Study Stopped
Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.
Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening
UPQUAL
Using Precision Performance Measurement To Conduct Focused Quality Improvement. Sub-study 2
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Mar 2009
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 11, 2009
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
December 1, 2011
CompletedDecember 5, 2011
November 1, 2011
9 months
March 11, 2009
September 2, 2011
November 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Completion of CRC Screening
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.
6 months from initial contact
Secondary Outcomes (1)
The Secondary Outcome for the Study is the Time to Screening Completion.
6 months after randomization
Study Arms (3)
Usual Care
NO INTERVENTIONUsual 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.
Behavioral: Letter Only
EXPERIMENTALBehavioral: 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.
Behavioral: Letter and Educational DVD
EXPERIMENTALBehavioral: 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern Medical Faculty Foundation General Internal Medicine Clinic
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination prior to collection of primary or secondary outcome measures, hence no analyses of the primary or secondary outcomes were performed.Thus, the only results reported are baseline characteristics of enrolled participants.
Results Point of Contact
- Title
- Kenzie A. Cameron, PhD, MPH
- Organization
- Northwestern University, Department of General Internal Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Kenzie Cameron, PhD
Northwestern University, Department of General Internal Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
March 11, 2009
First Posted
March 12, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
December 5, 2011
Results First Posted
December 1, 2011
Record last verified: 2011-11