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Open Access Study protocol

Get screened: a pragmatic randomized controlled trial to increase mammography and colorectal cancer screening in a large, safety net practice

Kevin Fiscella1*, Amanat Yosha2, Samantha K Hendren3, Sharon Humiston4, Paul Winters2, Pat Ford5, Starlene Loader5, Raymond Specht5, Shirley Pope5, Amna Adris5 and Steven Marcus5

Author Affiliations

1 Department of Family Medicine and Community & Preventive Medicine, University of Rochester; 1381 South Ave, Rochester, NY 14620, USA

2 Departments of Family Medicine, University of Rochester; 1381 South Ave, Rochester, NY 14620, USA

3 Department of Surgery, University of Michigan, 2124 Taubman Center, 1500 East Medical Center Drive SPC-5343, Ann Arbor, MI 48109, USA

4 Emergency Medicine Services Division, Children's Mercy Hospitals and Clinics; 2401 Gillham Road, Kansas City, MO 64108, USA

5 Departments of Family Medicine, Highland Hospital; 1381 South Ave, Rochester, NY 14620, USA

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BMC Health Services Research 2010, 10:280  doi:10.1186/1472-6963-10-280

Published: 23 September 2010

Abstract

Background

Most randomized controlled trials of interventions designed to promote cancer screening, particularly those targeting poor and minority patients, enroll selected patients. Relatively little is known about the benefits of these interventions among unselected patients.

Methods/Design

"Get Screened" is an American Cancer Society-sponsored randomized controlled trial designed to promote mammography and colorectal cancer screening in a primary care practice serving low-income patients. Eligible patients who are past due for mammography or colorectal cancer screening are entered into a tracking registry and randomly assigned to early or delayed intervention. This 6-month intervention is multimodal, involving patient prompts, clinician prompts, and outreach. At the time of the patient visit, eligible patients receive a low-literacy patient education tool. At the same time, clinicians receive a prompt to remind them to order the test and, when appropriate, a tool designed to simplify colorectal cancer screening decision-making. Patient outreach consists of personalized letters, automated telephone reminders, assistance with scheduling, and linkage of uninsured patients to the local National Breast and Cervical Cancer Early Detection program. Interventions are repeated for patients who fail to respond to early interventions. We will compare rates of screening between randomized groups, as well as planned secondary analyses of minority patients and uninsured patients. Data from the pilot phase show that this multimodal intervention triples rates of cancer screening (adjusted odds ratio 3.63; 95% CI 2.35 - 5.61).

Discussion

This study protocol is designed to assess a multimodal approach to promotion of breast and colorectal cancer screening among underserved patients. We hypothesize that a multimodal approach will significantly improve cancer screening rates.

The trial was registered at Clinical Trials.gov NCT00818857