Mortality from colorectal cancer (CRC) can be reduced through screening programs. Regardless of the primary strategy (fecal occult blood testing, sigmoidoscopy, colonoscopy, fecal DNA, computed tomographic colonography [virtual colonoscopy]) colonoscopy is required to evaluate positive screening tests and to detect or remove colonic neoplasia. Colonoscopy quality is critical to effectiveness and an essential component of quality is adherence to the preparation regimen to cleanse the bowel prior to the procedure;moreover, it has been shown that the preparation regimen itself is a significant barrier to adherence to screening. Adherence to colonoscopy is low among African Americans;moreover, adherence to the colonoscopy preparation is especially low in this population, which contributes to the increased incidence and mortality from colorectal cancer. To address these issues, this SBIR will evaluate the feasibility of developing an interactive, multimedia intervention to increase adherence to the bowel preparation regimen for colonoscopy. Our hypothesis is that an interactive, multimedia intervention delivering a culturally sensitive message to African Americans will improve the quality of the colonoscopy examination and increase adherence to colonoscopy itself, thereby reducing CRC mortality in this population. Phase I of this feasibility project has 3 specific aims: 1) develop a pilot interactive, multimedia intervention to improve adherence to the preparation regimen for colonoscopy, 2) pilot test the intervention in African Americans and revise the intervention based on outcomes, 3) validate the outcome measures (preparation quality, patient satisfaction, willingness to repeat colonoscopy) that will be used in a large, randomized trial to test the revised intervention. Focus groups of African American patients and their healthcare providers will be conducted to elicit key issues to address with the interactive, multimedia intervention. Development of the intervention will be based on constructs of the Health Belief Model and the Cognitive Model of Multi-Media Learning. The pilot intervention will be tested in a sample of African American patients scheduled for colonoscopy and revised based on feedback and performance of the intervention. The outcome measures will consist of preparation quality, defined by the Boston Scale and assessed through a novel computer-based preparation assessment tool, patient satisfaction with preparation, and willingness to have another colonoscopy in the future. These measures will be validated in the sample in order for a properly powered randomized controlled study to be conducted in the target population. Phase II of this program will consist of completion of the final intervention and implementation of a randomized clinical trial to compare the interactive, multimedia intervention with """"""""usual care"""""""" to determine the effectiveness of the intervention to improve the quality of colonoscopy preparation. Phase III will focus on developing the commercial aspects such as production, marketing, and distribution of the intervention to consumers including physicians, hospitals, clinics, ambulatory surgery centers, as well as patients. While our initial efforts will focus on African Americans we expect that the elements of the interactive multimedia intervention can be used to target other racial and ethnic groups to reduce current disparities in colorectal cancer mortality.

Public Health Relevance

Colonoscopy quality is essential to optimize strategies to reduce mortality from colorectal cancer. Poor preparation results in higher rates of missing cancers and pre-cancerous polyps, and increases the difficulty and duration of the procedure. Adherence to the bowel cleansing necessary to prepare the patient for colonoscopy constitutes a major barrier to not only the quality of the colonoscopy examination but also adherence to the colonoscopy itself. Our prior work demonstrates low adherence to colonoscopy among African Americans, with specific low adherence to the colonoscopy preparation. This project will develop and test a novel interactive, multimedia intervention to increase understanding and adherence to the preparation regimen for colonoscopy. Although preparation quality is important for all persons, this intervention will be targeted to African Americans since they are at increased risk of non-adherence to the preparation.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43TR000355-01A1
Application #
8252471
Study Section
Special Emphasis Panel (ZRG1-RPHB-C (10))
Program Officer
Brazhnik, Olga
Project Start
2012-09-01
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
1
Fiscal Year
2012
Total Cost
$188,537
Indirect Cost
Name
Qurve Learning, LLC
Department
Type
DUNS #
831725440
City
Queensbury
State
NY
Country
United States
Zip Code
12804