Access to Genetic Information Leveraging Innovative Technology (AGILITY)

Study Overview
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Brief Summary
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AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs.

Detailed Description
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AGILITY is a type 1 hybrid trial that will test the effectiveness of a chatbot to provide pre-test information about genetic screening for tier 1 conditions. A randomized control trial of 2400 adult participants from diverse primary care clinics at the University of Florida Gainesville to receive virtual information about tier 1 condition genetic testing from a chatbot or traditional genetic counseling. The assessment of the outcome of the trial is to determine whether the chatbot is inferior to genetic counseling. Non-inferiority will be determined based on informed choice to undergo testing (or not). Implementation outcomes of acceptability, feasibility, and appropriateness will be evaluated to inform future potential through interviews with patients, primary care providers and GCs. This trial will provide evidence of whether chatbots can serve to address a shortage of genetic counselors by extending pre-test education in a population screening environment to alternate sources such as chatbots. Inclusion of an observation arm for individuals with positive family history who then are offered traditional clinical genetic service is a strength of the design that will allow for contrast between populations and service models as well. Inclusion of assessments of feasibility, acceptability, and appropriateness from multiple stakeholders is critical to future study design and implementation potential.

Official Title
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Access to Genetic Information Leveraging Innovative Technology

Conditions
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Genetic Testing

Intervention / Treatment
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* Behavioral: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Male or Female University of Florida Gainesville primary care patients Negative family history for hereditary breast and ovarian cancer, and Lynch syndrome and familial hypercholesterolemia Exclusion Criteria: Positive family history of hereditary breast and ovarian cancer, and Lynch syndrome, and familial hypercholesterolemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional chat bot
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Virtual Genetic Counseling | |
| Other: Chatbot<br>computer program that that uses machine learning to provide tailored counseling to patients | Behavioral: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)<br>* information about genetic testing through technology<br>* Other names: Chatbot;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Informed Choice | The number of participants that made an informed choice (Multi-dimensional Model of Informed Choice) following a chatbot intervention compared to the number of participants that made an informed choice following genetic counseling. Informed choice is measured using a composite tool that includes understanding of relevant knowledge (1-8 items-higher scores indicate greater knowledge), attitudes toward testing (1-5 items-higher scores represent more positive attitudes), and whether the test decision is congruent with personal values (positive or negative about testing in relation to whether testing was accepted or declined). | Immediately after arm completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test-related Affect | Compare Test-related affect scale response assessed by the Feelings About Genomic Testing Results Scale (Response ranges 0-12 on the negative emotions subscale, 0-16 on the positive feelings subscale, 0-12 on the uncertainty subscale, and 0-8 on the privacy concerns subscale, all with a higher score indicating greater functional impairment.) between usual care and the intervention group at 3 months. | 3 months | 
| Test-related Affect | ompare Test-related affect scale response assessed by the Feelings About Genomic Testing Results Scale (Response ranges 0-12 on the negative emotions subscale, 0-16 on the positive feelings subscale, 0-12 on the uncertainty subscale, and 0-8 on the privacy concerns subscale, all with a higher score indicating greater functional impairment.) between usual care and the intervention group at 6 months. | 6 months | 
| Decisional Conflict | Compare Decisional conflict assessed by the Ottawa Decisional Conflict Scale (Response range 1-10 higher scores denote greater decisional conflict) between usual care and the intervention group at 3 months. | 3 months | 
| Decisional Conflict | Compare Decisional conflict assessed by the Ottawa Decisional Conflict Scale (Response range 1-10 higher scores denote greater decisional conflict) between usual care and the intervention group at 6 months. | 6 months |