Coronary Artery Disease Clinical Trial
— FHAMeOfficial title:
Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
Verified date | November 2023 |
Source | University of Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 627 |
Est. completion date | December 2024 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 69 Years |
Eligibility | Inclusion Criteria: - 30-69 years of age Exclusion Criteria: - Pregnancy - Must be patients of staff physicians (i.e. no resident patients) - Must have email address registered in the OCEAN system |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with new documentation of family history in EMR | The proportion of patients with new documentation of family history in the EMR within 30 days after the visit, compared to patients in control group practices | 30 days post visit | |
Primary | Positive family history documentation | The proportion of patients in the intervention arm with positive documented family history in the EMR, compared to patients in control group practices | 30 days post visit | |
Primary | Proportion of patients in each study arm with new documentation of family history in EMR | The proportion of patients with new documentation of family history in the EMR for each study arm as a whole, over the full 6-month period of the study | 6 months | |
Primary | Proportion of patients, for each consenting clinician, with new documentation of family history in EMR | The proportion of patients with new documentation of family history in the EMR for each consenting clinician, 6 months prior to the intervention and 6 months after | 1 year | |
Primary | Family history of breast/ovarian/colorectal/prostate cancer | Proportion of patients with documented family history of cancer in the EMR measured through the number of 1st degree relatives | 30 days post visit | |
Primary | Changes in risk-appropriate screening based on family history | Through the use of UTOPIAN data which is routinely collected and qualitative interviews with family physicians using semi-structured interview guides, we will explore whether the FH strategy enables risk-appropriate screening based on FH, and referral of patients at high FH risk to genetics | 30 days post visit | |
Secondary | Recruitment rate | Rate of practice and participant recruitment during the intervention period | 6 months | |
Secondary | Participation rate | Proportion of patients completing the questionnaire, and providers attending the webinar, reviewing family history, using clinical tools, and having family history discussions with patients | 6 months | |
Secondary | Usage of family history information | Exploring how family history was obtained and used by patients and physicians through questionnaires and qualitative interviews | 30 days | |
Secondary | Attitudes towards the FHAMe intervention | Exploring patient and team experiences and attitudes to the innovation through questionnaires and qualitative interviews | 30 days |
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