Impact of Family History and Decision Support on High-risk Cancer Screening
1 other identifier
interventional
505
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Aug 2017
Typical duration for not_applicable colorectal-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2020
CompletedResults Posted
Study results publicly available
August 19, 2021
CompletedJuly 27, 2023
July 1, 2023
3 years
September 18, 2014
June 29, 2021
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants Who Received Recommended Colorectal Cancer Screening
12 months
Number of Patients Who Received Referral for Genetic Consultation
12 months
Study Arms (2)
Immediate
EXPERIMENTALPatients will complete a family health history platform at enrollment
Delayed
ACTIVE COMPARATORPatients will complete a family health history platform 12 months following enrollment
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
Madison, Wisconsin, 53705-2254, United States
Related Publications (2)
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.
PMID: 31590688RESULTVoils 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.
PMID: 36307642DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Corrine Voils, PhD
- Organization
- William S Middleton Memorial Veterans Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Corrine I. Voils, PhD
William S. Middleton Memorial Veterans Hospital, Madison, WI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2014
First Posted
September 25, 2014
Study Start
August 1, 2017
Primary Completion
July 13, 2020
Study Completion
July 13, 2020
Last Updated
July 27, 2023
Results First Posted
August 19, 2021
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share