Trial Outcomes & Findings for Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening (NCT NCT01103479)
NCT ID: NCT01103479
Last Updated: 2015-05-06
Results Overview
CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
569 participants
Primary outcome timeframe
within 6 months of provider recommendation
Results posted on
2015-05-06
Participant Flow
Recruitment for this study took place between September 15, 2010 and January 30, 2013 across seven federally qualified health centers as well as one large academic health center.
Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach the point in the pre-test survey where randomization took place. Therefore they were not assigned to groups. In this study, 3 of the 569 enrolled participants did not reach randomization.
Participant milestones
| Measure |
Control
Participants will complete interviewer-administered pre- and post-test
|
Physician Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
|
Physician and Patient Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
|
|---|---|---|---|
|
Overall Study
STARTED
|
168
|
210
|
188
|
|
Overall Study
COMPLETED
|
163
|
201
|
174
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
14
|
Reasons for withdrawal
| Measure |
Control
Participants will complete interviewer-administered pre- and post-test
|
Physician Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
|
Physician and Patient Intervention
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
|
|---|---|---|---|
|
Overall Study
Up to date with CRC screening
|
1
|
9
|
12
|
|
Overall Study
Family history of CRC
|
1
|
0
|
2
|
|
Overall Study
Active cancer
|
1
|
0
|
0
|
|
Overall Study
Saw non-study physician
|
2
|
0
|
0
|
Baseline Characteristics
Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Control
n=163 Participants
Participants will complete interviewer-administered pre- and post-test
|
Physician Intervention
n=201 Participants
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
|
Physician and Patient Intervention
n=174 Participants
Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
|
Total
n=538 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.46 years
STANDARD_DEVIATION 6.07 • n=99 Participants
|
58.71 years
STANDARD_DEVIATION 6.24 • n=107 Participants
|
57.03 years
STANDARD_DEVIATION 6.09 • n=206 Participants
|
57.79 years
STANDARD_DEVIATION 6.17 • n=157 Participants
|
|
Sex: Female, Male
Female
|
124 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
397 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
141 Participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
82 participants
n=99 Participants
|
111 participants
n=107 Participants
|
93 participants
n=206 Participants
|
286 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
68 participants
n=99 Participants
|
88 participants
n=107 Participants
|
75 participants
n=206 Participants
|
231 participants
n=157 Participants
|
|
Race/Ethnicity, Customized
Other/Missing
|
13 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
21 participants
n=157 Participants
|
|
Region of Enrollment
United States
|
163 participants
n=99 Participants
|
201 participants
n=107 Participants
|
174 participants
n=206 Participants
|
538 participants
n=157 Participants
|
|
Survey Language
English
|
100 participants
n=99 Participants
|
118 participants
n=107 Participants
|
106 participants
n=206 Participants
|
324 participants
n=157 Participants
|
|
Survey Language
Spanish
|
63 participants
n=99 Participants
|
83 participants
n=107 Participants
|
68 participants
n=206 Participants
|
214 participants
n=157 Participants
|
|
Insurance Status (more than one may apply)
Private
|
21 participants
n=99 Participants
|
30 participants
n=107 Participants
|
27 participants
n=206 Participants
|
78 participants
n=157 Participants
|
|
Insurance Status (more than one may apply)
Medicare
|
47 participants
n=99 Participants
|
68 participants
n=107 Participants
|
52 participants
n=206 Participants
|
167 participants
n=157 Participants
|
|
Insurance Status (more than one may apply)
Medicaid
|
51 participants
n=99 Participants
|
71 participants
n=107 Participants
|
67 participants
n=206 Participants
|
189 participants
n=157 Participants
|
|
Insurance Status (more than one may apply)
Uninsured
|
66 participants
n=99 Participants
|
52 participants
n=107 Participants
|
42 participants
n=206 Participants
|
160 participants
n=157 Participants
|
|
Health Care System
Community FQHC
|
99 participants
n=99 Participants
|
174 participants
n=107 Participants
|
154 participants
n=206 Participants
|
427 participants
n=157 Participants
|
|
Health Care System
Academic Health Center
|
64 participants
n=99 Participants
|
27 participants
n=107 Participants
|
20 participants
n=206 Participants
|
111 participants
n=157 Participants
|
|
Years of Education
0 - 6 years
|
44 participants
n=99 Participants
|
38 participants
n=107 Participants
|
35 participants
n=206 Participants
|
117 participants
n=157 Participants
|
|
Years of Education
