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Clinical Trials/NCT02247336
NCT02247336
Completed
Not Applicable

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

VA Office of Research and Development2 sites in 1 country505 target enrollmentAugust 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
VA Office of Research and Development
Enrollment
505
Locations
2
Primary Endpoint
Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2017
End Date
July 13, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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;

Exclusion Criteria

  • n/a (contained within inclusion criteria)

Outcomes

Primary Outcomes

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

Time Frame: 12 months

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

Secondary Outcomes

  • Number of Participants Who Received Recommended Colorectal Cancer Screening(12 months)
  • Number of Patients Who Received Referral for Genetic Consultation(12 months)

Study Sites (2)

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