Cost Talk: Discussing Cancer Care Costs

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2022

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

  • Behavioral: Option Grid Decision Aid
    • -A table with side-by-side comparisons of treatment options organized as responses to patients’ frequently asked questions

Arms, Groups and Cohorts

  • No Intervention: Arm 1: Usual Care
    • 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
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Number of patients who had a decisional conflict
    • Time Frame: 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.
  • Number of patients who engaged in high-quality shared decision-making – CollaboRATE
    • Time Frame: 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.

Participating in This Clinical Trial

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
  • Must be patients of one of the participating providers

Exclusion Criteria

-Patients who cannot give informed consent due to cognitive or emotional barriers

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Robert Wood Johnson Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mary Politi, Ph.D., Principal Investigator, Washington University School of Medicine
    • Glyn Elwyn, M.D., Ph.D., MSc, Principal Investigator, Dartmouth College
  • Overall Contact(s)
    • Mary Politi, Ph.D., 314-747-1967, mpoliti@wustl.edu

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