7 - 12 years
|
41 participants
n=99 Participants
|
64 participants
n=107 Participants
|
52 participants
n=206 Participants
|
157 participants
n=157 Participants
|
|
Years of Education
13 or more years
|
76 participants
n=99 Participants
|
98 participants
n=107 Participants
|
86 participants
n=206 Participants
|
260 participants
n=157 Participants
|
|
Years of Education
Missing data
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
4 participants
n=157 Participants
|
|
Household Income
<$20,000/year
|
101 participants
n=99 Participants
|
137 participants
n=107 Participants
|
111 participants
n=206 Participants
|
349 participants
n=157 Participants
|
|
Household Income
$20,000 - $40,000/year
|
22 participants
n=99 Participants
|
28 participants
n=107 Participants
|
23 participants
n=206 Participants
|
73 participants
n=157 Participants
|
|
Household Income
$40,001 - $100,000/year
|
13 participants
n=99 Participants
|
6 participants
n=107 Participants
|
8 participants
n=206 Participants
|
27 participants
n=157 Participants
|
|
Household Income
Not sure/Don't know
|
23 participants
n=99 Participants
|
26 participants
n=107 Participants
|
27 participants
n=206 Participants
|
76 participants
n=157 Participants
|
|
Household Income
Refused/Missing
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
13 participants
n=157 Participants
|
|
Health status
Poor
|
28 participants
n=99 Participants
|
28 participants
n=107 Participants
|
25 participants
n=206 Participants
|
81 participants
n=157 Participants
|
|
Health status
Fair
|
75 participants
n=99 Participants
|
107 participants
n=107 Participants
|
88 participants
n=206 Participants
|
270 participants
n=157 Participants
|
|
Health status
Good
|
39 participants
n=99 Participants
|
46 participants
n=107 Participants
|
44 participants
n=206 Participants
|
129 participants
n=157 Participants
|
|
Health status
Very Good
|
18 participants
n=99 Participants
|
10 participants
n=107 Participants
|
12 participants
n=206 Participants
|
40 participants
n=157 Participants
|
|
Health status
Excellent
|
2 participants
n=99 Participants
|
10 participants
n=107 Participants
|
4 participants
n=206 Participants
|
16 participants
n=157 Participants
|
|
Health status
Missing
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
2 participants
n=157 Participants
|
|
Health Literacy
Inadequate
|
51 participants
n=99 Participants
|
86 participants
n=107 Participants
|
67 participants
n=206 Participants
|
204 participants
n=157 Participants
|
|
Health Literacy
Marginal/Adequate
|
96 participants
n=99 Participants
|
97 participants
n=107 Participants
|
88 participants
n=206 Participants
|
281 participants
n=157 Participants
|
|
Health Literacy
Missing
|
16 participants
n=99 Participants
|
18 participants
n=107 Participants
|
19 participants
n=206 Participants
|
53 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: within 6 months of provider recommendationCRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
Outcome measures
| Measure |
Control
n=163 Participants
Participants will complete interviewer-administered pre- and post-test
|
Intervention
n=375 Participants
Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
|
|---|---|---|
|
Colorectal Cancer (CRC) Screening Completion
|
17 participants
|
69 participants
|
PRIMARY outcome
Timeframe: within 6 months of provider recommendationCRC screening completion via FOBT, FIT or Colonoscopy
Outcome measures
| Measure |
Control
n=201 Participants
Participants will complete interviewer-administered pre- and post-test
|
Intervention
n=174 Participants
Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
|
|---|---|---|
|
Colorectal Cancer (CRC) Screening Completion
|
41 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 6 months following patient enrollment into studyProvider recommendation of CRC Screening based on chart review
Outcome measures
| Measure |
Control
n=163 Participants
Participants will complete interviewer-administered pre- and post-test
|
Intervention
n=375 Participants
Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
|
|---|---|---|
|
Provider Recommendation of CRC Screening
|
70 participants
|
216 participants
|
SECONDARY outcome
Timeframe: 6 months following patient enrollment into studyProvider recommendation of CRC Screening based on chart review
Outcome measures
| Measure |
Control
n=201 Participants
Participants will complete interviewer-administered pre- and post-test
|
Intervention
n=174 Participants
Participants in either the Physician Intervention or Physician and Patient Intervention Arms.
Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening
Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
|
|---|---|---|
|
Provider Recommendation of CRC Screening
|
113 participants
|
103 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physician Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physician and Patient Intervention
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