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| ID | Type | Description | Link |
|---|---|---|---|
| Pro00047666 | Other Identifier | DUHS IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MeTree - Patient | Experimental | 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 - Provider | Experimental | MeTree collects family health history data and generates risk scores and specific risk-based recommendation for preventive care to providers as clinical decision support. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MeTree | Other | Software program collecting family health history and generating clinical decision support for risk-based preventive care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year | 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. | Baseline, 3 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Satisfaction When Using the MeTree Tool | 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 | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey S Ginsburg, MD PHD | Duke University, Institute for Genome Science and Policy | Principal Investigator |
| Lori Orlando, MD | Duke University, Department of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Grant Medical Center | Fairfield | California | 94535 | United States | ||
| Essentia Institute of Rural Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36474257 | Derived | Wu RR, Myers RA, Neuner J, McCarty C, Haller IV, Harry M, Fulda KG, Dimmock D, Rakhra-Burris T, Buchanan A, Ginsburg GS, Orlando LA. Implementation-effectiveness trial of systematic family health history based risk assessment and impact on clinical disease prevention and surveillance activities. BMC Health Serv Res. 2022 Dec 6;22(1):1486. doi: 10.1186/s12913-022-08879-2. | |
| 33160339 |
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| ID | Title | Description |
|---|---|---|
| FG000 | MeTree - Patients | 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 |
| FG001 | MeTree - Providers | Providers using MeTree risk assessment program for clinical decision support |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MeTree - Patients | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year | 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. | Patients who completed intervention and meeting criteria for genetic counseling | Posted | Count of Participants | Participants | Baseline, 3 and 12 months |
|
1 year
All-Cause Mortality and Serious Adverse Events were not monitored/assessed for either Arm/Group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MeTree - Patients | 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 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lori A. Orlando, Director Program in Precision Medicine | Duke University Medical Center | 919-660-6606 | orlan002@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | Feb 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006331 | Heart Diseases |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Number of Participants Reporting Comfort When Using the MeTree Tool | 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 | 3 months |
| Number of Participants Reporting Anxiety When Using the MeTree Tool | 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 | 3 months |
| Number of Participants Reporting Preparedness When Using the MeTree Tool | 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 | 3 months |
| Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load | Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months. | 3 months |
| Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow | 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) | 1 year |
| Duluth |
| Minnesota |
| 55805 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of North Texas Health Science Center | Fort Worth | Texas | 76107 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Derived |
| Orlando LA, Wu RR, Myers RA, Neuner J, McCarty C, Haller IV, Harry M, Fulda KG, Dimmock D, Rakhra-Burris T, Buchanan A, Ginsburg GS. At the intersection of precision medicine and population health: an implementation-effectiveness study of family health history based systematic risk assessment in primary care. BMC Health Serv Res. 2020 Nov 7;20(1):1015. doi: 10.1186/s12913-020-05868-1. |
| 30866001 | Derived | Wu RR, Myers RA, Buchanan AH, Dimmock D, Fulda KG, Haller IV, Haga SB, Harry ML, McCarty C, Neuner J, Rakhra-Burris T, Sperber N, Voils CI, Ginsburg GS, Orlando LA. Effect of Sociodemographic Factors on Uptake of a Patient-Facing Information Technology Family Health History Risk Assessment Platform. Appl Clin Inform. 2019 Mar;10(2):180-188. doi: 10.1055/s-0039-1679926. Epub 2019 Mar 13. |
| 26597091 | Derived | Wu RR, Myers RA, McCarty CA, Dimmock D, Farrell M, Cross D, Chinevere TD, Ginsburg GS, Orlando LA; Family Health History Network. Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study. Implement Sci. 2015 Nov 24;10:163. doi: 10.1186/s13012-015-0352-8. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants Reporting Satisfaction When Using the MeTree Tool | 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 | Patients who completed 3 months post survey and reported their level of satisfaction | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants Reporting Comfort When Using the MeTree Tool | 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 | Patients who completed 3 months post survey and reported on their level of comfort | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants Reporting Anxiety When Using the MeTree Tool | 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 | Patients who completed 3 months post survey and reported on anxiety with answering the questions | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Participants Reporting Preparedness When Using the MeTree Tool | 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 | Patients who completed 3 months post survey and reported on preparedness | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load | Evaluate physicians' perceptions of satisfaction, the MeTree tool's impact on work load and its effectiveness via survey and informal interviews at 3 months. | Consented providers who completed provider post implementation survey | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow | 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) | Posted | Count of Participants | Participants | 1 year |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 2,520 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 100 |
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| D002318 | Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|
| Somewhat unsatisfactory |
|
| Very Poor |
|
| Not Answered |
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| Title | Measurements |
|---|
|
| did not answer |
|
| Title | Measurements |
|---|
|
| Did not answer |
|
| Title | Measurements |
|---|
|
| Did not answer |
|