| Primary | Percent Correct on the Knowledge Measure (Objective Knowledge Score) | To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care | | Posted | | Mean | Standard Deviation | percentage of answers correct | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00084.6± 14.2
- OG00159.7± 18.0
|
|
| |
| Primary | Decisional Conflict (SURE Measure) |
- To determine whether the CDT reduces uncertainty about choice. Participants are asked to report how sure they feel about their choice, if they have enough information to understand the choice, if they are clear about the risks and benefits, and if they have enough support to make a choice. Results are compared between the BREASTChoice and Enhanced Usual Care groups.
- Higher SURE values indicate certainty in choice
- Scores range from 0-4
| | Posted | | Mean | Standard Deviation | score on a scale | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 |
|
| Primary | Decision Process (Decision Quality Index Subscale) |
- The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicating a more shared decision making process
- Assess the extent to which patients were meaningfully involved in decision-making with their clinicians
| | Posted | | Mean | Standard Deviation | score on a scale | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | |
|
| Secondary | Quality of Life as Measured by the BREAST-Q Questionnaire |
- Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being
- Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
| | Posted | | Mean | Standard Deviation | score on a scale | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score |
- Top collaboRATE score = the percentage of patients from whom there was 'gold standard' shared decision making as assessed by the collaboRATE measure
- The top score is coded as '1', if the response to all three collaboRATE items was less than 9. Then the investigators calculated the percentage of all encounters that were coded as '1' indicating gold standard shared decision making.
| 3 participants from Arm 1 were excluded from the outcome measure as their data was missing. 1 participants from Arm 2 was excluded from the outcome measure as her data was missing. | Posted | | Count of Participants | | Participants | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement | -3 questions consisting of the following:
- I am confident I can tell my healthcare provider concerns that I have about breast reconstruction even when he or she does not ask (confidence in healthcare provider)
- I am confident I can find trustworthy sources of information about my breast reconstruction decision (confidence in trustworthy sources)
- I know the different options available for breast reconstruction (knowledge on breast reconstruction options)
| 3 participants in the BREASTChoice arm did not provide an answer to this question and are not evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Receipt of Reconstruction | Assessed if participants received reconstruction | 2 participants in the Enhanced Usual Care arm have not had their reconstruction surgery but are planning to schedule it but it is outside the follow-up window. | Posted | | Count of Participants | | Participants | | Through follow-up (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Type of Reconstruction | Assessed what type of reconstruction participants received | Only patients who had reconstruction are applicable for this outcome measure | Posted | | Count of Participants | | Participants | | Through completion of follow-up (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Timing of Reconstruction |
- Assessed timing of reconstruction
- Immediate is defined as reconstruction at the time of mastectomy
- Delayed is defined as reconstruction any time after the mastectomy and performed as a separate surgery
| Only patients who had reconstruction are applicable for this outcome measure | Posted | | Count of Participants | | Participants | | Through completion of follow-up (approximately 6 months) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | |
|
| Secondary | Time Spent on Tool | How long participants spent on the BREASTChoice tool | -Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure | Posted | | Median | Full Range | minutes | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Consult Time | Assessed the time between when the plastic/reconstructive surgeon entered and exited the consult room (not including time spent with a resident, nurse, or other clinical staff) | | Posted | | Mean | Full Range | minutes | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) | Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. |
|
| Secondary | Usability as Measured by the Computer System Usability Questionnaire (CSUQ) |
- Assessed ease of usability of the BREASTChoice tool
- Scale is from 1 (strongly disagree) to 7 (strongly agree)
| -Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure | Posted | | Mean | Full Range | score on a scale | | Through completion of breast consultation appointment (total participant time approximately 30 minutes) | | | | ID | Title | Description |
|---|
| OG000 | Arm 1: BREASTChoice (Decision Tool) | Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes. | | OG001 | Arm 2: Enhanced Usual Care (Surgical Care Booklet) |
|