Back to resultsAIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Primary Purpose
Thyroid Nodules, Thyroid Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling using the electronic conversation aid
Sponsored by
About this trial
This is an interventional other trial for Thyroid Nodules focused on measuring thyroid nodules, shared decision making
Eligibility Criteria
Inclusion Criteria:
- Adults >18 years old presenting for evaluation of a thyroid nodule
Exclusion Criteria:
- Patients with hyperthyroidism
- Patients with previous biopsy of the nodule of interest
- Pregnant patients
- Prisoners
Sites / Locations
- University of FloridaRecruiting
- Mayo ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Counseling using the electronic conversation aid
Outcomes
Primary Outcome Measures
Qualitative analysis of the patient and clinician experience using the conversation aid
The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid.
Secondary Outcome Measures
Full Information
NCT ID
NCT04472026
First Posted
July 10, 2020
Last Updated
July 26, 2023
Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04472026
Brief Title
AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Official Title
Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There is an epidemic of thyroid cancer that is harmful to patients and the medical system. The study hypothesizes that the use of an electronic conversation aid during clinical visits can help patients and clinicians collaborate when deciding the next step in management for a thyroid nodule. The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules, Thyroid Cancer
Keywords
thyroid nodules, shared decision making
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Counseling using the electronic conversation aid
Intervention Type
Behavioral
Intervention Name(s)
Counseling using the electronic conversation aid
Intervention Description
This conversation aid will help you and your doctor discuss ways to care for your thyroid nodule. We will evaluate the acceptability of the conversation aid and barriers to implementation in clinical practice. Post visit semi structured interviews and recordings of the clinical visits will be qualitatively analyzed. We hypothesize that the conversation aid will be accepted and facilitate the decision making process.
Primary Outcome Measure Information:
Title
Qualitative analysis of the patient and clinician experience using the conversation aid
Description
The clinical visit and post visit semi-structure interviews of patient and clinicians that have used the conversation aid will be analyzed qualitatively to better understand the acceptability of the conversation aid in clinical practice and used to further update the conversation aid.
Time Frame
Up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults >18 years old presenting for evaluation of a thyroid nodule
Exclusion Criteria:
Patients with hyperthyroidism
Patients with previous biopsy of the nodule of interest
Pregnant patients
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eddison Godinez Leiva
Phone
352-294-5723
Email
Eddison.GodinezLeiva@medicine.ufl.edu
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina, MD
First Name & Middle Initial & Last Name & Degree
Naykky Singh Ospina
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Behnken.
Phone
507-293-0177
Email
Behnken.Emma@mayo.edu
First Name & Middle Initial & Last Name & Degree
Victor Montori, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid
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