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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247336
• Other study ID #: IIR 12-378
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: July 13, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. completion date: July 13, 2020
• Est. primary completion date: July 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Family health history platform (MeTree)
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

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	William S. Middleton Memorial Veterans Hospital, Madison, WI	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 pat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Provider Referral for Risk-appropriate Colorectal Cancer Screening	Patients who receive guideline-recommended referral consistent with the risk stratum determined by the family health history platform.	12 months
Secondary	Number of Participants Who Received Recommended Colorectal Cancer Screening	Among patients who received a referral, the percentage who received recommended colorectal cancer screening.	12 months
Secondary	Number of Patients Who Received Referral for Genetic Consultation	Of patients who received a recommendation for genetic consultation based on the family history platform, the percentage who received a referral for genetic consultation.	12 months