Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Colorectal Cancer Clinical Trial

Official title:

Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01103479
• Other study ID #: R01CA140177-01
• Secondary ID: R01CA140177
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 12, 2010
• Last updated: April 14, 2015
• Start date: April 2010
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• 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 (CRC) screening guidelines, communication skills, and health literacy training
• 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 DVD on CRC and CRC screening

Locations

Country	Name	City	State
United States	Access Community Health Network	Chicago	Illinois
United States	University of Illinois Hospital & Health Sciences System	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Colorectal Cancer (CRC) Screening Completion	CRC screening completion via FOBT, FIT or Colonoscopy	within 6 months of provider recommendation	No
Secondary	Provider Recommendation of CRC Screening	Provider recommendation of CRC Screening based on chart review	6 months following patient enrollment into study	No