Outreach for Patients With Uncompleted Colorectal Cancer Screening Orders (UPQUAL)

Tracking Information
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; (submitted: October 24, 2011)	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.
Original Primary Outcome Measures ICMJE; (submitted: November 18, 2008)	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; (submitted: October 24, 2011)	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.
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
Condition ICMJE	Colorectal Cancer Screening; Prevention & Control
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.
Study Arms	Experimental: Intervention Group Received Educational Outreach Intervention: Behavioral: Educational outreach; No Intervention: Usual Care Control Group Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 18, 2008)	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: Patient's physician has ordered a preventive screening test; Patient has not completed this test in 3 months; Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic. Exclusion Criteria: Patient has been given a more recent order for the same screening test.; Patient has significant life stress as noted in the Electronic Health Record (EHR)
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Kenzie A Cameron, PhD, MPH Northwestern University
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