Family History App in Personalized Medicine (FHAMe): A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 627
- 试验地点
- 2
- 主要终点
- Proportion of patients, for each consenting clinician, with new documentation of family history in EMR
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-69 years of age
排除标准
- •Pregnancy
- •Must be patients of staff physicians (i.e. no resident patients)
- •Must have email address registered in the OCEAN system
研究组 & 干预措施
Intervention
In addition to usual care, patients will be asked to answer questions about any family history through the use of a questionnaire.
干预措施: FHAMe Intervention (Other)
Usual Care
Patients receive usual care, which consists of health care providers inquiring about and dealing with family history as they would in usual practice.
结局指标
主要结局
Proportion of patients, for each consenting clinician, with new documentation of family history in EMR
时间窗: 1 year
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
Proportion of patients with new documentation of family history in EMR
时间窗: 30 days post visit
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
时间窗: 30 days post visit
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
时间窗: 6 months
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
Family history of breast/ovarian/colorectal/prostate cancer
时间窗: 30 days post visit
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
时间窗: 30 days post visit
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
次要结局
- Recruitment rate(6 months)
- Attitudes towards the FHAMe intervention(30 days)
- Usage of family history information(30 days)
- Participation rate(6 months)
研究者
June Carroll
Principal Investigator
University of Toronto