Trigger Finger Preference Elicitation Tool
Primary Purpose
Trigger Finger, Trigger Thumb, Trigger Digit
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preference elicitation tool
handout
Sponsored by
About this trial
This is an interventional health services research trial for Trigger Finger
Eligibility Criteria
Inclusion Criteria:
- diagnosis of trigger finger
Exclusion Criteria:
- prior trigger finger treatment
Sites / Locations
- Stanford Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
intervention- tool
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03909490
Brief Title
Trigger Finger Preference Elicitation Tool
Official Title
Does the Use of a Preference Elicitation Tool at Point of Care in Trigger Finger Change Decisional Conflict?
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Logistics (research personnel)
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigger Finger, Trigger Thumb, Trigger Digit, Trigger Finger Disorder, Trigger Thumb, Left Thumb, Trigger Thumb, Right Thumb, Trigger Finger, Ring Finger, Trigger Finger, Index Finger, Trigger Finger, Middle Finger, Trigger Finger, Little Finger, Trigger Thumb, Unspecified Thumb, Trigger Finger, Unspecified Finger
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Title
intervention- tool
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Preference elicitation tool
Intervention Description
Ranking tool to assess patient preferences for trigger finger treatment
Intervention Type
Other
Intervention Name(s)
handout
Intervention Description
handout with information about trigger fingers
Primary Outcome Measure Information:
Title
Decisional Conflict Scale (DCS)
Description
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
Time Frame
Immediately after visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of trigger finger
Exclusion Criteria:
prior trigger finger treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Kamal
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Trigger Finger Preference Elicitation Tool
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