Examining Choice Architecture for Genetic Testing Decisions

Study Overview
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Brief Summary
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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
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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.

Official Title
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Examining Choice Architecture for Genetic Testing Decisions

Conditions
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Decision Making

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: rare genetic disease<br>Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism) | Behavioral: choice decision frame<br>* active choice for genetic testing<br>Behavioral: opt-in decision frame<br>* gain frame for genetic testing<br>Behavioral: opt-out decision frame<br>* loss frame for genetic testing<br>Behavioral: enhanced choice (context) decision frame<br>* consequences of genetic testing<br>Behavioral: enhanced choice (norms) decision frame<br>* social norms for genetic testing<br>Behavioral: enhanced choice (affect) decision frame<br>* commitments for genetic testing<br>|
| Other: common genetic disease<br>Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer) | Behavioral: choice decision frame<br>* active choice for genetic testing<br>Behavioral: opt-in decision frame<br>* gain frame for genetic testing<br>Behavioral: opt-out decision frame<br>* loss frame for genetic testing<br>Behavioral: enhanced choice (context) decision frame<br>* consequences of genetic testing<br>Behavioral: enhanced choice (norms) decision frame<br>* social norms for genetic testing<br>Behavioral: enhanced choice (affect) decision frame<br>* commitments for genetic testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic testing decision | Opting yes for genetic testing or no refusing genetic testing | after reading the scenario and viewing frame (approximately 10 minutes) | 
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) |