Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229554
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-09-27
Brief Title:
Survey of ColoRectal Cancer Education and Environment Needs
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Assessing and Addressing Patient Colorectal Cancer Screening Barriers
Status:
COMPLETED
Status Verified Date:
2009-01
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:
SCREEN
Brief Summary:
Despite strong evidence for the effectiveness and cost-effectiveness of a variety of colorectal cancer CRC screening methods for reducing CRC mortality current CRC screening rates fall far below the levels needed to significantly impact CRC mortality Unfortunately however the existing literature on patient CRC screening behavior does not yet provide a sufficient evidence base for making sound recommendations regarding how to most effectively improve upon these rates in the VA This study will inform future CRC screening promotion efforts and make important scientific contributions to existing literature by a delineating the relative contribution of patient cognitive environmental and background factors to CRC screening behavior using a multi-level theory driven analysis approach on a nationally representative sample and b identifying the determinants of variation in CRC screening behavior across vulnerable population subgroups
Detailed Description:
Background Rationale
Despite strong evidence for the effectiveness and cost-effectiveness of a variety of colorectal cancer CRC screening methods for reducing CRC mortality current CRC screening rates fall far below the levels needed to significantly impact CRC mortality Unfortunately however the existing literature on patient CRC screening behavior does not yet provide a sufficient evidence base for making sound recommendations regarding how to most effectively improve upon these rates in the VA This study will inform future CRC screening promotion efforts and make important scientific contributions to existing literature by a delineating the relative contribution of patient cognitive environmental and background factors to CRC screening behavior using a multi-level theory driven analysis approach on a nationally representative sample and b identifying the determinants of variation in CRC screening behavior across vulnerable population subgroups
Objectives
The overall goal of this study was to address significant gaps in the existing evidence base in order to inform the development of effective patient-directed interventions to increase CRC screening among veterans age 50 and older This was accomplished by using data collected from a mailed patient survey and theory-based analysis approaches to uncover key barriers to screening adherence and to identify fruitful intervention approaches for modifying them The specific primary objectives of this study were to 1 Estimate the relative effect of patient cognitive knowledge attitudes and self-efficacy environmental social network and medical care characteristics and background demographics health status prior screening experiences factors on CRC screening behavior 2 Identify factors that contribute to any disparities in CRC screening behavior by raceethnicity or other patient characteristics 3 Identify from these analyses a priority population subgroups to target in future interventions ie those at the greatest risk of failing to be screened and b priority factors to target in future interventions ie those that are not only strongly associated with CRC screening but also prevalent in the target population and amenable to intervention as well as those that are most likely to ameliorate race and other disparities Secondary objectives included 1 assessing patient values and preferences regarding the various CRC screening modality options 2 estimating stage of readiness to adopt CRC screening in the study population and 3 validating measures of CRC knowledge and self-reported screening behavior
Methods
This is an observational study based on a nationally representative cross-sectional mailed survey of 3744 male and female veterans age 50-75 who have had one or more primary care visits at a VA Medical facility in the past two years The survey sample was drawn using a two stage procedure where we first randomly select 24 VA facilities stratified by size and racial mix and then select a simple random sample of 156 eligible veterans from each sampled facility Prior to the national survey a pilot survey was conducted with the purpose of refining both the study instruments and the study protocol The sample consisted of 900 randomly selected veterans from the Minneapolis VA Medical Center meeting the same sampling eligibility criteria used for the national mailed survey The mailed patient questionnaire made up primarily of previously validated measures included measures of self-reported CRC screening behavior patient demographic health social network and medical care characteristics CRC screening knowledge attitudes social norms and self-efficacy and attitudes toward medical care Additional measures of organizational-level CRC screening practices from a recently completed VA facility survey were linked to the patient surveyThe primary outcome is whether the patient is currently compliant with CRC screening guidelines ie received either a fecal occult blood test in the past year a sigmoidoscopy or double contrast barium enema in the past five years or a colonoscopy in the past ten years The primary analyses tested using logistic regression and a multi-level structural equation modeling approach specific hypotheses about the association between this measure and patient background cognitive and environmental factors and their interactions Additional analyses conducted include a multinomial logistic regression to assess patient screening mode preferences and their determinants and logistic and multinomial logistics regression analyses with interactions to determine whether and why any observed patterns in CRC screening behavior vary by race
Status
Completed
Despite strong evidence for the effectiveness and cost-effectiveness of a variety of colorectal cancer CRC screening methods for reducing CRC mortality current CRC screening rates fall far below the levels needed to significantly impact CRC mortality Unfortunately however the existing literature on patient CRC screening behavior does not yet provide a sufficient evidence base for making sound recommendations regarding how to most effectively improve upon these rates in the VA This study will inform future CRC screening promotion efforts and make important scientific contributions to existing literature by a delineating the relative contribution of patient cognitive environmental and background factors to CRC screening behavior using a multi-level theory driven analysis approach on a nationally representative sample and b identifying the determinants of variation in CRC screening behavior across vulnerable population subgroups
Objectives
The overall goal of this study was to address significant gaps in the existing evidence base in order to inform the development of effective patient-directed interventions to increase CRC screening among veterans age 50 and older This was accomplished by using data collected from a mailed patient survey and theory-based analysis approaches to uncover key barriers to screening adherence and to identify fruitful intervention approaches for modifying them The specific primary objectives of this study were to 1 Estimate the relative effect of patient cognitive knowledge attitudes and self-efficacy environmental social network and medical care characteristics and background demographics health status prior screening experiences factors on CRC screening behavior 2 Identify factors that contribute to any disparities in CRC screening behavior by raceethnicity or other patient characteristics 3 Identify from these analyses a priority population subgroups to target in future interventions ie those at the greatest risk of failing to be screened and b priority factors to target in future interventions ie those that are not only strongly associated with CRC screening but also prevalent in the target population and amenable to intervention as well as those that are most likely to ameliorate race and other disparities Secondary objectives included 1 assessing patient values and preferences regarding the various CRC screening modality options 2 estimating stage of readiness to adopt CRC screening in the study population and 3 validating measures of CRC knowledge and self-reported screening behavior
Methods
This is an observational study based on a nationally representative cross-sectional mailed survey of 3744 male and female veterans age 50-75 who have had one or more primary care visits at a VA Medical facility in the past two years The survey sample was drawn using a two stage procedure where we first randomly select 24 VA facilities stratified by size and racial mix and then select a simple random sample of 156 eligible veterans from each sampled facility Prior to the national survey a pilot survey was conducted with the purpose of refining both the study instruments and the study protocol The sample consisted of 900 randomly selected veterans from the Minneapolis VA Medical Center meeting the same sampling eligibility criteria used for the national mailed survey The mailed patient questionnaire made up primarily of previously validated measures included measures of self-reported CRC screening behavior patient demographic health social network and medical care characteristics CRC screening knowledge attitudes social norms and self-efficacy and attitudes toward medical care Additional measures of organizational-level CRC screening practices from a recently completed VA facility survey were linked to the patient surveyThe primary outcome is whether the patient is currently compliant with CRC screening guidelines ie received either a fecal occult blood test in the past year a sigmoidoscopy or double contrast barium enema in the past five years or a colonoscopy in the past ten years The primary analyses tested using logistic regression and a multi-level structural equation modeling approach specific hypotheses about the association between this measure and patient background cognitive and environmental factors and their interactions Additional analyses conducted include a multinomial logistic regression to assess patient screening mode preferences and their determinants and logistic and multinomial logistics regression analyses with interactions to determine whether and why any observed patterns in CRC screening behavior vary by race
Status
Completed
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