Cost Talk: Discussing Cancer Care Costs

• ClinicalTrials.gov Identifier: NCT04397016
• Recruitment Status: Completed
• First Posted: May 21, 2020
• Last Update Posted: September 26, 2022
• Sponsor: Washington University School of Medicine
• Collaborator: Robert Wood Johnson Foundation
• Information provided by (Responsible Party): Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Option Grid Decision Aid	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Cost Talk: a Randomized Stepped Wedge Trial of Interventions Helping Patients Discuss Cancer Care Costs With Clinicians During Shared Decision Making
• Actual Study Start Date: June 12, 2020
• Actual Primary Completion Date: April 20, 2022
• Actual Study Completion Date: July 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Frequency of cost conversations [ Time Frame: Immediately after the clinic or virtual visit ]
2. Initiator (surgeon, patient, or caregiver) of cost conversations [ Time Frame: Immediately after the clinic or virtual visit ]
3. Whether or not a referral is made to address costs [ Time Frame: Immediately after the clinic or virtual visit ]

Secondary Outcome Measures :

1. 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.
2. 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.

Other Outcome Measures:

1. Decision regret [ Time Frame: 3 month follow-up ]
   -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
2. Number of patients who had a decisional conflict [ Time Frame: 3 month follow-up ]
   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. Financial toxicity [ Time Frame: 3 month follow-up ]
   • 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Missouri

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Robert Wood Johnson Foundation

Investigators

• Principal Investigator: Mary Politi, Ph.D.; Washington University School of Medicine
• Principal Investigator: Glyn Elwyn, M.D., Ph.D., MSc; Dartmouth College

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT04397016
• Other Study ID Numbers: 202004249
• First Posted: May 21, 2020
• Last Update Posted: September 26, 2022
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:

Prostate Cancer; Treatment Costs

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases