Understanding and Addressing Patient and Provider Preferences Around Discussions of Cost of Breast Cancer Care
NCT ID: NCT03780491
Last Updated: 2020-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-11-05
2020-11-16
Brief Summary
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Aim 1: Further understand patient preferences and attendant associations for cost discussions through a patient survey of newly diagnosed breast cancer patients.
Aim 2: Study the influence of provider communication about cost on shared decision making, uptake of financial counseling, financial well-being and satisfaction through an intervention to encourage discussion of cost by breast cancer surgeons with subsequent referral to financial counseling.
Detailed Description
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For this study, the investigators will use a pre and post design with 100 total participants. All visits will be audiorecorded, transcribed, and coded for whether cost was discussed in the control group and whether the intervention was successfully implemented in the intervention group as well as shared decision making using the observer-OPTION scale. The first 50 patients will have usual care with providers conducting the visit in their typical manner.
From our past studies, study team discusses cost in 15% of visits, though these discussion tend to be very superficial. The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) The investigators will recommend treatments for the participants' cancer based on what the investigators think gives them the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for their doctors to know what their costs will be, but the investigators will do our best to give participants some general information. 4) The investigators have resources available to help participants get more specific information so that participants can plan appropriately. 5) Do participants have any specific concerns about cost that participants would like to share with me? The investigators will encourage study team to have this discussion at the beginning of the consult, but the exact timing will be according to study team judgment.
After the visit, all patients will complete a patient satisfaction survey and will be offered a referral to a financial counselor at our institution. Financial counseling will take place per our usual institutional protocols either in person or over the phone. Our financial counselors are aware that they may see an increased volume of patients during the study period and the investigators will provide funding to cover the increased need. Volume will be tracked during the study period and compared to the non-study period and between the groups.
At the first three to six-month follow-up visit with the surgeon, participants will again complete the IFDFW, a validated patient satisfaction scale\[26\], and the Satisfaction with Decision Scale.\[27\].
Data will have personal health identifiers removed from the data for the analysis portion of the study. PHI will not be reused without first seeking IRB approval.
The investigators will enroll 100 patients in two consecutive groups of 50. This gives us 80% power with a two sided significance level of 0.05 for seeing a 27-30% improvement (0.27-0.3 higher score) in our primary outcome of financial well-being as measured by the IFDFW in the intervention group at 3-6 months after the initial visit; the average pre-score on the IFDFW is 5.52 in past studies with improvements of 0.32-1.18 seen in past studies of education interventions to improve financial well-being.\[24\] This level of difference may not be achievable with this small study, but will provide data for powering a larger study.
Maximizer-Minimizer status, uptake of financial counseling, patient satisfaction, decision satisfaction, and demographic variables will be evaluated for associations with financial well-being using logistic regression methods.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Control
The first 50 patients will have usual care with providers conducting the visit in their typical manner.
No interventions assigned to this group
Cost Discussion
The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
Cost Discussion
The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
Interventions
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Cost Discussion
The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
Eligibility Criteria
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Inclusion Criteria
* All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Utah
OTHER
Responsible Party
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Cindy Matsen, MD
Assistant Professor, Physician
Locations
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University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Bakshi, N., et al., Shared decision making or physician advocate for a particular treatment option: A spectrum of approaches to decision making about disease modifying therapies in sickle cell disease. Blood, 2016. 128(22).
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Other Identifiers
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114421
Identifier Type: -
Identifier Source: org_study_id