Trial Outcomes & Findings for AIM1: Adequate Selection of Patients for Thyroid Biopsy: Evaluation of a Shared Decision Making Conversation Aid (NCT NCT04472026)
NCT ID: NCT04472026
Last Updated: 2024-07-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians)
Results posted on
2024-07-31
Participant Flow
The study aims to update a conversation aid prototype that was developed to support shared decision making in the diagnosis of thyroid cancer. Adult patients with thyroid nodules presenting for consultation were recruited from two clinical centers (University of Florida, Gainesville and Mayo Clinic, Rochester). Enrollment started on 07/16/2020 and was completed on 08/02/2021.
Participant milestones
| Measure |
Intervention Group
Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: 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.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
Clinicians Starting
|
13
|
|
Overall Study
Clinicians Completing
|
12
|
|
Overall Study
Patients Starting
|
53
|
|
Overall Study
Patient Completing
|
49
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Intervention Group
Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: 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.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Age was not collected from clinicians
Baseline characteristics by cohort
| Measure |
Intervention Group: Patients
n=53 Participants
Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: 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.
|
Intervention Group: Clinicians
n=13 Participants
Counseling using the electronic conversation aid
Counseling using the electronic conversation aid: This conversation aid will help you and your patient discuss ways to care for their 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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=53 Participants • Age was not collected from clinicians
|
—
|
62 years
n=53 Participants • Age was not collected from clinicians
|
|
Sex: Female, Male
Female
|
42 Participants
n=53 Participants
|
8 Participants
n=13 Participants
|
50 Participants
n=66 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=53 Participants
|
5 Participants
n=13 Participants
|
16 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
53 Participants
n=66 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants
|
13 Participants
n=13 Participants
|
13 Participants
n=66 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
5 Participants
n=66 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
47 Participants
n=66 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=53 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=66 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=53 Participants
|
13 Participants
n=13 Participants
|
14 Participants
n=66 Participants
|
PRIMARY outcome
Timeframe: Up to the time the post visit interview was completed (on average 1 weeks after the clinical visit for patients and 1 month after completion of 3 visit using the tool for clinicians)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.
Outcome measures
| Measure |
Patients Receiving Care With the Conversation Aid
n=49 Participants
Post visit semi structured interviews and recordings of the clinical visits of patients who received care with the conversation aid
|
Clinician Providing Care With the Conversation Aid
n=12 Participants
Review of clinical visit and post visit interviews of clinicians providing care with the conversation aid
|
|---|---|---|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (benefits patients)
|
0 Participants
|
4 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (benefits clinicians)
|
0 Participants
|
2 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (tool features and components)
|
12 Participants
|
0 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (Understanding the medical condition, situation and options)
|
12 Participants
|
0 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (Interaction with the clinician)
|
12 Participants
|
0 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Negative (Suggestions for improvement related to TNOC features/components)
|
7 Participants
|
0 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Negative (Impact on the interaction)
|
6 Participants
|
0 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Positive (tool features)
|
0 Participants
|
4 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Negative (using TNOC is a change in their routine)
|
0 Participants
|
1 Participants
|
|
Qualitative Analysis of the Patient and Clinician Experience Using the Conversation Aid
Negative (Improvements to support the use of TNOC in routine Practice)
|
0 Participants
|
1 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place