Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers

Danil V Makarov, Zachary Feuer, Shannon Ciprut, Natalia Martinez Lopez, Angela Fagerlin, Michele Shedlin, Heather T Gold, Huilin Li, Gina Lynch, Rueben Warren, Peter Ubel, Joseph E Ravenell, Danil V Makarov, Zachary Feuer, Shannon Ciprut, Natalia Martinez Lopez, Angela Fagerlin, Michele Shedlin, Heather T Gold, Huilin Li, Gina Lynch, Rueben Warren, Peter Ubel, Joseph E Ravenell

Abstract

Background: Black men are disproportionately affected by prostate cancer, the most common non-cutaneous malignancy among men in the USA. The United States Preventive Services Task Force (USPSTF) encourages prostate-specific antigen (PSA) testing decisions to be based on shared decision-making (SDM) clinician professional judgment, and patient preferences. However, evidence suggests that SDM is underutilized in clinical practice, especially among the most vulnerable patients. The purpose of this study is to evaluate the efficacy of a community health worker (CHW)-led decision-coaching program to facilitate SDM for prostate cancer screening among Black men in the primary care setting, with the ultimate aim of improving/optimizing decision quality.

Methods: We proposed a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening discussions in Black men at a primary care FQHC. This study enrolled Black men who were patients at the participating clinical site and up to 15 providers who cared for them. We estimated to recruit 228 participants, ages 40-69 to be randomized to either (1) a decision aid along with decision coaching on PSA screening from a CHW or (2) receiving a decision aid along with CHW-led interaction on modifying dietary and lifestyle to serve as an attention control. The independent randomization process was implemented within each provider and we controlled for age by dividing patients into two strata: 40-54 years and 55-69 years. This sample size sufficiently powered the detection differences in the primary study outcomes: knowledge, indicative of decision quality, and differences in PSA screening rates. Primary outcome measures for patients will be decision quality and decision regarding whether to undergo PSA screening. Primary outcome measures for providers will be acceptability and feasibility of the intervention. We will examine how decision coaching about prostate cancer screening impact patient-provider communication. These outcomes will be analyzed quantitatively through objective, validated scales and qualitatively through semi-structured, in-depth interviews, and thematic analysis of clinical encounters. Through a conceptual model combining elements of the Preventative Health Care Model (PHM) and Informed Decision-Making Model, we hypothesize that the prostate cancer screening decision coaching intervention will result in a preference-congruent decision and decisional satisfaction. We also hypothesize that this intervention will improve physician satisfaction with counseling patients about prostate cancer screening.

Discussion: Decision coaching is an evidence-based approach to improve decision quality in many clinical contexts, but its efficacy is incompletely explored for PSA screening among Black men in primary care. Our proposal to evaluate a CHW-led decision-coaching program for PSA screening has high potential for scalability and public health impact. Our results will determine the efficacy, cost-effectiveness, and sustainability of a CHW intervention in a community clinic setting in order to inform subsequent widespread dissemination, a critical research area highlighted by USPSTF.

Trial registration: The trial was registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration number NCT03726320 , on October 31, 2018.

Keywords: Community health worker; PSA; Prostate cancer; Racial disparity; Randomized controlled trial; Screening; Shared decision-making.

Conflict of interest statement

The authors have no financial or non-financial competing interests to be declared.

Figures

Fig. 1
Fig. 1
Overview of the methods
Fig. 2
Fig. 2
Quantitative patient measures
Fig. 3
Fig. 3
Quantitative provider measures

