Trial Outcomes & Findings for Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs (NCT NCT01191411)
NCT ID: NCT01191411
Last Updated: 2017-05-23
Results Overview
To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value\<0.025 will be considered statistically significant.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5970 participants
Primary outcome timeframe
1 year
Results posted on
2017-05-23
Participant Flow
Participant milestones
| Measure |
Mailed Invitations for FIT Test Kits
Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
|
Mailed Invitations for a Colonoscopy
Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
|
Visit Based Care
No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1593
|
479
|
3898
|
|
Overall Study
COMPLETED
|
648
|
118
|
471
|
|
Overall Study
NOT COMPLETED
|
945
|
361
|
3427
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
Baseline characteristics by cohort
| Measure |
Mailed Invitations for FIT Test Kits
n=1593 Participants
Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
|
Mailed Invitations for a Colonoscopy
n=479 Participants
Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
|
Visit Based Care
n=3898 Participants
No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
|
Total
n=5970 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 3 • n=99 Participants
|
59 years
STANDARD_DEVIATION 3 • n=107 Participants
|
59 years
STANDARD_DEVIATION 3 • n=206 Participants
|
59 years
STANDARD_DEVIATION 3 • n=7 Participants
|
|
Sex: Female, Male
Female
|
993 Participants
n=99 Participants
|
286 Participants
n=107 Participants
|
2517 Participants
n=206 Participants
|
3796 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
600 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
1381 Participants
n=206 Participants
|
2174 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
653 participants
n=99 Participants
|
195 participants
n=107 Participants
|
1600 participants
n=206 Participants
|
2448 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
370 participants
n=99 Participants
|
128 participants
n=107 Participants
|
913 participants
n=206 Participants
|
1411 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
445 participants
n=99 Participants
|
122 participants
n=107 Participants
|
1140 participants
n=206 Participants
|
1707 participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
125 participants
n=99 Participants
|
34 participants
n=107 Participants
|
245 participants
n=206 Participants
|
404 participants
n=7 Participants
|
|
Primary Language
English
|
1322 participants
n=99 Participants
|
410 participants
n=107 Participants
|
3253 participants
n=206 Participants
|
4985 participants
n=7 Participants
|
|
Primary Language
Spanish
|
271 participants
n=99 Participants
|
69 participants
n=107 Participants
|
645 participants
n=206 Participants
|
985 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Overall, out of 1593 patients assigned to FIT outreach, 648 were screened; out of 479 assigned to colonoscopy outreach, 118 were screened; and out of 3898 assigned to usual care, 471 were screened.
To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value\<0.025 will be considered statistically significant.
Outcome measures
| Measure |
Mailed Invitations for FIT Test Kits
n=1593 Participants
Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
|
Mailed Invitations for a Colonoscopy
n=479 Participants
Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
|
Visit Based Care
n=3898 Participants
No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
|
|---|---|---|---|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
All groups - screened
|
40.7 percentage of participants
|
24.6 percentage of participants
|
12.1 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Men - screened
|
38.7 percentage of participants
|
23.3 percentage of participants
|
10.7 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Women - screened
|
41.9 percentage of participants
|
25.2 percentage of participants
|
12.8 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Whites - screened
|
34.2 percentage of participants
|
20.5 percentage of participants
|
9.4 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Blacks - screened
|
43 percentage of participants
|
26.6 percentage of participants
|
15.2 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Hispanics - screened
|
48.1 percentage of participants
|
28.7 percentage of participants
|
13.2 percentage of participants
|
|
Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem.
Other races/ethnicities - screened
|
41.6 percentage of participants
|
26.5 percentage of participants
|
12.7 percentage of participants
|
Adverse Events
Mailed Invitations for FIT Test Kits
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Mailed Invitations for a Colonoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visit Based Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mailed Invitations for FIT Test Kits
n=1593 participants at risk
Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.
Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.
Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
|
Mailed Invitations for a Colonoscopy
n=479 participants at risk
Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.
Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.
Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.
Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
|
Visit Based Care
n=3898 participants at risk
No invitation to complete colorectal cancer screening.
Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.
Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Serious Adverse Event - Perforated cecum
|
100.0%
1/1 • Number of events 1 • Data for reporting serious adverse event was collected over a 3 month period.
|
—
0/0 • Data for reporting serious adverse event was collected over a 3 month period.
|
—
0/0 • Data for reporting serious adverse event was collected over a 3 month period.
|
Other adverse events
Adverse event data not reported
Additional Information
Keith E. Argenbright, MD
University of Texas Southwestern Medical Center
Phone: 817-288-9898
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place