Carpal Tunnel SyndromeNCT03730376
Decision Making in Hypothetical Carpal Tunnel Syndrome
A study testing Cost Information in people with Carpal Tunnel Syndrome, run by Stanford University at 1 site in United States.
Trial summary
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Cost Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Mar 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients presenting to hand clinic OR mturk workers
- age 18 or older
Who cannot join
- traumatic mechanism of injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.
Read the detailed description
Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Cost Information
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cost InformationOther
participants will be given information on the personal and societal costs
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control group will be given a hypothetical scenario about carpal tunnel syndrome and asked to make a treatment decision for that hypothetical patient. |
| Intervention | Experimental | Participants in the intervetion group will be given a hypothetical scenario about carpal tunnel syndrome as well as information about the cost of treatment and asked to make a treatment decision for that hypothetical patient. Receives: Other: Cost Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision to have Treatment
Participants are asked to answer "Should you get surgery right now," with the options of definitely yes, probably, maybe, maybe not, probably not, and definitely not
Measured: immediately after completing survey
Secondary outcomes (1)
Opinion on healthcare costs
a 7 item, likert response questionnaire used to elicit participant opinions on cost in health care. This is a non-validated tool.
Measured: immediately after completing survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Participants will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730376
- Sponsor's protocol ID
- 47392, 47580
- Status last verified
- Mar 2020
- First submitted
- 2 Nov 2018
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient and Consumer Decision Making in a Hypothetical Case of Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT03730376
- Acronym / sponsor ID
- 47392, 47580
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 5 Nov 2018 (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.
Participants will be presented with a hypothetical scenario of carpal tunnel and asked to make a decision for that case.
Detailed description
Participants will be randomized into 1 of 2 groups and receive a hypothetical scenario of carpal tunnel, with or without cost information, and asked to decide if that hypothetical patient should undergo a carpal tunnel release.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group will be given a hypothetical scenario about carpal tunnel syndrome and asked to make a treatment decision for that hypothetical patient. |
| Intervention | Experimental | Other: Cost InformationParticipants in the intervetion group will be given a hypothetical scenario about carpal tunnel syndrome as well as information about the cost of treatment and asked to make a treatment decision for that hypothetical patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients presenting to hand clinic OR mturk workers
- age 18 or older
Key exclusion criteria (1 listed)
- traumatic mechanism of injury
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 |
|---|---|---|
| Cost Informationparticipants will be given information on the personal and societal costs | Other | Intervention |
Primary outcome
Decision to have Treatment
Time frame: immediately after completing survey
Participants are asked to answer "Should you get surgery right now," with the options of definitely yes, probably, maybe, maybe not, probably not, and definitely not
1 secondary outcome
Opinion on healthcare costs
Time frame: immediately after completing survey
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 19 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cost Information in people with Carpal Tunnel Syndrome, run by Stanford University 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 2 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 19 Mar 2020. 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?
Decision to have Treatment (time frame: immediately after completing survey). 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 19 Mar 2020.