Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
February 28, 2011 updated by: Columbia University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10027
- Columbia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multi-component Academic Detailing
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
12-month followup
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
Time Frame: 12-month followup
|
12-month followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sherri Sheinfeld Gorin, PhD, Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Estimate)
March 1, 2011
Last Update Submitted That Met QC Criteria
February 28, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAA9722
- U57/CCU224079
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.