Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Physician Intervention; Behavioral: Physician and Patient Intervention

• Registration Number: NCT01103479
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-14
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Results First Submitted: 2014-08-28
• Results First Submitted QC: 2014-08-28
• Results First Posted: 2014-09-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 569

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physician Intervention	Physician Intervention	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
Physician and Patient Intervention	Physician and Patient Intervention	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

Primary Outcome Measures

Name	Time	Method
Colorectal Cancer (CRC) Screening Completion	within 6 months of provider recommendation	CRC screening completion via FOBT, FIT or Colonoscopy

Secondary Outcome Measures

Name	Time	Method
Provider Recommendation of CRC Screening	6 months following patient enrollment into study	Provider recommendation of CRC Screening based on chart review

Trial Locations

Locations (2)

Access Community Health Network; 🇺🇸 Chicago, Illinois, United States

University of Illinois Hospital & Health Sciences System; 🇺🇸 Chicago, Illinois, United States