An interventional study of decision science-based design in COVID-19 Testing and Decision Making, sponsored by Barry Dewitt. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by Barry Dewitt · Not applicable, Interventional, and Other
To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).
To test competing sets of information for consumers on how to interpret hypothetical SARS-CoV-2 home test kit results and whether they report plans to take CDC [Centers for Disease Control]-recommended actions to protect themselves and others given their test results and two critical aspects of their clinical context: symptoms, recent close exposures. Participants will be randomized to receive either information from the FDA authorized Ellume home test kit (the first kit authorized for over the counter use) for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention).
Participants will be randomized to receive either information from the FDA authorized Ellume home test kit for what actions to take for a negative or positive COVID-19 test (usual care) or a decision science-based design of similar length (intervention). They will be given time to read the documents and the opportunity to download a full "instructions for use" document (the FDA authorized for the ELLUME test kit). They will then be randomized to one of four conditions, asking them to imagine a clinical context: a person with no symptoms and no close COVID-19 contact, no symptoms and close contact,
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 360 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Barry Dewitt as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
information from an FDA authorized home test kit for what actions to take for a negative or positive COVID-19 test
Information from a decision science-based design (of similar length to the FDA authorized home test kit information) for what actions to take for a negative or positive COVID-19 test
Other: decision science-based design
decision science-based design explaining actions to take for a negative or positive COVID-19 test
choice of action to take with negative test
choice of actions consistent with CDC-recommendations (eg, isolate or not) for various clinical scenarios (eg, with/without known exposure, with/without symptoms) Which of the following are safe for Jamie to do over the next week about being around others? \[safe, not safe\] 1. Take no additional precautions. 2. Stay at home except to visit close family or friends. Take no additional precautions at home 3. Stay at home except when going to the grocery store. Take no additional precautions at home 4. Stay at home all the time, without exceptions. Take no additional precautions at home. 5. Stay at home all the time, without exceptions and avoid contact with others, including others in the household
Time frame: day 1
Likelihood of COVID-19 infection (qualitative)
Judgments about the likelihood of COVID-19 infection with a negative or positive test result How likely is it that Jamie is infected with COVID-19? (choose one) 1. Definitely yes 2. Very likely 3. Likely 4. Unlikely 5. Very Unlikely 6. Definitely not
Time frame: day 1
Likelihood of COVID-19 infection (quantitative)
Judgments about the likelihood of COVID-19 infection with a negative ot positive test result Response using a "slider" to capture numeric estimate
Time frame: day 1
safe practices
Change in intent to practice standard public health practices to reduce COVID-19 transmission (hand washing, social distancing, masks) - question asked before and after seeing test result What else do you think Jamie should do to protect himself and others from COVID-19? \[choose: all of the time, most of the time, some of the time, a little of the time, none of the time\] In general 1. Wash hands often 2. Avoid close contact with people who seem sick (e.g., cough, sneeze, fever) 3. Stay home Outside your home 4. Try to avoid crowds 5. Wear a mask when around others 6. Keep 6 feet from others 7. Avoid contact with anyone
Time frame: day 1
ease of use of information rating
how easy/hard is it to use information about interpreting test results How easy or difficult was it to read the information about interpreting the test result?" (check one) 1. Very difficult 2. Difficult 3. Neutral 4. Easy 5. Very easy
Time frame: day 1
usefulness of information rating
how useful is the information about interpreting test results The information about interpreting the home test kit results was (check one) 1. Extremely useful 2. Useful 3. Neutral 4. Useless 5. Completely useless
Time frame: day 1
helpfulness of information for what to do given positive test result
How helpful was the information for what to if test was positive The information helped me know what to do if test result is positive a. Strongly agree 1. Agree 2. Neutral 3. Disagree 4. Strongly disagree
Time frame: day 1
helpfulness of information for what to do given negative test result
How helpful was the information for what to if test was negative The information helped me know what to do if test result is negative a. Strongly agree 1. Agree 2. Neutral 3. Disagree 4. Strongly disagree
Time frame: day 1
Assess effect of the FDA authorized description of test accuracy
According to the test's FDA-authorized label, a clinical study conducted in the USA in 2020 showed that the test "correctly identified 96% of positive samples and 100% of negative samples in patients with symptoms. In people without symptoms the test correctly identified 91% of positive samples and 96% of negative samples." Based on this information, if Jamie has COVID now, what is the chance that the test will be wrong and say that he does not? RESPONSE (probability estimate) using slider
Time frame: day 1
ordering postest probability of infection
correct ordering of posttest probability of infection risk (derived from qualitative and quantitative ratings)
Time frame: day 1
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.