Trial Outcomes & Findings for Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention (NCT NCT00122187)
NCT ID: NCT00122187
Last Updated: 2015-04-24
Results Overview
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
6 months
Results posted on
2015-04-24
Participant Flow
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.
Participating VAMCs were chosen that had electronic registries for gastroenterology (GI) endoscopic procedures available.
Participant milestones
| Measure |
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
|
Usual Care
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
|
Overall Study
Matched by Colonoscopy Volume
|
4
|
4
|
|
Overall Study
Randomized to Intervention or Usual Care
|
4
|
4
|
|
Overall Study
Intervention Implemented
|
3
|
4
|
|
Overall Study
Post-intervention Data Collection
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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
|
Usual Care
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
|---|---|---|
|
Overall Study
Withdrew because of resource limitations
|
2
|
2
|
Baseline Characteristics
Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention
Baseline characteristics by cohort
| Measure |
Electronic Consult System
n=4 Participants
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
|
Usual Care
n=4 Participants
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Not collected
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Sex/Gender, Customized
Not collected
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Sites that completed the intervention and post-intervention data collection were included in the analysis
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Outcome measures
| Measure |
Electronic Consult System 1st Site (1a)
n=1 Participants
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
|
Electronic Consult System 2nd Site (2a)
n=1 Participants
A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
|
Usual Care 1st Site (1b)
n=1 Participants
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
Usual Care 2nd Site (2b)
n=1 Participants
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
|---|---|---|---|---|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
pre intervention--consult within 30 days FOBT+
|
39 percent patients receiving GI consult
|
47 percent patients receiving GI consult
|
64 percent patients receiving GI consult
|
51 percent patients receiving GI consult
|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
post intervention--consult within 30 days FOBT+
|
68 percent patients receiving GI consult
|
80 percent patients receiving GI consult
|
63 percent patients receiving GI consult
|
48 percent patients receiving GI consult
|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
pre intervention--consult within 90 days FOBT+
|
46 percent patients receiving GI consult
|
50 percent patients receiving GI consult
|
70 percent patients receiving GI consult
|
56 percent patients receiving GI consult
|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
post intervention--consult within 90 days FOBT+
|
72 percent patients receiving GI consult
|
82 percent patients receiving GI consult
|
69 percent patients receiving GI consult
|
56 percent patients receiving GI consult
|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
pre intervention--consult within 180 days FOBT+
|
50 percent patients receiving GI consult
|
55 percent patients receiving GI consult
|
71 percent patients receiving GI consult
|
62 percent patients receiving GI consult
|
|
Percent of Patients Receiving GI Consult for FOBT+ Results
post intervention--consult within 180 days FOBT+
|
74 percent patients receiving GI consult
|
86 percent patients receiving GI consult
|
72 percent patients receiving GI consult
|
59 percent patients receiving GI consult
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Sites that completed the intervention and post-intervention data collection were included in the analysis
Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
Outcome measures
| Measure |
Electronic Consult System 1st Site (1a)
n=1 Participants
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
|
Electronic Consult System 2nd Site (2a)
n=1 Participants
A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
|
Usual Care 1st Site (1b)
n=1 Participants
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
Usual Care 2nd Site (2b)
n=1 Participants
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
|
|---|---|---|---|---|
|
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
|
12 percent patients with GI consult+workup
|
19 percent patients with GI consult+workup
|
4 percent patients with GI consult+workup
|
|
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
|
21 percent patients with GI consult+workup
|
13 percent patients with GI consult+workup
|
5 percent patients with GI consult+workup
|
|
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
|
26 percent patients with GI consult+workup
|
44 percent patients with GI consult+workup
|
15 percent patients with GI consult+workup
|
|
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
|
39 percent patients with GI consult+workup
|
50 percent patients with GI consult+workup
|
17 percent patients with GI consult+workup
|
|
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
|
29 percent patients with GI consult+workup
|
48 percent patients with GI consult+workup
|
22 percent patients with GI consult+workup
|
|
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
|
42 percent patients with GI consult+workup
|
54 percent patients with GI consult+workup
|
22 percent patients with GI consult+workup
|
Adverse Events
Electronic Consult System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place