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Prescreening to Increase Therapeutic Oncology Trial Enrollment at the Largest Public Hospital in the United States
Wu, Jennifer; Yakubov, Amin; Abdul-Hay, Maher; Love, Erica; Kroening, Gianna; Cohen, Deirdre; Spalink, Christy; Joshi, Ankeeta; Balar, Arjun; Joseph, Kathie-Ann; Ravenell, Joseph; Mehnert, Janice
PURPOSE/UNASSIGNED:The recruitment of underserved patients into therapeutic oncology trials is imperative. The National Institutes of Health mandates the inclusion of minorities in clinical research, although their participation remains under-represented. Institutions have used data mining to match patients to clinical trials. In a public health care system, such expensive tools are unavailable. METHODS/UNASSIGNED:The NYU Clinical Trials Office implemented a quality improvement program at Bellevue Hospital Cancer Center to increase therapeutic trial enrollment. Patients are screened through the electronic medical record, tumor board conferences, and the cancer registry. Our analysis evaluated two variables: number of patients identified and those enrolled into clinical trials. RESULTS/UNASSIGNED:Two years before the program, there were 31 patients enrolled. For a period of 24 months (July 2017 to July 2019), we identified 255 patients, of whom 143 (56.1%) were enrolled. Of those enrolled, 121 (84.6%) received treatment, and 22 (15%) were screen failures. Fifty-five (38.5%) were referred to NYU Perlmutter Cancer Center for therapy. Of the total enrollees, 64% were female, 56% were non-White, and overall median age was 55 years (range: 33-88 years). Our participants spoke 16 different languages, and 57% were non-English-speaking. We enrolled patients into eight different disease categories, with 38% recruited to breast cancer trials. Eighty-three percent of our patients reside in low-income areas, with 62% in both low-income and Health Professional Shortage Areas. CONCLUSION/UNASSIGNED:Prescreening at Bellevue has led to a 4.6-fold increase in patient enrollment to clinical trials. Future research into using prescreening programs at public institutions may improve access to clinical trials for underserved populations.
PMID: 34748371
ISSN: 2688-1535
CID: 5050262
Interaction between race and prostate cancer treatment benefit in the Veterans Health Administration
Rude, Temitope; Walter, Dawn; Ciprut, Shannon; Kelly, Matthew D; Wang, Chan; Fagerlin, Angela; Langford, Aisha T; Lepor, Herbert; Becker, Daniel J; Li, Huilin; Loeb, Stacy; Ravenell, Joseph; Leppert, John T; Makarov, Danil V
BACKGROUND:Studies have demonstrated that Black men may undergo definitive prostate cancer (CaP) treatment less often than men of other races, but it is unclear whether they are avoiding overtreatment of low-risk disease or experiencing a reduction in appropriate care. The authors' aim was to assess the role of race as it relates to treatment benefit in access to CaP treatment in a single-payer population. METHODS:The authors used the Veterans Health Administration (VHA) Corporate Data Warehouse to perform a retrospective cohort study of veterans diagnosed with low- or intermediate-risk CaP between 2011 and 2017. RESULTS:The authors identified 35,427 men with incident low- or intermediate-risk CaP. When they controlled for covariates, Black men had 1.05 times the odds of receiving treatment in comparison with non-Black men (P < .001), and high-treatment-benefit men had 1.4 times the odds of receiving treatment in comparison with those in the low-treatment-benefit group (P < .001). The interaction of race and treatment benefit was significant, with Black men in the high-treatment-benefit category less likely to receive treatment than non-Black men in the same treatment category (odds ratio, 0.89; P < .001). CONCLUSIONS:Although race does appear to influence the receipt of definitive treatment in the VHA, this relationship varies in the context of the patient's treatment benefit, with Black men receiving less definitive treatment in high-benefit situations. The influence of patient race at high treatment benefit levels invites further investigation into the driving forces behind this persistent disparity in this consequential group.
PMID: 34184271
ISSN: 1097-0142
CID: 4926392
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
A Population Health Equity Approach Reveals Persisting Disparities in Colorectal Cancer Screening in New York City South Asian Communities
Patel, Shilpa; Kranick, Julie; Manne, Sharon; Shah, Krina; Raveis, Victoria; Ravenell, Joseph; Yi, Stella; Kwon, Simona; Islam, Nadia
To assess colorectal cancer (CRC) screening among South Asians (SAs) and explore the challenges and facilitators to CRC screening among SA subgroups in New York City (NYC). Fifty-one semi-structured in-depth interviews and surveys were conducted among SA immigrants in NYC. Qualitative results suggested challenges to CRC screening were related to socio-cultural factors, such as a lack of knowledge on CRC and CRC screening, and structural factors, such as cost and language. A physician referral was the most cited facilitator to CRC screening. Participants reported culturally and linguistically adapted education and information on CRC and CRC screening would help to overcome noted challenges. Our findings support the development of targeted, linguistically and culturally adapted campaigns for this population that facilitate access to health systems and leverage natural community assets and social support systems.
