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New York Prevention Care Manager Project / Medicaid Managed Care Organization Version


N/A
50 Years
64 Years
Not Enrolling
Female
Breast Cancer, Cervical Cancer, Colorectal Cancer

Thank you

Trial Information

New York Prevention Care Manager Project / Medicaid Managed Care Organization Version


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening

Outcome Description:

Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Allen J. Dietrich, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000537346

NCT ID:

NCT00477646

Start Date:

July 2007

Completion Date:

February 2011

Related Keywords:

  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
  • colon cancer
  • rectal cancer
  • breast cancer
  • cervical cancer
  • Breast Neoplasms
  • Uterine Cervical Neoplasms
  • Colorectal Neoplasms

Name

Location

Clinical Directors Network, Incorporated New York, New York  10018