Examining Choice Architecture for Genetic Testing Decisions

Decision Making Clinical Trial

Official title:

Examining Choice Architecture for Genetic Testing Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372888
• Other study ID #: 20.205.01e
• Status: Completed
• Phase: N/A
• Start date: March 11, 2020
• Est. completion date: March 30, 2020

Study information

• Verified date: July 2021
• Source: Boston College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: March 30, 2020
• Est. primary completion date: March 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Decision Making

Intervention

Behavioral:
• choice decision frame
active choice for genetic testing
• opt-in decision frame
"gain" frame for genetic testing
• opt-out decision frame
"loss" frame for genetic testing
• enhanced choice (context) decision frame
consequences of genetic testing
• enhanced choice (norms) decision frame
social norms for genetic testing
• enhanced choice (affect) decision frame
commitments for genetic testing

Locations

Country	Name	City	State
United States	Boston College	Chestnut Hill	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston College

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dwyer AA, Shen H, Zeng Z, Gregas M, Zhao M. Framing Effects on Decision-Making for Diagnostic Genetic Testing: Results from a Randomized Trial. Genes (Basel). 2021 Jun 20;12(6). pii: 941. doi: 10.3390/genes12060941. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic testing decision	Opting "yes" for genetic testing or "no" refusing genetic testing	after reading the scenario and viewing frame (approximately 10 minutes)
Primary	Satisfaction with Decision Scale (SWD)	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	study completion (approximately 30 minutes)
Primary	Decisional Regret Scale (DRS)	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	study completion (approximately 30 minutes)
Secondary	Newest Vital Sign (NVS)	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	study completion (approximately 30 minutes)
Secondary	Experience with genetic disease	Single "yes"/"no" question to determine a personal or family experience the genetic condition being presented in the scenario (arm)	Baseline (study onset)

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