PMID: 32060860
ISSN: 1543-0154
CID: 4304702
Including Medical Footage and Emotional Content in Organ Donation Educational Videos for Latinx Viewers
Wall, Stephen P; Castillo, Patricio; Shuchat Shaw, Francine; Norman, Elizabeth; Martinez-Lopez, Natalia; Lopez-Rios, Mairyn; Paulino, Hehidy; Homer, Bruce; Plass, Jan L; Ravenell, Joseph E
We assessed whether videos with medical footage of organ preservation and transplantation plus sad, unresolved, or uplifting stories differentially affect deceased organ donor registration among clients in Latinx-owned barbershops and beauty salons. In a 2 × 3 randomized controlled trial, participants (N = 1,696, mean age 33 years, 67% female) viewed one of six videos. The control portrayed a mother who received a kidney (uplifting), excluding medical footage. Experimental videos included medical footage and/or showed a mother waiting (unresolved) or sisters mourning their brother's death (sad). Regression models assessed relative impact of medical footage and storylines on: (1) registry enrollment, (2) donation willingness stage of change, and (3) emotions. Randomization yielded approximately equal groups relative to age, sex, education, religion, nativity, baseline organ donation willingness, beliefs, and emotions. Overall, 14.8% of participants registered. Neither medical footage, sad, nor unresolved stories differentially affected registration and changes in organ donation willingness. Sad and unresolved stories increased sadness and decreased positive affect by ~0.1 logits compared with the uplifting story. Educational videos about organ donation which excluded or included medical footage and varying emotional valence of stories induced emotions marginally but did not affect viewers' registration decisions differently. Heterogeneity of responses within video groups might explain the attenuated impact of including medical footage and varying emotional content. In future work, we will report qualitative reasons for participants' registration decisions by analyzing the free text responses from the randomized trial and data from semistructured interviews that were conducted with a subset of participants.
PMID: 34253089
ISSN: 1552-6127
CID: 4937492
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 ( www.clinicaltrials.gov ), registration number NCT03726320 , on October 31, 2018.
PMCID:7876807
PMID: 33568208
ISSN: 1745-6215
CID: 4779852
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 [Editorial]
V. Makarov, Danil; 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.
ISI:000719424800005
ISSN: 2405-4569
CID: 5142662
Assessment of Racial/Ethnic Disparities in Hospitalization and Mortality in Patients With COVID-19 in New York City
Ogedegbe, Gbenga; Ravenell, Joseph; Adhikari, Samrachana; Butler, Mark; Cook, Tiffany; Francois, Fritz; Iturrate, Eduardo; Jean-Louis, Girardin; Jones, Simon A; Onakomaiya, Deborah; Petrilli, Christopher M; Pulgarin, Claudia; Regan, Seann; Reynolds, Harmony; Seixas, Azizi; Volpicelli, Frank Michael; Horwitz, Leora Idit
Importance/UNASSIGNED:Black and Hispanic populations have higher rates of coronavirus disease 2019 (COVID-19) hospitalization and mortality than White populations but lower in-hospital case-fatality rates. The extent to which neighborhood characteristics and comorbidity explain these disparities is unclear. Outcomes in Asian American populations have not been explored. Objective/UNASSIGNED:To compare COVID-19 outcomes based on race and ethnicity and assess the association of any disparities with comorbidity and neighborhood characteristics. Design, Setting, and Participants/UNASSIGNED:This retrospective cohort study was conducted within the New York University Langone Health system, which includes over 260 outpatient practices and 4 acute care hospitals. All patients within the system's integrated health record who were tested for severe acute respiratory syndrome coronavirus 2 between March 1, 2020, and April 8, 2020, were identified and followed up through May 13, 2020. Data were analyzed in June 2020. Among 11 547 patients tested, outcomes were compared by race and ethnicity and examined against differences by age, sex, body mass index, comorbidity, insurance type, and neighborhood socioeconomic status. Exposures/UNASSIGNED:Race and ethnicity categorized using self-reported electronic health record data (ie, non-Hispanic White, non-Hispanic Black, Hispanic, Asian, and multiracial/other patients). Main Outcomes and Measures/UNASSIGNED:The likelihood of receiving a positive test, hospitalization, and critical illness (defined as a composite of care in the intensive care unit, use of mechanical ventilation, discharge to hospice, or death). Results/UNASSIGNED:Among 9722 patients (mean [SD] age, 50.7 [17.5] years; 58.8% women), 4843 (49.8%) were positive for COVID-19; 2623 (54.2%) of those were admitted for hospitalization (1047 [39.9%] White, 375 [14.3%] Black, 715 [27.3%] Hispanic, 180 [6.9%] Asian, 207 [7.9%] multiracial/other). In fully adjusted models, Black patients (odds ratio [OR], 1.3; 95% CI, 1.2-1.6) and Hispanic patients (OR, 1.5; 95% CI, 1.3-1.7) were more likely than White patients to test positive. Among those who tested positive, odds of hospitalization were similar among White, Hispanic, and Black patients, but higher among Asian (OR, 1.6, 95% CI, 1.1-2.3) and multiracial patients (OR, 1.4; 95% CI, 1.0-1.9) compared with White patients. Among those hospitalized, Black patients were less likely than White patients to have severe illness (OR, 0.6; 95% CI, 0.4-0.8) and to die or be discharged to hospice (hazard ratio, 0.7; 95% CI, 0.6-0.9). Conclusions and Relevance/UNASSIGNED:In this cohort study of patients in a large health system in New York City, Black and Hispanic patients were more likely, and Asian patients less likely, than White patients to test positive; once hospitalized, Black patients were less likely than White patients to have critical illness or die after adjustment for comorbidity and neighborhood characteristics. This supports the assertion that existing structural determinants pervasive in Black and Hispanic communities may explain the disproportionately higher out-of-hospital deaths due to COVID-19 infections in these populations.
PMID: 33275153
ISSN: 2574-3805
CID: 4694552
Understanding the Patient Experience Through the Lenses of Racial/Ethnic and Gender Patient-Physician Concordance
Schoenthaler, Antoinette; Ravenell, Joseph
PMID: 33165607
ISSN: 2574-3805
CID: 4684242