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Implementing the NYU Electronic Patient Visit Assessment (ePVA)© for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial

Van Cleave, Janet H; Brody, Abraham A; Schulman-Green, Dena; Hu, Kenneth S; Li, Zujun; Johnson, Stephen B; Major, Vincent J; Lominska, Christopher E; Bauman, Jessica R; Hanania, Alexander N; Tatlonghari, Ghia V; Tsikis, Marcely; Egleston, Brian L
BACKGROUND:for HNC as a digital patient-reported symptom monitoring system that enables early symptom detection and real-time interventions at the point of care. With this study protocol, we aim to test the effectiveness of the ePVA in improving HNC outcomes in real-world settings and to identify implementation strategies optimizing its effectiveness. METHODS:We will conduct a longitudinal mixed-methods hybrid type I study at four National Cancer Institute-designated Comprehensive Cancer Centers serving diverse populations in rural and urban settings (New York University, the University of Kansas Cancer Center, Fox Chase Cancer Center, and Baylor College of Medicine) guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Patient eligibility criteria include having histologically diagnosed HNC and undergoing radiation therapy with or without chemotherapy for curative intent. We will also interview clinicians caring for patients with HNC at the participating institutions regarding facilitators and barriers to implementing the ePVA. The accrual goal is 270 patients. Aim 1 is to determine the effect of the ePVA on HNC symptoms in a two-arm (usual care vs. ePVA + usual care) trial. The study's primary outcomes are patients' self-reported social function, senses of taste and smell, and swallowing, measured by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35. For Aim 2, we will interview patients (n = 40) as well as clinicians (n = 30) caring for patients with HNC at the participating institutions regarding facilitators and barriers to implementing the ePVA. In Aim 3, we will integrate Aims 1 and 2 data to identify strategies that optimize the use of the ePVA. DISCUSSION/CONCLUSIONS:The overarching goal of this research is to advance cancer care by identifying implementation standards for effective, widespread use of the ePVA that apply to all patient-reported outcomes in cancer care. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov NCT06030011. Registered on 8 September 2023.
PMCID:12690913
PMID: 41366462
ISSN: 1745-6215
CID: 5977322

Banking Status as a Moderator of Outcomes in a Randomized Controlled Trial Targeting Financial Stress and Smoking

Rogers, Erin S; Wysota, Christina N; Sherman, Scott E
BACKGROUND:Financial capability is an understudied social determinant of health (SDoH). Bank account ownership, an indicator of financial capability, has been linked to better health. No research has explored how bank account ownership relates to health behaviors, such as tobacco use. OBJECTIVES/OBJECTIVE:To examine participant characteristics, intervention use, and intervention outcomes among subgroups of unbanked and banked participants enrolled in a randomized controlled trial (RCT) that integrated financial coaching and SDoH referrals into smoking cessation treatment for low-income individuals (N = 257). DESIGN/METHODS:Secondary analysis of an RCT. INTERVENTIONS/METHODS:The parent RCT provided a multi-component intervention (N = 136) that included smoking cessation coaching, nicotine replacement therapy, money management coaching, and referral to financial empowerment services and other SDoH resources. A waitlisted control group (N = 121) received usual care. MEASURES/METHODS:Bivariate analyses compared baseline characteristics and multivariable logistic regression compared intervention use by banking status. Within unbanked and banked subgroups, logistic regression examined treatment group differences (intervention vs. control) in self-reported 7-day abstinence and financial stress at 6 months. RESULTS:At baseline, 36% (n = 92) of participants were unbanked. Unbanked participants had lower income and education, higher unemployment, and greater financial distress (all p < 0.05). Intervention use did not differ by banking status (p > 0.05). At 6 months, unbanked participants had high abstinence rates in the intervention and control groups (ITT 21% vs. 13%, p > 0.05) and no significant treatment group differences in financial stress (p > 0.05). Among banked participants, the intervention group reported higher abstinence than the control group (ITT 19% vs. 6%, p = 0.01) and reduced financial stress across multiple domains (all p = 0.01). CONCLUSIONS:A significant portion of participants in the RCT were unbanked, but being unbanked was not a barrier to smoking cessation. The intervention reduced financial stress among banked participants only. Further research is needed to develop interventions that can support unbanked individuals' health and financial well-being. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov Identifier: NCT03187730.
PMID: 41331201
ISSN: 1525-1497
CID: 5974892

