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

NCT ID: NCT02247336

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2020-07-13

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Immediate

Patients will complete a family health history platform at enrollment

Group Type: EXPERIMENTAL

Family health history platform (MeTree)

Intervention Type: 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

Delayed

Patients will complete a family health history platform 12 months following enrollment

Group Type: ACTIVE_COMPARATOR

Family health history platform (MeTree)

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• primary care physician,
• physician assistant, or nurse practitioner;
• at least one half-day of primary care clinic per week.

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corrine I. Voils, PhD

Role: PRINCIPAL_INVESTIGATOR

William S. Middleton Memorial Veterans Hospital, Madison, WI

Locations

Durham VA Medical Center, Durham, NC

Durham, North Carolina, United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 31590688 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36307642 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIR 12-378

Identifier Type: -

Identifier Source: org_study_id