Colorectal Cancer
Conditions
Keywords
education, preventive service, screening, Colorectal Cancer Screening, Prevention & Control
Brief summary
The purpose of this study is to evaluate whether patient outreach is effective at increasing compliance with preventative screenings for those patients who, based on national quality standards, have become newly eligible for screening measures. We hypothesize that educational outreach may increase completion rates.
Interventions
BEHAVIORALLetter Only
Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
BEHAVIORALLetter and Educational DVD
Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
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
Age
50 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patient of Northwestern Medical Faculty Foundation General Internal Medicine * Patient has a scheduled appointment with a GIM physician in the next several weeks * Patient will be 50 years old at the time of this appointment * Patient is male or female
Exclusion criteria
* This is the first time the patient is seen in the NMFF GIM clinic * There is a prior completion of CRC screening noted in EHR. * There is a prior order placed for CRC screening in EHR. * Patient has a history of CRC * Patient has a diagnosis of ulcerative colitis, inflammatory bowel disease, Crohn's Disease, or documented colectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of CRC Screening | 6 months from initial contact | What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Secondary Outcome for the Study is the Time to Screening Completion. | 6 months after randomization | This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual. |
Countries
United States
Participant flow
Recruitment details
The trial took place at a large urban academic primary care internal medicine practice in Chicago, IL. The trial enrolled patients between March and December 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 to one of the three study arms.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test. | 21 |
| Behavioral: Letter Only Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. | 18 |
| Behavioral: Letter and Educational DVD Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician. | 21 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | trial was terminated prior to completion | 21 | 18 | 21 |
Baseline characteristics
| Characteristic | Usual Care | Behavioral: Letter Only | Behavioral: Letter and Educational DVD | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 18 Participants | 21 Participants | 60 Participants |
| Region of Enrollment United States | 21 participants | 18 participants | 21 participants | 60 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 14 Participants | 42 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 18 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 18 | 0 / 21 |
Outcome results
Primary
Completion of CRC Screening
What would have been reported as this Outcome Measure is the number of participants who completed screening. We planned to review electronic health records of participants 6 months post randomization to look for either: (1) note in free text MD note documenting receipt of one form of colorectal cancer (CRC) screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.
Time frame: 6 months from initial contact
Population: Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.
Comparison: Please note that no analyses were performed as the trial was stopped due to low enrollment.p-value: <0.017Chi-squared
Secondary
The Secondary Outcome for the Study is the Time to Screening Completion.
This Outcome Measure would have reported the length of time, measured in days, that occurred between the date of randomization and the completed screening date. We planned to review the electronic health records of participants 6 months post randomization to look for either: (1)note in free text MD note documenting receipt of one form of CRC screening during study period or (2)lab results from fecal occult blood test, sigmoidoscopy, or colonoscopy. Screening completion equaled presence of a lab result or physician note in chart. No patient charts were reviewed due to low accrual.
Time frame: 6 months after randomization
Population: Although 60 individuals were randomized to condition, the trial was halted prior to primary or secondary outcome chart reviews. Hence there are no results to report.
Comparison: Please note that no analyses were performed as the trial was stopped due to low enrollment.p-value: <0.017Chi-squared