Family History App in Personalized Medicine

NCT04726319 | Completed

• 1 other identifier: 20-0270-E
• Study Type: interventional
• Target: 627
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer, Breast; Cancer, Ovarian; Cancer, Colorectal; Cancer, Prostate; Melanoma; Coronary Artery Disease; Diabetes Mellitus, Type 2

Keywords

Family history; Family medicine; Genetics; Personalized medicine

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

• Recruitment rate

  6 months

• Participation rate

  6 months

• Usage of family history information

  30 days

• Attitudes towards the FHAMe intervention

  30 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: FHAMe Intervention

Usual Care

NO INTERVENTION

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

Interventions

FHAMe Intervention OTHER

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.

Intervention

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age

You may not qualify if:

• Pregnancy
• Must be patients of staff physicians (i.e. no resident patients)
• Must have email address registered in the OCEAN system

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Melanoma; Coronary Artery Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• June Carroll, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Matched-paired randomized control trial

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: September 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: January 27, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)