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

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VA Office of Research and Development

Status

Completed

Conditions

Colorectal Cancer

Treatments

Behavioral: Family health history platform (MeTree)

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02247336
IIR 12-378

Details and patient eligibility

About

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.

Full 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.

Enrollment

505 patients

Sex

All

Ages

40 to 64 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

505 participants in 2 patient groups

Immediate
Experimental group
Description:
Patients will complete a family health history platform at enrollment
Treatment:
Behavioral: Family health history platform (MeTree)
Delayed
Active Comparator group
Description:
Patients will complete a family health history platform 12 months following enrollment
Treatment:
Behavioral: Family health history platform (MeTree)

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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