Prostate cancer is the second leading cause of cancer death among men in the US.1 and harms Black men disproportionately.2 Prostate cancer comprises nearly one-third of all new cancers in Black men, affecting almost 30,000 men each year. The incidence rate is 70% higher for Black men compared with other racial and ethnic groups, and mortality is 2–3 times higher compared with White men. Low socioeconomic status has been found to be a predictor of poor prostate cancer outcomes, including mortality; however the Black-White disparity persists even when accounting for all of these other factors.3
Prostate cancer mortality has declined since the adoption of PSA screening. While some of this benefit is a result of screening, the exact effect is difficult to quantify.4,5 Although screening unquestionably detects many early stage cancers, over-diagnosis of indolent cancers, leading to over-treatment, remains a significant concern.6,7 The USPSTF recommends an informed decision making, or “shared decision making” (SDM) approach, to PSA screening between men aged 55 to 69 years and their healthcare providers, and other organizations recommend screening Black men at age 40.8 SDM includes three critical steps - information exchange, deliberation, and shared decision - rooted in the ethical principles of autonomy (respect for a patient’s opinions and choices), justice (“what is deserved”) and beneficence (actions to maximize benefit and minimize harm).9,10
While many groups advocate for SDM, including the Institute of Medicine11 and USPSTF,12 it is rarely achieved in clinical practice.13,14 A nationally representative study of men considering PSA screening reported that only half were asked their preferences, and the pros and cons of screening were discussed only 32% of the time.15,16 These studies suggest most prostate cancer screening decisions do not meet criteria for SDM as they lack a balanced discussion of decision consequences and preference clarification. SDM is particularly important for PSA screening among Black men, among whom the balance of risks and benefits is not definitively established but likely favor screening. Black men remain a vulnerable population and the group at highest risk death from prostate cancer.
Decision coaching is the process by which a non-healthcare provider coach “provides a patient with individualized, nondirective guidance to meet decision making needs in preparation for consultation” with a healthcare provider.17 Decision coaching improves incorporation of patients’ values and goals into treatment decisions, promotes SDM, and improves communication between patients and providers.18,19−24 Prior studies have employed nurses as decision coaches and demonstrated improvement in decision making scores but are difficult to disseminate due to cost considerations.25,26 Other studies have attempted to employ lower-cost personnel as decision coaches such as college students27; however, in many instances a decision coach with specific cultural sensitivities is required. A lower-cost, high efficacy decision coach for prostate cancer screening is needed critically.
The CHW model is effective in communities requiring a culturally sensitive, contextualized approach to health promotion and intervention.28,29 The strength of this model is derived from the multi-theoretical roots of community organizing, social support, social networks, self-efficacy, and peer models.28,29 A community health worker is a public health worker that can provide liaison between health services and their community to facilitate access and optimize the quality and cultural competence of services delivered. A CHW intervention can be a low-cost approach to improve community health and well-being and can bridge the cultural and social barriers between underserved communities and the health care system.28,30−32 CHWs are effective in supporting cancer screening decisions in the Black community.33,34 In this randomized control trial, we aim to demonstrate that CHW-led decision coaching can be a feasible, low-cost intervention to improve patient decision making and enhance provider experience.
Objectives
Study Aim
Our study proposes the following specific aims:
1) To test whether a CHW-led decision coaching program affects decision quality, the decision-making process, patient-provider communication, and PSA utilization for Black men in the primary care setting; 2) To assess whether a CHW-led decision coaching program improves provider experience with counseling Black men considering PSA screening.; 3) To determine the cost and budget impact of a CHW-led decision coaching program for PSA screening; 4)To assess participant attitudes, behaviors, and norms around PSA screening and assess perceptions of the feasibility, acceptability, and sustainability of CHW-led decision coaching in the primary care setting.
Study Design
The study is a randomized control trial to evaluate the effectiveness of a CHW-led decision-coaching program to facilitate SDM for prostate cancer screening decisions among Black men at a primary care FQHC. We will enroll 228 Black men aged 40–69 years who are patients at the participating clinical site and the providers who care for them (n = 8). Patients will be randomized to either the intervention or the control arm of the study. Participants in the intervention arm will receive a decision aid by mail and will receive CHW-led decision coaching on PSA screening 1 hour before their appointment, while those in the control arm will still receive the decision aid by mail but will have a CHW-led discussion on cardiovascular dietary and lifestyle modification rather than PSA screening; the discussion of cardiovascular risk reduction will serve as an attention control.
Patients will complete four surveys: 1) baseline at enrollment in the clinic prior to coaching, (2) immediately following coaching, but before provider consultation, (3) following provider consultation, and (4) at 6 months post-clinic visit. Providers at the FQHC will complete three surveys: 1) at study initiation, 2) after each patient encounter, and 3) at study completion immediately before participating in a semi-structured interview that will assess perceptions of the intervention’s acceptability and feasibility. We will explore communication in both patient and provider groups. The protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and fulfills the SPIRIT checklist (see Additional file 1). An overview of the methods is shown in Fig. 1.
Sample size calculation
In determining the recruitment target, we considered the detectable group differences in patient knowledge and decision quality based on pilot study data, differences in PSA screening rates between the control and intervention arms, and expected dropout. In our PSA pilot study, the means for knowledge change were 2.6 (SD = 2.81) and 5.1 (SD = 3.19) in the control and intervention arms, respectively. Using a two-sided Z-test for two proportions, a total group of 182 subjects with 91 subjects in each arm can achieve 80% power to detect a 20% difference in the post-intervention PSA screening rate between control and CHW arms at 5% Type I error. Conservatively, assuming 20% dropout, 228 participants will be recruited to achieve a final sample of 182 (91/arm) patients. This sample size will allow us to be sufficiently powered to detect differences in our primary study outcomes: knowledge, decision quality, and differences in PSA screening.