Colorectal Neoplasms
Conditions
Keywords
Colorectal Cancer Screening, Fecal Occult Blood Testing
Brief summary
The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations. Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT). Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date. Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period. Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.
Interventions
BEHAVIORALReminder and Outreach Intervention
This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
51 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Fecal occult blood test (FOBT) completed in the past year * Age 51-75 * Preferred language English or Spanish
Exclusion criteria
* Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date * Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of a Fecal Occult Blood Test (FOBT) | within 6 months of randomization | This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants. |
Countries
United States
Participant flow
Recruitment details
Eligible patients identified by query of electronic health record.
Participants by arm
| Arm | Count |
|---|---|
| Reminder and Outreach Intervention Participants randomized to this arm will receive the Reminder and Outreach intervention.
Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results. | 225 |
| Usual Care Control Group Patients assigned to this arm will receive usual care. | 225 |
| Total | 450 |
Baseline characteristics
| Characteristic | Reminder and Outreach Intervention | Usual Care Control Group | Total |
|---|---|---|---|
| Age, Continuous | 59.5 years STANDARD_DEVIATION 6.1 | 59.6 years STANDARD_DEVIATION 5.7 | 59.5 years STANDARD_DEVIATION 5.9 |
| Insurance Status Insured | 51 participants | 53 participants | 104 participants |
| Insurance Status Uninsured | 174 participants | 172 participants | 346 participants |
| Race/Ethnicity, Customized Latino/Hispanic | 197 participants | 205 participants | 402 participants |
| Race/Ethnicity, Customized Other | 28 participants | 20 participants | 48 participants |
| Region of Enrollment United States | 225 participants | 225 participants | 450 participants |
| Sex: Female, Male Female | 158 Participants | 164 Participants | 322 Participants |
| Sex: Female, Male Male | 67 Participants | 61 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 225 | 0 / 225 |
| serious Total, serious adverse events | 0 / 225 | 0 / 225 |
Outcome results
Primary
Completion of a Fecal Occult Blood Test (FOBT)
This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.
Time frame: within 6 months of randomization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Reminder and Outreach Intervention | Completion of a Fecal Occult Blood Test (FOBT) | 185 participants |
| Usual Care Control Group | Completion of a Fecal Occult Blood Test (FOBT) | 84 participants |