References

    1. Cronin KA, Lake AJ, Scott S, Sherman RL, Noone AM, Howlader N, et al. Annual report to the nation on the status of cancer, part I: national cancer statistics. Cancer. 2018;124(13):2785–2800. doi: 10.1002/cncr.31551.
    1. American Cancer Society. Cancer Facts & Figures for African Americans 2019-2021. Am Cancer Soc 2019. Available from: . Accessed 18 Sept 2019.
    1. Du XL, Fang S, Coker AL, Sanderson M, Aragaki C, Cormier JN, et al. Racial disparity and socioeconomic status in association with survival in older men with local/regional stage prostate carcinoma. Cancer. 2006;106(6):1276–1285. doi: 10.1002/cncr.21732.
    1. Sandblom G, Varenhorst E, Rosell J, Löfman O, Carlsson P. Randomised prostate cancer screening trial: 20 year follow-up. BMJ. 2011;342:d1539. doi: 10.1136/bmj.d1539.
    1. Kjellman A, Akre O, Norming U, Törnblom M, Gustafsson O. 15-year followup of a population based prostate cancer screening study. J Urol. 2009;181(4):1615–1621. doi: 10.1016/j.juro.2008.11.115.
    1. Testing for Prostate Cancer. In: American Cancer Society; 2015. . Accessed 30 Sept 2019.
    1. Taylor KL, Davis JL, Turner RO, Johnson L, Schwartz MD, Kerner JF, et al. Educating African American men about the prostate cancer screening dilemma: a randomized intervention. Cancer Epidemiol Biomark Prev. 2006;15(11):2179–2188. doi: 10.1158/1055-9965.EPI-05-0417.
    1. American Urological Association. Early Detection of Prostate Cancer (2018) [Internet]. American Urological Association. 2018. Available from . Accessed 30 Sept 2019.
    1. National Commision for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research [Internet]. Bethesda: The Commission; 1979 [cited 2019 Sep 18]. Available from .
    1. Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango) Soc Sci Med. 1997;44(5):681–692. doi: 10.1016/S0277-9536(96)00221-3.
    1. Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the quality chasm: a new health system for the 21st century. Washington DC: National Academies Press (US); 2001. Available from . Accessed 30 Sept 2019
    1. Published Final Recommendation Summary: prostate cancer: screening. US Preventive Services Task Force 2018. . Accessed 30 Sep 2019.
    1. Makarov DV, Chrouser K, Gore JL, Maranchie J, Nielsen M, et al. AUA white paper on implementation of shared decision making into urological practice. Urology Practice. 2016;3(5):355–363. doi: 10.1016/j.urpr.2015.10.006.
    1. Legare F, Elwyn G, Fishbein M, Fremont P, Frosch D, Gagnon MP, et al. Translating shared decision-making into health care clinical practices: proof of concepts. Implement Sci. 2008;3:2. doi: 10.1186/1748-5908-3-2.
    1. Hoffman RM, Lewis CL, Pignone MP, Couper MP, Barry MJ, Elmore JG, et al. Decision-making processes for breast, colorectal, and prostate cancer screening: the DECISIONS survey. Med Decis Mak. 2010;30(5 Suppl):53S–64S. doi: 10.1177/0272989X10378701.
    1. Hoffman RM, Couper MP, Zikmund-Fisher BJ, et al. Prostate cancer screening decisions: results from the National Survey of Medical decisions (DECISIONS study) Arch Intern Med. 2009;169(17):1611–1618. doi: 10.1001/archinternmed.2009.262.
    1. Stacey D, Kryworuchko J, Bennett C, Murray MA, Mullan S, Légaré F. Decision coaching to prepare patients for making health decisions a systematic review of decision coaching in trials of patient decision aids. Med Decis Mak. 2012;32(3):E22–E33. doi: 10.1177/0272989X12443311.
    1. Sepucha KR, Belkora JK, Tripathy D, Esserman LJ. Building bridges between physicians and patients: results of a pilot study examining new tools for collaborative decision making in breast cancer. J Clin Oncol. 2000;18(6):1230–1238. doi: 10.1200/JCO.2000.18.6.1230.
    1. Haywood K, Marshall S, Fitzpatrick R. Patient participation in the consultation process: a structured review of intervention strategies. Patient Educ Couns. 2006;63(1–2):12–23. doi: 10.1016/j.pec.2005.10.005.
    1. Cegala DJ. Emerging trends and future directions in patient communication skills training. Health Commun. 2006;20(2):123–129. doi: 10.1207/s15327027hc2002_3.
