NCT00737646

Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5,066 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics. The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff. The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting. The intervention will be implemented within primary care clinics in two managed care organizations (MCOs). The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Usual care	No intervention will be conducted in this arm of the study.
BEHAVIORAL	Clinic-focused intervention	The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff. The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based. The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.
BEHAVIORAL	Clinic- and patient-focused	This arm will combine the clinic-focused intervention and the patient-focused intervention. The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-06-01
• Completion: 2011-12-01
• First posted: 2008-08-19
• Last updated: 2012-12-17

Locations

3 sites across 1 country: United States