Colorectal Cancer Screening, Prevention & Control
Conditions
Keywords
education, preventive service, screening
Brief summary
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventive screenings ordered by their physician. We hypothesize that educational outreach may increase completion rates.
Detailed description
We designed an intervention to focus on patients who have received and accepted a referral for colonoscopy, yet have exhibited some barriers to screening as demonstrated by a lack of screening completion. We conducted a randomized controlled trial to assess the effects of a multicomponent intervention (patient reminder, print and multimedia materials) on colorectal screening completion among this target population.
Interventions
BEHAVIORALEducational outreach
Participants will get a letter from their physician that explains that their records show the test has not been completed. The letter will be mailed along with an educational brochure and a DVD about colorectal cancer and colorectal cancer screening.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient's physician has ordered a preventive screening test * Patient has not completed this test in 3 months * Patient of Northwestern Medical Faculty Foundation General Internal Medicine Clinic.
Exclusion criteria
* Patient has been given a more recent order for the same screening test. * Patient has significant life stress as noted in the Electronic Health Record (EHR)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer Screening Completion. | 3 months post randomization | We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal Cancer Screening Completion | 6 months post randomization | We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening. |
Countries
United States
Participant flow
Recruitment details
This trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. This trial was enrolling patients between October 2008 and May 2009.
Pre-assignment details
We used data contained in the clinic's electronic health record to identify eligible patients. All eligible patients were randomly assigned in equal numbers to either the control or intervention arms. All eligible patients were randomized and assigned to groups until we reached target study size.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening. | 314 |
| Usual Care Control Group Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test. | 314 |
| Total | 628 |
Baseline characteristics
| Characteristic | Intervention Group | Usual Care Control Group | Total |
|---|---|---|---|
| Age Continuous | 57.90 years STANDARD_DEVIATION 7.1 | 58.03 years STANDARD_DEVIATION 6.6 | 58.0 years STANDARD_DEVIATION 6.9 |
| Colorectal Cancer (CRC) screening history Ever screened | 22 Participants | 24 Participants | 46 Participants |
| Colorectal Cancer (CRC) screening history Never screened | 292 Participants | 290 Participants | 582 Participants |
| Insurance Status Medicaid | 10 Participants | 10 Participants | 20 Participants |
| Insurance Status Medicare | 56 Participants | 63 Participants | 119 Participants |
| Insurance Status Private | 245 Participants | 236 Participants | 481 Participants |
| Insurance Status Uninsured | 3 Participants | 5 Participants | 8 Participants |
| Number of visits in past 2 years 1-2 | 69 Participants | 79 Participants | 148 Participants |
| Number of visits in past 2 years 3 | 80 Participants | 79 Participants | 159 Participants |
| Number of visits in past 2 years 4 | 54 Participants | 48 Participants | 102 Participants |
| Number of visits in past 2 years >=5 | 111 Participants | 108 Participants | 219 Participants |
| Race/Ethnicity, Customized Black | 79 participants | 77 participants | 156 participants |
| Race/Ethnicity, Customized Hispanic | 9 participants | 14 participants | 23 participants |
| Race/Ethnicity, Customized Other/unknown | 82 participants | 91 participants | 173 participants |
| Race/Ethnicity, Customized White | 144 participants | 132 participants | 276 participants |
| Region of Enrollment United States | 314 participants | 314 participants | 628 participants |
| Sex: Female, Male Female | 197 Participants | 192 Participants | 389 Participants |
| Sex: Female, Male Male | 117 Participants | 122 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Colorectal Cancer Screening Completion.
We reviewed electronic health records of participants 3 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Time frame: 3 months post randomization
Population: Analysis was based on intention to treat.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care Control Group | Colorectal Cancer Screening Completion. | Did not Complete Screening | 304 participants |
| Usual Care Control Group | Colorectal Cancer Screening Completion. | Completed Screening | 10 participants |
| Intervention Group | Colorectal Cancer Screening Completion. | Did not Complete Screening | 283 participants |
| Intervention Group | Colorectal Cancer Screening Completion. | Completed Screening | 31 participants |
Comparison: We compared the outcomes in the intervention and control groups using rate ratios and chi square test at 3 and 6 months, a 2 sided test with a p value \< .05 was used to determine significance. The study was powered to detect a 10-percentage point difference in screening completion between intervention and control groups if the control rate of completion as 20% or less with 80% power.p-value: <0.0595% CI: [1.5, 6.2]Chi-squared
Secondary
Colorectal Cancer Screening Completion
We reviewed electronic health records of participants 6 months post randomization to ascertain outcome. We looked for one or both of the following (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Participants were categorized as completing CRC screening if there was a lab result or physician note located in chart during study period. If no note or lab result was found in chart, then the participant was categorized as not completing CRC screening.
Time frame: 6 months post randomization
Population: Analysis was based on intention to treat.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care Control Group | Colorectal Cancer Screening Completion | Completed Screening | 38 participants |
| Usual Care Control Group | Colorectal Cancer Screening Completion | Did not Complete Screening | 276 participants |
| Intervention Group | Colorectal Cancer Screening Completion | Did not Complete Screening | 257 participants |
| Intervention Group | Colorectal Cancer Screening Completion | Completed Screening | 57 participants |
Comparison: Same as primary outcome.p-value: <0.0595% CI: [1.03, 2.2]Chi-squared