Advancing early and equitable detection of dementia: key learnings/challenges, recent innovations, and future directions

Chodosh, Joshua; Borson, Soo; Nordyke, Alexandra; Kwon, Simona C; Marsh, Karyn; Vedvyas, Alok; Lee, Matthew
Worldwide, over half of all individuals with dementia are undiagnosed. In the United States, racial, ethnic, and economic inequities mirror global findings, with higher rates of missed and delayed diagnosis and poorer diagnostic quality among minoritized and disadvantaged groups. For example, delayed diagnosis is more prevalent among people identifying as non-Hispanic Black or Latino than non-Hispanic White. Systematic efforts to improve detection can increase diagnosis rates; there is broad consensus that earlier detection and initiation of focused care and support services benefit both affected individuals and their loved ones. Systemic under-detection and its contributions to persistent population-level suffering underscore the importance of early detection of dementia as a key public health issue. Improving early detection calls for comprehensive, coordinated responses from local, regional, and national public health systems in partnership with health care delivery systems and community-based organizations. The Public Health Center of Excellence on Early Detection of Dementia (PHCOE on EDD), funded by the Centers for Disease Control and Prevention (CDC), is a national resource to promote understanding and implementation of evidence-based and evidence-informed public health strategy for early detection of dementia. We, together with the PHCOEs on Dementia Risk Reduction and Dementia Caregiving, and nearly four dozen state and local initiatives, seek to operationalize the priorities of the Building Our Largest Dementia Infrastructure for Alzheimer's Act and National Healthy Brain Initiative, established by federal legislation in 2018 and 2024. Our efforts support the CDC's mandate to build a national public health infrastructure for brain health and dementia.
PMCID:12736990
PMID: 41032250
ISSN: 1758-5341
CID: 5986962

Evaluating the role of visit audio recordings in triadic dementia care: study protocol

Barr, Paul J; Martinez-Pereira, Alejandra; O'Malley, James; Carpenter-Song, Elizabeth; Bruce, Martha L; Jacobson, Nicholas; Morgan, Brianna; Lee, Yi Shan; Fernandez, Gina; Onsando, W Moraa; Khaleghzadegan, Salar; Flaherty, Ellen; Ganoe, Craig; Hernandez, Diana; Mistler, Lisa; Oh, Lisa; Tarczewski, Susan; Chodosh, Joshua
BACKGROUND:Effective interpersonal communication is associated with improved health-related outcomes, yet it is unclear to what extent this occurs in triadic clinic visits for persons living with dementia (PLWD) and few tools exist to characterize triadic interpersonal communication and assess its effectiveness. The objective of this project is to characterize the interpersonal communication that occurs during triadic visits for PLWD, examine how interpersonal communication is related to health outcomes and use this understanding to adapt an innovative clinic visit audio recording intervention, HealthPAL (Personal Audio Library) for use in this setting. METHODS:Following the NIH Stage Model, we will redesign a visit recording platform, HealthPAL, which leverages natural language processing to structure visit information. In Aim 1, we will use an explanatory sequential mixed methods design. Informed by the Behavior Change Wheel, targets for behavior change will be identified using quantitative assessment of interpersonal communication during triadic visits (200 dyads, 3 visits annually; ∼600 visits), supplemented by semi-structured interviews with a purposive sample of triads (n = 42); In Aim 2, we will use participatory design methods (n = 60) to redesign HealthPAL using findings from Aim 1; and in Aim 3, we will use an open label, single-arm, multi-site pilot trial (n = 30) to determine usability, feasibility and acceptability of HealthPAL and gather preliminary data on its impact on interpersonal communication in triadic AD/ADRD visits. We hypothesize: (1) Constructs from models of interpersonal communication will be associated with health-related outcomes; (2) HealthPAL will surpass usability, feasibility, and acceptability metrics for dyads and clinicians. DISCUSSION/CONCLUSIONS:This work is a necessary first step to improving PLWD triadic care by identifying behaviors that impact triadic interpersonal communication and their associations with health-related outcomes. The novel intervention that we will develop--the use of visit recordings--and the diverse and extensive data we will collect will serve as a unique resource that can be leveraged to address other gaps in clinical knowledge related to the care of PLWD.
PMCID:12648846
PMID: 41291536
ISSN: 1471-2318
CID: 5968242

Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial

Adeyemi, Oluwaseun; Christina, Woo; Arcila-Mesa, Mauricio; Dickson, Victoria Vaughan; Ferris, Rosie; Tarpey, Thaddeus; Fletcher, Jason; Blaum, Caroline; Chodosh, Joshua
BACKGROUND:The Enhanced Quality in Primary Care for Elders with Diabetes-ADRD (EQUIPED-ADRD) is a quality improvement and pragmatic cluster-randomized controlled trial that uses clinical decision guidelines to streamline the care of older adults with diabetes mellitus and Alzheimer's disease/Alzheimer's disease-related Dementia (DM-AD/ADRD). This study tests whether the EQUIPED-ADRD intervention will increase the proportion of older adults with DM and AD/ADRD with desirable glycemic ranges, and reduce treatment burden, dementia severity, and healthcare utilization among participants and their care partners in the intervention arm compared to those in the control arm. METHODS:We will recruit older adults (≥65 years) with both DM and AD/ADRD diagnoses, who have care partners, and receive care at the enrolled New York University clinics. The intervention involves the use of panel managers to streamline the integration of clinical decision guidelines among primary care providers and improve the experiences of care partners and patients. Those in the control arm will have no panel management. We will conduct surveys and interviews, and extract data from EMR and Medicare claims to assess the association between the intervention and primary and secondary outcomes. The primary outcome is achieving within-range HbA1c, while the secondary outcomes include measures of healthcare utilization. Patient and care partner treatment burden, dementia symptoms, and care partner diabetes care distress. CONCLUSIONS:The EQUIPED-ADRD intervention (implemented between 2018 and 2021) will assess the effect of an institutional guideline on the quality of life and health outcomes of older adults with DM-AD/ADRD and their care partners. Clinical Trial NumberNCT03723707.
PMID: 41297852
ISSN: 1559-2030
CID: 5968412

Clostridioides difficile Infection Is Associated With Increased Colectomy Risk in Acute Severe Ulcerative Colitis Treated With Infliximab

Kahan, Tamara F; Delau, Olivia; Hong, Simon; Holmer, Ariela; Dodson, John; Shaukat, Aasma; Chodosh, Joshua; Hudesman, David; Axelrad, Jordan E; Faye, Adam S
BACKGROUND:Infliximab (IFX) is commonly used in the management of acute severe ulcerative colitis (ASUC), yet up to 30% of individuals still require colectomy within 1 year. Clinical data characterizing these patients, however, are limited. AIMS/OBJECTIVE:We aimed to determine risk factors for colectomy among patients with ASUC who received in-hospital IFX treatment. METHODS:We performed a retrospective analysis of patients with ASUC who were treated with at least one dose of IFX while admitted between 2014 and 2022. Cox proportional hazards (PH) models were used to assess demographic, clinical, and laboratory risk factors for colectomy within 30 days and 1 year of IFX initiation. RESULTS:Overall, 36/170 (21.2%) patients underwent colectomy within 1 year of IFX initiation, with 22 (12.9%) individuals requiring colectomy within 30 days. On univariable analysis, concomitant Clostridioides difficile infection during admission, a ≤50% decrease in C-reactive protein (CRP) and experiencing 3 or more bowel movements per day within 48 hours after an initial IFX dose were significantly associated with 1-year colectomy. On multivariable Cox PH analysis, C. difficile infection during admission (aHR=2.92, 95% CI: 1.12-7.58) and a higher CRP/albumin ratio on admission (aHR=1.13, 95% CI: 1.01-1.27) were associated with increased colectomy risk within 1 year of IFX initiation. CONCLUSIONS:C. difficile infection and a higher CRP/albumin ratio on admission are associated with decreased time to colectomy within 1 year of IFX among patients presenting with ASUC. These factors may aid in early risk stratification to minimize delays in JAK-inhibitor initiation or surgical referral.
PMID: 41201306
ISSN: 1539-2031
CID: 5960342

