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Family History App in Personalized Medicine (FHAMe)

Primary Purpose

Cancer, Breast, Cancer, Ovarian, Cancer, Colorectal

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FHAMe Intervention
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer, Breast focused on measuring Family history, Family medicine, Genetics, Personalized medicine

Eligibility Criteria

30 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual Care

Arm Description

In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire.

Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice.

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Recruitment rate
Rate of practice and participant recruitment during the intervention period
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
Usage of family history information
Exploring how family history was obtained and used by patients and physicians through questionnaires and qualitative interviews
Attitudes towards the FHAMe intervention
Exploring patient and team experiences and attitudes to the innovation through questionnaires and qualitative interviews

Full Information

First Posted
January 22, 2021
Last Updated
August 10, 2022
Sponsor
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04726319
Brief Title
Family History App in Personalized Medicine
Acronym
FHAMe
Official Title
Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Breast, Cancer, Ovarian, Cancer, Colorectal, Cancer, Prostate, Melanoma, Coronary Artery Disease, Diabetes Mellitus, Type 2
Keywords
Family history, Family medicine, Genetics, Personalized medicine

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Matched-paired randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
627 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice.
Intervention Type
Other
Intervention Name(s)
FHAMe Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with new documentation of family history in EMR
Description
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
Time Frame
30 days post visit
Title
Positive family history documentation
Description
The proportion of patients in the intervention arm with positive documented family history in the EMR, compared to patients in control group practices
Time Frame
30 days post visit
Title
Proportion of patients in each study arm with new documentation of family history in EMR
Description
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
Time Frame
6 months
Title
Proportion of patients, for each consenting clinician, with new documentation of family history in EMR
Description
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
Time Frame
1 year
Title
Family history of breast/ovarian/colorectal/prostate cancer
Description
Proportion of patients with documented family history of cancer in the EMR measured through the number of 1st degree relatives
Time Frame
30 days post visit
Title
Changes in risk-appropriate screening based on family history
Description
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
Time Frame
30 days post visit
Secondary Outcome Measure Information:
Title
Recruitment rate
Description
Rate of practice and participant recruitment during the intervention period
Time Frame
6 months
Title
Participation rate
Description
Proportion of patients completing the questionnaire, and providers attending the webinar, reviewing family history, using clinical tools, and having family history discussions with patients
Time Frame
6 months
Title
Usage of family history information
Description
Exploring how family history was obtained and used by patients and physicians through questionnaires and qualitative interviews
Time Frame
30 days
Title
Attitudes towards the FHAMe intervention
Description
Exploring patient and team experiences and attitudes to the innovation through questionnaires and qualitative interviews
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Carroll, MD
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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