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

Mary C Politi, Rachel C Forcino, Katelyn Parrish, Marie-Anne Durand, A James O'Malley, Glyn Elwyn, Mary C Politi, Rachel C Forcino, Katelyn Parrish, Marie-Anne Durand, A James O'Malley, Glyn Elwyn

Abstract

Background: Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision aid (Option Grid) containing cost information about slow-growing prostate cancer management options, combined with urologic surgeon training, on the frequency and quality of patient-urologic surgeon cost conversations, and (2) examine the impact of the decision aid and surgeon training on decision quality.

Methods: We will conduct a stepped-wedge cluster randomized trial in outpatient urology practices affiliated with a large academic medical center in the USA. We will randomize five urologic surgeons to four intervention sequences and enroll their patients with a first-time diagnosis of slow-growing prostate cancer independently at each period. Primary outcomes include frequency of cost conversations, initiator of cost conversations, and whether or not a referral is made to address costs. These outcomes will be collected by patient report (post-visit survey) and by observation (audio-recorded clinic visits) with consent. Other outcomes include the following: patient-reported decisional conflict post-visit and at 3-month follow-up, decision regret at 3-month follow-up, shared decision-making post-visit, communication post-visit, and financial toxicity post-visit and at 3-month follow-up; clinician-reported attitudes about shared decision-making before and after the study, and feasibility of sustained intervention use. We will use hierarchical regression analysis to assess patient-level outcomes, including urologic surgeon as a random effect to account for clustering of patient participants.

Discussion: This study evaluates a two-part intervention to improve cost discussions between urologic surgeons and patients when deciding how to manage slow-growing prostate cancer. Establishing the effectiveness of the strategy under study will allow for its replication in other clinical decision contexts.

Trial registration: ClinicalTrials.gov NCT04397016 . Registered on 21 May 2020.

Keywords: Clinical communication; Cost conversations; Costs of care; Financial toxicity; Prostate cancer; Shared decision-making; Stepped-wedge cluster randomized trial.

Conflict of interest statement

Mary Politi previously (2017-2019) received research funding from Merck & Co on a topic unrelated to this manuscript. Marie-Anne Durand has contributed to the development of the Option Grid patient decision aids, which are licensed to EBSCO Health. Dr. Durand receives consulting income from EBSCO Health, and may receive royalties in the future. Glyn Elwyn is the Founder and Director of &think LLC which owns the registered trademark for Option Grids TM patient decision aids; Founder and Director of SHARPNETWORK LLC, a provider of training for shared decision making. Prof. Elwyn provides advice in the domain of shared decision making and patient decision aids to (1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers), (2) EBSCO Health for Option Grids TM patient decision aids (Consultant), (3) Bind On Demand Health Insurance (Consultant), (4) PatientWisdom Inc (Adviser), and (5) abridge AI Inc (Chief Clinical Research Scientist). No other authors declare competing interests.

Figures

Fig. 1
Fig. 1
Study overview
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments

