Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders (UPQUAL)
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ClinicalTrials.gov Identifier: NCT00793455 |
Recruitment Status
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Completed
First Posted
: November 19, 2008
Results First Posted
: December 1, 2011
Last Update Posted
: December 1, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | November 17, 2008 | |||
First Posted Date ICMJE | November 19, 2008 | |||
Results First Submitted Date | September 1, 2011 | |||
Results First Posted Date | December 1, 2011 | |||
Last Update Posted Date | December 1, 2011 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Colorectal Cancer Screening Completion. [ Time Frame: 3 months post randomization ] We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. |
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Original Primary Outcome Measures ICMJE |
The primary outcome for the study is the time to screening completion. [ Time Frame: 3 months after randomization ] | |||
Change History | Complete list of historical versions of study NCT00793455 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Colorectal Cancer Screening Completion [ Time Frame: 6 months post randomization ] We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders | |||
Official Title ICMJE | Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-Study 1. | |||
Brief Summary | The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates. | |||
Detailed Description | We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Health Services Research |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Educational outreach
Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening. |
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Study Arms |
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Publications * | Cameron KA, Persell SD, Brown T, Thompson J, Baker DW. Patient outreach to promote colorectal cancer screening among patients with an expired order for colonoscopy: a randomized controlled trial. Arch Intern Med. 2011 Apr 11;171(7):642-6. doi: 10.1001/archinternmed.2010.468. Epub 2010 Dec 13. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
628 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | November 2009 | |||
Actual Primary Completion Date | November 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00793455 | |||
Other Study ID Numbers ICMJE | 1R18HS017163-01( U.S. AHRQ Grant/Contract ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Kenzie Cameron, Northwestern University | |||
Study Sponsor ICMJE | Northwestern University | |||
Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | |||
Investigators ICMJE |
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PRS Account | Northwestern University | |||
Verification Date | October 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |