Family History App in Personalized Medicine

Coronary Artery Disease Clinical Trial

— FHAMe  

Official title:

Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04726319
• Other study ID #: 20-0270-E
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Family history (FH) is one of the cornerstones of medicine, and provides a glimpse of the genetic make-up of a family. Family physicians (FPs) are in an ideal position to identify those at risk of harboring a genetic mutation requiring further genetics assessment. A challenge in the family medicine clinic is obtaining an adequate FH to triage appropriate patients for further assessment and management. Patients with an identified germline mutation have a variety of therapeutic options including prophylactic surgeries and high risk screening for hereditary cancer syndromes, cardiac devices for inherited cardiac conditions, and intensive statin therapy for those with hypercholesterolemia, all of which can be potentially life-saving.

A systematic review showed that the application of systematic tools which enable information gathering, improves FH accuracy and completeness. Patient-completed FH questionnaires are gaining attention with evidence of reasonable completeness and accuracy. However, challenges have been reported in incorporating these tools including uploading FH results into the EMR and into management strategies.

To address the challenge of obtaining an adequate FH and triaging appropriate patients for further assessment and possibly life-saving interventions, we propose to use a simple FH questionnaire, the "Family History Screening Questionnaire", which will be filled out by patients electronically with the results integrated into the EMR to identify families at risk of inherited diseases.

Overarching Research Objectives:

• To evaluate an innovative strategy to collect family history (FH) and improve personalized primary care. Strategies include: a novel Family History Screening questionnaire (FHSQ) (app), provider alerts, seamless integration into the electronic medical record (EMR), electronic clinical decision support through point-of-care tools, and patient and provider education

• Primary objective: to determine if this innovative strategy will increase the proportion of intervention patients that have updated documentation of family history in the EMR.

• Secondary objective: to describe contextual factors that may influence implementation of this family history strategy into primary care. To explore whether the intervention led to increased discussion about FH and resulted in more personalized screening/management.

This study will determine if increasing awareness of the importance of FH and facilitating collection through a novel FH app with physician alerts, integration into the EMR, electronic decision support and resources, is associated with: increased collection of FH in the EMR, FH discussion by patients and clinicians and personalized, risk appropriate screening/management. Development and implementation of this novel FH app and strategy have the potential to improve FH information exchange between patients and primary care providers, facilitate shared decision-making about personalized screening and management based on FH risk, reduce cancer deaths and chronic disease burden and build the foundation for personalized medicine.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast
• Cancer, Colorectal
• Cancer, Ovarian
• Cancer, Prostate
• Colorectal Neoplasms
• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Melanoma
• Ovarian Neoplasms
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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