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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Screening Active 52 to 75 Other CDC-NCCDPHP-R-01-PH-000018 NCT00134589

Trial Description

Summary

The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.

Further Study Information

Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.

We will conduct a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty large group practices will be recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, 30 patients between the ages of 52 and 75, without current CRC screening history, will be enrolled into the study. The intervention will continue for up to 2 years for still-unscreened participants. The main outcome will be receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).

Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.

Eligibility Criteria

Inclusion Criteria:

• Ages 52-75

• Aetna Health Plan member

• Average risk for colorectal cancer

• Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual’s age and type of screening)

Exclusion Criteria:

• History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease

• Family history of colorectal cancer/polyps

Trial Contact Information

Trial Lead Organizations/Sponsors

Centers for Disease Control

Karen Glanz, PhD, MPH

Principal Investigator

Raquel Vazquez, MPH		Ph: 404-727-5575
		Email: Rvazque@sph.emory.edu

Karen Glanz, PhD, MPH		Ph: 404-727-7536
		Email: kglanz@sph.emory.edu

U.S.A.
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Raquel Vazquez, MPH	Ph: 404-727-5575
			Email: Rvazque@sph.emory.edu
		Karen Glanz, PhD, MPH	Ph: 404-727-7536
			Email: kglanz@sph.emory.edu
		Karen Glanz, PhD, MPH	Principal Investigator
		Tracy Scott, PhD	Sub-Investigator
		Michael Pignone, MD, MPH	Sub-Investigator
		Barbara Rimer, DrPH	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00134589
Information obtained from ClinicalTrials.gov on May 27, 2008