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Patient and Provider Experiences With Precision Oncology: Qualitative Descriptive Study at the Department of Veterans Affairs
Becker, Daniel; Csehak, Kenneth; Barbaro, Alexander; Miller, Christian; Vo, Antoinette; Roman, Stefanie; Makarov, Danil; Sherman, Scott; Squires, Allison
BACKGROUND/UNASSIGNED:Precision oncology (PO) improves and extends the lives of patients living with cancer, but multiple studies have documented its underuse in practice. Specifically, studies note a significant lack of PO use within the Veterans Affairs (VA) medical system. A paucity of implementation of PO in oncologic practice poses a significant barrier to providing the most up-to-date guideline-based care. OBJECTIVE/UNASSIGNED:While several studies have explored determinants of PO use, we sought to contribute to the body of knowledge by additionally focusing on the unique perspectives of patients, as well as conducting a comprehensive study within the VA medical system, the United States' largest single-payer health care system. We conducted interviews with both patients and providers at multiple VA sites to identify and characterize barriers and facilitators of PO use in clinical care. METHODS/UNASSIGNED:Using a qualitative descriptive approach, we conducted semistructured interviews with 17 patients with cancer and 16 oncology providers recruited from multiple VA sites. Cancer types included prostate, gastrointestinal, and lung. Data were analyzed via a team-based coding approach using directed content analysis. Data were coded and then aggregated into themes and mapped to the Theoretical Domains Framework (TDF) and Behavior Change Wheel sources of behavior (Capability, Opportunity, and Motivation) based on the consensus of the study team. RESULTS/UNASSIGNED:The patient sample consisted of 17 all-male veterans seen at VA oncology clinics in 2022. Participants predominantly self-identified as White (n=9, 52.9%) or Black (n=6, 35.3%), and the majority (n=11, 64.7%) held a high school degree or a higher level of education. The provider sample consisted of 16 physicians, all of whom held MD degrees and practiced oncology. The provider sample represented 6 states, was 50% (8/16) female, and participants averaged 14 years in their current position. The overarching theme was the "Precision Oncology Feedback Loop," which captured the essence of the complex processes involved in facilitating PO care in the VA system. The TDF and Behavior Change Wheel helped categorize findings to identify where issues in the feedback loop could facilitate or generate barriers to care. CONCLUSIONS/UNASSIGNED:Our findings expand on the current literature by highlighting both patient and provider experiences across key TDF domains (Environmental Context and Resources, Knowledge, Memory, and Attention). The conceptual model produced by the analysis illustrates the complexities associated with the implementation. Our findings support the design of multilevel interventions that target increased knowledge or education, improved workflow, and ease of communication to enhance PO delivery.
PMCID:13120791
PMID: 42044630
ISSN: 2369-1999
CID: 6029092
Association Between Hospital Participation in the Global Budget Revenue Model and Surgical Outcomes Among Traditional Medicare Beneficiaries Undergoing Cancer Surgery
Ying, Meiling; Yang, Xiwei; Maddox, Karen Joynt; Li, Yue; Hirth, Richard; Pagán, José A; Dall, Christopher; Makarov, Danil; Huang, William; Corcoran, Anthony; Katz, Aaron; Hollenbeck, Brent; Shahinian, Vahakn
OBJECTIVE:To evaluate the relationship between the Global Budget Revenue (GBR) model and surgical outcomes. SUMMARY BACKGROUND DATA/BACKGROUND:Medicare tested GBR in Maryland, wherein hospitals received a fixed annual revenue to cover healthcare delivery for their population. The relationship between GBR implementation and outcomes after cancer surgery is unclear. METHODS:Observational difference-in-differences analysis using 100% national Medicare data to compare changes in outcomes between GBR hospitals and matched control hospitals before (2011-2013) and after (2014-2018) policy implementation in Traditional Medicare beneficiaries undergoing cystectomy, prostatectomy, or nephrectomy for cancer. The primary outcome was achievement of a textbook outcome, defined as the absence of in-hospital and 30-day mortality, postoperative complications, a prolonged length of stay (i.e., above the 75th percentile by procedure and year) and readmission within 30 days of discharge. The secondary outcome was Medicare inpatient spending. RESULTS:This study included 23 Maryland hospitals with 4,910 beneficiaries and 371 control hospitals with 57,456 beneficiaries. Textbook outcomes increased from 72.8% to 76.1% in GBR hospitals and from 70.2% to 70.5% in matched controls, a differential increase of 2.9 percentage points (95% CI, 0.5 to 5.3; P=0.02). The greater improvement at GBR hospitals was a result of reducing complications (-1.5 percentage points; 95% CI, -2.9 to -0.1) and limiting prolonged lengths of stay (-1.8 percentage points; 95% CI, -2.9 to -0.7). Medicare inpatient spending declined by $771 (95% CI, -$1,275 to -$267) more at GBR hospitals. CONCLUSIONS:The GBR was associated with improved surgical outcomes and lower Medicare inpatient spending.
