Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:
NCT01103479
First received: April 12, 2010
Last updated: April 4, 2013
Last verified: April 2013

April 12, 2010
April 4, 2013
April 2010
July 2013   (final data collection date for primary outcome measure)
Provider recommendation of CRC screening and patient CRC screening completion rates [ Time Frame: 6 months following patient enrollment in study ] [ Designated as safety issue: No ]
Primary outcome measure is provider recommendation of CRC screening and patient CRC screening completion rates at 6 months following patient enrollment in the study.
Same as current
Complete list of historical versions of study NCT01103479 on ClinicalTrials.gov Archive Site
Patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. [ Time Frame: Day of enrollment in study (pre/post measurement) ] [ Designated as safety issue: No ]
Secondary outcomes of this study are patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. This will be assessed by a pre/post test interview with the patient before their provider appointment and immediately after they see their provider at the health center.
Patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. [ Time Frame: 6 months after enrollment in study ] [ Designated as safety issue: No ]
Secondary outcomes of this study are patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. This will be assessed by a pre/post test interview with the patient before their provider appointment and immediately after they see their provider at the health center.
Not Provided
Not Provided
 
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Colorectal Cancer
  • 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
  • Behavioral: 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
  • No Intervention: Control
    Participants will complete interviewer-administered pre- and post-test
  • Experimental: Physician Training
    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
    Intervention: Behavioral: Physician Intervention
  • Experimental: 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
    Intervention: Behavioral: Physician and Patient Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
July 2013
July 2013   (final data collection date for primary outcome measure)

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)
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01103479
R01-CA140177-01
Yes
Kenzie Cameron, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Kenzie A Cameron, PhD Northwestern University
Northwestern University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP