Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Northwestern University569 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

569

Conditions

Colorectal Cancer

Interventions

Physician InterventionBEHAVIORAL

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

Physician and Patient InterventionBEHAVIORAL

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Access Community Health Network

Chicago, Illinois, United States

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Colorectal Cancer (CRC) Screening Completion

CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy

Time frame: within 6 months of provider recommendation

Colorectal Cancer (CRC) Screening Completion

CRC screening completion via FOBT, FIT or Colonoscopy

Time frame: within 6 months of provider recommendation

Secondary Outcomes

Provider Recommendation of CRC Screening

Provider recommendation of CRC Screening based on chart review

Time frame: 6 months following patient enrollment into study

Data from ClinicalTrials.gov

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