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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Behavioral: Family health history platform (MeTree)

• Registration Number: NCT02247336
• Lead Sponsor: VA Office of Research and Development

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.

Study Timeline

• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-25
• Study Start: 2017-08-01
• Primary Completion: 2020-07-13
• Study Completion: 2020-07-13
• Results First Submitted: 2021-06-29
• Results First Submitted QC: 2021-07-26
• Results First Posted: 2021-08-19
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 505

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

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Exclusion Criteria

n/a (contained within inclusion criteria)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate	Family health history platform (MeTree)	Patients will complete a family health history platform at enrollment
Delayed	Family health history platform (MeTree)	Patients will complete a family health history platform 12 months following enrollment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI; 🇺🇸 Madison, Wisconsin, United States