PMID: 41992386
ISSN: 1528-1140
CID: 6028192
Increasing reach of cancer care: provider perspectives on the value and use of teleoncology
Zullig, Leah L; Shapiro, Abigail; Eldridge, Madeleine R; Tumminello, Christa; Guzman, Ivonne; Sherman, Scott E; Makarov, Danil; Becker, Daniel; Passero, Vida; Dardashti, Navid; Kelley, Michael J; Steinhauser, Karen
PMID: 41965642
ISSN: 1472-6963
CID: 6025912
A randomized clinical trial of multi-level intervention to improve colorectal cancer screening rates at multiple federally qualified health care centers in New York City
Shaukat, Aasma; Hu, Jiyuan; Zhao, Yanan; Faulx, Gregory; Augustin, Ashley; Murphy, Sean; Stevens, Elizabeth; Ravenell, Joseph; Makarov, Danil; Napolitano, Daniel
INTRODUCTION/BACKGROUND:Colorectal cancer (CRC) screening rates among patients receiving care at multiple federally qualified health care centers (FQHCs) in New York city are low. Proactive outreach through mailed fecal immunochemical tests (FIT), reminders and navigation are evidence based interventions to improve CRC screening rates but remain untested in this study population. OBJECTIVE:To evaluate the effectiveness, implementation, and cost-effectiveness of a multilevel proactive outreach strategy to improve CRC screening rates among underserved adults in Brooklyn, New York. METHODS:This is a randomized controlled trial across five FQHCs serving predominantly Black and low-income populations. Adults aged 45-75 who are overdue for CRC screening are randomized to usual care or a multi-level proactive intervention. The intervention includes mailed education and FIT kits, patient navigation, and support for colonoscopy scheduling and follow-up. The primary outcome is CRC screening completion (FIT or colonoscopy) within six months. Secondary outcomes include colonoscopy follow-up after a positive FIT, implementation barriers and facilitators, and cost-effectiveness. RESULTS:A total of 1379 participants have been enrolled through May 2025. DISCUSSION/CONCLUSIONS:This trial addresses a critical gap in CRC prevention by testing a scalable, multilevel outreach model tailored to underserved populations. Findings will inform future strategies to enhance screening rates while reducing screening disparities through sustainable FQHC-based programs.
