Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Primary Purpose
Cervical Cancer
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Academic Detailing
Sponsored by
About this trial
This is an interventional screening trial for Cervical Cancer focused on measuring cervical cancer screening, medically underserved women, HPV vaccine
Eligibility Criteria
Inclusion Criteria:
- Charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed
Exclusion Criteria:
- Exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.
Sites / Locations
- Columbia University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multi-component Academic Detailing
Arm Description
Multi-component, academic detailing regarding ACS guidelines on cervical cancer screening approaches. Includes an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients.
Outcomes
Primary Outcome Measures
Number of asymptomatic female patients age 18-85 who receive or are referred for a recto-pelvic bimanual examination with the collection of the Pap smear (per ACS guidelines); collected via medical chart review
Secondary Outcome Measures
Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
Full Information
NCT ID
NCT00629993
First Posted
February 26, 2008
Last Updated
February 28, 2011
Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00629993
Brief Title
Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Official Title
Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator left the institution
Study Start Date
January 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Columbia University
Collaborators
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Primary care physicians have an important role to play in the delivery of cancer prevention and detection services to patients. Face-to-face counseling of physicians, called academic detailing, involves a brief and focused intervention, modeled on the practices of pharmaceutical companies. This type of intervention may increase physicians' attention to preventive opportunities and increase their screening behaviors.
Detailed Description
The specific aims of this proposal are:
To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician cervical cancer screening at 3- and 6-months post-randomization, compared to the rate observed in a service-as-usual control.
To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of cervical cancer screening guidelines to different physician subgroups.
To conduct a cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the cervical cancer intervention implemented in physicians' offices.
The long-term goal of this project therefore is to reduce cervical cancer risks among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
cervical cancer screening, medically underserved women, HPV vaccine
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-component Academic Detailing
Arm Type
Experimental
Arm Description
Multi-component, academic detailing regarding ACS guidelines on cervical cancer screening approaches.
Includes an interactive, digitized CD-ROM, focused on the discussion of risks and benefits, screening options or alternatives, values clarification, and mutual decision-making, alongside patient education materials designed for low literacy patients.
Intervention Type
Behavioral
Intervention Name(s)
Academic Detailing
Other Intervention Name(s)
Multi-component Academic Detailing
Intervention Description
It will involve multiple intervention components, some of which are standardized across physicians (i.e., self learning packets, post-tests for CME credit, CD-ROMS, videos, newsletters, culturally sensitive patient education materials, office staff informational sessions, chart and patient reminders, and a general office routine for cervical cancer counseling, including performance feedback, as well as media-ready materials). Academic detailing and the specific office routines will be customized to each physician, although the frequency of the detailing visits will be routinized across all participants, to reduce cost and to maximize its potential for dissemination.
Primary Outcome Measure Information:
Title
Number of asymptomatic female patients age 18-85 who receive or are referred for a recto-pelvic bimanual examination with the collection of the Pap smear (per ACS guidelines); collected via medical chart review
Time Frame
12-month followup
Secondary Outcome Measure Information:
Title
Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
Time Frame
12-month followup
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed
Exclusion Criteria:
Exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherri Sheinfeld Gorin, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
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