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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Family health history platform (MeTree)

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.

• Study Type: Interventional
• Enrollment (Actual): 505
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705-3875
      • Durham VA Medical Center, Durham, NC
  • Wisconsin
    • Madison, Wisconsin, United States, 53705-2254
      • William S. Middleton Memorial Veterans Hospital, Madison, WI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate; Patients will complete a family health history platform at enrollment	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
Active Comparator: Delayed; Patients will complete a family health history platform 12 months following enrollment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Corrine I. Voils, PhD, William S. Middleton Memorial Veterans Hospital, Madison, WI

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): July 13, 2020
• Study Completion (Actual): July 13, 2020

Study Registration Dates

• First Submitted: September 18, 2014
• First Submitted That Met QC Criteria: September 18, 2014
• First Posted (Estimated): September 25, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: colorectal cancer; early detection of cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IIR 12-378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No