Family History App in Personalized Medicine
NCT04726319 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 627
Last updated 2026-05-06
Summary
A complete family history (FH) may identify persons at high risk for certain conditions. They can be offered genetic testing and life-saving screening and treatment. In practice, complete FH is rarely collected or entered into the electronic medical record (EMR). The Family History Screening Questionnaire is a survey patients complete to tell whether they are at increased risk of specific cancers, heart disease or diabetes. We will test a new way to record FH that includes an app to improve use of FH by family physicians and patients. The strategy includes education for patients and physicians about the importance of FH; patient completion of the FH questionnaire prior to appointments; and prompts in the EMR. We expect this to help family physicians and patients interpret FH and make the best decisions. We will assess the proportion of patients with new EMR FH information. We will explore if the strategy increases appropriate referrals for screening and genetic consultation for those at increased FH risk. We will also obtain patients' and physicians' feedback on this strategy. This new approach may improve FH information exchange between patients and physicians, encourage shared decision-making and reduce cancer deaths and chronic disease burden.
Conditions
- Cancer, Breast
- Cancer, Ovarian
- Cancer, Colorectal
- Cancer, Prostate
- Melanoma
- Coronary Artery Disease
- Diabetes Mellitus, Type 2
Interventions
- OTHER
-
FHAMe Intervention
Patients will receive an invitation email prior to their scheduled clinical visit which includes information about the study, a link to the YouTube patient presentation, and a link to the consent form and questionnaire. Patients will be invited to fill out the questionnaire prior to their appointment. After patients complete the initial questionnaire, physicians will receive an EMR message on the day of patient's clinic visit alerting them that patient family history information is available and to complete the Family History Action Form. They will be prompted to respond to the message which will open the action form and ask what action the provider intends to take with this family history information. The form will then link to management support tools for use during the patient visit. All participants will attend their clinical visit after which they will receive a post-visit electronic survey regarding their clinical visit and whether family history was reviewed with their provider.
Sponsors & Collaborators
-
University of Toronto
lead OTHER
Principal Investigators
-
June Carroll, MD · MOUNT SINAI HOSPITAL
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-09-20
- Primary Completion
- 2022-06-30
- Completion
- 2026-01-27
Countries
- Canada
Study Locations
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