Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Heart and Blood Diseases

Diabetes Mellitus

Heart Diseases

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.

Software program collecting family health history and generating clinical decision support for risk-based preventive care

MeTree

Geoffrey S Ginsburg, MD PHD

Lori Orlando, MD

The outcome of this research will be a demonstration that family health history (FHH) risk data can be used efficiently to deliver more effective healthcare in geographically and ethnically diverse clinical care environments. Although FHH is a standard component of the medical interview its widespread adoption is hindered by three major barriers: (1) a dearth of standard collection methods; (2) the absence of health care provider access to complete FHH information; and (3) the need for clinical guidance for the interpretation and use of FHH. In addition, the time constraints of the busy provider and poor integration of FHH with paper medical records or electronic medical records (EMR) impede its widespread use. The investigators hypothesize that patient-driven and electronic collection of FHH for risk stratification will promote more informed decision-making by patients and providers, and improves adherence to risk-stratified preventive care guidelines. The study team will use an implementation sciences approach to integrate an innovative FHH system that collects FHH from patients. Intermountain Healthcare will provide the information technology expertise with EMR design to develop an innovative solution to a storage model standard for FHH data as well as a centralized standards-compliant open clinical decision support (OpenCDS) rule development architecture to analyze FHH and to generate evidence-based, individualized, disease risk, preventive care recommendations for both patients and providers.

Five health care delivery organizations will participate in this demonstration project: Duke University, the Medical College of Wisconsin, the Air Force, Essentia Health, and the University of North Texas Health Science Center. The study will take place in 'real world' clinical, socio-cultural, and demographically diverse (rural, underserved, academic, family medicine) care clinics (n=34) in 5 states (CA, MN, NC, WI, TX) that include genomic medicine 'early adopter' and 'naïve' sites, as well as those that are EMR-enabled and others that are not. The study team will recruit a minimum of 7000 English or Spanish speaking adults over a 3-year period and will capture process metrics and outcomes that are measured in the course of usual care. The goals are: 1) To optimize the collection of patient entered FHH in diverse clinical environments for coronary heart disease, thrombosis, and selected cancers, 2) to export FHH data to an OpenCDS platform and return CDS results to providers and patients (and to EMRs where relevant) and to explore the integration of genetic risk and FHH data at selected sites, 3) to assess the clinical and personal utility of FHH using a pragmatic observational study design to assess reach, adoption, integrity, exposure, and sustainability, and to capture, analyze, and report effectiveness outcomes at each stakeholder level: patient, provider, and clinic/system, and 4) to take a leadership role in the dissemination of guidelines for FHH intervention across in diverse practice settings.

Family Health History in Diverse Care Settings (FHH)

Family Health History in Diverse Care Settings

How many patients identified as meeting criteria for genetic counseling, how many providers ordered genetic counseling, and how many patients adhere to the provider recommendation at 1 year.

The study will assess satisfaction associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked their level of satisfaction with their experience using the web-based portal to enter information for their provider before their appointment

The study will assess comfort associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if the MeTree program was easy to use

The study will assess anxiety associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participant were asked if answering the questions made them anxious

The study will assess preparedness associated with using the MeTree tool via 3 months survey after completing the family health history collection. The participants were asked if they had enough information about some people in their family when completing MeTree

Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.

Evaluate which providers were successfully using MeTree in their clinical work flow and which patients are successfully using MeTree for their care. (surveys, monitoring of clinical workflow, patient recruitment reflects underlying clinic population)

Duke University

All-Cause Mortality and Serious Adverse Events were not monitored/assessed for either Arm/Group

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients as clinical decision support.

MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care

MeTree - Patients

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support.

MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care

MeTree - Providers

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to Providers as clinical decision support.

MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

12 mo survey ended early w/ approved by Duke IRB. Sufficient data obtained to perform the scientific analysis; the overall status of the study is still active, not recruiting. Participant contact completed.

Dr. Lori A. Orlando, Director Program in Precision Medicine

Patients who met genetic counseling criteria

Patients who received Genetic Counseling Order

Patients adhered to provider's recommendation-1yr

Providers who placed Genetic counseling order

Patients who completed intervention and meeting criteria for genetic counseling

Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year

Superior

Above Average

Very Satisfactory

Somewhat unsatisfactory

Very Poor

Not Answered

Patients who completed 3 months post survey and reported their level of satisfaction

Number of Participants Reporting Satisfaction When Using the MeTree Tool

Do not know

did not answer

Patients who completed 3 months post survey and reported on their level of comfort

Number of Participants Reporting Comfort When Using the MeTree Tool

Did not answer

Patients who completed 3 months post survey and reported on anxiety with answering the questions

Number of Participants Reporting Anxiety When Using the MeTree Tool

Patients who completed 3 months post survey and reported on preparedness

Number of Participants Reporting Preparedness When Using the MeTree Tool

Consented providers who completed provider post implementation survey

Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load

Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow

MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to patients and providers as clinical decision support.

MeTree: Software program collecting family health history and generating clinical decision support for risk-based preventive care

Providers using MeTree risk assessment program for clinical decision support

Overall Study

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast cancer patients being seen at SingHealth

Lori A Orlando, MD MPH

This study will create a Breast Cancer Clinical Decision Support Module in MeTree and validate and pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr.Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module.

