Designing a theory-based intervention to improve the ...

Urologic Oncology: Seminars and Original Investigations ] (2018) ∎∎∎–∎∎∎

Seminars article

Designing a theory-based intervention to improve the guideline-concordant use of imaging to stage incident prostate cancer Shannon Ciprut, M.H.S.a,b,c, Erica Sedlander, M.P.H.d, Kara L. Watts, M.D.e, Richard S. Matulewicz, M.D., M.S.f, Kurt C. Stange, M.D., Ph.D.g, Scott E. Sherman, M.D., M.P.H.a,c,h, Danil V. Makarov, M.D., M.H.S.a,b,c,h,i,* a

VA New York Harbor Healthcare System, New York University, New York, NY b Department of Urology, New York University, New York, NY c Department of Population Health, New York University, New York, NY d Department of Prevention and Community Health, George Washington University, Milken Institute School of Public Health, Washington, D.C e Department of Urology, Montefiore Medical Center, Bronx, NY f Department of Urology, Northwestern University, Chicago IL g Department of Family Medicine and Community Health, Case Western Reserve University, Cleveland, OH h New York University Cancer Institute, New York University, New York, NY i Robert F. Wagner Graduate School of Public Service, New York University, New York, NY Received 14 September 2017; received in revised form 11 December 2017; accepted 24 December 2017

Abstract Among US men, most new prostate cancer cases are clinically localized and do not require imaging as part of staging workup according to guidelines. Two leading specialty societies promote stewardship of health resources by encouraging guideline-concordant care, thereby limiting inappropriate and obsolete imaging. However, imaging to stage low-risk prostate cancer remains high, as almost half of men with localized prostate cancer undergo wasteful imaging following diagnosis. We employed a theory-based approach, based on current evidence and data on existing practice patterns revealing that providers are the drivers to imaging decisions, to design an intervention to improve guideline -concordant prostate cancer staging imaging across populations. We conceptualized preliminary results using the theoretical domains framework and the behavior change wheel, frameworks used concurrently to investigate physicians′ behaviors and intervention design in various clinical settings. Through these 2 frameworks, we designed a theory-based, physician-focused intervention to efficiently encourage guideline-concordant prostate cancer imaging, prostate cancer imaging stewardship (PCIS). Prostate cancer imaging stewardship consists of interventions (clinical order check, academic detailing, and audit and feedback) implemented at the individual, facility, and system level to enact provider behavior change by enabling facilitators and appealing to physician motivation. Published by Elsevier Inc. Keywords: prostate cancer; imaging; implementation; guidelines; Theoretical Domains Framework; Behavior Change Wheel

Introduction Funding: Funding for this study was provided by the United States Department of Veterans Affairs, Veterans Health Administration, Health Services Research, and Development Service. Dr. Makarov is a VA HSR&D Career Development Awardee at the Manhattan VHA (grant numbers CDA11-257 & CDP 11-254). The Edward Blank and Sharon Cosloy-Blank Family Foundation, The Gertrude and Louis Feil Family Charitable Lead Trust, the New York State Prostate Cancer Research Grant, and The NCI Cancer Center Support Grant P30CA016087 also contributed to the funding of this study. The views expressed in this article are those of the author(s) and do not necessarily represent the views of the Department of Veterans Affairs. * Corresponding author. Tel.: þ1-212-263-4961; fax: þ1-212-263-4983. E-mail address: [email protected] (D.V. Makarov).

Nearly half of men with low-volume, low-stage, prostate cancer (the most common noncutaneous malignancy among US men) undergo inappropriate, wasteful imaging as part of their staging workup [1]. Guideline-discordant prostate cancer imaging varies among different settings, but is rampant across health care systems [1–4]. Before widespread prostate-specific antigen screening, most incident cases were diagnosed at an advanced stage, requiring radiographic staging before treatment. For 2 decades following the advent of prostate-specific antigen screening,

https://doi.org/10.1016/j.urolonc.2017.12.019 1078-1439/r 2018 Published by Elsevier Inc.

