Impact of Family History and Decision Support on High-risk Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Family History and Decision Support on High-risk Cancer Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Behavioral: Family health history platform (MeTree)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate<br>Patients will complete a family health history platform at enrollment | Behavioral: Family health history platform (MeTree)<br>* 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<br>|
| Active Comparator: Delayed<br>Patients will complete a family health history platform 12 months following enrollment | Behavioral: Family health history platform (MeTree)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received Recommended Colorectal Cancer Screening | Among patients who received a referral, the percentage who received recommended colorectal cancer screening. | 12 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal cancer, early detection of cancer