This trial studies how well a breast cancer surgery decision aid works in increasing patient engagement in decision making for patients with newly diagnosed stage 0-III breast cancer. The trial also examines barriers to patient engagement even with the use of a decision aid, and if barriers are more likely to be experienced by socioeconomically disadvantaged patients.
The primary and secondary objectives of the study: PRIMARY OBJECTIVES: I. Test the effectiveness of a breast cancer surgery decision aid in increasing patient engagement in decision making (measured by knowledge and power) in clinics serving a high proportion of socioeconomically disadvantaged patients. II. Test the extent to which the effect of a decision aid on patient engagement is mediated through the mitigation of barriers and determine if persistent barriers are disproportionately experienced by socioeconomically disadvantaged patients. SECONDARY OBJECTIVES: I. Characterize how persistent barriers influence patient engagement in decision making in order to identify targets for adjunct interventions that could be implemented in clinics serving a high proportion of socioeconomically disadvantaged patients. Trial Design: OUTLINE: This is a multi-site cluster randomized trial using a stepped wedge design. Ten clinics will be recruited for participation. All clinics will begin in the usual care arm. Clinics will be randomized to the timing with which they cross-over to the decision aid intervention, with new clinics crossing over every 10 weeks. ARM I: usual care ARM II: decision aid intervention The only difference between patients enrolled before institutional crossover and patients enrolled after institutional crossover is those who are enrolled after institutional crossover will have been offered the decision aid as accepted practice in the clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
Usual Care
Web-based decision aid received prior to the surgical consultation
Patient Power: Self-efficacy in Patient Physician Interactions
Power is defined as patients' self-perceived capacity to influence the decision-making encounter. This construct is measured using the Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI)-5 point scale; the primary outcome measure is a total score ranging from 5-25, where higher scores indicate increased self-efficacy. The patient completes the PEPPI-5 questionnaire within 3 weeks post-surgical consultation.
Time frame: 3 weeks
Patient Power: Active Patient Participation
Power is also separately measured by the validated Active Patient Participation Behaviors System to assess active patient participation during the surgeon consultation and is measured off the audio-recording of the consultation; a summary measure of patient's active involvement in the interaction is coded by the study team and represents a total count of patients' communicative behaviors (i.e., count of patient asking questions, count of patient assertive responses and count of patient expressions of concern) ranging from 0-114, where higher scores indicate increased active patient participation. The consultation for a patient will typically be study day 1 (day of registration).
Time frame: 1 day
Patient Knowledge
Patient knowledge is measured from 5 knowledge questions in the Decision Quality Instrument-Breast Surgery survey, with a percent correct recorded as the secondary outcome measure, ranging from 0-100%. The patient completes the Decision Quality Instrument-Breast Surgery survey within 3 weeks post-surgical consultation.
Time frame: Up to 3 weeks
Concordance Between Personal Values and Surgery Received
This is a binary outcome reflecting whether surgery received (mastectomy; lumpectomy) was concordant or not with the patient's personal values. The patient's personal values are measured from 3 questions on the Decision Quality Instrument (DQI)-Breast Surgery survey; each question ranges from 0 (not at all important) to 10 (extremely important). . The patient completes the DQI within 3 weeks post-consultation. The method by Sepucha et al (2012) will be applied to determine concordance between personal values and surgery received.
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Epic Care-Dublin
Dublin, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Epic Care Partners in Cancer Care
Emeryville, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Epic Care Cyberknife Center
Walnut Creek, California, United States
Augusta University Medical Center
Augusta, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Island Urology
Honolulu, Hawaii, United States
...and 48 more locations
Time frame: Up to 3 weeks