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

This study has been terminated.
(Principal Investigator left the institution)
Sponsor:
Collaborator:
Information provided by:
Columbia University
ClinicalTrials.gov Identifier:
NCT00629993
First received: February 26, 2008
Last updated: February 28, 2011
Last verified: February 2011
  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:

  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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014