PMID: 41326264
ISSN: 1559-2030
CID: 5974742
Prostate Cancer Imaging Stewardship: a multi-modal, physician-centered intervention for guideline-concordant imaging
Makarov, Danil V; Thomas, Jerry K; Ciprut, Shannon; Rivera, Adrian J; Sherman, Scott E; Braithwaite, R Scott; Best, Sara L; Blakely, Stephen; D'Agostino, Louis A; Dahm, Philipp; Dash, Atreya; Leapman, Michael S; Leppert, John T; Sanchez, Alejandro; Shelton, Jeremy B; Tessier, Christopher D; Tenner, Craig T; Gold, Heather T; Shedlin, Michele G; Zeliadt, Steven B
BACKGROUND:Inappropriate imaging to stage low-risk prostate cancer is considered low-value care. Determining the effectiveness of a theory-based intervention, Prostate Cancer Imaging Stewardship (PCIS), to promote guideline-concordant imaging. METHODS:A stepped-wedge, cluster-randomized trial, PCIS, was conducted between March 2018 and March 2021 at ten Veterans Health Administration medical centers (VAMC) initially selected for prostate cancer volume, geographic diversity, and willingness to participate. Intervention initiation at sites were randomized in 3-month intervals. We enrolled 61 urology providers who treat prostate cancer at participating sites. Outcomes were assessed among 2,302 patients with incident prostate cancer aged 18-85 years. PCIS combines three evidence-based provider-focused behavior change strategies: 1) Clinical Reminder Order Check triggered when a provider attempted to order imaging for a patient with PSA < 20ng/mL; 2) VAMC-level academic detailing at initiation and every three months thereafter; 3) Audit and Feedback for providers to improve their imaging performance. The main outcome was guideline-discordant nuclear medicine bone scan (NMBS) imaging for low-risk prostate cancer patients. RESULTS:NMBS imaging would be consistent with National Comprehensive Cancer Network guidelines in 878 patients (38%) and inconsistent in 1424 patients (62%). Among patients not requiring NMBS, 141/690 (20.4%) received guideline-discordant imaging (ie, NMBS ordered) during Control compared to 109/734 (14.9%) during Intervention (OR = 0.54, p = .04). Among patients requiring a NMBS, 29/425 (6.8%) did not receive one (ie, guideline-discordant imaging) during Control compared to 25/453 (5.5%) during the Intervention (OR = 1.36, p = .36). CONCLUSION/CONCLUSIONS:PCIS significantly reduced low-value, guideline-discordant NMBS imaging among low-risk prostate cancer patients without negatively affecting necessary imaging for high-risk patients. CLINICAL TRIALS REGISTRATION/BACKGROUND:NCT03445559.
PMID: 40796156
ISSN: 1460-2105
CID: 5907222
Patterns of outpatient urinalysis testing and the detection of microscopic hematuria
Matulewicz, Richard S; Gold, Samuel; Baky, Fady; Nicholson, Andrew; Wahlstedt, Eric; Alba, Patrick; Bochner, Bernard H; Herr, Harry W; Goldfarb, David S; Lynch, Julie A; Barlow, Lamont; Assel, Melissa; Vickers, Andrew; Sherman, Scott E; Makarov, Danil V
OBJECTIVE:To evaluate urinalysis testing patterns within the Veterans Health Administration (VHA), estimate the proportion and likelihood of patients who completed a urinalysis to have microscopic hematuria (MH), and explore how urinalysis testing patterns may influence MH detection. METHODS:This was a retrospective cross-sectional study using VHA data. We identified adult patients without a known urologic cancer history who had at least 1 outpatient visit at any VHA site and at least 1 interpretable urinalysis performed in 2015. The factors associated with the number or urinalyses performed on each patient and associations with the presence of MH were investigated. RESULTS:Among 5,719,966 adults, 39% completed a urinalysis. Variation in the proportion of patients who completed urinalyses was highest by age, among patients with hypertension and diabetes, and by region. Of patients who underwent urinalysis and had no prior genitourinary cancer history, 54% did not have an interpretable urinalysis result. Among patients with at least one interpretable microscopic urinalysis, 37% had MH. This was more common among older patients, females, current smokers, and patients with more comorbidities. Variation in the likelihood of patients having MH remained after adjusting for multiple factors and when contextualized by urinalysis completion and interpretability patterns. CONCLUSION/CONCLUSIONS:The number of urinalyses performed in the VHA system is remarkably high. Detection of MH is influenced by the frequency of urinalysis testing and interpretability of results. The presence and detection of MH varies by factors which should be considered when adjudicating the need for further evaluation of MH.
PMID: 40669699
ISSN: 1527-9995
CID: 5897262
Fertility counseling in early-onset colorectal cancer and the impact of patient characteristics
Peng, Chengwei; Littman, Dalia; Masri, Lena; Sherman, Scott; Makarov, Danil V; Becker, Daniel J
PURPOSE/OBJECTIVE:This study evaluated how frequently patients with early onset colorectal cancer received fertility counseling and whether patient characteristics affected the likelihood of receiving such counseling. METHODS:We conducted a single-center retrospective review of all new patients seen by medical oncology for colorectal cancer who were age 55 years or younger for men and 50 years or younger for women. Associations between patient demographics and clinical characteristics with receipt of fertility counseling were explored using univariate analyses and multivariable logistical regression analyses. RESULTS:A total of 194 patients were included, of whom 15.5% received fertility counseling. Using multivariate analysis, we found that age < 40 (OR 15.587, p < 0.0001, 95% CI 4.841-50.191) and female sex (OR 3.979, p = 0.0292, 95% CI 1.150-13.770) were correlated with increased likelihood of fertility counseling. Patients living in areas of higher household income were more likely to receive fertility counseling, with a statistically significant difference between the 3rd and 1st quartiles of income (p = 0.0369, 95% CI 1.161-115.940). CONCLUSION/CONCLUSIONS:A majority of patients with EOCRC did not receive fertility counseling despite the known toxicities of CRC treatment modalities on fertility. Older age, male sex, and residence in areas of lower income were associated with decreased likelihood of receiving fertility counseling.