    1. Cegala DJ, Post DM. On addressing racial and ethnic health disparities: the potential role of patient communication skills interventions. Am Behav Sci. 2006;49(6):853–867. doi: 10.1177/0002764205283805.
    1. Street RL, Jr, Slee C, Kalauokalani DK, Dean DE, Tancredi DJ, Kravitz RL. Improving physician-patient communication about cancer pain with a tailored education-coaching intervention. Patient Educ Couns. 2010;80(1):42–47. doi: 10.1016/j.pec.2009.10.009.
    1. Davison BJ, Degner LF. Empowerment of men newly diagnosed with prostate cancer. Cancer Nurs. 1997;20(3):187–196. doi: 10.1097/00002820-199706000-00004.
    1. Griffin SJ, Kinmonth AL, Veltman MW, Gillard S, Grant J, Stewart M. Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials. Ann Fam Med. 2004;2(6):595–608. doi: 10.1370/afm.142.
    1. Myers RE, Daskalakis C, Kunkel EJ, Cocroft JR, Riggio JM, Capkin M, et al. Mediated decision support in prostate cancer screening: a randomized controlled trial of decision counseling. Patient Educ Couns. 2011;83(2):240–246. doi: 10.1016/j.pec.2010.06.011.
    1. Myers RE, Daskalakis C, Cocroft J, Kunkel EJ, Delmoor E, Liberatore M, et al. Preparing African-American men in community primary care practices to decide whether or not to have prostate cancer screening. J Natl Med Assoc. 2005;97(8):1143–1154.
    1. Belkora J, Volz S, Loth M, Teng A, Zarin-Pass M, Moore D, et al. Coaching patients in the use of decision and communication aids: RE-AIM evaluation of a patient support program. BMC Health Serv Res. 2015;15:209. doi: 10.1186/s12913-015-0872-6.
    1. Love MB, Gardner K, Legion V. Community health workers: who they are and what they do. Health Educ Behav. 1997;24(4):510–522. doi: 10.1177/109019819702400409.
    1. Wilson K, Brownstein J, Blanton C. Centers for Disease Control and Prevention. Community health advisors/community health workers: selected annotations and programs in the United States, Vol. III. Atlanta: Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion; 1998. Community health advisor use: insights from a national survey; pp. 11–19.
    1. Pew Health Professions Commission . Community health workers: integral yet often overlooked members of the health care workforce. San Francisco: University of California at San Francisco Center for Health Professions; 1994.
    1. Brownstein JN, Bone LR, Dennison CR, Hill MN, Kim MT, Levine DM. Community health workers as interventionists in the prevention and control of heart disease and stroke. Am J Prev Med. 2005;29(5):128–133. doi: 10.1016/j.amepre.2005.07.024.
    1. Boyd AS, Wilmoth MC. An innovative community-based intervention for African American women with breast cCancer: the witness project. Health Soc Work. 2006;31(1):77–80. doi: 10.1093/hsw/31.1.77.
    1. Shelton RC, Dunston SK, Leoce N, Jandorf L, Thompson HS, Erwin DO. Advancing understanding of the characteristics and capacity of African American women who serve as lay health advisors in community-based settings. Health Educ Behav. 2017;44(1):153–164. doi: 10.1177/1090198116646365.
    1. Walter LC, Bertenthal D, Lindquist K, Konety BR. PSA screening among elderly men with limited life expectancies. JAMA. 2006;296(19):2336–2342. doi: 10.1001/jama.296.19.2336.
    1. Gökce MI, Wang X, Frost J, Roberson P, Volk R, Brooks D, et al. Informed decision making before prostate-specific antigen screening: initial results using the American Cancer Society (ACS) decision aid (DA) among medically underserved men. Cancer. 2017;123(4):583–591. doi: 10.1002/cncr.30367.
    1. Myers RE. Decision counseling in cancer prevention and control. Health Psychol. 2005;24(4S):S71–S77. doi: 10.1037/0278-6133.24.4.S71.
    1. American Heart Association. Life’s Simple 7. 2020. . Accessed 25 Feb 2020.
    1. Sepucha K, Ozanne E, Silvia K, Partridge A, Mulley AG., Jr An approach to measuring the quality of breast cancer decisions. Patient Educ Couns. 2007;65(2):261–269. doi: 10.1016/j.pec.2006.08.007.
