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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00441311
Other study ID # AAAA6315
Secondary ID
Status Completed
Phase Phase 4
First received February 26, 2007
Last updated January 28, 2011
Start date May 2003
Est. completion date September 2006

Study information

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

Clinical Trial Summary

The aim is to assess the efficacy of an intervention, academic detailing, a brief, frequently repeated educational program, on increasing recommendations for colorectal cancer screening among primary care providers by comparison to a service-as-usual control. The study is a stratified randomized clinical trial of primary care physicians, stratified by distinct urban communities in the New York metropolitan area. The primary outcome is colorectal cancer screening recommendations measured via medical audit at 12-month followup after randomization.


Description:

The purpose of the present study is to adapt and extend the use of academic detailing to the dissemination of colorectal cancer (CRC) screening findings and guidelines to primary care physicians practicing in selected geographic areas in New York City. Since improving implementation of cancer screening guidelines also involves compliance by patients in completing the recommended tests or examinations, we will also seek to assess knowledge, attitude and screening behaviors of patients visiting primary care practitioners in our sample. Our long-term goal is to reduce colorectal cancer mortality among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.

The specific aims of the study are as follows:

- Aim 1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician CRC screening at 3and 6month postrandomization, compared to the rate observed in a serviceasusual control.

- Aim 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 CRC screening guidelines to different physician subgroups.

- Aim 3. To conduct cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the CRC intervention implemented in physicians' offices.


Recruitment information / eligibility

Status Completed
Enrollment 264
Est. completion date September 2006
Est. primary completion date July 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- Devote at least 50% of their practice to primary care

- Work in the study communities

- Are non-hospital based community practitioners

- Have no immediate plans to retire or to leave their practice.

Exclusion Criteria:

- Specialty physicians

- Intend to retire or otherwise leave practice over course of the study

- Other conditions that would preclude meaningful participation

- Not working in study communities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Behavioral:
Academic Detailing
The academic detailing intervention will involve multiple components some of which are standardized across physicians (i.e. self-learning packets, newsletters). Detailing will also 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 Medical Center New York New York

Sponsors (2)

Lead Sponsor Collaborator
Columbia University American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Honda K, Gorin SS. A model of stage of change to recommend colonoscopy among urban primary care physicians. Health Psychol. 2006 Jan;25(1):65-73. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Colorectal cancer screening recommendations Up to 12 months from the time of randomization No
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