Family Health History in Diverse Care Settings
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01956773|
Recruitment Status : Active, not recruiting
First Posted : October 8, 2013
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Heart Disease Cancer||Other: MeTree||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Family Health History in Diverse Care Settings|
|Actual Study Start Date :||April 11, 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: MeTree
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.
Software program collecting family health history and generating clinical decision support for risk-based preventive care
No Intervention: Control
to compare rates of risk management strategies in standard care during the time of MeTree use in the intervention arm.
- Increasing uptake of risk-management evidence based preventive strategies for the clinical decision support conditions [ Time Frame: Baseline, 3 and 12 months ]How many patients identified to be at increased risk for the clinical decision support conditions, how many providers order the recommended prevention strategy, and how many patients adhere to the provider recommendation.
- Measure patient-related outcomes associated with using the MeTree tool [ Time Frame: 3 months and 12 months ]The study will assess satisfaction, comfort, anxiety, and preparedness associated with using the MeTree tool via survey 3 and 12 months after completing the family history collection.
- Measure physician experience with MeTree [ Time Frame: 3 months ]Evaluate physicians' perceptions of satisfaction, the tool's impact on work load and its effectiveness via survey and informal interviews at 3 months.
- Implementation parameters for MeTree [ Time Frame: up to 3 years ]Formative evaluation of the implementation process which includes barriers and solutions to implementing MeTree into clinical practice setting.
- uptake of MeTree by clinical practices [ Time Frame: 1 year ]Evaluate which clinics/providers are 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956773
|United States, California|
|David Grant Medical Center|
|Fairfield, California, United States, 94535|
|United States, Minnesota|
|Essentia Institute of Rural Health|
|Duluth, Minnesota, United States, 55805|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|University of North Texas Health Science Center|
|Fort Worth, Texas, United States, 76107|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Geoffrey S Ginsburg, MD PHD||Duke University, Institute for Genome Science and Policy|
|Principal Investigator:||Lori Orlando, MD||Duke University, Department of Medicine|