    1. Marteau TM, Dormandy E, Michie S. A measure of informed choice. Health Expect. 2001;4(2):99–108. doi: 10.1046/j.1369-6513.2001.00140.x.
    1. Watson E, Hewitson P, Brett J, Bukach C, Evans E, Edwards A, et al. 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. Fenstermaker M, Hickman T, Gold H, Makarov D, Loeb S, Cole H, et al. Abstract A15: how does doctor-patient communication about prostate cancer screening influence African-American patients' decisional conflict around screening decisions? Cancer Epidemiol Biomark Prev. 2016; 10.1158/1538-7755.DISP15-A15.
    1. Edwards A, Elwyn G, Hood K, Robling M, Atwell C, Holmes-Rovner M, et al. The development of COMRADE--a patient-based outcome measure to evaluate the effectiveness of risk communication and treatment decision making in consultations. Patient Educ Couns. 2003;50(3):311–322. doi: 10.1016/S0738-3991(03)00055-7.
    1. Campbell C, Lockyer J, Laidlaw T, Macleod H. Assessment of a matched-pair instrument to examine doctor-patient communication skills in practising doctors. Med Educ. 2007;41(2):123–129. doi: 10.1111/j.1365-2929.2006.02657.x.
    1. O’Connor AM. User Manual - Decision Self-Efficacy Scale. 1995. . Accessed 18 Sep 2019.
    1. Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-physician interactions (PEPPI): validation of an instrument in older persons. J Am Geriatr Soc. 1998;46(7):889–894. doi: 10.1111/j.1532-5415.1998.tb02725.x.
    1. Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, et al. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Mak. 1996;16(1):58–64. doi: 10.1177/0272989X9601600114.
    1. Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, et al. Validation of a decision regret scale. Med Decis Mak. 2003;23(4):281–292. doi: 10.1177/0272989X03256005.
    1. O'Connor AM. Validation of a decisional conflict scale. Med Decis Mak. 1995;15(1):25–30. doi: 10.1177/0272989X9501500105.
    1. Shore BE, Franks P. Physician satisfaction with patient encounters: reliability and validity of an encounter-specific questionnaire. Med Car. 1986;24(7):580–589. doi: 10.1097/00005650-198607000-00002.
    1. Bertram DA, Opila DA, Brown JL, Gallagher SJ, Schifeling RW, Snow IS, et al. Measuring physician mental workload: reliability and validity assessment of a brief instrument. Med Care. 1992;30(2):95–104. doi: 10.1097/00005650-199202000-00001.
    1. Ritzwoller DP, Sukhanova A, Gaglio B, Glasgow RE. Costing behavioral interventions: a practical guide to enhance translation. Ann Behav Med. 2009;37(2):218–227. doi: 10.1007/s12160-009-9088-5.
    1. Gary TL, Batts-Turner M, Bone LR, Yeh HC, Wang NY, Hill-Briggs F, et al. A randomized controlled trial of the effects of nurse case manager and community health worker team interventions in urban African-Americans with type 2 diabetes. Control Clin Trials. 2004;25(1):53–66. doi: 10.1016/j.cct.2003.10.010.
    1. Vetter MJ, Bristow L, Ahrens J. A model for home care clinician and home health aide collaboration: diabetes care by nurse case managers and community health workers. Home Healthc Nurse. 2004;22(9):645–648. doi: 10.1097/00004045-200409000-00014.
    1. Staten LK, Gregory-Mercado KY, Ranger-Moore J, Will JC, Giuliano AR, Ford ES, et al. Provider counseling, health education, and community health workers: the Arizona WISEWOMAN project. J Women's Health. 2004;13(5):547–556. doi: 10.1089/1540999041281133.
    1. Aubert RE, Herman WH, Waters J, Moore W, Sutton D, Peterson BL, et al. Nurse case management to improve glycemic control in diabetic patients in a health maintenance organization. A randomized, controlled trial. Ann Intern Med. 1998;129(8):605–612. doi: 10.7326/0003-4819-129-8-199810150-00004.
    1. Kim K, Choi JS, Choi E, Nieman CL, Joo JH, Lin FR, et al. Effects of community-based health worker interventions to improve chronic disease management and care among vulnerable populations: a systematic review. Am J Public Health. 2016;106(4):e3–e28. doi: 10.2105/AJPH.2015.302987.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa