Colorectal Cancer
Conditions
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
Brief 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. 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: 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.
Interventions
Consult system is an event notification system programmed to function within the VA electronic medical record system.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients Receiving GI Consult for FOBT+ Results | 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 | 6 months | Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| Usual Care The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrew because of resource limitations | 2 | 2 |
Baseline characteristics
| Characteristic | Electronic Consult System | Usual Care | Total |
|---|---|---|---|
| Age, Customized Not collected | 4 participants | 4 participants | 8 participants |
| Sex/Gender, Customized Not collected | 4 participants | 4 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Percent of Patients Receiving GI Consult for FOBT+ Results
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Time frame: 6 months
Population: Sites that completed the intervention and post-intervention data collection were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 180 days FOBT+ | 74 percent patients receiving GI consult |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 90 days FOBT+ | 72 percent patients receiving GI consult |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 30 days FOBT+ | 68 percent patients receiving GI consult |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 90 days FOBT+ | 46 percent patients receiving GI consult |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 30 days FOBT+ | 39 percent patients receiving GI consult |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 180 days FOBT+ | 50 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 180 days FOBT+ | 55 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 180 days FOBT+ | 86 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 30 days FOBT+ | 80 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 30 days FOBT+ | 47 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 90 days FOBT+ | 50 percent patients receiving GI consult |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 90 days FOBT+ | 82 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 30 days FOBT+ | 64 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 30 days FOBT+ | 63 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 180 days FOBT+ | 71 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 90 days FOBT+ | 69 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 180 days FOBT+ | 72 percent patients receiving GI consult |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 90 days FOBT+ | 70 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 180 days FOBT+ | 59 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 30 days FOBT+ | 51 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 30 days FOBT+ | 48 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 90 days FOBT+ | 56 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | post intervention--consult within 90 days FOBT+ | 56 percent patients receiving GI consult |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult for FOBT+ Results | pre intervention--consult within 180 days FOBT+ | 62 percent patients receiving GI consult |
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
Time frame: 6 months
Population: Sites that completed the intervention and post-intervention data collection were included in the analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 30 days FOBT+ | 4 percent patients with GI consult+workup |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 30 days FOBT+ | 30 percent patients with GI consult+workup |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 90 days FOBT+ | 18 percent patients with GI consult+workup |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 90 days FOBT+ | 49 percent patients with GI consult+workup |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 180days FOBT+ | 25 percent patients with GI consult+workup |
| Electronic Consult System 1st Site (1a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 180days FOBT+ | 51 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 180days FOBT+ | 42 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 90 days FOBT+ | 39 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 30 days FOBT+ | 12 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 90 days FOBT+ | 26 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 30 days FOBT+ | 21 percent patients with GI consult+workup |
| Electronic Consult System 2nd Site (2a) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 180days FOBT+ | 29 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 30 days FOBT+ | 13 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 90 days FOBT+ | 44 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 90 days FOBT+ | 50 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 180days FOBT+ | 54 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 180days FOBT+ | 48 percent patients with GI consult+workup |
| Usual Care 1st Site (1b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 30 days FOBT+ | 19 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 180days FOBT+ | 22 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 180days FOBT+ | 22 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 30 days FOBT+ | 5 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | post intervention--consult+workup in 90 days FOBT+ | 17 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 30 days FOBT+ | 4 percent patients with GI consult+workup |
| Usual Care 2nd Site (2b) | Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | pre intervention--consult+workup in 90 days FOBT+ | 15 percent patients with GI consult+workup |