Examining Choice Architecture for Genetic Testing Decisions

NCT ID: NCT04372888

Last Updated: 2024-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1012 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-11

Study Completion Date

2020-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decision Making

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
participants are blinded to arm and decision frame

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

rare genetic disease

Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism)

Group Type OTHER

choice decision frame

Intervention Type BEHAVIORAL

active choice for genetic testing

opt-in decision frame

Intervention Type BEHAVIORAL

"gain" frame for genetic testing

opt-out decision frame

Intervention Type BEHAVIORAL

"loss" frame for genetic testing

enhanced choice (context) decision frame

Intervention Type BEHAVIORAL

consequences of genetic testing

enhanced choice (norms) decision frame

Intervention Type BEHAVIORAL

social norms for genetic testing

enhanced choice (affect) decision frame

Intervention Type BEHAVIORAL

commitments for genetic testing

common genetic disease

Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer)

Group Type OTHER

choice decision frame

Intervention Type BEHAVIORAL

active choice for genetic testing

opt-in decision frame

Intervention Type BEHAVIORAL

"gain" frame for genetic testing

opt-out decision frame

Intervention Type BEHAVIORAL

"loss" frame for genetic testing

enhanced choice (context) decision frame

Intervention Type BEHAVIORAL

consequences of genetic testing

enhanced choice (norms) decision frame

Intervention Type BEHAVIORAL

social norms for genetic testing

enhanced choice (affect) decision frame

Intervention Type BEHAVIORAL

commitments for genetic testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

choice decision frame

active choice for genetic testing

Intervention Type BEHAVIORAL

opt-in decision frame

"gain" frame for genetic testing

Intervention Type BEHAVIORAL

opt-out decision frame

"loss" frame for genetic testing

Intervention Type BEHAVIORAL

enhanced choice (context) decision frame

consequences of genetic testing

Intervention Type BEHAVIORAL

enhanced choice (norms) decision frame

social norms for genetic testing

Intervention Type BEHAVIORAL

enhanced choice (affect) decision frame

commitments for genetic testing

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boston College

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew A Dwyer, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Boston College

Chestnut Hill, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34202935 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20.205.01e

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Building Healthy Children
NCT01888809 COMPLETED NA
Pathways to Fatherhood
NCT03966352 COMPLETED
Project CHOICES Efficacy Study
NCT00153478 COMPLETED PHASE2
Boston Birth Cohort Study
NCT03228875 RECRUITING
Referral Training and eGen Trials
NCT06695663 RECRUITING NA