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S. Ciprut et al. / Urologic Oncology: Seminars and Original Investigations ] (2018) ∎∎∎–∎∎∎

most new prostate cancer cases have been diagnosed at a clinically localized stage. There is near unanimous agreement that routine radiographic staging is obsolete [5] because of its lack of utility and its potential harm. In spite of efforts to curb this practice, the routine use of imaging to stage low-risk prostate cancer remains high. The American Urological Association (AUA) and the American Society of Clinical Oncology (ASCO) continue to promote stewardship of health care resources and have made persistent attempts to reduce inappropriate prostate cancer imaging through campaigns such as “Choosing Wisely” [6,7]. Prior quality improvement efforts seeking to limit rates of inappropriate imaging utilized in prostate cancer staging have been based on common sense strategies aimed at behavioral modifications, rather than theory-based behavioral psychology [8,9]. Many tools in common use are not evidence-based and have demonstrated mixed results: that is, successfully decreasing inappropriate imaging but simultaneously and unintentionally decreasing appropriate imaging [9]. Moreover, those previous efforts were only partially effective in decreasing inappropriate imaging for low-risk patients. Therefore, based on current evidence and data on existing practice patterns, we employed a theory-based approach to design an intervention to improve guideline-concordant prostate cancer staging imaging across populations. Our goal was to develop a widely transportable method to inform clinicians, policymakers, and patients interested in selectively using imaging to guide initial treatment decisions for men with newly diagnosed low-risk prostate cancer.

Approach to intervention design We used the Veterans Health Administration Quality Enhancement Research Initiative (VA QUERI) [10] process to

guide data collection and subsequent intervention design. QUERI is a program that promotes the systematic translation of research data to intervention implementation with the goal to improve health care practices and outcomes. To begin the QUERI process, we initially identified a high-volume problem: the inappropriate overuse of imaging among men with low-risk prostate cancer. Next, we identified best practices through a synthesis of recommendations pertaining to imaging use for the specific patient population from various professional societies [11,12], including the National Comprehensive Cancer Network (NCCN) and AUA [5]. We then defined existing practice patterns and their deviation from best practices by performing a quantitative documentation of the prevalence and correlates of guideline-discordant prostate cancer imaging rates across VHA [4]. While these quantitative data provided the foundation for describing the scope of the problem and to generate hypotheses regarding its causes, they were unable to definitively explain this behavior; a type of insight than only quantitative data could offer. We sought to evaluate the motivations behind the behaviors of physicians and patients as well as to a framework to translate those insights into concrete, feasible behavior change interventions to promote best practices. Results were conceptualized using the relevant domains of the theoretical domains framework (TDF) [13] and the behavior change wheel (BCW) [14]. The research team that developed the TDF report that evidence-based guidelines tend to fail to be applied because of poor understanding of the processes involved in physician behavior change (Fig. 1) [13,15]. They describe a consensus theoretical framework for use in developing strategies for implementation research including 14 domains to explain behavior: (1) knowledge, (2) skills, (3) social/professional role and identity, (4) beliefs about capabilities, (5) optimism, (6)

Fig. 1. The theoretical domains framework [13]. (Color version of the figure available online.)

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beliefs about consequences, (7) reinforcement, (8) intentions, (9) goals, (10) memory, attention, and decision processes, (11) environmental context and resources, (12) social influences, (13) emotion, and (14) behavioral regulation [13,16]. TDF has been validated and used to affect provider behavior across a variety of health systems, particularly where barriers to implementation are characterized with qualitative data [16]. The BCW is a comprehensive, multilevel synthesis of 19 existing behavior change frameworks representing intervention tactics influencing individual behavior that can be used to influence population health (Fig. 2). The 3 major levels are sources of behavior, intervention function, and policy categories, with the innermost representing the individual. T [17]. At this individual level, capability (psychological and physical), opportunity (within social and physical environment), and motivation (automatic and reflective) influence each other and serve as drivers of individual behavior. At the second level, interventions can be mapped to influence each of these elements, including education, persuasion, incentivization, and enablement. Each of these intervention methods can ultimately affect policy at the population level, the third and outermost layer of the wheel, including guidelines, service provision, and regulation. This combination of theoretical frameworks provides a deep understanding of key behaviors as well as the optimal interventions to change those behaviors in the effort to improve population health. The BCW and TDF have been used in conjunction to investigate physicians’ behaviors and intervention design in various clinical settings;[18–20] together, they can function synergistically: TDF provides a specific understanding of the key behaviors while BCW provides an understanding of interventions to target behavior change.