References

    1. Yousuf ZS. Financial toxicity of cancer care: it’s time to intervene. J Natl Cancer Inst. 2016;108:djv370. doi: 10.1093/jnci/djv370.
    1. Zafar SY, Peppercorn JM, Schrag D, Taylor DH, Goetzinger AM, Zhong X, Abernethy AP. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist. 2013;18(4):381–390. doi: 10.1634/theoncologist.2012-0279.
    1. Kim P. Cost of cancer care: the patient perspective. J Clin Oncol. 2007;25(2):228–232. doi: 10.1200/JCO.2006.07.9111.
    1. Ramsey SD, Bansal A, Fedorenko CR, Blough DK, Overstreet KA, Shankaran V, Newcomb P. Financial insolvency as a risk factor for early mortality among patients with cancer. J Clin Oncol. 2016;34(9):980–986. doi: 10.1200/JCO.2015.64.6620.
    1. Wharam JF, Zhang F, Lu CY, Wagner AK, Nekhlyudov L, Earle CC, Soumerai SB, Ross-Degnan D. Breast cancer diagnosis and treatment after high-deductible insurance enrollment. J Clin Oncol. 2018;36(11):1121–1127. doi: 10.1200/JCO.2017.75.2501.
    1. Kale HP, Carroll NV. Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors. Cancer. 2016;122:1283–1289. doi: 10.1002/cncr.29808.
    1. Fenn KM, Evans SB, McCorkle R, DiGiovanna MP, Pusztai L, Sanft T, Hofstatter EW, Killelea BK, Knobf MT, Lannin DR, Abu-Khalaf M, Horowitz NR, Chagpar AB. Impact of financial burden of cancer on survivors’ quality of life. J Oncol Pract. 2014;10(5):332–338. doi: 10.1200/JOP.2013.001322.
    1. Gordon LG, Merollini KMD, Lowe A, Chan RJ. A systematic review of financial toxicity among cancer survivors: we can’t pay the co-pay. Patient - Patient-Centered Outcomes Res. 2017;10(3):295–309. doi: 10.1007/s40271-016-0204-x.
    1. Bullock AJ, Hofstatter EW, Yushak ML, Buss MK. Understanding patients’ attitudes toward communication about the cost of cancer care. J Oncol Pract. 2012;8(4):e50–e58. doi: 10.1200/JOP.2011.000418.
    1. Wong YN, Egleston BL, Sachdeva K, Eghan N, Pirollo M, Stump TK, Beck JR, Armstrong K, Schwartz JS, Meropol NJ. Cancer patients’ trade-offs among efficacy, toxicity, and out-of-pocket cost in the curative and noncurative setting. Med Care. 2013;51(9):838–845. doi: 10.1097/MLR.0b013e31829faffd.
    1. Meropol NJ, Schrag D, Smith TJ, et al. American Society of Clinical Oncology guidance statement: the cost of cancer care. J Clin Oncol. 2009;27. Epub ahead of print. 10.1200/JCO.2009.23.1183.
    1. Henrikson NB, Chang E, Ulrich K, et al. Communication with physicians about health care costs: survey of an insured population. Perm J. 2017;21:1–8.
    1. Kelly RJ, Forde PM, Elnahal SM, Forastiere AA, Rosner GL, Smith TJ. Patients and physicians can discuss costs of cancer treatment in the clinic. J Oncol Pract. 2015;11(4):308–312. doi: 10.1200/JOP.2015.003780.
    1. Politi MC, Yen RW, Elwyn G, Kurien N, Czerwinski SG, Schubbe D, Saunders CH, Durand MA. Encounter decision aids can prompt breast cancer surgery cost discussions: analysis of recorded consultations. Med Decis Mak. 2020;40(1):62–71. doi: 10.1177/0272989X19893308.
    1. Espinoza Suarez NR, LaVecchia CM, Ponce OJ, et al. Using shared decision-making tools and patient-clinician conversations about costs. Mayo Clin Proc Innov Qual Outcomes. 2020;4(4):416–423. doi: 10.1016/j.mayocpiqo.2020.04.013.
    1. Gordon LG, Walker SM, Mervin MC, et al. Financial toxicity: a potential side effect of prostate cancer treatment among Australian men. Eur J Cancer Care (Engl) 2017;26:1–10. doi: 10.1111/ecc.12744.
    1. Mossanen M, Smith AB. Addressing financial toxicity: the role of the urologist. J Urol. 2018;200(1):43–45. doi: 10.1016/j.juro.2017.10.039.
    1. Leopold C, Araujo-Lane C, Rosenberg C, Gilkey M, Wagner AK. Out-of-pocket cancer care costs and value frameworks: a case study in a community oncology practice with a financial navigator program. PharmacoEconomics - Open. 2020;4(2):389–392. doi: 10.1007/s41669-019-0170-z.
    1. Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363. Epub ahead of print. 10.1136/bmj.k1614.
    1. Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017;4:CD001431.
