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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.
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:
a. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Consult System | Device | Consult system is an event notification system programmed to function within the VA electronic medical record system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Receiving GI Consult for FOBT+ Results | Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results | 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 | 6 months |
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Inclusion Criteria:
- VA Medical Centers with either CORI (Clinical Outcomes Research Initiative) or electronic notes/descriptions documenting GI endoscopic procedures
Exclusion Criteria:
- VA Medical Centers without electronic GI procedure documentation
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| Name | Affiliation | Role |
|---|---|---|
| Linda L. Humphrey, MD MPH | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | United States | ||
| Southern Arizona VA Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19726776 | Result | 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. | |
| 18946069 | Result | Messersmith 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. |
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Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Usual Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tucson |
| Arizona |
| 85723 |
| United States |
| VA Eastern Colorado Health Care System, Denver, CO | Denver | Colorado | 80220 | United States |
| Overton Brooks VA Medical Center | Shreveport | Louisiana | 71101-4295 | United States |
| Minneapolis | Minneapolis | Minnesota | 55417 | United States |
| Durham VA Medical Center, Durham, NC | Durham | North Carolina | 27705 | United States |
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
| Tennessee Valley Healthcare System Nashville Campus, Nashville, TN | Nashville | Tennessee | 37212-2637 | United States |
| VA Medical & Regional Office Center, White River | White River Junction | Vermont | 05009-0001 | United States |
| 21327529 | Result | Humphrey 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. |
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
| Matched by Colonoscopy Volume |
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| Randomized to Intervention or Usual Care |
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| Intervention Implemented |
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| Post-intervention Data Collection |
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| COMPLETED |
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| NOT COMPLETED |
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The population is the number of VAMCs that enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Usual Care | The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants in this study were VAMCs rather than human subjects. Age of participants was not collected because it was not applicable. | Number | participants |
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| Sex/Gender, Customized | Participants in this study were VAMCs rather than human subjects. Gender of participants was not collected because it was not applicable. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Patients Receiving GI Consult for FOBT+ Results | Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results | Sites that completed the intervention and post-intervention data collection were included in the analysis | Posted | Number | percent patients receiving GI consult | 6 months |
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| Primary | 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 | Sites that completed the intervention and post-intervention data collection were included in the analysis | Posted | Number | percent patients with GI consult+workup | 6 months |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 0 | 0 | 0 | ||
| EG001 | Usual Care | The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Humphrey | VAHSRD | 503-220-8262 | 57176 | linda.humphrey@va.gov |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D012004 | Rectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| post intervention--consult within 30 days FOBT+ |
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| pre intervention--consult within 90 days FOBT+ |
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| post intervention--consult within 90 days FOBT+ |
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| pre intervention--consult within 180 days FOBT+ |
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| post intervention--consult within 180 days FOBT+ |
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The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
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