Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00355004
Status:
COMPLETED
Last Update Posted:
2013-12-19
First Post:
2006-07-19
Brief Title:
Computerized and Mailed Reminders in Increasing the Rate of Colorectal Cancer Screening in Adults With an Average Risk for Colorectal Cancer
Sponsor:
Harvard Medical School HMS and HSDM
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Improving Systems for Colorectal Cancer Screening
Status:
COMPLETED
Status Verified Date:
2007-01
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:
None
Brief Summary:
RATIONALE Screening may help doctors find colorectal cancer sooner when it may be easier to treat Computerized and mailed reminders may help increase the rate of colorectal cancer screening in adults with an average risk for colorectal cancer
PURPOSE This randomized clinical trial is studying how well computerized and mailed reminders work in increasing the rate of colorectal cancer screening in adults with an average risk for colorectal cancer
PURPOSE This randomized clinical trial is studying how well computerized and mailed reminders work in increasing the rate of colorectal cancer screening in adults with an average risk for colorectal cancer
Detailed Description:
OBJECTIVES
Primary
Determine whether rates of colorectal cancer CRC screening can be increased among average-risk adults by using patient-specific active electronic clinical reminders for primary care physicians during office visits and mailed reminders and fecal occult blood test cards for patients
Secondary
Calculate baseline rates of CRC screening in terms of patient demographic characteristics primary care physician and practice group by using computerized clinical information systems to identify patients due for screening
Assess baseline rates of CRC screening among patients insured by different health plans
Determine whether the impact of the interventions is related to efforts by health plans to promote CRC screening
Evaluate patients willingness to use a validated web-based tool to estimate their personal risk of CRC
OUTLINE This is a randomized controlled study Patients are randomized to 1 of 2 arms arms I or III Physicians are randomized to 1 of 2 arms arms II or IV
Arm I Patients receive mailed reminders for colorectal cancer CRC screening Patients also receive fecal occult blood testing FOBT instructions and cards Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened Patients who return positive FOBT cards undergo colonoscopy within 1 month The patients primary care physician may receive computerized screening reminders at the time of the patients office visit and may order CRC screening tests online
Arm II Patients receive no mailings The patients primary care physician may receive computerized screening reminders at the time of the patients office visit and may order CRC screening tests online
Arm III Patients receive mailed reminders for CRC screening The patients primary care physician may order CRC screening tests online but will not receive active computerized reminders Patients also receive FOBT instructions and cards Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened Patients who return positive FOBT cards will be scheduled to undergo colonoscopy within 1 month
Arm IV Patients receive no mailings The patients primary care physician may order CRC screening tests online but will not receive active computerized reminders
Patients are followed for 15 months to determine screening rates
PROJECTED ACCRUAL A total of 21860 patients will be accrued for this study
Primary
Determine whether rates of colorectal cancer CRC screening can be increased among average-risk adults by using patient-specific active electronic clinical reminders for primary care physicians during office visits and mailed reminders and fecal occult blood test cards for patients
Secondary
Calculate baseline rates of CRC screening in terms of patient demographic characteristics primary care physician and practice group by using computerized clinical information systems to identify patients due for screening
Assess baseline rates of CRC screening among patients insured by different health plans
Determine whether the impact of the interventions is related to efforts by health plans to promote CRC screening
Evaluate patients willingness to use a validated web-based tool to estimate their personal risk of CRC
OUTLINE This is a randomized controlled study Patients are randomized to 1 of 2 arms arms I or III Physicians are randomized to 1 of 2 arms arms II or IV
Arm I Patients receive mailed reminders for colorectal cancer CRC screening Patients also receive fecal occult blood testing FOBT instructions and cards Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened Patients who return positive FOBT cards undergo colonoscopy within 1 month The patients primary care physician may receive computerized screening reminders at the time of the patients office visit and may order CRC screening tests online
Arm II Patients receive no mailings The patients primary care physician may receive computerized screening reminders at the time of the patients office visit and may order CRC screening tests online
Arm III Patients receive mailed reminders for CRC screening The patients primary care physician may order CRC screening tests online but will not receive active computerized reminders Patients also receive FOBT instructions and cards Patients who remain overdue for screening at 6 months after the initial mailing receive a follow-up letter reminding them of their need to be screened Patients who return positive FOBT cards will be scheduled to undergo colonoscopy within 1 month
Arm IV Patients receive no mailings The patients primary care physician may order CRC screening tests online but will not receive active computerized reminders
Patients are followed for 15 months to determine screening rates
PROJECTED ACCRUAL A total of 21860 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HCHP-1305 | None | None | None |
| HMS-M11960-103 | None | None | None |