PMID: 40347312
ISSN: 1433-7339
CID: 5839682
Efficacy of a Clinical Decision Support Tool to Promote Guideline-Concordant Evaluations in Patients With High-Risk Microscopic Hematuria: A Cluster Randomized Quality Improvement Project
Matulewicz, Richard S; Tsuruo, Sarah; King, William C; Nagler, Arielle R; Feuer, Zachary S; Szerencsy, Adam; Makarov, Danil V; Wong, Christina; Dapkins, Isaac; Horwitz, Leora I; Blecker, Saul
PURPOSE/UNASSIGNED:We aimed to determine whether implementation of clinical decision support (CDS) tool integrated into the electronic health record of a multisite academic medical center increased the proportion of patients with AUA "high-risk" microscopic hematuria (MH) who receive guideline concordant evaluations. MATERIALS AND METHODS/UNASSIGNED:We conducted a two-arm cluster randomized quality improvement project in which 202 ambulatory sites from a large health system were randomized to either have their physicians receive at time of test results an automated CDS alert for patients with "high-risk" MH with associated recommendations for imaging and cystoscopy (intervention) or usual care (control). Primary outcome was met if a patient underwent both imaging and cystoscopy within 180 days from MH result. Secondary outcomes assessed individual completion of imaging, cystoscopy, or placement of imaging orders. RESULTS/UNASSIGNED:= .09). CONCLUSIONS/UNASSIGNED:Implementing an electronic health record-integrated CDS tool to promote evaluation of patients with high-risk MH did not lead to improvements in patient completion of a full guideline-concordant evaluation. The development of an algorithm to trigger a CDS alert was demonstrated to be feasible and effective. Further multilevel assessment of barriers to evaluation is necessary to continue to improve the approach to evaluating high-risk patients with MH.
PMID: 39854625
ISSN: 1527-3792
CID: 5802662
Unpacking overuse of androgen deprivation therapy for prostate cancer to inform de-implementation strategies
Skolarus, Ted A; Hawley, Sarah T; Forman, Jane; Sales, Anne E; Sparks, Jordan B; Metreger, Tabitha; Burns, Jennifer; Caram, Megan V; Radhakrishnan, Archana; Dossett, Lesly A; Makarov, Danil V; Leppert, John T; Shelton, Jeremy B; Stensland, Kristian D; Dunsmore, Jennifer; Maclennan, Steven; Saini, Sameer; Hollenbeck, Brent K; Shahinian, Vahakn; Wittmann, Daniela A; Deolankar, Varad; Sriram, S
BACKGROUND:Many men with prostate cancer will be exposed to androgen deprivation therapy (ADT). While evidence-based ADT use is common, ADT is also used in cases with no or limited evidence resulting in more harm than benefit, i.e., overuse. Since there are risks of ADT (e.g., diabetes, osteoporosis), it is important to understand the behaviors facilitating overuse to inform de-implementation strategies. For these reasons, we conducted a theory-informed survey study, including a discrete choice experiment (DCE), to better understand ADT overuse and provider preferences for mitigating overuse. METHODS:Our survey used the Action, Actor, Context, Target, Time (AACTT) framework, the Theoretical Domains Framework (TDF), the Capability, Opportunity, Motivation-Behavior (COM-B) Model, and a DCE to elicit provider de-implementation strategy preferences. We surveyed the Society of Government Service Urologists listserv in December 2020. We stratified respondents based on the likelihood of stopping overuse as ADT monotherapy for localized prostate cancer ("yes"/"probably yes," "probably no"/"no"), and characterized corresponding Likert scale responses to seven COM-B statements. We used multivariable regression to identify associations between stopping ADT overuse and COM-B responses. RESULTS:Our survey was completed by 84 respondents (13% response rate), with 27% indicating "probably no"/"no" to stopping ADT overuse. We found differences across respondents who said they would and would not stop ADT overuse in demographics and COM-B statements. Our model identified 2 COM-B domains (Opportunity-Social, Motivation-Reflective) significantly associated with a lower likelihood of stopping ADT overuse. Our DCE demonstrated in-person communication, multidisciplinary review, and medical record documentation may be effective in reducing ADT overuse. CONCLUSIONS:Our study used a behavioral theory-informed survey, including a DCE, to identify behaviors and context underpinning ADT overuse. Specifying behaviors supporting and gathering provider preferences in addressing ADT overuse requires a stepwise, stakeholder-engaged approach to support evidence-based cancer care. From this work, we are pursuing targeted improvement strategies. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov, NCT03579680.
