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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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.
Matthew J Downey, MD
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
United States: Institutional Review Board
|Penn State College of Medicine, Penn State Milton S. Hershey Medical Center||Hershey, Pennsylvania 17033|