Pilot Study of the National Colorectal Cancer Roundtable Toolbox (NCCRT) to Increase Colorectal Cancer Screening Rates
|ClinicalTrials.gov Identifier: NCT00503737|
Recruitment Status : Unknown
Verified July 2007 by Penn State University.
Recruitment status was: Not yet recruiting
First Posted : July 19, 2007
Last Update Posted : November 5, 2007
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Screening||Behavioral: National Colorectal Cancer Roundtable Toolbox||Not Applicable|
The specific aims of the intervention are: (1) To increase the knowledge of primary care providers as it pertains to current guidelines and communication strategies about colorectal cancer screening (CRCS); (2) To assist offices design a colorectal cancer screening policy, (3) To assist offices adopt a colorectal cancer reminder system and (4) To increase the screening rates of CRC screening. A secondary aim of this project is to synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox. Our hypothesis is that the practices that implement the toolbox will have a higher rate of colorectal cancer screening than the control group and physician knowledge about CRCS will be increased.
Two of the three sites will be randomly chosen by a number generator to be the intervention sites using the toolbox; the third will be used as a control site. Primary care providers will be defined as Family Practice physicians, General Internists, Nurse Practitioners, and Physician Assistants. Each site has on average of 5-12 providers.
Measurements of baseline rates of CRCS will be assessed by HIPAA compliant chart review for participating providers in the practice by our research coordinator. A list of qualifying patients will be generated by our billing department based on time seen, and billing code. These charts will then be randomly pulled and reviewed by our research coordinator to determine the percentage of eligible subjects who were screened for colorectal cancer (CRC) at each site. A total of 300 charts will be reviewed, broken down into 150 charts pre intervention and 150 charts post intervention. The post intervention chart review will be done at 1 year so that the patients can complete CRCS. The chart review will be done per site (i.e. no link between the individual providers and the patient will be made.) Also the sites will be de-identified so that there is no physician, or group of physicians who are held up to scrutiny.
CRC screening will be considered complete if one of the following was done: (1) Fecal occult blood test (FOBT) in the past year, (2) flexible sigmoidoscopy in the past 5 years, (3) FOBT in the past year and flexible sigmoidoscopy in the past five years (4) double contrast barium enema in the past five years, or (5) colonoscopy in the past 10 years. This will serve as a baseline-screening rate for each practice. Recordable data will be as follows: Sex, Race, Age, Site, Did provider recommend CRCS?, Did the subject follow through with recommendation?, If so, what was the chosen screening modality?, Does the subject have a family history of a 1st or 2nd degree relative with CRC?, Does the subject have a family history of a 1st or 2nd degree relative with adenomatous polyps? For the providers in the intervention group, they will be asked to attend a lunchtime lecture given by the PI on CRCS. They will also be asked to do a 20 question pre and post intervention questionnaire and a pre and post intervention health care provider survey. They will also be provided with brochures from the American Cancer Society. The providers in the control group will only complete the survey and the questionnaire.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||September 2007|
|Estimated Study Completion Date :||September 2010|
- Increase the knowledge of providers as it pertains to current guidelines and strategies about CRCS; assist offices design a CRCS policy, assist offices adopt a CRC reminder system and increase the screening rates of CRC. [ Time Frame: 2 years ]
- synthesize information about the strengths and weaknesses of the toolbox from the primary care physician's (PCP) point of view to aid in future development of an interactive, web-based version of the Toolbox. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503737
|Contact: Matthew J Downey, MD||717 firstname.lastname@example.org|
|Contact: Brenda J Hershey-Fell, RN||717 email@example.com|
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Not yet recruiting|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Matthew J Downey, MD||Penn State College of Medicine, Penn State Milton S. Hershey Medical Center|