Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
120
-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction
-Interactive web based tool. Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcome. The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participants representative photos of breast reconstruction outcomes, and assesses patients' knowledge and preferences
Washington University School of Medicine
St Louis, Missouri, United States
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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.
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
* Section 1 Knowledge (primary outcome) - set of multiple choice questions about breast reconstruction, implants, flap surgeries, and side effects * Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's certainty about surgery (it total score less than 4, indicates higher decisional conflict) * Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available * Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction * Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort.
* Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects * Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict) * Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available * Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit) * Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit).
* Asks 15 questions * Age, education, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, heath literacy, health insurance status, and (1) question on if participant spoke to another provider about breast reconstruction decision
* 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.
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
Receipt of Reconstruction
Assessed if participants received reconstruction
Time frame: Through follow-up (approximately 6 months)
Type of Reconstruction
Assessed what type of reconstruction participants received
Time frame: Through completion of follow-up (approximately 6 months)
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
Time frame: Through completion of follow-up (approximately 6 months)
Time Spent on Tool
How long participants spent on the BREASTChoice tool
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)
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)
Time frame: Through completion of breast consultation appointment (total participant time approximately 30 minutes)