Cost Talk: Discussing Cancer Care Costs

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Option Grid Decision Aid

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Option Grid Decision Aid; -A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision regret	-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	3 month follow-up
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.	3 month follow-up
Financial toxicity	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.	3 month follow-up

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Glyn Elwyn, M.D., Ph.D., MSc, Dartmouth College

Publications and helpful links

General Publications

• 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.

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2020
• Primary Completion (ACTUAL): April 20, 2022
• Study Completion (ACTUAL): July 2, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (ACTUAL): May 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Treatment Costs
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 202004249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No