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OpenTrials
Completed

NCT Number: NCT02247336

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

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.

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Key information

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durham VA Medical Center, Durham, NC, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Family health history platform (MeTree)

Behavioral

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

Primary outcomes

  1. 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

  1. Number of Participants Who Received Recommended Colorectal Cancer Screening

    Time frame: 12 months

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

  2. Number of Patients Who Received Referral for Genetic Consultation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2014
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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