Malignant Neoplasm of Large Intestine
Conditions
Keywords
colorectal cancer screening, fecal occult blood testing (FOBT), vulnerable populations, community health center
Brief summary
The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.
Detailed description
Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.
Interventions
OTHERCare manager outreach
Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009
Exclusion criteria
Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of a Colorectal Cancer Screening | within 4 months of the initiation of outreach (by June 30, 2010) | Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010) |
Countries
United States
Participant flow
Recruitment details
All eligible patients within the health center were randomized to usual care or care manager outreach. Eligibility for randomization was assessed on 12/31/2009. Outreach was conducted from 2/25/2010 through 4/30/2010.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager. | 98 |
| Care Manager Outreach Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit | 104 |
| Total | 202 |
Baseline characteristics
| Characteristic | Usual Care | Care Manager Outreach | Total |
|---|---|---|---|
| Age Continuous | 60 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 7 | 60 years STANDARD_DEVIATION 8 |
| Sex: Female, Male Female | 58 Participants | 67 Participants | 125 Participants |
| Sex: Female, Male Male | 40 Participants | 37 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 104 |
| serious Total, serious adverse events | 0 / 98 | 0 / 104 |
Outcome results
Primary
Completion of a Colorectal Cancer Screening
Patients who have documentation within the electronic health record of completion of a guideline approved form of colorectal cancer screening (colonoscopy, sigmoidoscopy, or fecal occult blood testing (FOBT)) within 4 months of the initiation of the outreach intervention (by June 30, 2010)
Time frame: within 4 months of the initiation of outreach (by June 30, 2010)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Completion of a Colorectal Cancer Screening | 5 participants |
| Care Manager Outreach | Completion of a Colorectal Cancer Screening | 31 participants |