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Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122187
First received: July 18, 2005
Last updated: April 8, 2014
Last verified: April 2014
Results First Received: December 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Colorectal Cancer
Intervention: Device: Electronic Consult System

  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
We recruited 8 Veterans Affairs medical centers (VAMCs) to be involved with this trial evaluating a new method of processing positive colorectal cancer screening tests compared with usual care. 4 VAMCs (2 control and 2 intervention sites) dropped out of the study and 4 completed it.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.

Reporting Groups
  Description
Electronic Consult System A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
Usual Care The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.

Participant Flow:   Overall Study
    Electronic Consult System     Usual Care  
STARTED     4     4  
Matched by Colonoscopy Volume     4     4  
Randomized to Intervention or Usual Care     4     4  
Intervention Implemented     3     4  
Post-intervention Data Collection     2     2  
COMPLETED     2     2  
NOT COMPLETED     2     2  
Withdrew because of resource limitations                 2                 2  



  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.
The population is the number of VAMCs that enrolled in the study.

Reporting Groups
  Description
Electronic Consult System A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
Usual Care The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Total Total of all reporting groups

Baseline Measures
    Electronic Consult System     Usual Care     Total  
Number of Participants  
[units: participants]
  4     4     8  
Age, Customized [1]
[units: participants]
     
Not collected     4     4     8  
Gender, Customized [2]
[units: participants]
     
Not collected     4     4     8  
[1] Participants in this study were VAMCs rather than human subjects. Age of participants was not collected because it was not applicable.
[2] Participants in this study were VAMCs rather than human subjects. Gender of participants was not collected because it was not applicable.



  Outcome Measures
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1.  Primary:   Percent of Patients Receiving GI Consult for FOBT+ Results   [ Time Frame: 6 months ]

2.  Primary:   Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results   [ Time Frame: 6 months ]


  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
Half of the sites randomized did not complete the study. GI referral rates should have been nearly 100%, yet were not. Because of programming limitations, we were unable to evaluate the type of diagnostic interventions the patients received.


  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: Linda Humphrey
Organization: VAHSRD
phone: 503-220-8262 ext 57176
e-mail: linda.humphrey@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122187     History of Changes
Other Study ID Numbers: CRT 02-059
Study First Received: July 18, 2005
Results First Received: December 5, 2013
Last Updated: April 8, 2014
Health Authority: United States: Federal Government