Access to Genetic Information Leveraging Innovative Technology (AGILITY) (AGILITY)

Access to Genetic Information Leveraging Innovative Technology

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.

Study Overview

• Status: Withdrawn
• Conditions: Genetic Testing
• Intervention / Treatment: Behavioral: AGILITY (Access to Genetic Information Leveraging Innovative TechnologY)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of Florida
• Investigators: Principal Investigator: Barbara Biesecker, PhD, RTI International; Principal Investigator: Alexander S Parker, PhD, University of Florida

Publications and helpful links

General Publications

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
• Turbitt E, Chrysostomou PP, Peay HL, Heidlebaugh AR, Nelson LM, Biesecker BB. A randomized controlled study of a consent intervention for participating in an NIH genome sequencing study. Eur J Hum Genet. 2018 May;26(5):622-630. doi: 10.1038/s41431-018-0105-7. Epub 2018 Feb 16.
• Lewis MA, Paquin RS, Roche MI, Furberg RD, Rini C, Berg JS, Powell CM, Bailey DB Jr. Supporting Parental Decisions About Genomic Sequencing for Newborn Screening: The NC NEXUS Decision Aid. Pediatrics. 2016 Jan;137 Suppl 1(Suppl 1):S16-23. doi: 10.1542/peds.2015-3731E.
• Dormandy E, Hooper R, Michie S, Marteau TM. Informed choice to undergo prenatal screening: a comparison of two hospitals conducting testing either as part of a routine visit or requiring a separate visit. J Med Screen. 2002;9(3):109-14. doi: 10.1136/jms.9.3.109.
• Li M, Bennette CS, Amendola LM, Ragan Hart M, Heagerty P, Comstock B, Tarczy-Hornoch P, Fullerton SM, Regier DA, Burke W, Trinidad SB, Jarvik GP, Veenstra DL, Patrick DL. The Feelings About genomiC Testing Results (FACToR) Questionnaire: Development and Preliminary Validation. J Genet Couns. 2019 Apr;28(2):477-490. doi: 10.1007/s10897-018-0286-9. Epub 2018 Dec 14.
• Ames AG, Jaques A, Ukoumunne OC, Archibald AD, Duncan RE, Emery J, Metcalfe SA. Development of a fragile X syndrome (FXS) knowledge scale: towards a modified multidimensional measure of informed choice for FXS population carrier screening. Health Expect. 2015 Feb;18(1):69-80. doi: 10.1111/hex.12009. Epub 2012 Oct 15.
• Jaques AM, Sheffield LJ, Halliday JL. Informed choice in women attending private clinics to undergo first-trimester screening for Down syndrome. Prenat Diagn. 2005 Aug;25(8):656-64. doi: 10.1002/pd.1218.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202100637

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No