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Preliminary work to develop the intervention We have previously investigated and reported quantitative demonstrations of wide variation in prostate cancer imaging practices [1]. Inappropriate imaging rates among men with low-risk prostate cancer have been reported as high as 19% to 74% in a community cohort, 10% to 48% in a SEERMedicare cohort and 41% in VHA [2–4,21]. While these rates are high, there is a concomitant significant underuse of appropriate imaging among men diagnosed with high-risk disease. In a SEER-Medicare cohort of men with high-risk prostate cancer, for whom a bone scan and abdominal computed tomography are indicated by AUA guidelines, 70% to 75% and 57% to 58% underwent bone scan and abdominal computed tomography scans, respectively. for a total rate of 66% receiving guideline-concordant appropriate imaging. Within the VHA the combined rate of appropriate imaging among men with high-risk prostate cancer averages 70% [2,21]. The specific drivers of the behaviors creating these practice gaps were unknown at the time. With these data establishing prostate cancer staging imaging as a problem, we explored barriers and facilitators to guideline-concordant imaging using a theory-based, qualitative approach. We conducted 39 semistructured interviews, including a sample of 22 patients and 17 physicians with varying clinical practices from 3 high-volume Veteran's Health Administration (VA) medical centers. Key themes explored included physician knowledge, attitudes, and practices related to the use of imaging to stage prostate cancer, and patient attitudes and behaviors related to the use of imaging. Through a series of in-depth interviews with a diverse sample of prostate cancer patients and clinicians, we discovered that prostate cancer patients report a high degree of trust in their physicians and report little concern about

Fig. 2. The behavior change wheel [14]. (Color version of the figure available online.)

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S. Ciprut et al. / Urologic Oncology: Seminars and Original Investigations ] (2018) ∎∎∎–∎∎∎

risks of radiographic staging. Physicians report trust in imaging guidelines but also a high degree of self-efficacy to disregard them, especially among more senior practitioners. Our findings have suggested a discrepancy between early career physicians, who felt that clinical practice would benefit from adherence to stricter protocols, and more senior physicians, who felt that medicine was an art that could not be protocolized [21]. We used TDF in an exploration of barriers to guideline-concordant prostate cancer imaging and found the 5 most important domains among physicians were (1) beliefs about capabilities, (2) knowledge, (3) social influences, (4) beliefs about consequences, and (5) environmental context and resources [21]. This suggested that a theory-based, physician-focused intervention could effectively and efficiently encourage guideline-concordant prostate cancer imaging. However, the specifics of such an intervention were not defined. In order to develop an intervention addressing the 5 specific TDF domains driving prostate cancer imaging, we applied the BCW to map the relevant domains to effective interventions [14]. We focused our efforts on the following BCW intervention functions: education, persuasion, modeling, enablement, coercion, and incentivization. This constellation was appealing because it covered a broad array of evidence-based physician behavior change interventions and also seemed to have strong face validity when considering what types of interventions might be effective in convincing physicians to adhere to guidelines.

Intervention to improve guideline-concordant imaging Combining these 2 frameworks, we designed a theorybased, physician-focused intervention to efficiently encourage guideline-concordant prostate cancer imaging. The prostate cancer imaging stewardship intervention (PCIS) is a multilevel combination of 3 evidence-based interventions (computer-based clinical order check, audit and feedback, academic detailing) designed to improve guideline-concordant prostate cancer imaging in an additive manner [22]. This strategy is consistent with the data that we generated [23] and is likely to be successful because it relies on multiple interventions [24] and has a theoretical rationale for why these interventions would be effective together [22]. The PCIS intervention, outlined in Fig. 3, consists of interventions implemented at the individual, facility, and system level to enact provider behavior change by appealing to physician motivation. A clinical order check is an evidence-based, systems-level method to effect behavior change [25–28]. The order check is a pop-up notification that appears in the local electronic health record when a provider attempts to order a potentially guideline-discordant bone scan or other imaging of the abdomen or pelvis. Guideline reminder statements appear, addressing the education function. To fulfill the order, the provider must circumvent the “soft-stop” and explain reasons for doing so.

