Colorectal Cancer
Conditions
Keywords
colorectal cancer, early detection of cancer
Brief summary
Family health history can help identify patients at higher than average risk for disease. There is no standardized system for collecting and updating family health history, using this information to determine a patient's disease risk level, and providing screening recommendations to patients and providers. Patients will enter their family health history into MeTree, a family history software program. The program will produce screening recommendations tailored to the patient's family health history. The investigators will examine whether this process increases physician referrals for, and patient uptake of, guideline-recommended screening for colorectal cancer.
Detailed description
Eligible patients are aged 40-65 years, enrolled in primary care, do not have a personal history of colorectal cancer, and have some knowledge of family health history. In Aim 1, a retrospective chart review will be conducted to determine the baseline rate of documenting family health history of colorectal cancer in the medical record for patients enrolled in the Aim 2 randomized trial. In Aim 2, consented patients will be randomized to provide patient-entered family health history and receive patient and provider decision support at enrollment or 12 months later (wait-list control). The primary outcome is risk-appropriate CRC screening/surveillance referral for patients 12 months post-enrollment. Secondary outcomes include patient uptake of recommendations and referral for genetic consultation 12 months post-enrollment. In Aim 3, qualitative interviews will be conducted with physicians and clinic leaders; data will be analyzed using conventional content analysis. In Aim 4, data will be obtained from the administrative databases and patient medical records to conduct a budget impact analysis.
Interventions
BEHAVIORALFamily health history platform (MeTree)
Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
Primary care provider inclusion criteria: * primary care physician, * physician assistant, or nurse practitioner; * at least one half-day of primary care clinic per week. Patient inclusion criteria: * assigned to an enrolled PCP; * English as preferred language; * no plans to relocate or leave the VA system in the next 12 months; * at least one primary care appointment in the 18 months prior to enrollment; * upcoming PCP appointment with assigned PCP; * aged 40-64 years; no previous history of colorectal cancer or adenomatous polyps or inflammatory bowel disease; * no endoscopy within previous 3 years; some knowledge of family health history
Exclusion criteria
n/a (contained within inclusion criteria)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening | 12 months | Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received Recommended Colorectal Cancer Screening | 12 months | Among patients who received a referral, the percentage who received recommended colorectal cancer screening. |
| Number of Patients Who Received Referral for Genetic Consultation | 12 months | Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Patients will complete MeTree at enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree | 252 |
| Delayed Patients will complete MeTree 12 months following enrollment
MeTree: Participants will enter their family health history information into MeTree, patients and providers will receive a decision support document and pedigree | 253 |
| Total | 505 |
Baseline characteristics
| Characteristic | Immediate | Delayed | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 7.1 | 51.3 years STANDARD_DEVIATION 7.7 | 51.4 years STANDARD_DEVIATION 7.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 12 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 242 Participants | 240 Participants | 482 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Ever had a colonoscopy or sigmoidoscopy | 101 Participants | 97 Participants | 198 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 77 Participants | 87 Participants | 164 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 12 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 9 Participants | 16 Participants |
| Race (NIH/OMB) White | 156 Participants | 139 Participants | 295 Participants |
| Sex: Female, Male Female | 56 Participants | 28 Participants | 84 Participants |
| Sex: Female, Male Male | 196 Participants | 225 Participants | 421 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 252 | 0 / 253 |
| other Total, other adverse events | 0 / 252 | 0 / 253 |
| serious Total, serious adverse events | 0 / 252 | 0 / 253 |
Outcome results
Primary
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.
Time frame: 12 months
Population: The analysis sample is the number of patients who completed the family health history assessment, as risk level was necessary to determine risk-appropriate referrals.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate | Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening | 219 Participants |
| Delayed | Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening | 232 Participants |
Comparison: Using alpha=0.05, 80% power, and a risk-appropriate screening referral rate for the delayed arm ranging from 60% to 70%, n = 250 participants with a completed a family health history assessment per arm with 40 providers was needed to detect differences between arms in appropriate referral ranging from 12% to 13.2%. Sample size calculations accounted for provider clustering using an intra-class correlation coefficient of 0.02 to adjust variance for a Z-test of the difference of two proportions.p-value: 0.1695% CI: [0.4, 1.2]Regression, Logistic
Secondary
Number of Participants Who Received Recommended Colorectal Cancer Screening
Among patients who received a referral, the percentage who received recommended colorectal cancer screening.
Time frame: 12 months
Population: Analytic sample is participants who had a referral for colorectal cancer screening
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate | Number of Participants Who Received Recommended Colorectal Cancer Screening | 55 Participants |
| Delayed | Number of Participants Who Received Recommended Colorectal Cancer Screening | 68 Participants |
p-value: 0.2395% CI: [0.04, 1.2]Regression, Logistic
Secondary
Number of Patients Who Received Referral for Genetic Consultation
Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.
Time frame: 12 months
Population: Subgroup of veterans who received a recommendation for genetic counseling from the family health history platform
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate | Number of Patients Who Received Referral for Genetic Consultation | 1 Participants |
| Delayed | Number of Patients Who Received Referral for Genetic Consultation | 1 Participants |