Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503737
Status:
COMPLETED
Last Update Posted:
2018-05-29
First Post:
2007-07-17
Brief Title:
Pilot Study of the National Colorectal Cancer Roundtable Toolbox NCCRT to Increase Colorectal Cancer Screening Rates
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Clinicians 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 physicians 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None