Trial Outcomes & Findings for Family Health History in Diverse Care Settings (FHH) (NCT NCT01956773)

NCT ID: NCT01956773

Last Updated: 2023-08-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2620 participants
• Primary outcome timeframe: Baseline, 3 and 12 months
• Results posted on: 2023-08-02

Participant Flow

Participant milestones

Measure	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	MeTree - Providers Providers using MeTree risk assessment program for clinical decision support
Overall Study STARTED	2520	100
Overall Study COMPLETED	1892	99
Overall Study NOT COMPLETED	628	1

Reasons for withdrawal

Measure	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	MeTree - Providers Providers using MeTree risk assessment program for clinical decision support
Overall Study Lost to Follow-up	628	1

Baseline Characteristics

Family Health History in Diverse Care Settings (FHH)

Baseline characteristics by cohort

Measure	MeTree - Patients n=2520 Participants 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 - Providers n=100 Participants 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 n=2620 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1666 Participants n=5 Participants	99 Participants n=7 Participants	1765 Participants n=5 Participants
Age, Categorical >=65 years	854 Participants n=5 Participants	1 Participants n=7 Participants	855 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants	41 years n=7 Participants	59 years n=5 Participants
Sex: Female, Male Female	1725 Participants n=5 Participants	61 Participants n=7 Participants	1786 Participants n=5 Participants
Sex: Female, Male Male	795 Participants n=5 Participants	39 Participants n=7 Participants	834 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	0 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1578 Participants n=5 Participants	0 Participants n=7 Participants	1578 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	900 Participants n=5 Participants	100 Participants n=7 Participants	1000 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	30 Participants n=5 Participants	12 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	165 Participants n=5 Participants	1 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) White	1779 Participants n=5 Participants	81 Participants n=7 Participants	1860 Participants n=5 Participants
Race (NIH/OMB) More than one race	48 Participants n=5 Participants	1 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	495 Participants n=5 Participants	3 Participants n=7 Participants	498 Participants n=5 Participants
Region of Enrollment United States	2520 participants n=5 Participants	100 participants n=7 Participants	2620 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 and 12 months

Population: Patients who completed intervention and meeting criteria for genetic counseling

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.

Outcome measures

Measure	MeTree - Patients n=1838 Participants 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
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year Patients who met genetic counseling criteria	571 Participants
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year Patients who received Genetic Counseling Order	49 Participants
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year Patients adhered to provider's recommendation-1yr	32 Participants
Number of Participants With Uptake of Genetic Counseling for Those at Risk of Hereditary Conditions at 1 Year Providers who placed Genetic counseling order	31 Participants

SECONDARY outcome

Timeframe: 3 months

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

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

Outcome measures

Measure	MeTree - Patients n=1102 Participants 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
Number of Participants Reporting Satisfaction When Using the MeTree Tool Superior	69 Participants
Number of Participants Reporting Satisfaction When Using the MeTree Tool Above Average	459 Participants
Number of Participants Reporting Satisfaction When Using the MeTree Tool Very Satisfactory	474 Participants
Number of Participants Reporting Satisfaction When Using the MeTree Tool Somewhat unsatisfactory	59 Participants
Number of Participants Reporting Satisfaction When Using the MeTree Tool Very Poor	23 Participants
Number of Participants Reporting Satisfaction When Using the MeTree Tool Not Answered	18 Participants

SECONDARY outcome

Timeframe: 3 months

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

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

Outcome measures

Measure	MeTree - Patients n=1102 Participants 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
Number of Participants Reporting Comfort When Using the MeTree Tool Do not know	20 Participants
Number of Participants Reporting Comfort When Using the MeTree Tool No	78 Participants
Number of Participants Reporting Comfort When Using the MeTree Tool Yes	988 Participants
Number of Participants Reporting Comfort When Using the MeTree Tool did not answer	16 Participants

SECONDARY outcome

Timeframe: 3 months

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

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

Outcome measures

Measure	MeTree - Patients n=1102 Participants 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
Number of Participants Reporting Anxiety When Using the MeTree Tool Do not know	14 Participants
Number of Participants Reporting Anxiety When Using the MeTree Tool No	1032 Participants
Number of Participants Reporting Anxiety When Using the MeTree Tool Yes	43 Participants
Number of Participants Reporting Anxiety When Using the MeTree Tool Did not answer	13 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Patients who completed 3 months post survey and reported on preparedness

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

Outcome measures

Measure	MeTree - Patients n=1102 Participants 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
Number of Participants Reporting Preparedness When Using the MeTree Tool Do not know	59 Participants
Number of Participants Reporting Preparedness When Using the MeTree Tool No	377 Participants
Number of Participants Reporting Preparedness When Using the MeTree Tool Yes	646 Participants
Number of Participants Reporting Preparedness When Using the MeTree Tool Did not answer	20 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Consented providers who completed provider post implementation survey

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

Outcome measures

Measure	MeTree - Patients n=43 Participants 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
Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load Acceptable Tool - Yes	34 Participants
Number of Physicians Who Gave Their Perceptions of Satisfaction and the MeTree Tool's Impact on Work Load Acceptable Tool - No	9 Participants

SECONDARY outcome

Timeframe: 1 year

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)

Outcome measures

Measure	MeTree - Patients n=100 Participants 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
Number of Providers Who Were Successfully Using MeTree in Their Clinical Work Flow	100 Participants

Adverse Events

MeTree - Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MeTree - Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

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

Duke University Medical Center

Phone: 919-660-6606

Email: orlan002@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place