Skip to main content
Clinical Trials/NCT04397016
NCT04397016CompletedNot Applicable

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

Washington University School of Medicine2 sites in 1 country117 target enrollmentStarted: June 12, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
117
Locations
2
Primary Endpoint
Frequency of cost conversations

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts 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

Outcomes

Primary Outcomes

Frequency of cost conversations

Time Frame: Immediately after the clinic or virtual visit

Initiator (surgeon, patient, or caregiver) of cost conversations

Time Frame: Immediately after the clinic or virtual visit

Whether or not a referral is made to address costs

Time Frame: Immediately after the clinic or virtual visit

Secondary Outcomes

  • Number of patients who had a decisional conflict(Immediately after the clinic or virtual visit)
  • Number of patients who engaged in high-quality shared decision-making - CollaboRATE(Immediately after the clinic or virtual visit)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

Loading locations...

Similar Trials

Cost Talk: Discussing Cancer Care Costs | Clinical Trial