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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,012

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

19 days study duration

Study Start

First participant enrolled

March 11, 2020

Completed

15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed

4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed

29 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed

Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

15 days

First QC Date

April 28, 2020

Last Update Submit

August 5, 2024

Conditions

Decision Making

Outcome Measures

Primary Outcomes (3)

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 Outcomes (2)

Newest Vital Sign (NVS)
study completion (approximately 30 minutes)
Experience with genetic disease
Baseline (study onset)

Study Arms (2)

rare genetic disease

OTHER

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

Behavioral: choice decision frameBehavioral: opt-in decision frameBehavioral: opt-out decision frameBehavioral: enhanced choice (context) decision frameBehavioral: enhanced choice (norms) decision frameBehavioral: enhanced choice (affect) decision frame

common genetic disease

OTHER

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