Colorectal CancerNCT00122187
Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention
A study testing Electronic Consult System in people with Colorectal Cancer, run by US Department of Veterans Affairs at 9 sites in United States.
Trial summary
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Results from randomized clinical trials and intervention studies have suggested that implementation of a CRC screening program for men and women over age 50 results in reduced CRC mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Electronic Consult System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 9 sitesUnited States
- Study dates
- Aug 2005to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- VA Medical Centers with either CORI (Clinical Outcomes Research Initiative) or electronic notes/descriptions documenting GI endoscopic procedures
Who cannot join
- VA Medical Centers without electronic GI procedure documentation
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705
Minneapolis
Minneapolis, Minnesota, 55417
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239
Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101-4295
Southern Arizona VA Health Care System
Tucson, Arizona, 85723
VA Medical & Regional Office Center, White River
White River Junction, Vermont, 05009-0001
About this study
Official title: Translation of Colorectal Cancer Screening Guidelines: A System Intervention
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Results from randomized clinical trials and intervention studies have suggested that implementation of a CRC screening program for men and women over age 50 results in reduced CRC mortality. However, for this reduction to be fully realized, it is imperative that all positive screening tests are followed by complete diagnostic evaluation (CDE). Numerous intervention programs have been used to improve initial CRC screening rates, but data indicate that outside the research setting, less than half of patients with a positive fecal occult blood test (FOBT) screening result undergo CDE. To enhance the translation of this best practice recommendation to clinical practice, the investigators propose to implement an electronic event notification intervention (CRC-ENS) directed at making physician and system level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE.
Read the detailed description
Objectives: 1.To implement an electronic CRC screening event notification system intervention to improve complete evaluation of patients with a positive FOBT at four of eight VAMCs randomized to this intervention vs usual care.
2.To conduct a qualitative evaluation to identify implementation barriers and facilitators, and to guide modifications of the CRC-ENS. 3.To conduct an outcome evaluation to determine the effectiveness of the intervention to:
- increase the proportion of patients with a positive FOBT receiving CDE. b. reduce the time-lag between notification of a positive FOBT result and scheduling of a follow-up endoscopic procedure. 4. To improve patient compliance with follow-up recommendations through combined scheduling.
Methods: The CRC-ENS intervention employs a relatively simple alteration to the current electronic mechanism for notifying the primary care provider (PCP) of when a positive FOBT is recorded. With the CRC-ENS, this notification will be forwarded to the gastroenterology (GI) clinic as well as the PCP. This notification at the GI clinic will set off a cascade of events that would normally only be triggered by a consult request from the PCP. In this translation study, eight participating VHA sites will be randomly assigned to either the CRC-ENS intervention or usual care group. The proposed project will take two years to complete. During the first project year, the participating sites will be recruited and randomized. Pre-intervention change of awareness strategies will be initiated at all intervention sites. The CRC-ENS intervention will be implemented in the second project year, and formative evaluation (including two sets of focus groups) will be carried out throughout the intervention period. Post-intervention data collection, outcome evaluation and dissemination of results will be carried out in months 18-24.
- Conditions
- Colorectal Cancer
- Being tested
- Electronic Consult System
- Keywords
- cancer, colonoscopy, mass screening, colorectal cancer, colorectal carcinoma, reminder systems, rectal cancers, colorectal tumor, guidelines, CRC secondary prevention, colorectal neoplasms, colonic neoplasms, colonic diseases, hemoccult testing
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Colonic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Consult SystemDevice
Consult system is an event notification system programmed to function within the VA electronic medical record system.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Consult System | Experimental | A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results Receives: Device: Electronic Consult System |
| Usual Care | No intervention | The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients Receiving GI Consult for FOBT+ Results
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Measured: 6 months
Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results
Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startAug 2005
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Linda L. Humphrey, MD MPH, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122187
- Sponsor's protocol ID
- CRT 02-059
- Status last verified
- Sep 2013
- First submitted
- 18 Jul 2005
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tsai TT, Nallamothu BK, Prasad A, Saint S, Bates ER. Clinical problem-solving. A change of heart. N Engl J Med. 2009 Sep 3;361(10):1010-6. doi: 10.1056/NEJMcps0903023. No abstract available.
PubMed 19726776Messersmith WA, Ahnen DJ. Targeting EGFR in colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1834-6. doi: 10.1056/NEJMe0806778. No abstract available.
