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Interactive Multimedia Intervention to Improve Colonoscopy and Bowel Prep Adhere

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43TR000355-01A1
Agency Tracking Number: R43TR000355
Amount: $188,537.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NCATS
Solicitation Number: PA11-096
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 831725440
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (518) 743-0456
Business Contact
Phone: (518) 743-0456
Research Institution

DESCRIPTION (provided by applicant): 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 tocleanse 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 theintervention. 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 colonoscopyin 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 thatthe 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.

* Information listed above is at the time of submission. *

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