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

Translation of Colorectal Cancer Screening Guidelines: A System Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00122187
Enrollment
8
Registered
2005-07-21
Start date
2005-08-31
Completion date
2008-05-31
Last updated
2015-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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

DEVICEElectronic Consult System

Consult system is an event notification system programmed to function within the VA electronic medical record system.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frameDescription
Percent of Patients Receiving GI Consult for FOBT+ Results6 monthsPercent 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+ Results6 monthsPercent 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

ArmCount
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
Total8

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrew because of resource limitations22

Baseline characteristics

CharacteristicElectronic Consult SystemUsual CareTotal
Age, Customized
Not collected
4 participants4 participants8 participants
Sex/Gender, Customized
Not collected
4 participants4 participants8 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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

Time frame: 6 months

Population: Sites that completed the intervention and post-intervention data collection were included in the analysis

ArmMeasureGroupValue (NUMBER)
Electronic Consult System 1st Site (1a)Percent of Patients Receiving GI Consult for FOBT+ Resultspost 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspre 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+ Resultspre 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+ Resultspre 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre intervention--consult within 180 days FOBT+62 percent patients receiving GI consult
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

Time frame: 6 months

Population: Sites that completed the intervention and post-intervention data collection were included in the analysis

ArmMeasureGroupValue (NUMBER)
Electronic Consult System 1st Site (1a)Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspre 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspre 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+ Resultspre 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+ Resultspost 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+ Resultspost 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+ Resultspost 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+ Resultspre 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+ Resultspre intervention--consult+workup in 90 days FOBT+15 percent patients with GI consult+workup

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026