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

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
National Colorectal Cancer Roundtable Toolbox
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring colorectal cancer screening, National Colorectal Cancer Roundtable Toolbox

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Any provider not at the clinics of interest

Sites / Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Colorectal Cancer Screening Toolkit

Standard of Care Colorectal Cancer Screening

Arm Description

Toolbox includes tools and guides designed increase screening by primary care physicians

Primary Care physician will screen for colorectal cancer as per his/her standard practice

Outcomes

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.

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.

Full Information

First Posted
July 17, 2007
Last Updated
May 24, 2018
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00503737
Brief Title
Pilot Study of the National Colorectal Cancer Roundtable Toolbox (NCCRT) to Increase Colorectal Cancer Screening Rates
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 1, 2010 (Actual)
Study Completion Date
September 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
colorectal cancer screening, National Colorectal Cancer Roundtable Toolbox

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colorectal Cancer Screening Toolkit
Arm Type
Active Comparator
Arm Description
Toolbox includes tools and guides designed increase screening by primary care physicians
Arm Title
Standard of Care Colorectal Cancer Screening
Arm Type
No Intervention
Arm Description
Primary Care physician will screen for colorectal cancer as per his/her standard practice
Intervention Type
Behavioral
Intervention Name(s)
National Colorectal Cancer Roundtable Toolbox
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Health care providers who are currently practicing and recommending CRCS. Exclusion Criteria: Any provider not at the clinics of interest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew J Downey, MD
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Links:
URL
http://nccrt.org/resource-center/
Description
The National Colorectal Cancer Roundtable Toolbox (NCCRT) to increase colorectal cancer screening rates in Primary Care Practices

Learn more about this trial

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

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