    1. Elwyn G, Lloyd A, Joseph-Williams N, Cording E, Thomson R, Durand MA, Edwards A. Option Grids: shared decision making made easier. Patient Educ Couns. 2013;90(2):207–212. doi: 10.1016/j.pec.2012.06.036.
    1. Evans R, Edwards A, Brett J, Bradburn M, Watson E, Austoker J, Elwyn G. Reduction in uptake of PSA tests following decision aids: systematic review of current aids and their evaluations. Patient Educ Couns. 2005;58(1):13–26. doi: 10.1016/j.pec.2004.06.009.
    1. Watson E, Hewitson P, Brett J, Bukach C, Evans R, Edwards A, Elwyn G, Cargill A, Austoker J. Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men’s knowledge, attitudes and intention to be tested. Patient Educ Couns. 2006;63(3):367–379. doi: 10.1016/j.pec.2006.05.005.
    1. Agoritsas T, Heen AF, Brandt L, et al. Decision aids that really promote shared decision making: the pace quickens. BMJ. 2015;350. Epub ahead of print. 10.1136/bmj.g7624.
    1. Eldefrawy A, Katkoori D, Abramowitz M, et al. Active surveillance vs. treatment for low-risk prostate cancer: a cost comparison. Urol Oncol Semin Orig Investig. 2013;31:576–580.
    1. Hunter WG, Zafar SY, Hesson A, Davis JK, Kirby C, Barnett JA, Ubel PA. Discussing health care expenses in the oncology clinic: analysis of cost conversations in outpatient encounters. J Oncol Pract. 2017;13(11):e944–e956. doi: 10.1200/JOP.2017.022855.
    1. Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013;93(1):102–107. doi: 10.1016/j.pec.2013.05.009.
    1. Agency for Healthcare Research and Quality. Clinician & Group Survey and Instructions, . (Accessed 30 Sept 2016).
    1. Légaré F, Kearing S, Clay K, Gagnon S, D'Amours D, Rousseau M, O'Connor A. Are you SURE?: Assessing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010;56(8):e308–14.
    1. Brehaut JC, O’Connor AM, Wood TJ, et al. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–292. doi: 10.1177/0272989X03256005.
    1. de Souza JA, Yap BJ, Hlubocky FJ, Wroblewski K, Ratain MJ, Cella D, Daugherty CK. The development of a financial toxicity patient-reported outcome in cancer: the COST measure. Cancer. 2014;120(20):3245–3253. doi: 10.1002/cncr.28814.
    1. de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araújo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: the validation of the COmprehensive Score for financial Toxicity (COST) Cancer. 2017;123(3):476–484. doi: 10.1002/cncr.30369.
    1. Légare F, Borduas F, Freitas A, et al. Development of a simple 12-item theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions. PLoS One. 2014;9:1–10. doi: 10.1371/journal.pone.0091013.
    1. O’Connor A, Cranney A. Sample tool: acceptability (osteoporosis therapy). Ottawa Hospital Research Institute. 2000. . (Accessed 25 June 2020).
    1. Chew LD, Griffin JM, Partin MR, Noorbaloochi S, Grill JP, Snyder A, Bradley KA, Nugent SM, Baines AD, VanRyn M. Validation of screening questions for limited health literacy in a large VA outpatient population. J Gen Intern Med. 2008;23(5):561–566. doi: 10.1007/s11606-008-0520-5.
    1. Elwyn G, Durand MA, Song J, et al. A three-talk model for shared decision making: multistage consultation process. BMJ. 2017;359:j4891. doi: 10.1136/bmj.j4891.
    1. Smith KT, Monti D, Mir N, Peters E, Tipirneni R, Politi MC. Access is necessary but not sufficient: factors influencing delay and avoidance of health care services. MDM Policy Pract. 2018;3(1):238146831876029. doi: 10.1177/2381468318760298.
    1. Agency for Healthcare Research and Quality. Number of people with care in thousands by condition. Med Expend Panel Surv. .
    1. Politi MC, Kuzemchak MD, Liu J, et al. Show Me My Health Plans: using a decision aid to improve decisions in the federal health insurance marketplace. MDM Policy Pract. 2016;1(1):2381468316679998.
    1. Hemming K. Sample size calculations for stepped wedge trials using design effects are only approximate in some circumstances. Trials. 2016;17(1):234. doi: 10.1186/s13063-016-1359-4.
    1. Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014;16(1):e2. doi: 10.2196/jmir.3085.

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