PMCID:11005280
PMID: 38594740
ISSN: 2662-2211
CID: 5725762
Disparities in the Delivery of Prostate Cancer Survivorship Care in the USA: A Claims-based Analysis of Urinary Adverse Events and Erectile Dysfunction Among Prostate Cancer Survivors
Mmonu, Nnenaya; Kamdar, Neil; Roach, Mack; Sarma, Aruna; Makarov, Danil; Zabar, Sondra; Breyer, Benjamin
BACKGROUND AND OBJECTIVE/UNASSIGNED:Incidence rates for prostate cancer (PCa) diagnosis and mortality are higher for Black men. It is unknown whether similar disparities exist in survivorship care. We assessed the delivery and quality of survivorship care for Black men undergoing PCa therapy in terms of the burden of and treatment for urinary adverse events (UAEs) and erectile dysfunction (ED). METHODS/UNASSIGNED:We queried Optum Clinformatics data for all patients diagnosed with PCa from January 1, 2002 to December 31, 2017 and identified those who underwent primary PCa treatment. Index cohorts were identified in each year and followed longitudinally until 2017. Data for UAE diagnoses, UAE treatments, and ED treatments were analyzed in index cohorts. Cox proportional-hazards regression models were used to examine associations of race with UAE diagnosis, UAE treatment, and ED treatment. KEY FINDINGS AND LIMITATIONS/UNASSIGNED:We identified 146, 216 patients with a PCa diagnosis during the study period, of whom 55, 149 underwent primary PCa treatment. In the primary treatment group, 32.7% developed a UAE and 28.2% underwent UAE treatment. The most common UAEs were urinary incontinence (11%), ureteral obstruction/stricture (4.5%), bladder neck contracture (4.5%), and urethral stricture (3.7%). The most common UAE treatments were cystoscopy (13%), suprapubic tube placement (6%), and urethral dilation (5%). Overall, UAE diagnosis rates were higher for Black patients, who had significantly higher risk of urethral obstruction, rectourethral fistula, urinary incontinence, cystitis, urinary obstruction, and ureteral fistula. Overall, UAE treatment rates were lower for Black patients, who had significantly higher risk of fecal diversion and/or rectourethral fistula repair (adjusted hazard ratio [aHR] 1.71, 95% confidence interval [CI] 1.04-2.79). Regarding ED treatments, Black patients had higher risk of penile prosthesis placement (aHR 1.591, 95% CI 1.26-2.00) and intracavernosal injection (aHR 1.215, 95% CI 1.08-1.37). CONCLUSIONS AND CLINICAL IMPLICATIONS/UNASSIGNED:Despite a high UAE burden, treatment rates were low in a cohort with health insurance. Black patients had a higher UAE burden and lower UAE treatment rates. Multilevel interventions are needed to address this stark disparity. ED treatment rates were higher for Black patients. PATIENT SUMMARY/UNASSIGNED:We reviewed data for patients treated for prostate cancer (PCa) and found that 32.7% were diagnosed with a urinary adverse event (UAE) following their PCa treatment. The overall treatment rate for these UAEs was 28.2%. Analysis by race showed that the UAE diagnosis rate was higher for Black patients, who were also more likely to receive treatment for erectile dysfunction.
PMCID:10998258
PMID: 38585209
ISSN: 2666-1683
CID: 5725532