Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients will complete a family health history platform at enrollment

Patients will complete a family health history platform 12 months following enrollment

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

Family health history platform (MeTree)

Corrine I. Voils, PhD

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.

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.

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

Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.

Among patients who received a referral, the percentage who received recommended colorectal cancer screening.

Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.

VA Office of Research and Development

Patients completed the family history platform at enrollment

Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree

Immediate

Patients completed the family history platform 12 months following enrollment

Participants entered their family health history information into the family history platform, and patients and providers received a decision support document and pedigree

Delayed

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

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

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Ever had a colonoscopy or sigmoidoscopy

Corrine Voils, PhD

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.

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.

Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening

Analytic sample is participants who had a referral for colorectal cancer screening

Number of Participants Who Received Recommended Colorectal Cancer Screening

Subgroup of veterans who received a recommendation for genetic counseling from the family health history platform

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Impact of Family History and Decision Support on High-risk Cancer Screening	NCT02247336	Colorectal Canc...	Family health h...	40 Years - 64 Years	VA Office of Research and Development
Impact of Family History and Decision Support on High-risk Cancer Screening	NCT02247336	Colorectal Canc...	Family health h...	40 Years - 64 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for family health history platform (metree)