Examining Choice Architecture for Genetic Testing Decisions

Not Applicable

Completed

• Conditions: Decision Making
• Interventions: Behavioral: choice decision frame; Behavioral: opt-in decision frame; Behavioral: opt-out decision frame; Behavioral: enhanced choice (context) decision frame; Behavioral: enhanced choice (norms) decision frame; Behavioral: enhanced choice (affect) decision frame

• Registration Number: NCT04372888
• Lead Sponsor: Boston College

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.

Study Timeline

• Study Start: 2020-03-11
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-30
• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-30
• Study First Posted: 2020-05-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1012

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
common genetic disease	opt-out decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)
rare genetic disease	opt-out decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
rare genetic disease	enhanced choice (norms) decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
rare genetic disease	opt-in decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
rare genetic disease	enhanced choice (affect) decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
rare genetic disease	enhanced choice (context) decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
common genetic disease	opt-in decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)
common genetic disease	enhanced choice (context) decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)
common genetic disease	enhanced choice (norms) decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)
common genetic disease	enhanced choice (affect) decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)
rare genetic disease	choice decision frame	Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)
common genetic disease	choice decision frame	Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)

Primary Outcome Measures

Name	Time	Method
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
Genetic testing decision	after 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

Secondary Outcome Measures

Name	Time	Method
Experience with genetic disease	Baseline (study onset)	Single "yes"/"no" question to determine a personal or family experience the genetic condition being presented in the scenario (arm)
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

Trial Locations

Locations (1)

Boston College; 🇺🇸 Chestnut Hill, Massachusetts, United States