Project Details - Ongoing
- Grant Number:R18 HS026699
- Funding Mechanism:
- AHRQ Funded Amount:$1,200,000
- Principal Investigator:
- Project Dates:9/1/2019 to 8/31/2022
- Care Setting:
- Medical Condition:
- Type of Care:
- Health Care Theme:
Breast cancer is the most common non-cutaneous cancer among women in the United States. Women considering mastectomy as their surgical treatment have the choice of breast reconstruction either at the time of mastectomy or as a delayed procedure post-mastectomy. Breast reconstruction can restore body image and improve quality of life. However, the risk of a major complication following mastectomy with immediate breast reconstruction is approximately 23 percent, which is higher than most elective procedures. Many patients considering mastectomy lack adequate knowledge of risk information to make informed decisions; many surgeons also underestimate risks of the procedure or feel unsure how to address them during decision discussions. There are currently no reliable methods for integrating patient-specific information into the clinician-patient encounter to personalize these decision discussions. The occurrence of complications and resultant additional procedures may come as a surprise to patients insufficiently informed of risk, leading to decision regret.
The investigators previously developed a clinical decision support (CDS) tool called the Breast Reconstruction Education and Support Tool (BREASTChoice), designed to provide personalized risk prediction to patients and surgeons before and during clinical visits.
The overall objectives of this current research are to refine BREASTChoice and test its effectiveness. The specific aims are as follows:
- Elicit stakeholder input and evaluate the implementation potential of BREASTChoice.
- Optimize and modify BREASTChoice based on stakeholder input and usability testing, and plan for implementation into routine care.
- Evaluate the effects of the updated BREASTChoice on decision quality, decisional conflict, and treatment choice in a randomized controlled trial in a diverse population.
The study will take place at three hospital locations with racially and socioeconomically diverse patients. To achieve the first goal, investigators will engage stakeholders, including patients, information technology specialists, hospital administrators, and clinicians, through qualitative interviews and through the formation of a Stakeholder Advisory Group. To achieve the second goal, investigators will recruit patients and clinicians to use BREASTChoice and document participants' thoughts, feelings, and questions as they navigate through specific aspects of the CDS tool. Investigators will observe workflows at the study sites to evaluate feasibility, acceptability, and optimal timing of administering BREASTChoice. To achieve the third goal, patients will be randomized to use the CDS tool or engage in usual care. After using the CDS tool and before surgery, participants will complete a questionnaire that measures reconstruction preferences, knowledge, decisional conflict, treatment choice, health literacy, and socio-demographic characteristics. After the visit during which they discuss reconstruction with a surgeon, they will complete a measure of the quality of shared decision making. Their surgery choice will be documented and collected from the medical record. The investigators will explore whether those using the CDS tool choose a reconstruction option that aligns with their risk and preferences.
Ultimately, the investigators hope that BREASTChoice will translate evidence about breast reconstruction into practice, though a novel combination of risk-analytical modeling, and patient-centered decision support, with the overall outcome to improve decision quality and decrease complication rates.