Clinical trial NCT04397016: Cost Talk: Discussing Cancer Care Costs
Official title: Cost Talk: a Randomized Stepped Wedge Trial of Interventions Helping Patients Discuss Cancer Care Costs With Clinicians During Shared Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Treatment Costs
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2020-05-21
Enrollment: 117
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of cost conversations
timeFrame: Immediately after the clinic or virtual visit
measure: Initiator (surgeon, patient, or caregiver) of cost conversations
timeFrame: Immediately after the clinic or virtual visit
measure: Whether or not a referral is made to address costs
timeFrame: Immediately after the clinic or virtual visit
Secondary outcomes:
measure: Number of patients who had a decisional conflict
timeFrame: Immediately after the clinic or virtual visit
measure: Number of patients who engaged in high-quality shared decision-making - CollaboRATE
timeFrame: Immediately after the clinic or virtual visit
Other outcomes:
measure: Decision regret
timeFrame: 3 month follow-up
measure: Number of patients who had a decisional conflict
timeFrame: 3 month follow-up
measure: Financial toxicity
timeFrame: 3 month follow-up
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Mary Politi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Glyn Elwyn, M.D., Ph.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Politi MC, Forcino RC, Parrish K, Durand MA, O'Malley AJ, Elwyn G. Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making. Trials. 2021 Jun 29;22(1):422. doi: 10.1186/s13063-021-05369-4.