This is a single-arm hybrid implementation trial of men with metastatic castrate-resistant prostate cancer (mCRPC) involving a patient-administered mobile app for consultation audio recordings.
PRIMARY OBJECTIVE: 1\. To evaluate change in participant informed decision-making after provision of a consultation audio recording application. SECONDARY OBJECTIVES: 1. Reach. To evaluate the percentage of invited participants who enroll. Reasons for not enrolling will be assessed. 2. Adoption. To evaluate the percentage of providers who agree to be recorded. 3. Adoption. To evaluate the percentage of participants who create an audio recording. 4. Adoption. To evaluate the percentage of participants who listen to the audio recording or read its automatically generated transcript. 5. Implementation. To evaluate the percentage of participants who report receiving instructions on how to record. 6. To evaluate participant-reported shared decision-making effort. 7. To evaluate whether participant-reported anxiety changes after provision of a consultation audio recording app. 8. To evaluate barriers, facilitators, and experiences of recording app use, particularly in the context of treatment decision-making by conducting participant interviews, provider surveys, and interviews with providers. 9. Treatment received. EXPLORATORY OBJECTIVES: 1. To evaluate whether provision of a consultation audio recording app improves participant-reported knowledge retention of docetaxel. 2. To evaluate accuracy of app auto-generated transcription. 3. To evaluate degree of provider decision support and communication skills. Participants are set up with an application prior to the first physician visit and then followed-up 7 days, 28 days and 60 days after their physician encounter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
51
Smartphone or tablet mobile application which allows for voice recording
University of California, San Francisco
San Francisco, California, United States
Mean change in docetaxel knowledge score over time
Change in docetaxel knowledge score is measured by participant report of knowledge using a docetaxel knowledge instrument, measured at baseline and 7 days post-appointment. The instrument was developed based on facts that patients and providers deem are important when making a treatment decision that includes docetaxel as an option for mCRPC (e.g., disease, prognosis, risks, benefits, alternatives). The score is standardized, ranging from from 0 to 100, with higher scores indicating a greater knowledge in docetaxel. Mean change in scores will be reported, as well as standard deviations.
Time frame: Up to 2 weeks
Mean change in informed subscale of Decisional Conflict Scale over time
The informed subscale of the Decisional Conflict Scale is comprised of 3 items given a score value of 0 = 'strongly agree to 4 = 'strongly disagree'. The items are summed, divided by 3, and then multiplied by 25. Scores range from 0 (feels extremely informed) to 100 (feels extremely uninformed).
Time frame: Up to 2 weeks
Proportion of invited participants who consent to the study
The proportion of participants who consented to the study from the total number of participants contacted will be reported.
Time frame: 1 day
Proportion of approached patients' providers who agree to be recorded
The proportion of approached patients' providers who agree to be recorded from the total number of patients' providers approached to participate will be reported.
Time frame: 1 day
Mean change in participant-reported anxiety over time
The Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short form (4a) consists of 4 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Participants will be measured at baseline and 7 days post-appointment and compared over time.
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Time frame: Up to 2 weeks
Proportion of enrolled participants who create a recording
The proportion of enrolled participants who created a recording of the total number of participants in the study will be reported.
Time frame: Up to 2 weeks
Proportion of enrolled participants who listen to the recording
The proportion of enrolled participants who listen to the recording or read its automatically generated transcript, measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Time frame: Up to 2 weeks
Proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app
The proportion of enrolled participants who report they received both mailed/emailed instructions to install/use the app measured by participant-reported survey at 7 days post-appointment of the total number of participants in the study will be reported.
Time frame: Up to 2 weeks
Proportion of participants who report high shared decision-making effort
High shared decision-making effort will be measured at 7 days post-appointment using the collaboRATE scale. The collaboRATE scale is a 3-item, 10-point Likert scale, where each encounter is scored as either '1' if the response to all three collaboRATE items is 9, or '0' if the response to any of the three collaboRATE items is less than 9. The percentage of all participants with a code of '1' will be calculated.
Time frame: Up to 2 weeks
Proportion of patients who received docetaxel
Docetaxel treatment received at 30 days post-appointment will be reported with a 95% confidence interval will be reported.
Time frame: Up to 30 days
Proportion of patients who received docetaxel
Docetaxel treatment received at 60 days post-appointment will be reported with a 95% confidence interval will be reported.
Time frame: Up to 60 days