Decision MakingNCT04372888
Examining Choice Architecture for Genetic Testing Decisions
A study testing choice decision frame, opt-in decision frame and opt-out decision frame in people with Decision Making, run by Boston College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Decision Making
- What is being tested?
- choice decision frame, opt-in decision frame and opt-out decision frame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,012 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform)
Who cannot join
- age <18yrs or >65yrs or residing outside of North America
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Decision Making
- Being tested
- choice decision frame, opt-in decision frame, opt-out decision frame, enhanced choice (context) decision frame, enhanced choice (norms) decision frame
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choice decision frameBehavioural
active choice for genetic testing
opt-in decision frameBehavioural
"gain" frame for genetic testing
opt-out decision frameBehavioural
"loss" frame for genetic testing
enhanced choice (context) decision frameBehavioural
consequences of genetic testing
enhanced choice (norms) decision frameBehavioural
social norms for genetic testing
enhanced choice (affect) decision frameBehavioural
commitments for genetic testing
| Study group | Role | What they receive |
|---|---|---|
| rare genetic disease | Other | Hypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism) Receives: 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 |
| common genetic disease | Other | Hypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer) Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic testing decision
Opting "yes" for genetic testing or "no" refusing genetic testing
Measured: 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
Measured: 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
Measured: study completion (approximately 30 minutes)
Secondary outcomes (2)
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
Measured: 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)
Measured: Baseline (study onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start11 Mar 2020
- Primary completion26 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision MakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,012 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew A Dwyer, PhD, Principal investigator, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372888
- Sponsor's protocol ID
- 20.205.01e
- Status last verified
- Aug 2024
- First submitted
- 28 Apr 2020
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34202935
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Choice Architecture for Genetic Testing Decisions
- ClinicalTrials.gov ID
- NCT04372888
- Acronym / sponsor ID
- 20.205.01e
- Conditions
- Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,012 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomization to 1 of 6 decision frames for two disease testing scenarios (arms)
| Arm | Type | Receives |
|---|---|---|
| rare genetic disease | Other | 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 frameHypothetical scenario 1: rare, life-altering genetic condition (congenital hypogonadotropic hypogonadism) |
| common genetic disease | Other | 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 frameHypothetical scenario 2: common, life-threatening genetic condition (hereditary breast and ovarian cancer) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform)
Key exclusion criteria (1 listed)
- age <18yrs or >65yrs or residing outside of North America
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| choice decision frameactive choice for genetic testing | Behavioural | common genetic disease, rare genetic disease |
| opt-in decision frame"gain" frame for genetic testing | Behavioural | common genetic disease, rare genetic disease |
| opt-out decision frame"loss" frame for genetic testing | Behavioural | common genetic disease, rare genetic disease |
| enhanced choice (context) decision frameconsequences of genetic testing | Behavioural | common genetic disease, rare genetic disease |
| enhanced choice (norms) decision framesocial norms for genetic testing | Behavioural | common genetic disease, rare genetic disease |
| enhanced choice (affect) decision framecommitments for genetic testing | Behavioural | common genetic disease, rare genetic disease |
Primary outcome
Genetic testing decision
Time frame: 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)
Time frame: 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
Decisional Regret Scale (DRS)
Time frame: 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
2 secondary outcomes
Newest Vital Sign (NVS)
Time frame: study completion (approximately 30 minutes)
Experience with genetic disease
Time frame: Baseline (study onset)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Results publication: PubMed 34202935Dwyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew A Dwyer, PhD principal investigator
Boston College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing choice decision frame, opt-in decision frame and opt-out decision frame in people with Decision Making, run by Boston College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic testing decision (time frame: after reading the scenario and viewing frame (approximately 10 minutes)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.