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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA248972 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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. This entry (Aim 1) has an associated study (Aim 2) registered under NCT04463719
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Counseling using the electronic conversation aid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling using the electronic conversation aid | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naykky Singh Ospina | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Mayo Clinic |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients and clinicians included in the study and are reported individually and not as dyads. Clinicians age, race/ethnicity were not collected (0 noted below). The patient data is used to describe the overall age of the population. No information was collected from guest.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group: Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was not collected from clinicians |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 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) |
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed due to the nature of the intervention.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed due to the nature of the intervention. The intervention in this study was the use of a conversation aid during the clinical visit. No medication, drug, or test were performed during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naykky Singh Ospina | University Of Florida | 352) 273-8656 | naykky.singhospina@medicine.ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 23, 2023 | Apr 19, 2024 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D016606 | Thyroid Nodule |
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| BG001 | Intervention Group: Clinicians | 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. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity not collected for clinicians. | Count of Participants | Participants |
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| Race (NIH/OMB) | Race not collected for clinicians. | Count of Participants | Participants |
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| Clinician Providing Care With the Conversation Aid |
Review of clinical visit and post visit interviews of clinicians providing care with the conversation aid |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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