Outreach for Patients That Are Newly Eligible for Colorectal Cancer Screening (UPQUAL)

This study has been terminated.
(Lack of sufficient participants meeting the eligibility criteria to complete study in proposed and acceptable time frame.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:
NCT00860249
First received: March 11, 2009
Last updated: November 30, 2011
Last verified: November 2011
Results First Received: September 2, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Health Services Research
Condition: Colorectal Cancer
Interventions: Behavioral: Letter Only
Behavioral: Letter and Educational DVD

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned to one of the three study arms.

Reporting Groups
  Description
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.
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.
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.

Participant Flow:   Overall Study
    Usual Care     Behavioral: Letter Only     Behavioral: Letter and Educational DVD  
STARTED     21     18     21  
COMPLETED     0     0     0  
NOT COMPLETED     21     18     21  
trial was terminated prior to completion                 21                 18                 21  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    Usual Care     Behavioral: Letter Only     Behavioral: Letter and Educational DVD     Total  
Number of Participants  
[units: participants]
  21     18     21     60  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     21     18     21     60  
>=65 years     0     0     0     0  
Gender  
[units: participants]
       
Female     15     13     14     42  
Male     6     5     7     18  
Region of Enrollment  
[units: participants]
       
United States     21     18     21     60  



  Outcome Measures
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1.  Primary:   Completion of CRC Screening   [ Time Frame: 6 months from initial contact ]

2.  Secondary:   The Secondary Outcome for the Study is the Time to Screening Completion.   [ Time Frame: 6 months after randomization ]
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Measure Type Secondary
Measure Title The Secondary Outcome for the Study is the Time to Screening Completion.
Measure Description 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.
Time Frame 6 months after randomization  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.

Reporting Groups
  Description
Usual Care Usual Care - participants receive usual care
Behavioral: Letter Only Participants in this arm will receive 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 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.

Measured Values
    Usual Care     Behavioral: Letter Only     Behavioral: Letter and Educational DVD  
Number of Participants Analyzed  
[units: participants]
  0     0     0  
The Secondary Outcome for the Study is the Time to Screening Completion.  
[units: participants]
           


Statistical Analysis 1 for The Secondary Outcome for the Study is the Time to Screening Completion.
Groups [1] All groups
Method [2] Chi-squared
P Value [3] <0.017
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Please note that no analyses were performed as the trial was stopped due to low enrollment.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  We used the Bonferroni calculation to adjust for the planned multiple comparisons among the three groups.




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:  
Name/Title: Kenzie A. Cameron, PhD, MPH
Organization: Northwestern University, Department of General Internal Medicine
phone: 312-503-3910
e-mail: K-Cameron@northwestern.edu


No publications provided


Responsible Party: Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier: NCT00860249     History of Changes
Other Study ID Numbers: 1R18HS17163-02
Study First Received: March 11, 2009
Results First Received: September 2, 2011
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board