Coordinated Endoscopic Colorectal Cancer Screening

Preventive Health Services Clinical Trial

Official title:

Coordinated Endoscopic Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327457
• Other study ID #: S1796-21/23 (NCE)
• Status: Completed
• Phase: N/A
• First received: May 16, 2006
• Last updated: February 18, 2011
• Start date: June 2002
• Est. completion date: March 2005

Study information

• Verified date: February 2011
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

Description:

The investigators aim to use a randomized design to test the effects of 1) tailored physician recommendations, relative to non-specific recommendations, and 2) coordinated physician office management systems on patient adherence to colorectal cancer screening recommendations.

To accomplish these aims, the investigators propose 1) to use existing physician practice-based computerized patient registration systems to define populations of 50 to 79 year-old pri-mary care patients, 2) to use mailed questionnaires to determine colorectal cancer risk factor status and prior colorectal cancer screening history, 3) to use responses from mailed questionnaires to identify persons not adhering to colorectal cancer screening guidelines, 4) to use computer driven algorithms to help physicians prepare and deliver individually tailored and written colorectal cancer screening recommendations, and 5) to develop, implement, and evaluate a centralized service for delivering high quality screening flexible sigmoidoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: March 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• history of colorectal cancer or polyps

• flexible sigmoidoscopy within five years of enrollment

• barium enema within five years of enrollment

• colonoscopy within five years of enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Preventive Health Services

Intervention

Behavioral:
• Help with physician office and patient management

• Tailored physician recommendation letter

Locations

Country	Name	City	State
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
University of Pittsburgh	Association of Schools of Public Health, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ling BS, Schoen RE, Trauth JM, Wahed AS, Eury T, Simak DM, Solano FX, Weissfeld JL. Physicians encouraging colorectal screening: a randomized controlled trial of enhanced office and patient management on compliance with colorectal cancer screening. Arch I — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical record verified flexible sigmoidoscopy or colonoscopy