Trigger FingerNCT03909490
Trigger Finger Preference Elicitation Tool
A study testing Preference elicitation tool and handout in people with Trigger Finger and Trigger Thumb, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a patient's level of decisional conflict for their treatment decision regarding their trigger finger, and study if the use of a preference elicitation tool at point of care is able to alter the level of decisional conflict Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigger Finger, Trigger Thumb, Trigger Digit
- What is being tested?
- Preference elicitation tool and handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 1 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of trigger finger
Who cannot join
- prior trigger finger treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: Does the Use of a Preference Elicitation Tool at Point of Care in Trigger Finger Change Decisional Conflict?
The purpose of this study is to evaluate a patient's level of decisional conflict for their treatment decision regarding their trigger finger, and study if the use of a preference elicitation tool at point of care is able to alter the level of decisional conflict
Read the detailed description
All patients presenting to the Hand Surgery clinic for evaluation of a new trigger finger will be approached for inclusion in the study. Upon diagnosis, a patient diagnosed with a trigger will be informed of the study, asked if they would like to participate, and consented into the study. Patients will then be randomized to a control group versus our test group. The control group will be given a generic handout about trigger finger and the treatment options. They will then complete the decisional conflict survey without using the tool. The second group will use the tool and then complete the decisional conflict survey.
The standard of care is not being altered- all treatment options will still be available to patients and they have select whatever option is most in line with their preference for treatment. The purpose of the tool is to facilitate preference elicitation for treatment.
- Conditions
- Trigger Finger, Trigger Thumb, Trigger Digit, Trigger Finger Disorder, Trigger Thumb, Left Thumb, Trigger Thumb, Right Thumb
- Being tested
- Preference elicitation tool, handout
- Medical subject headings
- Trigger Finger Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preference elicitation toolOther
Ranking tool to assess patient preferences for trigger finger treatment
handoutOther
handout with information about trigger fingers
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: handout |
| intervention- tool | Experimental | Not described Receives: Other: Preference elicitation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
Decisional Conflict Scale (DCS) is a validated tool that measures a state of uncertainty about a course of action. DCS is a 16 item scale, scores range from 0-100, with higher scores indicating greater decisional conflict
Measured: Immediately after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start20 Mar 2019
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Logistics (research personnel)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigger FingerStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
- Investigators
- Robin Kamal, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909490
- Sponsor's protocol ID
- 45990
- Status last verified
- Nov 2021
- First submitted
- 8 Apr 2019
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a Preference Elicitation Tool at Point of Care in Trigger Finger Change Decisional Conflict?
- ClinicalTrials.gov ID
- NCT03909490
- Acronym / sponsor ID
- 45990
- Conditions
- Trigger Finger, Trigger Thumb, Trigger Digit, Trigger Finger Disorder, Trigger Thumb, Left Thumb, Trigger Thumb, Right Thumb
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Logistics (research personnel)
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 10 Apr 2019 (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 purpose of this study is to evaluate a patient's level of decisional conflict for their treatment decision regarding their trigger finger, and study if the use of a preference elicitation tool at point of care is able to alter the level of decisional conflict
Detailed description
All patients presenting to the Hand Surgery clinic for evaluation of a new trigger finger will be approached for inclusion in the study. Upon diagnosis, a patient diagnosed with a trigger will be informed of the study, asked if they would like to participate, and consented into the study. Patients will then be randomized to a control group versus our test group. The control group will be given a generic handout about trigger finger and the treatment options. They will then complete the decisional conflict survey without using the tool. The second group will use the tool and then complete the decisional conflict survey.
The standard of care is not being altered- all treatment options will still be available to patients and they have select whatever option is most in line with their preference for treatment. The purpose of the tool is to facilitate preference elicitation for treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: handout |
| intervention- tool | Experimental | Other: Preference elicitation tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of trigger finger
Key exclusion criteria (1 listed)
- prior trigger finger treatment
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 |
|---|---|---|
| Preference elicitation toolRanking tool to assess patient preferences for trigger finger treatment | Other | intervention- tool |
| handouthandout with information about trigger fingers | Other | Control |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: Immediately after visit
Decisional Conflict Scale (DCS) is a validated tool that measures a state of uncertainty about a course of action. DCS is a 16 item scale, scores range from 0-100, with higher scores indicating greater decisional conflict
Results and safety
The study was stopped early (reason given: Logistics (research personnel)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- 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.
Robin Kamal principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preference elicitation tool and handout in people with Trigger Finger and Trigger Thumb, 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 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: stopped early, as of the sponsor's last update on 12 Nov 2021. 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 was stopped early (reason given: Logistics (research personnel)). Results are not available in the source record.
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?
Decisional Conflict Scale (DCS) (time frame: Immediately after visit). 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 Nov 2021.