Clinical trial NCT02247336: Impact of Family History and Decision Support on High-risk Cancer Screening
Official title: Impact of Family History and Decision Support on High-risk Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
early detection of cancer
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2014-09-25
Enrollment: 505
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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;
* 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)

Primary outcomes:
measure: Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants Who Received Recommended Colorectal Cancer Screening
timeFrame: 12 months
measure: Number of Patients Who Received Referral for Genetic Consultation
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Corrine I. Voils, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldstein KM, Fisher DA, Wu RR, Orlando LA, Coffman CJ, Grubber JM, Rakhra-Burris T, Wang V, Scheuner MT, Sperber N, Datta SK, Nelson RE, Strawbridge E, Provenzale D, Hauser ER, Voils CI. An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial. Trials. 2019 Oct 7;20(1):576. doi: 10.1186/s13063-019-3659-y.
citation: Voils CI, Coffman CJ, Wu RR, Grubber JM, Fisher DA, Strawbridge EM, Sperber N, Wang V, Scheuner MT, Provenzale D, Nelson RE, Hauser E, Orlando LA, Goldstein KM. A Cluster Randomized Trial of a Family Health History Platform to Identify and Manage Patients at Increased Risk for Colorectal Cancer. J Gen Intern Med. 2023 May;38(6):1375-1383. doi: 10.1007/s11606-022-07787-9. Epub 2022 Oct 28.