Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Physician Intervention
* Behavioral: Physician and Patient Intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will complete interviewer-administered pre- and post-test | |
| Experimental: Physician Intervention<br>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 | Behavioral: Physician Intervention<br>* 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<br>|
| Experimental: Physician and Patient Intervention<br>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 | Behavioral: Physician and Patient Intervention<br>* 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 DVD on CRC and CRC screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal Cancer (CRC) Screening Completion | CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy | within 6 months of provider recommendation | 
| Colorectal Cancer (CRC) Screening Completion | CRC screening completion via FOBT, FIT or Colonoscopy | within 6 months of provider recommendation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Recommendation of CRC Screening | Provider recommendation of CRC Screening based on chart review | 6 months following patient enrollment into study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Detection of Cancer, Colorectal Cancer Screening