The value of precision medicine within clinical care is becoming increasingly more evident. Nowhere is this clearer than in the field of oncology. With recognition of the value of genetics in clinical care, the National Cancer Centre Singapore (NCCS) established a Cancer Genetics Service in 2006. This service performs a valuable function within NCCS by overseeing the care of patients found to have hereditary cancer syndromes and providing consultation to clinical oncologists on the appropriate, targeted role of genetic testing within cancer care. While the Cancer Genetics Service is available to all clinicians within NCCS, with the continually growing and evolving understanding of how genetics plays a role in cancer and cancer treatment, there are no clear, consistent guidelines on when to request consultation. This leads to both over- and underutilization of services with some patients being referred who do not require it and others being missed whose care would benefit from the expertise of a cancer geneticist.

In an effort to address these inconsistencies in care, the study team proposes to further develop and evaluate the implementation of a Duke-developed precision medicine software program, MeTree, within NCCS breast cancer clinics. MeTree is a patient-facing family history based risk assessment tool and clinical decision aid that was developed by researchers within Duke's Center for Applied Genomics and Precision Medicine (CAGPM). The initial intent of MeTree was to assist clinicians in identifying patients at greater than population risk based on a number of clinical and family health history (FHH) factors for a range of common conditions (including cancer) and provide clinical decision support (CDS) with specific recommendations based on common U.S. guidelines for prevention and screening.MeTree has been thoroughly tested and validated and is currently being implemented across five U.S. healthcare systems by way of a large cooperative grant through NHGRI's IGNITE network.2-7 Dr. Orlando is co-PI of this study and Dr. Wu served as a site PI.

Through the efforts of Drs. Wu and Orlando, among others, a research agreement was recently signed between Duke University and the National Heart Center Singapore (NHCS) to allow testing of MeTree within a cardiovascular epidemiologic study, the Biobank study (MeTree-Biobank pilot). The Biobank study is providing data to the SPECTRA healthy population database developed by the SingHealth/Duke-NUS Institute of Precision Medicine (PRISM). SPECTRA aims to collect detailed phenotypic and genomic information on 5,000 healthy Singaporeans. MeTree will be used to collect detailed FHH on Biobank participants. This collaboration is part of a larger partnership between CAGPM and PRISM to further develop cross-institution collaborations. Enrollment in the Biobank study is currently underway and incorporation of MeTree into the data capture flow started June 2017.

This proposal leverages the larger collaborative work already started to explore clinically meaningful applications of MeTree within SingHealth. While MeTree has been shown to be clinically effective within primary care clinics in the U.S., SingHealth's oncologists are interested in leveraging MeTree's risk assessment features both to establish a more organized, standardized, and systematic process for collecting information to enhance cancer management and to maximize the advances in precision medicine for the benefit of cancer patients. Therefore, in collaboration with SingHealth oncologist Dr. Ngeow, the principal investigators propose to explore, develop, and pilot a prototype MeTree cancer module through the following two aims:

Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth.

APPROACH Specific Aim 1: Create a Breast Cancer Clinical Decision Support Module in MeTree. The prototype will focus on breast cancer, as a demonstration case, since the prevalence is high, the value of risk assessment is established, and MeTree already assesses risk for both familial and hereditary forms. To achieve this aim the investigators will work with Dr. Joanne Ngeow, head of the Cancer Genetics Service at NCCS, to understand current risk assessment practices in the oncology clinics, identify gaps and inefficiencies in meeting Singapore's risk assessment guidelines, and adapt MeTree to facilitate uptake of guideline-based care. All aspects of risk assessment will be evaluated, from gathering the right type of data to understanding the appropriate clinical actions that follow from each risk assessment result. The goals will be to: 1) create a MeTree integration plan for both patients and providers that will optimize its value, 2) incorporate additional data elements and risk algorithms into MeTree as appropriate, 3) generate tailored clinical decision support for the patient and their oncologist to facilitate appropriate ordering and interpretation of genetic tests. Drs. Wu, Orlando, and Ngeow will work together on all three steps, with Dr. Ngeow's expertise in genetics and oncology at SingHealth being critical for ensuring the team develops a useful and facile tool that meets the needs of SingHealth oncologists.

Deliverables These efforts will provide a breast cancer clinical decision support module that is ready for implementation testing in a breast cancer clinical environment. It will be a model upon which additional cancer CDS modules could be built, tested, and implemented.

Specific Aim 2: Validate and Pilot the Breast Cancer Clinical Decision Support Module in a clinical setting within SingHealth. To assess the feasibility and potential clinical utility of the Breast Cancer Clinical Decision Support Module, the investigators will perform a mixed-methods hybrid type II implementation-effectiveness pilot in the NCCS cancer genetics clinic and one additional surgical breast cancer clinic. The results of this 12-week pilot will inform both its potential impact on clinical care and how further to optimize it for broader clinical integration.

Family History in a Singapore Oncology Population

Development and Clinical Implementation Pilot of an Oncology-specific Risk Assessment Tool in Singapore

measure rate of increased hereditary cancer risk found in breast cancer population

measure provider actions in response to risk report (i.e. genetic counselling (GC) referrals ordered.)

measure participant actions in response to genetic counselling referrals ordered (i.e GC completed)

measure patient satisfaction through post-MeTree survey

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Family Health History in Diverse Care Settings (FHH)	NCT01956773	Diabetes Heart Disease Cancer	MeTree	18 Years -	Duke University
Family History in a Singapore Oncology Population	NCT04639934	Breast Cancer	MeTree	18 Years -	Duke University

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Spots Global Cancer Trial Database for metree

Every month we try and update this database with for metree cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for metree cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.