| Primary | Proportion of Eligible Patients for Feasibility | Proportion of participants that are eligible relative to total trial referrals.To measure the proportion of eligible patients after review of upcoming clinical visits, enrollment and refusal reasons, ability to randomize patients and tolerability by patients and clinicians of the required assessments (time to complete assessments and obtain complete assessment at 6 months of follow up). | Number of patients that were screened for inclusion in the study | Posted | | Count of Participants | | Participants | | at 6 months of follow up | | | | ID | Title | Description |
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| OG000 | Eligible Patient for the Study | Eligible patients for the study and for randomization |
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| Eligible Patients Based on Chart Review | | | Patients not eligible based on chart review | |
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| Secondary | Patient's Acceptance to Participate in the Study | From eligible patients that were invited to participate, the proportion of patients that agreed to enter the study | | Posted | | Count of Participants | | Participants | | first visit | | | | ID | Title | Description |
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| OG000 | Eligible Patients Invited to Participate in the Study | All patients that were eligible and invited to participate in the study |
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| Secondary | Adequate Randomization | Proportion of patients that were randomized and completed the study | | Posted | | Count of Participants | | Participants | | initial clinical visit | | | | ID | Title | Description |
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| OG000 | Adequate Randomization | Proportion of patients that were post randomization exclusion due to identification of exclusion criteria during the visit |
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| Secondary | Completeness of Baseline Survey (Patients) | Proportion of patients that completed the baseline survey | | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | Completeness of Baseline Survey (Patients) | Proportion of patients that completed the baseline survey |
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| Secondary | Patient Survey (6 Months) | Proportion of patients that completed the 6 month survey | From the initial group of 86 patients, 6 were diagnosed with cancer and not eligible for the follow up survey. | Posted | | Count of Participants | | Participants | | 6 months | | | | ID | Title | Description |
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| OG000 | Completeness of 6-month Survey (Patients) | Proportion of patients that completed the 6-month survey |
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| Secondary | Clinician Baseline Survey | | 17 clinicians care for the patients in the study and were asked to complete a baseline survey | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | Completeness of Baseline Survey (Clinicians) | Proportion of clinicians that completed the baseline survey |
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| Secondary | Knowledge | To assess knowledge transfer related to thyroid nodules, patients completed a 12-item questionnaire with Yes/No and "I don't know" response options, related to thyroid nodule knowledge. Higher score indicate increased number of correct answers. | 43 patients were included in each arm, completion of survey items related to knowledge were available for 40 patients in the intervention group and 41 patients in the control group. | Posted | | Mean | Standard Deviation | correct response | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Decisional Conflict | Decisional conflicts reflects degree of conflict with the decision made. This construct was evaluated with a validated questionnaire that includes 16-items, with the total score transformed into a 1-100 scale, with higher scores indicating greater decisional conflict. | 43 were randomized in each arm in the study, and for 31 in the intervention group items related the decisional conflict scale in the survey were completed and 23 for those in the control group. | Posted | | Median | Inter-Quartile Range | score on a scale | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | OPTION Score | Observing Patient Involvement (OPTION), evaluates the extent to which clinicians engaged patients in decision making, higher levels more engagement, range (0-100) | 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group. | Posted | | Median | Inter-Quartile Range | score on a scale | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Visit Duration | Length of the clinical visit | 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group. | Posted | | Mean | Standard Deviation | minutes | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Diagnostic Decision | Proportion of patients undergoing thyroid biopsy | 43 patients were randomized in the study, the outcome of next diagnostic test (undergoing thyroid biopsy) was assessed from clinical chart review which was available for all patients. | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Fidelity | Fidelity of use of the conversation aid during clinical visit, evaluating using 12 items during review of clinical visit. Higher percentage refers to higher number of items observed. | 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group. | Posted | | Mean | Standard Error | percentage of items of the conversation | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Risk Communication | Proportion of visits in which thyroid cancer risk was communicated evaluated through review of clinical visit, as yes/no outcome. | 43 patients were randomized in the study, and clinical visit recordings were available for 42 patients in the intervention group and 43 patients in the control group. | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Satisfaction With the Communication (Patient) | Likert score, lower number more satisfied, 1-7 | 43 patients were randomized in each arm, for all patients in the intervention group items related to satisfaction were completed in the survey and for 41 in the control group these items were completed in the survey. | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Satisfaction With the Visit (Clinician) | Likert score, higher numbers better, 1-5 options | Clinicians expressed satisfaction with the clinical visit through a survey, that was completed for all patients in the intervention group (43) and (42) in the control group. | Posted | | Mean | Standard Deviation | units on a scale | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Counseling using the electronic conversation aid Counseling using the electronic conversation aid: Patients receive counseling about thyroid biopsy with the use of the conversation aid. | | OG001 | Control Group | Routine counseling only counseling by routine care: Patients receive counseling by routine care without the use of the conversation aid |
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| Secondary | Worry About Thyroid Cancer | Worry about thyroid cancer diagnosis assessed through a survey item, including the options Not at all, rarely/a little or somewhat or a lot | 43 patients were randomized in each arm, survey responses for this outcome were available for 43 participants in the intervention group and 41 participants in the control group. | Posted | | Count of Participants | | Participants | | baseline | | | | ID | Title | Description |
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| OG000 | Intervention Group | Participants received care supplemented by the use of a conversation aid during the clinical visit | | OG001 | Control Group | Participant received routine care not supplemented by the use of a conversation aid during the clinical visit |
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| Secondary | Distress Due to Thyroid Nodule (6 Months) | Impact of Event Scale evaluates distress with a new medical situation (new thyroid nodule in this case). The scale includes 6 items, with a score range from 0 to 24 points, with higher values indicating more distress. | From the initial population of 86 participants (43 in each group), 6 were diagnosed with thyroid cancer and were not eligible for evaluation of outcomes at 6 months of follow up. Leaving 42 eligible patients in the intervention group (1 cancer diagnosis) of which 29 completed the follow up survey and 38 in the control group (5 cancer diagnoses) of which 21 completed the follow up survey. | Posted | | Mean | Standard Deviation | units on a scale | | 6 months | | | | ID | Title | Description |
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| OG000 | Intervention Group | Patients that received care supplemented by the use of a conversation aid during the visit | | OG001 | Control Group | Patients that received care without the use of a conversation aid during the clinical visit |
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