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Examining Choice Architecture for Genetic Testing Decisions

Examining Choice Architecture for Genetic Testing Decisions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04372888
Enrollment
1012
Registered
2020-05-04
Start date
2020-03-11
Completion date
2020-03-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making

Brief summary

The goal of this application is to gain a deeper understanding of decision-making for genetic testing and identify effective choice-architecture-based strategies to improve decisions in genetic testing. The investigators hypothesize that choice architecture (i.e. framing) affects decision-making for hypothetical genetic testing scenarios.

Detailed description

After providing opt-in electronic consent, eligible consented participants will be randomized to one of two hypothetical genetic testing scenarios (rare, life-altering genetic condition or common, life-threatening genetic condition). The genetic testing scenarios include brief detailed information about genetic testing (i.e. how results may influence treatment decisions) as well as information about standard approaches to treatment. Subjects will be randomized to receive a framing conditions (e.g. choice, opt-in, opt-out, enhanced choice). Participants will select a preferred testing option to the hypothetical scenario and will complete several validated instruments.

Interventions

BEHAVIORALchoice decision frame

active choice for genetic testing

BEHAVIORALopt-in decision frame

gain frame for genetic testing

BEHAVIORALopt-out decision frame

loss frame for genetic testing

BEHAVIORALenhanced choice (context) decision frame

consequences of genetic testing

BEHAVIORALenhanced choice (norms) decision frame

social norms for genetic testing

BEHAVIORALenhanced choice (affect) decision frame

commitments for genetic testing

Sponsors

Boston College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Masking description

participants are blinded to arm and decision frame

Intervention model description

Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform)

Exclusion criteria

* age \<18yrs or \>65yrs or residing outside of North America

Design outcomes

Primary

MeasureTime frameDescription
Genetic testing decisionafter reading the scenario and viewing frame (approximately 10 minutes)Opting yes for genetic testing or no refusing genetic testing
Satisfaction with Decision Scale (SWD)study completion (approximately 30 minutes)SWD is a validated 6-item instrument, items are scored on a 1-5 scale with higher scores indicating greater satisfaction with the decision taken
Decisional Regret Scale (DRS)study completion (approximately 30 minutes)DRS is a validated 5-item instrument, items are scored on a 1-5 scale with higher scores indicating more regret with the decision taken

Secondary

MeasureTime frameDescription
Newest Vital Sign (NVS)study completion (approximately 30 minutes)NVS is a validated 6-item instrument, questions are based on reading and interpreting a food label, higher scores (more correct answers) indicate greater levels of literacy and numeracy abilities
Experience with genetic diseaseBaseline (study onset)Single yes/no question to determine a personal or family experience the genetic condition being presented in the scenario (arm)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026