Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10027


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

AAAA9722


NCT ID:

NCT00629993


Secondary ID:

U57/CCU224079


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Principal Investigator left the institution


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

282


Enrollment Type:

Actual


Overall Contact Information

Official Name:Sherri Sheinfeld Gorin, PhD
Principal Investigator
Columbia University

Study Dates

Start Date:January 2004
Completion Date:August 2010
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:February 2011
Last Changed Date:February 28, 2011
First Received Date:February 26, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
Time Frame:12-month followup
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Academic Detailing
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
Arm Name:Multi-component Academic Detailing
Other Name:Multi-component Academic Detailing

Study Arms

Study Arm Type:Experimental
Arm Name:Multi-component Academic Detailing
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:Centers for Disease Control and Prevention

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.