Pilot Study of the National Colorectal Cancer Roundtable Toolbox (NCCRT) to Increase Colorectal Cancer Screening Rates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Penn State University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00503737
First received: July 17, 2007
Last updated: November 2, 2007
Last verified: July 2007
  Purpose

The American Cancer Society and The Centers for Disease Control and Prevention in collaboration with The National Colorectal Cancer Roundtable published "How to Increase Colorectal Cancer Screening rates in Practice: A Primary Care Clinician's Evidence-Based Toolbox and Guide" in 2005. This toolbox outlines evidence-based interventions aimed at increasing colorectal cancer screening by primary care providers and their office staff. The Toolbox contains the tools to design a multifaceted intervention to increase primary care physician rates of colorectal cancer screening (CRCS). This is a pilot study to look at implementing the toolbox and its affects.


Condition Intervention
Colorectal Cancer Screening
Behavioral: National Colorectal Cancer Roundtable Toolbox

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: September 2007
Estimated Study Completion Date: September 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health care providers who are currently practicing and recommending CRCS.

Exclusion Criteria:

  • Any provider not at the clinics of interest
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503737

Contacts
Contact: Matthew J Downey, MD 717 531-1017 mdowney@psu.edu
Contact: Brenda J Hershey-Fell, RN 717 531-7725 bhershey-fell@psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Matthew J Downey, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00503737     History of Changes
Other Study ID Numbers: 25737
Study First Received: July 17, 2007
Last Updated: November 2, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
colorectal cancer screening
National Colorectal Cancer Roundtable Toolbox

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 22, 2014