Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities

Cervical Cancer Clinical Trial

Official title:

Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00629993
• Other study ID #: AAAA9722
• Secondary ID: U57/CCU224079
• Status: Terminated
• Phase: Phase 4
• First received: February 26, 2008
• Last updated: February 28, 2011
• Start date: January 2004
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The specific aims of this proposal are:

1. 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.

2. 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.

3. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 282
• Est. completion date: August 2010
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12-month followup	No
Secondary	Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment		12-month followup	No