Prostate Cancer
Conditions
Keywords
Prostate Cancer, Treatment Costs
Brief summary
The purpose of this study is to investigate whether an encounter decision aid (used during a consultation) containing cost information about options, combined with clinician training about cost discussions and available financial resources, influence surgeon-patient cost conversations, referrals to address costs, patients' financial stress, and high-quality decision-making for patients with slow-growing prostate cancer.
Detailed description
The study will use a stepped wedge design to evaluate the encounter decision aid. Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, the surgeons will be randomized to the intervention arm at staggered time points to undergo training and begin using the decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. This study will consist of two aims. The first aim is to examine the use of an encounter decision aid with cost information on the presence and impact of out-of-pocket cost conversations. The investigators will train participating clinicians on how to use the decision aid intervention and available financial resources. With patient and clinician consent, the investigators will audio record clinical encounters and measure cost conversations using a previously-developed checklist to code transcripts derived from the audio recordings. Patients can still participate if they do not consent to audio recording as these topics will be assessed in the self-report survey after their clinic or virtual visit. The second aim will examine the impact of an encounter decision aid with cost information on high-quality decision-making. The investigators will collect a post-visit questionnaire from participating patients, including patient-reported measures of decisional conflict, decision regret, and the shared decision-making process. Participants will be sent a follow-up questionnaire 3 months after their initial study enrollment to assess decision regret and financial toxicity.
Interventions
BEHAVIORALOption Grid Decision Aid
-A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions
Sponsors
Robert Wood Johnson Foundation
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This is a stepped wedge randomized trial. The intervention condition (the relevant Option Grid decision aid that includes cost information about option) is sequentially assigned to participating surgeons in 4 clusters. By the end of recruitment, all surgeons will have been exposed to the intervention (about 100 surgeon-patient encounters using the Option Grid) and will have provided data for the control (about 100 control cases). Independent eligible patients will be enrolled at each period within a cluster, thus, analyzed as a repeated cross-sectional study. Periods (steps) are set intervals of time. The length of each step is 3 months. Steps 1-3 provide data from both conditions within each cluster (step 0 provides data only from the control while step 4 provides data only from the Option Grid arm) and data is collected from all clusters. Each step will add one clinician to the Option Grid arm.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Visiting a participating urologist/urologic surgeon to discuss treatment options * Slow growing prostate cancer defined as Gleason score of 6 or 7 (3+4) and/or PSA (prostate-specific antigen) level less than 10ng/ml or at surgeon's discretion * Must be patients of one of the participating providers
Exclusion criteria
-Patients who cannot give informed consent due to cognitive or emotional barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether or not a referral is made to address costs | Immediately after the clinic or virtual visit |
| Frequency of cost conversations | Immediately after the clinic or virtual visit |
| Initiator (surgeon, patient, or caregiver) of cost conversations | Immediately after the clinic or virtual visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who engaged in high-quality shared decision-making - CollaboRATE | Immediately after the clinic or virtual visit | -CollaboRATE is a validated, 3-item measure of the patient's perspective on the level of engagement in their decision. Using the recommended top score method of analysis, each encounter is coded as '1', if the response to all three collaboRATE items is 9, or '0' if the response to any of the three collaboRATE items less than 9. Higher scores represent more shared decision making. |
| Number of patients who had a decisional conflict | Immediately after the clinic or virtual visit | The Decisional Conflict Scale assesses whether individuals feel they have enough information to make a choice, have enough support to make a choice, and are clear about their values for risks and benefits of the choice. The 4-item SURE measure of decisional conflict will be used which is scored with a cutoff value indicating whether there is the presence of decisional conflict or not. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Decision regret | 3 month follow-up | -The validated Decision Regret Scale consists of five items on a five-point scale from strongly disagree to strongly agree. Higher scores indicate greater decision regret. The investigators will measure regret at the 3-month follow-up and and compare outcomes between groups |
| Financial toxicity | 3 month follow-up | * The investigators will use the validated COST measure of financial toxicity to examine the burden of care costs on patients and their distress about these costs. Higher values indicate more financial toxicity. * COST (Comprehensive Score for Financial Toxicity) is a short questionnaire made up of 11 statements. Items are scored on a Likert scale from 0 (not at all) to 4 (very much). Total scores can range from 0 to 44. |
| Number of patients who had a decisional conflict | 3 month follow-up | The Decisional Conflict Scale assesses whether individuals feel they have enough information to make a choice, have enough support to make a choice, and are clear about their values for risks and benefits of the choice. The 4-item SURE measure of decisional conflict will be used which is scored with a cutoff value indicating whether there is the presence of decisional conflict or not. |
Countries
United States
Outcome results
None listed