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Trial record 24 of 3562 for:    colon cancer AND Colonic Diseases

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122187
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : January 27, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Colorectal Cancer
Intervention Device: Electronic Consult System
Enrollment 8
Recruitment Details 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 Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.
Arm/Group Title Electronic Consult System Usual Care
Hide Arm/Group Description A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Period Title: Overall Study
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
Reason Not Completed
Withdrew because of resource limitations             2             2
Arm/Group Title Electronic Consult System Usual Care Total
Hide Arm/Group Description A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
The population is the number of VAMCs that enrolled in the study.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Not collected Number Analyzed 4 participants 4 participants 8 participants
4 4 8
[1]
Measure Description: Participants in this study were VAMCs rather than human subjects. Age of participants was not collected because it was not applicable.
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Not collected Number Analyzed 4 participants 4 participants 8 participants
4 4 8
[1]
Measure Description: Participants in this study were VAMCs rather than human subjects. Gender of participants was not collected because it was not applicable.
1.Primary Outcome
Title Percent of Patients Receiving GI Consult for FOBT+ Results
Hide Description Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Sites that completed the intervention and post-intervention data collection were included in the analysis
Arm/Group Title Electronic Consult System 1st Site (1a) Electronic Consult System 2nd Site (2a) Usual Care 1st Site (1b) Usual Care 2nd Site (2b)
Hide Arm/Group Description:
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Overall Number of Participants Analyzed 1 1 1 1
Measure Type: Number
Unit of Measure: percent patients receiving GI consult
pre intervention--consult within 30 days FOBT+ 39 47 64 51
post intervention--consult within 30 days FOBT+ 68 80 63 48
pre intervention--consult within 90 days FOBT+ 46 50 70 56
post intervention--consult within 90 days FOBT+ 72 82 69 56
pre intervention--consult within 180 days FOBT+ 50 55 71 62
post intervention--consult within 180 days FOBT+ 74 86 72 59
2.Primary Outcome
Title Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results
Hide Description Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Sites that completed the intervention and post-intervention data collection were included in the analysis
Arm/Group Title Electronic Consult System 1st Site (1a) Electronic Consult System 2nd Site (2a) Usual Care 1st Site (1b) Usual Care 2nd Site (2b)
Hide Arm/Group Description:
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Overall Number of Participants Analyzed 1 1 1 1
Measure Type: Number
Unit of Measure: percent patients with GI consult+workup
pre intervention--consult+workup in 30 days FOBT+ 4 12 19 4
post intervention--consult+workup in 30 days FOBT+ 30 21 13 5
pre intervention--consult+workup in 90 days FOBT+ 18 26 44 15
post intervention--consult+workup in 90 days FOBT+ 49 39 50 17
pre intervention--consult+workup in 180days FOBT+ 25 29 48 22
post intervention--consult+workup in 180days FOBT+ 51 42 54 22
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events were not formally monitored because participants were VAMCs, not human subjects. The study involved extracting information from individual medical records at each VAMC. There were no reported problems involving this use of records.
 
Arm/Group Title Electronic Consult System Usual Care
Hide Arm/Group Description A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
All-Cause Mortality
Electronic Consult System Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Electronic Consult System Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Electronic Consult System Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Linda Humphrey
Organization: VAHSRD
Phone: 503-220-8262 ext 57176
EMail: linda.humphrey@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00122187     History of Changes
Other Study ID Numbers: CRT 02-059
First Submitted: July 18, 2005
First Posted: July 21, 2005
Results First Submitted: December 5, 2013
Results First Posted: January 27, 2014
Last Update Posted: April 24, 2015