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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:
NCT00793455
First received: November 17, 2008
Last updated: October 24, 2011
Last verified: October 2011
Results First Received: September 1, 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
Conditions: Colorectal Cancer Screening
Prevention & Control
Intervention: Behavioral: Educational outreach

  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
This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 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 in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.

Reporting Groups
  Description
Intervention Group Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
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.

Participant Flow:   Overall Study
    Intervention Group     Usual Care Control Group  
STARTED     314     314  
COMPLETED     314     314  
NOT COMPLETED     0     0  



  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
Intervention Group Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
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.
Total Total of all reporting groups

Baseline Measures
    Intervention Group     Usual Care Control Group     Total  
Number of Participants  
[units: participants]
  314     314     628  
Age  
[units: years]
Mean ± Standard Deviation
  57.90  ± 7.1     58.03  ± 6.6     58.0  ± 6.9  
Gender  
[units: participants]
     
Female     197     192     389  
Male     117     122     239  
Race/Ethnicity, Customized  
[units: participants]
     
White     144     132     276  
Black     79     77     156  
Hispanic     9     14     23  
Other/unknown     82     91     173  
Region of Enrollment  
[units: participants]
     
United States     314     314     628  
Number of visits in past 2 years  
[units: Participants]
     
1-2     69     79     148  
3     80     79     159  
4     54     48     102  
>=5     111     108     219  
Colorectal Cancer (CRC) screening history  
[units: Participants]
     
Ever screened     22     24     46  
Never screened     292     290     582  
Insurance Status  
[units: Participants]
     
Private     245     236     481  
Medicare     56     63     119  
Medicaid     10     10     20  
Uninsured     3     5     8  



  Outcome Measures
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1.  Primary:   Colorectal Cancer Screening Completion.   [ Time Frame: 3 months post randomization ]

2.  Secondary:   Colorectal Cancer Screening Completion   [ Time Frame: 6 months post randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This study does not identify the timing of the intervention that would have the most impact. Mailings occurred 3 months or more after the order was placed, contacting patients sooner may have been more effective.


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


Results Point of Contact:  
Name/Title: Kenzie A. Cameron, PhD, MPH
Organization: Northwestern University
phone: 312-503-3910
e-mail: k-cameron@northwestern.edu


Publications of Results:

Responsible Party: Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier: NCT00793455     History of Changes
Other Study ID Numbers: 1R18HS17163-01
Study First Received: November 17, 2008
Results First Received: September 1, 2011
Last Updated: October 24, 2011
Health Authority: United States: Institutional Review Board