to be screened.
- Pilot testing: Patients from the barrier interviews and other eligible Medicaid Managed Care Organization (MMCO) patients receive scripted telephone calls from a Prevention Care Manager to assist them in getting up-to-date on their cancer screening tests over 3 months.
Part 2 (randomized control trial): Patients are stratified according to treatment center (Community/Migrant health center vs Diagnostic and Treatment Center) and age. Patient are randomized to 1 of 2 intervention arms.
- Arm I (Prevention Care Manager): Patients are stratified according to the number of tests for which they are up-to-date at baseline. Patients receive reminder letters encouraging them to contact their primary care provider for colorectal, breast, and cervical cancer screening and 3 to 4 telephone support calls to help them become up to date for colorectal, breast, and cervical cancer screening.
- Arm II (usual care): Patients receive usual care according to their primary care physician.
In both arms, patients are followed for 18 months.
PROJECTED ACCRUAL: A total of 2,600 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10018
- Clinical Directors Network, Incorporated
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
- Enrolled in a participating Medicaid Managed Care Organization (MMCO) as a Medicaid patient for ≥ 12 months
Not up-to-date (UTD) for colorectal cancer screening
UTD status defined by any of the following:
- Home fecal occult blood test within the past 12 months
- Flexible sigmoidoscopy within the past 5 years
- Double-contrast barium enema within the past 5 years
- Colonoscopy within the past 10 years
- Registered to receive primary care from a participating Community/Migrant Health Center, Diagnostic and Treatment Center, or other participating practice in New York City
- Must have a telephone available
No MMCO claim for any of the following:
- Colorectal, breast, or cervical cancer
- Colon polyp removal
- Total colectomy
PATIENT CHARACTERISTICS:
- Female
- Able to use telephone
- No plans to move for ≥ 1 year
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Prevention Care Management
Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening
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Telephone support over 18 months to help women become screened for breast, cervical and colon cancer.
Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.
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无干预：Usual Care
Usual Care.
A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
大体时间：18 months
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Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.
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18 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Percentage of patients UTD for breast and cervical cancer screening
大体时间：18 months
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18 months
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Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
大体时间：18 months
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18 months
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合作者和调查者
调查人员
- 学习椅：Allen J. Dietrich, MD、Norris Cotton Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Prevention Care Management的临床试验
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UConn HealthUniversity of Texas at Austin; Oregon Social Learning Center邀请报名
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George Washington UniversityTranscultural Psychosocial Organization Nepal完全的
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Copenhagen University Hospital at HerlevRigshospitalet, Denmark未知
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