Genetic Testing
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALAGILITY (Access to Genetic Information Leveraging Innovative TechnologY)
information about genetic testing through technology
Sponsors
University of Florida
RTI International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Masking description
Investigator masked from randomization until results analysis.
Intervention model description
Interventional chat bot
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Informed Choice | Immediately after arm completion | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-related Affect | 3 months | 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. |
| Decisional Conflict | 3 months | 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. |
Outcome results
None listed