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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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New York
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New York, New York, Verenigde Staten, 10018
- Clinical Directors Network, Incorporated
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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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Geen tussenkomst: Usual Care
Usual Care.
A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening
Tijdsspanne: 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.
|
18 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Percentage of patients UTD for breast and cervical cancer screening
Tijdsspanne: 18 months
|
18 months
|
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Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening
Tijdsspanne: 18 months
|
18 months
|
Medewerkers en onderzoekers
Onderzoekers
- Studie stoel: Allen J. Dietrich, MD, Norris Cotton Cancer Center
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDR0000537346
- P30CA023108 (Subsidie/contract van de Amerikaanse NIH)
- DMS-20253
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