Examining Choice Architecture for Genetic Testing Decisions

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.

Study Overview

• Status: Completed
• Conditions: Decision Making
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 1012
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02476
      • Boston College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Boston College
• Investigators: Principal Investigator: Andrew A Dwyer, PhD, Boston College

Publications and helpful links

General Publications

• 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):941. doi: 10.3390/genes12060941.

Helpful Links

• link to full text article

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20.205.01e

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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