Fig. 3. The PCIS intervention.

This practice exemplifies the functions of enablement and incentivization of appropriate imaging practices through active discouragement of inappropriate orders. Upon implementing this feature, the number of opt outs and their qualitative justifications should be extracted electronically for analysis. The strategy is technologically simple, straightforward, and is considered to be a best practice [29]. Audit and feedback is an effective individual-level intervention for changing health care provider behavior resulting in small but potentially clinically important benefits [22,30]. Audit and feedback consists of examining an individual provider’s imaging patterns, evaluating orders for appropriateness, and providing a feedback report that demonstrates the rates of inappropriate and appropriate imaging. To optimally engage providers through persuasion and incentivization, the report should also contain benchmarks to institutional and national imaging rates. Moreover, the report serves as an educational tool. Audit and feedback capitalizes upon these BCW intervention functions addressing beliefs about capabilities and consequences, knowledge, and social influence determined to be crucial TDF domains in our preliminary qualitative work [21,31]. Academic detailing, also known as educational outreach, is an individual and facility-level intervention with consistent evidence of provider behavior improvements [22,32]. These sessions may occur periodically throughout the intervention period and remind providers of fundamental guideline details, in turn encouraging providers to discuss difficult clinical cases with their peers. This strategy addresses the BCW intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by the following TDF domains: beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources [21,31,33].

Rationale for planned implementation Individually, the 3 described intervention strategies are known to demonstrate a modest effect on provider behavior [26,30,32]. Previous studies detailing implementation efforts of the individual intervention strategies have demonstrated feasibility as well as moderate behavior change with the intent of limiting a behavior among a population of health care providers [34–38]. An implementation assessment of a combination of provider-focused interventions within a smoking cessation program helped to refine our

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S. Ciprut et al. / Urologic Oncology: Seminars and Original Investigations ] (2018) ∎∎∎–∎∎∎

strategies to enhance participation and uptake [29,39]. Each intervention strategy focuses on all 3 factors (capability, opportunity, motivation) that drive behavior within the COM-B model [17]. This synergistic strategy is theoretically more effective and efficient than implementation of each intervention alone, but our empiric understanding of the efficacy, acceptability, and sustainability of this process is limited [22,40,41]. We will explicitly evaluate these domains upon implementation [26]. Our intervention addresses several gaps in implementation science to improve urologic health care. Notably, the utilization of our evidence-based behavioral interventions as a multilevel package has not yet been evaluated in terms of empirical efficacy among a population of surgeons [22,26,30,32]. Previous reports of implementation efforts often focused on primary care physicians and rarely on surgical subspecialists [26,30,32]. Previous efforts to curb inappropriate prostate cancer imaging have reported only system-level, quantitative data, ignoring the experiences of providers [42]. We will explicitly explore these physicianlevel data, critical for future dissemination, using a mixed methods approach, including qualitative interviews with providers. Additionally, prior analyses of prostate cancer imaging guideline implementation efforts were either retrospective [42] or lacked a control group [8,9]. Results may be affected by unmeasured confounding or secular trends. Due to the prospective nature of our study design, we will assess the existence of a causal association between the behavioral intervention and facility-level guideline-concordant imaging. At this time, optimal methods of PCIS implementation are unclear. Throughout the implementation process in clinical settings, we will record and discuss important lessons learned with regard to our initial approach. These experiences will lead us to develop the most efficient strategies and procedures for future implementation and dissemination.

Conclusion A behavioral intervention is well-suited to optimize appropriate imaging, grounded in conceptual framework for intervention design. The combined understanding of our exploratory investigation through the TDF and BCW has allowed us to develop a comprehensive, theory-based intervention strategy to target behavior by enabling facilitators and mitigating barriers for behavior change specific to urologic providers.

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