Clinical trial NCT05159011: Access to Genetic Information Leveraging Innovative Technology (AGILITY)
Official title: Access to Genetic Information Leveraging Innovative Technology
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Genetic Testing
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional chat bot
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Informed Choice
timeFrame: Immediately after arm completion
Secondary outcomes:
measure: Test-related Affect
timeFrame: 3 months
measure: Test-related Affect
timeFrame: 6 months
measure: Decisional Conflict
timeFrame: 3 months
measure: Decisional Conflict
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: RTI International
name: Barbara Biesecker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Alexander S Parker, PhD
role: PRINCIPAL_INVESTIGATOR
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