Opt OutNCT03351881
Evaluation of Attitudes Towards Organ Donation in Individualistic or Collectivistic Countries
A study testing Description of Organ Donation Policy in people with Opt Out and Opt In, run by Yale-NUS College at 1 site in Singapore.
Trial summary
People make decisions every day, both for themselves and on behalf of others. In the case of organ donations, despite the opt-out systems used in Singapore where the default is a presumed consent on the part of the individual, the actualized donation rate is lower than expect. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opt Out, Opt In, Opt Neutral
- What is being tested?
- Description of Organ Donation Policy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2016to May 2019
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Research participants should be above the age of 21, able to understand English fully, and have no active mental disorder or intellectual impairment.
Who cannot join
- Below the age of 21, unable to understand English fully, or have active mental disorder or intellectual impairment.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Yale-NUS College
Singapore, 138527
Jean Liu, PhD, jeanliu@yale-nus.edu.sg
About this study
Official title: Nudging Policies in Asia: Evaluating Singapore's Opt-out System for Organ Donation
People make decisions every day, both for themselves and on behalf of others. In the case of organ donations, despite the opt-out systems used in Singapore where the default is a presumed consent on the part of the individual, the actualized donation rate is lower than expect. This is partially because family members are called in to make surrogate decisions on behalf of the patient, especially patients near brain death or have been certified to be brain dead.
To address the shortfall in organ donations, the investigators plan to run three studies:
Read more
- First, the investigators seek to conduct a representative survey of the public's perception towards organ donation. The investigators will focus on their views towards donating their own vs. family members' organs, and to explore the role of cultural influences on decision-making.
- Second, the investigators will conduct the survey focusing on NUS students and the ways they respond to an opt-out, opt-in, or mandatory organ donation system.
- Third, the investigators will conduct the survey on an online platform (MTurk) to gather the views of participants across India and USA about organ donation.
The studies have the potential to improve actualized organ donation rates, as well as to inform the medical community in their communication with family members.
- Conditions
- Opt Out, Opt In, Opt Neutral
- Being tested
- Description of Organ Donation Policy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of Organ Donation PolicyOther
Participants will read about an organ donation policy type (opt-out, opt-in, or opt-neutral) and rate what they think or feel about it.
| Study group | Role | What they receive |
|---|---|---|
| Opt Out | Active comparator | Not described Receives: Other: Description of Organ Donation Policy |
| Opt In | Active comparator | Not described Receives: Other: Description of Organ Donation Policy |
| Opt Neutral | Active comparator | Not described Receives: Other: Description of Organ Donation Policy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to Donate Organ
Likelihood of participants choosing to donate organs after brain death
Measured: At the point of the survey, right after participants have read about the organ donation policy condition which they have been assigned.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startSep 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opt OutStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351881
- Sponsor's protocol ID
- HSS-1502-P02-02
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2017
- Last updated
- 12 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging Policies in Asia: Evaluating Singapore's Opt-out System for Organ Donation
- ClinicalTrials.gov ID
- NCT03351881
- Acronym / sponsor ID
- HSS-1502-P02-02
- Conditions
- Opt Out, Opt In, Opt Neutral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 24 Nov 2017 (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.
People make decisions every day, both for themselves and on behalf of others. In the case of organ donations, despite the opt-out systems used in Singapore where the default is a presumed consent on the part of the individual, the actualized donation rate is lower than expect. This is partially because family members are called in to make surrogate decisions on behalf of the patient, especially patients near brain death or have been certified to be brain dead.
To address the shortfall in organ donations, the investigators plan to run three studies:
- First, the investigators seek to conduct a representative survey of the public's perception towards organ donation. The investigators will focus on their views towards donating their own vs. family members' organs, and to explore the role of cultural influences on decision-making.
- Second, the investigators will conduct the survey focusing on NUS students and the ways they respond to an opt-out, opt-in, or mandatory organ donation system.
- Third, the investigators will conduct the survey on an online platform (MTurk) to gather the views of participants across India and USA about organ donation.
The studies have the potential to improve actualized organ donation rates, as well as to inform the medical community in their communication with family members.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Opt Out | Active comparator | Other: Description of Organ Donation Policy |
| Opt In | Active comparator | Other: Description of Organ Donation Policy |
| Opt Neutral | Active comparator | Other: Description of Organ Donation Policy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Research participants should be above the age of 21, able to understand English fully, and have no active mental disorder or intellectual impairment.
Key exclusion criteria (1 listed)
- Below the age of 21, unable to understand English fully, or have active mental disorder or intellectual impairment.
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 |
|---|---|---|
| Description of Organ Donation PolicyParticipants will read about an organ donation policy type (opt-out, opt-in, or opt-neutral) and rate what they think or feel about it. | Other | Opt In, Opt Neutral, Opt Out |
Primary outcome
Decision to Donate Organ
Time frame: At the point of the survey, right after participants have read about the organ donation policy condition which they have been assigned.
Likelihood of participants choosing to donate organs after brain death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Description of Organ Donation Policy in people with Opt Out and Opt In, run by Yale-NUS College at 1 site in Singapore.
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: status not confirmed, as of the sponsor's last update on 12 Feb 2018. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision to Donate Organ (time frame: At the point of the survey, right after participants have read about the organ donation policy condition which they have been assigned.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2018.