Cost Talk: Discussing Cancer Care Costs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cost Talk: a Randomized Stepped Wedge Trial of Interventions Helping Patients Discuss Cancer Care Costs With Clinicians During Shared Decision Making

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Option Grid Decision Aid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm 1: Usual Care<br>Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, they will be randomized to the intervention arm at staggered time points to undergo training and begin using the Option Grid decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. Usual Care-Participating clinicians have treatment options discussion with patients with slow-growing prostate cancer. Visits are audio-recorded and/or described by patient self-report measure. | |
| Experimental: Arm 2: Option Grid<br>Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, they will be randomized to the intervention arm at staggered time points to undergo training and begin using the Option Grid decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. Decision Aid-Participating surgeons use an encounter decision aid to discuss treatment options with patients who have slow-growing prostate cancer. Visits are audio-recorded and/or evaluated by patient self-report measure. | Behavioral: Option Grid Decision Aid<br>* -A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Whether or not a referral is made to address costs |  | Immediately after the clinic or virtual visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had a decisional conflict | 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. | Immediately after the clinic or virtual visit | 
| Number of patients who engaged in high-quality shared decision-making - CollaboRATE | -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. | Immediately after the clinic or virtual visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Treatment Costs