PubMed 18946069Humphrey LL, Shannon J, Partin MR, O'Malley J, Chen Z, Helfand M. Improving the follow-up of positive hemoccult screening tests: an electronic intervention. J Gen Intern Med. 2011 Jul;26(7):691-7. doi: 10.1007/s11606-011-1639-3. Epub 2011 Feb 15.
PubMed 21327529
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of Colorectal Cancer Screening Guidelines: A System Intervention
- ClinicalTrials.gov ID
- NCT00122187
- Acronym / sponsor ID
- CRT 02-059
- Conditions
- Colorectal Cancer
- Keywords
- cancer, colonoscopy, mass screening, colorectal cancer, colorectal carcinoma, reminder systems, rectal cancers, colorectal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Aug 2005
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Jul 2005 (estimated)
- Results
- Posted 27 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States. Results from randomized clinical trials and intervention studies have suggested that implementation of a CRC screening program for men and women over age 50 results in reduced CRC mortality. However, for this reduction to be fully realized, it is imperative that all positive screening tests are followed by complete diagnostic evaluation (CDE). Numerous intervention programs have been used to improve initial CRC screening rates, but data indicate that outside the research setting, less than half of patients with a positive fecal occult blood test (FOBT) screening result undergo CDE. To enhance the translation of this best practice recommendation to clinical practice, the investigators propose to implement an electronic event notification intervention (CRC-ENS) directed at making physician and system level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE.
Detailed description
Objectives: 1.To implement an electronic CRC screening event notification system intervention to improve complete evaluation of patients with a positive FOBT at four of eight VAMCs randomized to this intervention vs usual care.
2.To conduct a qualitative evaluation to identify implementation barriers and facilitators, and to guide modifications of the CRC-ENS. 3.To conduct an outcome evaluation to determine the effectiveness of the intervention to:
- increase the proportion of patients with a positive FOBT receiving CDE. b. reduce the time-lag between notification of a positive FOBT result and scheduling of a follow-up endoscopic procedure. 4. To improve patient compliance with follow-up recommendations through combined scheduling.
Methods: The CRC-ENS intervention employs a relatively simple alteration to the current electronic mechanism for notifying the primary care provider (PCP) of when a positive FOBT is recorded. With the CRC-ENS, this notification will be forwarded to the gastroenterology (GI) clinic as well as the PCP. This notification at the GI clinic will set off a cascade of events that would normally only be triggered by a consult request from the PCP. In this translation study, eight participating VHA sites will be randomly assigned to either the CRC-ENS intervention or usual care group. The proposed project will take two years to complete. During the first project year, the participating sites will be recruited and randomized. Pre-intervention change of awareness strategies will be initiated at all intervention sites. The CRC-ENS intervention will be implemented in the second project year, and formative evaluation (including two sets of focus groups) will be carried out throughout the intervention period. Post-intervention data collection, outcome evaluation and dissemination of results will be carried out in months 18-24.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Consult System | Experimental | Device: Electronic Consult SystemA new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results |
| Usual Care | No intervention | –The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- VA Medical Centers with either CORI (Clinical Outcomes Research Initiative) or electronic notes/descriptions documenting GI endoscopic procedures
Key exclusion criteria (1 listed)
- VA Medical Centers without electronic GI procedure documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Consult SystemConsult system is an event notification system programmed to function within the VA electronic medical record system. | Device | Electronic Consult System |
Primary outcome
Percent of Patients Receiving GI Consult for FOBT+ Results
Time frame: 6 months
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results
Time frame: 6 months
Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19726776Tsai TT, Nallamothu BK, Prasad A, Saint S, Bates ER. Clinical problem-solving. A change of heart. N Engl J Med. 2009 Sep 3;361(10):1010-6. doi: 10.1056/NEJMcps0903023. No abstract available.
- Results publication: PubMed 18946069Messersmith WA, Ahnen DJ. Targeting EGFR in colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1834-6. doi: 10.1056/NEJMe0806778. No abstract available.
- Results publication: PubMed 21327529Humphrey LL, Shannon J, Partin MR, O'Malley J, Chen Z, Helfand M. Improving the follow-up of positive hemoccult screening tests: an electronic intervention. J Gen Intern Med. 2011 Jul;26(7):691-7. doi: 10.1007/s11606-011-1639-3. Epub 2011 Feb 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda L. Humphrey, MD MPH principal investigator
VA Portland Health Care System, Portland, OR
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Consult System in people with Colorectal Cancer, run by US Department of Veterans Affairs at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Patients Receiving GI Consult for FOBT+ Results (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122187, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.