- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860249
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening (UPQUAL)
November 30, 2011 updated by: Kenzie Cameron, Northwestern University
Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures.
We hypothesize that educational outreach may increase completion rates.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern Medical Faculty Foundation General Internal Medicine Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient of Northwestern Medical Faculty Foundation General Internal Medicine
- Patient has a scheduled appointment with a GIM physician in the next several weeks
- Patient will be 50 years old at the time of this appointment
- Patient is male or female
Exclusion Criteria:
- This is the first time the patient is seen in the NMFF GIM clinic
- There is a prior completion of CRC screening noted in EHR.
- There is a prior order placed for CRC screening in EHR.
- Patient has a history of CRC
- Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Usual Care
Usual Care.
Participants in this arm will receive Usual care until outcome assessment is performed at 6 months following randomization.
At that time, they will be sent a letter reminding them to obtain the ordered preventative service test, however no further outcomes will be assessed.
Thus, during the course of the study, all participants in this arm will have solely received usual care.
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|
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Experimental: Behavioral: Letter Only
Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
|
Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
|
|
Experimental: Behavioral: Letter and Educational DVD
Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
It will be accompanied by an educational DVD about the screening.
The participants will receive this prior to a scheduled upcoming appointment with their physician.
|
Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
It will be accompanied by an educational DVD about the screening.
The participants will receive this prior to a scheduled upcoming appointment with their physician.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of CRC Screening
Time Frame: 6 months from initial contact
|
What would have been reported as this Outcome Measure is the number of participants who completed screening.
We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Screening completion equaled presence of a lab result or physician note in chart.
No patient charts were reviewed due to low accrual.
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6 months from initial contact
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Secondary Outcome for the Study is the Time to Screening Completion.
Time Frame: 6 months after randomization
|
This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date.
We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy.
Screening completion equaled presence of a lab result or physician note in chart.
No patient charts were reviewed due to low accrual.
|
6 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kenzie Cameron, PhD, Northwestern University, Department of General Internal Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
March 11, 2009
First Submitted That Met QC Criteria
March 11, 2009
First Posted (Estimate)
March 12, 2009
Study Record Updates
Last Update Posted (Estimate)
December 5, 2011
Last Update Submitted That Met QC Criteria
November 30, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R18HS017163-02 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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