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Protocol: A multi-modal, physician-centered intervention to improve guideline-concordant prostate cancer imaging

Makarov, Danil V; Ciprut, Shannon; Kelly, Matthew; Walter, Dawn; Shedlin, Michele G; Braithwaite, Ronald Scott; Tenner, Craig T; Gold, Heather T; Zeliadt, Steven; Sherman, Scott E
BACKGROUND:Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer. METHODS:We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites. DISCUSSION/CONCLUSIONS:This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed. TRIAL REGISTRATION/ NCT03445559. Prospectively registered on February 26, 2018.
PMID: 34663435
ISSN: 1745-6215
CID: 5037252

Evaluating Quality Improvement and Patient Safety Amongst Practicing Urologists: Analysis of the 2018 American Urological Association Census

Li, Kevin D; Hakam, Nizar; Sadighian, Michael J; Holler, Jordan T; Nabavizadeh, Behnam; Amend, Gregory M; Fang, Raymond; Meeks, William; Makarov, Danil; Breyer, Benjamin N
OBJECTIVE:To describe factors associated with Quality improvement and patient safety (QIPS) participation using 2018 American Urological Association Census data. QIPS have become increasingly important in medicine. However, studies about QIPS in urology suggest low levels of participation, with little known about factors predicting non-participation. METHODS:Results from 2339 census respondents were weighted to estimate 12,660 practicing urologists in the United States. Our primary outcome was participation in QIPS. Predictor variables included demographics, practice setting, rurality, fellowship training, QIPS domains in practice, years in practice, and non-clinical/clinical workload. RESULTS:QIPS participants and non-participants significantly differed in distributions of age (P = .0299), gender (P = .0013), practice setting (P <.0001), employment (employee vs partner vs owner vs combination; P <.0001), and fellowship training (P <.0001). QIPS participants reported fewer years in practice (21.3 vs 25.9, P = .018) and higher clinical (45.2 vs 39.2, P = .022) and non-clinical (8.76 vs 5.28, P = .002) work hours per week. Non-participation was associated with male gender (OR = 2.68, 95% CI 1.03-6.95) and Asian race (OR = 2.59, 95% CI 1.27-5.29) for quality programs and private practice settings (ORs = 8.72-27.8) for patient safety initiatives. CONCLUSION/CONCLUSIONS:QIPS was associated with academic settings. Interventions to increase rates of quality and safety participation should target individual and system-level factors, respectively. Future work should discern barriers to QIPS engagement and its clinical benefits.
PMID: 34331999
ISSN: 1527-9995
CID: 4988422

COVID-19 outcomes in hospitalized patients with active cancer: Experiences from a major New York City health care system

Fu, Chen; Stoeckle, James H; Masri, Lena; Pandey, Abhishek; Cao, Meng; Littman, Dalia; Rybstein, Marissa; Saith, Sunil E; Yarta, Kinan; Rohatgi, Abhinav; Makarov, Danil V; Sherman, Scott E; Morrissey, Christy; Jordan, Alexander C; Razzo, Beatrice; Theprungsirikul, Poy; Tsai, Joseph; Becker, Daniel J
BACKGROUND:The authors sought to study the risk factors associated with severe outcomes in hospitalized coronavirus disease 2019 (COVID-19) patients with cancer. METHODS:The authors queried the New York University Langone Medical Center's records for hospitalized patients who were polymerase chain reaction-positive for severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) and performed chart reviews on patients with cancer diagnoses to identify patients with active cancer and patients with a history of cancer. Descriptive statistics were calculated and multivariable logistic regression was used to determine associations between clinical, demographic, and laboratory characteristics with outcomes, including death and admission to the intensive care unit. RESULTS:A total of 4184 hospitalized SARS CoV-2+ patients, including 233 with active cancer, were identified. Patients with active cancer were more likely to die than those with a history of cancer and those without any cancer history (34.3% vs 27.6% vs 20%, respectively; P < .01). In multivariable regression among all patients, active cancer (odds ratio [OR], 1.89; CI, 1.34-2.67; P < .01), older age (OR, 1.06; CI, 1.05-1.06; P < .01), male sex (OR for female vs male, 0.70; CI, 0.58-0.84; P < .01), diabetes (OR, 1.26; CI, 1.04-1.53; P = .02), morbidly obese body mass index (OR, 1.87; CI, 1.24-2.81; P < .01), and elevated D-dimer (OR, 6.41 for value >2300; CI, 4.75-8.66; P < .01) were associated with increased mortality. Recent cancer-directed medical therapy was not associated with death in multivariable analysis. Among patients with active cancer, those with a hematologic malignancy had the highest mortality rate in comparison with other cancer types (47.83% vs 28.66%; P < .01). CONCLUSIONS:The authors found that patients with an active cancer diagnosis were more likely to die from COVID-19. Those with hematologic malignancies were at the highest risk of death. Patients receiving cancer-directed therapy within 3 months before hospitalization had no overall increased risk of death. LAY SUMMARY/UNASSIGNED:Our investigators found that hospitalized patients with active cancer were more likely to die from coronavirus disease 2019 (COVID-19) than those with a history of cancer and those without any cancer history. Patients with hematologic cancers were the most likely among patients with cancer to die from COVID-19. Patients who received cancer therapy within 3 months before hospitalization did not have an increased risk of death.
PMID: 34096048
ISSN: 1097-0142
CID: 4899602

Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers

Makarov, Danil V; Ciprut, Shannon; Martinez-Lopez, Natalia; Fagerlin, Angela; Thomas, Jerry; Shedlin, Michele; Gold, Heather T; Li, Huilin; Bhat, Sandeep; Warren, Rueben; Ubel, Peter; Ravenell, Joseph E
We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.
PMID: 34426097
ISSN: 2405-4569
CID: 5061072

Population-Level Assessment of Smoking-Related Beliefs and Behaviors Among Survivors of Genitourinary Cancers: An Application of the Theory of Planned Behavior

Brake, Lee; Myrie, Akya; Zhao, Calvin; Feuer, Zach; Taylor, Jacob; Bjurlin, Marc A; Sherman, Scott E; Makarov, Danil V; Matulewicz, Richard S
OBJECTIVE:To describe attitudes, perceptions, and beliefs related to smoking and smoking cessation among survivors of genitourinary cancers using a theory-based framework. METHODS:We performed a cross-sectional analysis of Wave III of the PATH study, a prospective cohort survey study assessing tobacco-use patterns and attitudes among a representative population-based sample of US adults. All adult current smokers with a history of urologic cancer were included. Primary outcomes were mapped to components of the Theory of Planned Behavior (TPB) and included: attempts to quit, readiness to quit, plan to quit, being told to quit, peers views toward smoking, regret about smoking, the perceived relationship between smoking and cancer/overall health. Secondary outcomes include: time to first cigarette, utilization of smoking cessation aids. Population weighted percentages with 95% confidence intervals were estimated. RESULTS:Our cohort represents a population estimate of 461,182 adult current smokers with a history of genitourinary cancer. The majority of respondents (90%) perceived smoking to be harmful to one's health and 83% were regretful about having started smoking. An equal proportion of respondents indicated that they were "very ready to quit," "somewhat ready to quit," or "not ready to quit." Among all respondents, 73% had been told by a physician to quit in the past year but only 7% indicated that they had used prescription medication and only 21% had used nicotine replacement therapy to help with smoking cessation. CONCLUSION/CONCLUSIONS:There is significant variation in attitudes, behaviors, and perceptions related to smoking and smoking cessation among survivors of genitourinary malignancy. Patient-level smoking cessation interventions may need to be highly personalized for optimal success.
PMID: 33577901
ISSN: 1527-9995
CID: 4835552

Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial

Nickols, Nicholas G; Goetz, Matthew B; Graber, Christopher J; Bhattacharya, Debika; Soo Hoo, Guy; Might, Matthew; Goldstein, David B; Wang, Xinchen; Ramoni, Rachel; Myrie, Kenute; Tran, Samantha; Ghayouri, Leila; Tsai, Sonny; Geelhoed, Michelle; Makarov, Danil; Becker, Daniel J; Tsay, Jun-Chieh; Diamond, Melissa; George, Asha; Al-Ajam, Mohammad; Belligund, Pooja; Montgomery, R Bruce; Mostaghel, Elahe A; Sulpizio, Carlie; Mi, Zhibao; Dematt, Ellen; Tadalan, Joseph; Norman, Leslie E; Briones, Daniel; Clise, Christina E; Taylor, Zachary W; Huminik, Jeffrey R; Biswas, Kousick; Rettig, Matthew B
BACKGROUND:Therapeutic targeting of host-cell factors required for SARS-CoV-2 entry is an alternative strategy to ameliorate COVID-19 severity. SARS-CoV-2 entry into lung epithelium requires the TMPRSS2 cell surface protease. Pre-clinical and correlative data in humans suggest that anti-androgenic therapies can reduce the expression of TMPRSS2 on lung epithelium. Accordingly, we hypothesize that therapeutic targeting of androgen receptor signaling via degarelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, will suppress COVID-19 infection and ameliorate symptom severity. METHODS:This is a randomized phase 2, placebo-controlled, double-blind clinical trial in 198 patients to compare efficacy of degarelix plus best supportive care versus placebo plus best supportive care on improving the clinical outcomes of male Veterans who have been hospitalized due to COVID-19. Enrolled patients must have documented infection with SARS-CoV-2 based on a positive reverse transcriptase polymerase chain reaction result performed on a nasopharyngeal swab and have a severity of illness of level 3-5 (hospitalized but not requiring invasive mechanical ventilation). Patients stratified by age, history of hypertension, and severity are centrally randomized 2:1 (degarelix: placebo). The composite primary endpoint is mortality, ongoing need for hospitalization, or requirement for mechanical ventilation at 15 after randomization. Important secondary endpoints include time to clinical improvement, inpatient mortality, length of hospitalization, duration of mechanical ventilation, time to achieve a normal temperature, and the maximum severity of COVID-19 illness. Exploratory analyses aim to assess the association of cytokines, viral load, and various comorbidities with outcome. In addition, TMPRSS2 expression in target tissue and development of anti-viral antibodies will also be investigated. DISCUSSION/CONCLUSIONS:In this trial, we repurpose the FDA approved LHRH antagonist degarelix, commonly used for prostate cancer, to suppress TMPRSS2, a host cell surface protease required for SARS-CoV-2 cell entry. The objective is to determine if temporary androgen suppression with a single dose of degarelix improves the clinical outcomes of patients hospitalized due to COVID-19. TRIAL REGISTRATION/ NCT04397718. Registered on May 21, 2020.
PMID: 34225789
ISSN: 1745-6215
CID: 4959342

The cost, survival, and quality-of-life implications of guideline-discordant imaging for prostate cancer

Winn, Aaron N; Kelly, Matthew; Ciprut, Shannon; Walter, Dawn; Gold, Heather T; Zeliadt, Steven B; Sherman, Scott E; Makarov, Danil V
BACKGROUND:National Comprehensive Cancer Network (NCCN) guidelines for incident prostate cancer staging imaging have been widely circulated and accepted as best practice since 1996. Despite these clear guidelines, wasteful and potentially harmful inappropriate imaging of men with prostate cancer remains prevalent. AIM/OBJECTIVE:To understand changing population-level patterns of imaging among men with incident prostate cancer, we created a state-transition microsimulation model based on existing literature and incident prostate cancer cases. METHODS:To create a cohort of patients, we identified incident prostate cancer cases from 2004 to 2009 that were diagnosed in men ages 65 and older from SEER. A microsimulation model allowed us to explore how this cohort's survival, quality of life, and Medicare costs would be impacted by making imaging consistent with guidelines. We conducted a probabilistic analysis as well as one-way sensitivity analysis. RESULTS:When only imaging high-risk men compared to the status quo, we found that the population rate of imaging dropped from 53 to 38% and average per-person spending on imaging dropped from $236 to $157. The discounted and undiscounted incremental cost-effectiveness ratios indicated that ideal upfront imaging reduced costs and slightly improved health outcomes compared with current practice patterns, that is, guideline-concordant imaging was less costly and slightly more effective. CONCLUSION/CONCLUSIONS:This study demonstrates the potential reduction in cost through the correction of inappropriate imaging practices. These findings highlight an opportunity within the healthcare system to reduce unnecessary costs and overtreatment through guideline adherence.
PMID: 34137520
ISSN: 2573-8348
CID: 4936812

The Association of Veterans' PSA Screening Rates with Changes in USPSTF Recommendations

