Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
This study has been terminated.
(Principal Investigator left the institution)
Sponsor:
Columbia University
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00629993
First received: February 26, 2008
Last updated: February 28, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Behavioral: Academic Detailing |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Screening |
| Official Title: | Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities |
Resource links provided by NLM:
Further study details as provided by Columbia University:
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 [ Time Frame: 12-month followup ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment [ Time Frame: 12-month followup ] [ Designated as safety issue: No ]
| Enrollment: | 282 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
Behavioral: Academic Detailing
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 Name: Multi-component Academic Detailing
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629993
Locations
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10027 | |
Sponsors and Collaborators
Columbia University
Investigators
| Principal Investigator: | Sherri Sheinfeld Gorin, PhD | Columbia University |
More Information
No publications provided
| Responsible Party: | Vicki Benard, Ph.D., Project Officer, Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00629993 History of Changes |
| Other Study ID Numbers: | AAAA9722, U57/CCU224079 |
| Study First Received: | February 26, 2008 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Columbia University:
|
cervical cancer screening medically underserved women HPV vaccine |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013