Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Northwestern University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Colorectal Cancer

Treatments: Behavioral: Physician Intervention; Behavioral: Physician and Patient Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01103479

R01CA140177 (U.S. NIH Grant/Contract)

R01CA140177-01

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

Full description

This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

Enrollment: 569 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients aged 50-75 years of age (in month 1 of the study)
• Patients have had two or more visits to the clinic during the past two years
• ACCESS Community Health Network patients
• University of Illinois Hospital & Health Sciences System patients
• Patients ages 50 - 75 as of the start of the intervention study
• English or Spanish-Speaking

Exclusion criteria

• Patients <50 or > 75 years of age
• Patients who have had fewer than two or more visits to the clinic during the past two years
• Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
• Unable to speak English or Spanish
• Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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569 participants in 3 patient groups

Control

No Intervention group

Description:

Participants will complete interviewer-administered pre- and post-test

Physician Intervention

Experimental group

Description:

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Treatment:

Behavioral: Physician Intervention

Physician and Patient Intervention

Experimental group

Description:

Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Treatment:

Behavioral: Physician and Patient Intervention