Becker, Daniel J; Rude, Temitope; Walter, Dawn; Wang, Chan; Loeb, Stacy; Li, Huilin; Ciprut, Shannon; Kelly, Matthew; Zeliadt, Steven B; Fagerlin, Angela; Lepor, Herbert; Sherman, Scott; Ravenell, Joseph E; Makarov, Danil V
BACKGROUND:In 2012, the United States Preventative Services Task Force (USPSTF) formally recommended against all Prostate Specific Antigen (PSA) screening for prostate cancer. Our goal was to characterize PSA screening trends in the Veterans Health Administration (VA) before and after the USPSTF recommendation, and to determine if PSA screening was more likely to be ordered based on a Veteran's race or age. METHODS:Using the VA Corporate Data Warehouse, we created 10 annual groups of PSA-eligible men covering 2009-2018. We identified all PSA tests performed in the VA to determine yearly rates of PSA screening. All statistical tests were two-sided. RESULTS:The overall rate of PSA testing in the VA decreased from 63.3% in 2009 to 51.2% in 2018 (p<.001). PSA screening rates varied markedly by age group during our study period, with men aged 70-80 having the highest initial rate and greatest decline (70.6% in 2009 to 48.4% in 2018, p<.001). Men aged 55-69 saw a smaller decline (65.2% in 2009 to 58.9% in 2018, p<.001) while the youngest men, aged 40-54, had an increase in PSA screening (26.2% in 2009 to 37.8 in 2018, p<.001). CONCLUSIONS:In this analysis of PSA screening rates among veterans before and after the 2012 USPSTF recommendation against screening, we found that overall PSA screening decreased only modestly, continuing for more than half of the men in our study. Veterans of different races had similar screening rates, suggesting that VA care may minimize racial disparities. Veterans of varying age experienced significantly different trends in PSA screening.
PMID: 32797212
ISSN: 1460-2105
CID: 4566242

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

Makarov, Danil V; Feuer, Zachary; Ciprut, Shannon; Lopez, Natalia Martinez; Fagerlin, Angela; Shedlin, Michele; Gold, Heather T; Li, Huilin; Lynch, Gina; Warren, Rueben; Ubel, Peter; Ravenell, Joseph E
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/CONCLUSIONS: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/BACKGROUND:The trial was registered prospectively with the National Institute of Health registry ( ), registration number NCT03726320 , on October 31, 2018.
PMID: 33568208
ISSN: 1745-6215
CID: 4779852

Tobacco Screening and Treatment during Outpatient Urologic Office Visits in the United States

Bernstein, Ari P; Bjurlin, Marc A; Sherman, Scott E; Makarov, Danil V; Rogers, Erin; Matulewicz, Richard S
PURPOSE/OBJECTIVE:Tobacco-use is a causative or exacerbating risk factor for benign and malignant urologic disease. However, it is not well known how often urologists screen for tobacco use and provide tobacco cessation treatment at the population level. Therefore, we sought to evaluate how often urologists see patients for tobacco-related diagnoses in the outpatient setting and how often these visits include tobacco-use screening and treatment. MATERIALS AND METHODS/METHODS:We used the National Ambulatory Medical Care Survey (NAMCS) public use files for the years 2014-2016 to identify all outpatient urology visits with adults 18 years and older. Clinic visit reasons were categorized according to diagnoses associated with the encounter: all urologic diagnoses, a tobacco-related urologic condition, or a urologic cancer. Our primary outcome was the percentage of visits during which tobacco screening was reported. Secondary outcomes included reported delivery of cessation counseling and provision of cessation pharmacotherapy. RESULTS:We identified 4,625 unique urologic outpatient encounters, representing a population-weighted estimate of 63.9 million visits over three years. Approximately a third of all urology visits were for a tobacco-related urologic diagnoses and 15% were for urologic cancers. An estimated 1.1 million visits over three years were with patients who identified as current tobacco users. Of all visits, 70% included tobacco screening. However, only 7% of visits with current smokers included counseling and only 3% were prescribed medications. No differences in screening and treatment were observed between visit types. CONCLUSIONS:Urologists regularly see patients for tobacco-related conditions and frequently, though not universally, screen patients for tobacco. However, urologists rarely offer counseling or cessation treatment. These findings may represent missed opportunities to decrease the morbidity associated with tobacco use.
PMID: 33525926
ISSN: 1527-3792
CID: 4799222