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

Patient Utilization of Remote Patient Monitoring in a Pilot Implementation at a Federally Qualified Health Center

Groom, Lisa L; Schoenthaler, Antoinette M; Budhrani, Rishika; Mann, Devin M; Brody, Abraham A
PMID: 40735809
ISSN: 1556-3669
CID: 5903442

The Neighborhoods Study: Examining the social exposome in Alzheimer's disease and related dementias

George, Grace C; Keller, Sarah A; Abner, Erin; Adar, Sara; Alosco, Michael L; Apostolova, Liana G; Bakulski, Kelly; Barnes, Lisa L; Bateman, James R; Batterman, Stuart; Beach, Thomas G; Bendlin, Barbara B; Bennett, David A; Betthauser, Tobey J; Brewer, James; Buckingham, William; Carrión, Carmen I; Chodosh, Joshua; Craft, Suzanne; Croff, Raina; Fabio, Anthony; Farias, Sarah Tomaszewski; Feldman, Eva L; Goldstein, Felicia; Goutman, Stephen A; Green-Harris, Gina; Henderson, Victor; Karikari, Thomas K; Kofler, Julia; Kucharska-Newton, Anna; Lamar, Melissa; Lanata, Serggio; Lepping, Rebecca J; Lingler, Jennifer; Lockhart, Samuel; Mahnken, Jonathan; Marsh, Karyn; Mathew, Jomol; Mecca, Adam P; Meyer, Oanh; Miller, Bruce; Morris, Jill; Neugroschl, Judith; O'Connor, Maureen K; Paulson, Henry; Perrin, Richard J; Pettigrew, Corinne; Pierce, Aimee; Powell, W Ryan; Pyarajan, Saiju; Raji, Cyrus A; Reiman, Eric; Risacher, Shannon; Rissman, Robert; Espivnosa, Patricia Rodriguez; Sano, Mary; Saykin, Andrew J; Serrano, Geidy E; Singh, Vikas; Soldan, Anja; Sultzer, David; van Dyck, Christopher H; Whitmer, Rachel; Wisniewski, Thomas; Woltjer, Randall; Yu, Menggang; Zhu, Carolyn W; Kind, Amy J H
INTRODUCTION/BACKGROUND:The Neighborhoods Study (TNS) is a novel investigation of adverse social exposome and brain health leveraging 22 Alzheimer's Disease Research Centers (ADRCs). TNS aims to understand if the adverse social exposures increase Alzheimer's disease and related dementias (ADRD) risk. METHODS:TNS uses innovative methods to determine lifetime addresses of living (n = ≈ 3116) and brain bank cohorts (n = ≈ 8637). Addresses are linked to time-concordant adverse social exposome using the Area Deprivation Index (ADI) and summarized over time. Brain health measures are provided by the National Alzheimer's Coordinating Center. RESULTS:We highlight a general overview and methodology of TNS. Data collection is ongoing; however, preliminary findings indicate that the adverse social exposome is related to ADRD biomarkers, neuropathology, and cognitive function. DISCUSSION/CONCLUSIONS:TNS is the largest study of adverse social exposome and ADRD, using the ADRC network to build robust scientific consortia. Its findings will inform ADRD interventions, precision medicine, and policy. HIGHLIGHTS/CONCLUSIONS:The Neighborhoods Study (TNS) investigates adverse social exposome and brain health. TNS is a collaboration among 22 Alzheimer's Disease Research Centers. TNS will give insight on environmental and exposomal factors which may be modifiable. Participant lifetime addresses are linked to temporal adverse social exposome metrics. This study's findings will inform precision approaches to mitigate dementia risk.
PMCID:12613078
PMID: 41230793
ISSN: 1552-5279
CID: 5965812

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