Cost Talk: Discussing Cancer Care Costs

NCT04397016 | Completed

• 1 other identifier: 202004249
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Treatment Costs

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Other Outcomes (3)

• Decision regret

  3 month follow-up

• Number of patients who had a decisional conflict

  3 month follow-up

• Financial toxicity

  3 month follow-up

Study Arms (2)

Arm 1: Usual Care

NO INTERVENTION

* 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.

Arm 2: Option Grid

EXPERIMENTAL

* 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

Interventions

Option Grid Decision Aid BEHAVIORAL

-A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions

Arm 2: Option Grid

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Politi MC, Forcino RC, Parrish K, Durand MA, O'Malley AJ, Moses R, Cooksey K, Elwyn G. The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial. Health Expect. 2023 Oct;26(5):2023-2039. doi: 10.1111/hex.13810. Epub 2023 Jul 2.

  PMID: 37394739 DERIVED

• 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.

  PMID: 34187547 DERIVED

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mary Politi, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Glyn Elwyn, M.D., Ph.D., MSc

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 21, 2020
• Study Start: June 12, 2020
• Primary Completion: April 20, 2022
• Study Completion: July 2, 2022
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)