Browsing by Author "Shah, Nirmish"
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Item Open Access A multilevel mHealth intervention boosts adherence to hydroxyurea in individuals with sickle cell disease.(Blood advances, 2023-09) Hankins, Jane S; Brambilla, Donald; Potter, Michael B; Kutlar, Abdullah; Gibson, Robert; King, Allison A; Baumann, Ana A; Melvin, Cathy; Gordeuk, Victor R; Hsu, Lewis L; Nwosu, Chinonyelum; Porter, Jerlym S; Alberts, Nicole M; Badawy, Sherif M; Simon, Jena; Glassberg, Jeffrey A; Lottenberg, Richard; DiMartino, Lisa; Jacobs, Sara; Fernandez, Maria E; Bosworth, Hayden B; Klesges, Lisa M; Shah, NirmishHydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested two mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week pre-intervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; p<0.001) and sustained (39.7% to 51.4%, p<0.001). Mean HbF increased (10.95% to 12.78%; p=0.03). Self-reported pain frequency fell (3.54 to 3.35 events/year; p=0.041). InCharge Health was used >or=1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with >or=1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, p=0.0045) and weeks 25-36 (1.25 events/patient, p=0.0015). PDC increased with app use(p<0.001), with the greatest effect in those with private insurance (p=0.0078), in older subjects (p=0.033), and those with lower pain interference (p=0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, four unreported), only 11.2% used HU Toolbox >or=1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence has the potential to improve adherence and provide clinical benefits. A definitive randomized study is warranted.Item Open Access Characterizing epigenetic aging in an adult sickle cell disease cohort.(Blood advances, 2024-01) Lê, Brandon M; Hatch, Daniel; Yang, Qing; Shah, Nirmish; Luyster, Faith S; Garrett, Melanie E; Tanabe, Paula; Ashley-Koch, Allison E; Knisely, Mitchell RAbstract
Sickle cell disease (SCD) affects ∼100 000 predominantly African American individuals in the United States, causing significant cellular damage, increased disease complications, and premature death. However, the contribution of epigenetic factors to SCD pathophysiology remains relatively unexplored. DNA methylation (DNAm), a primary epigenetic mechanism for regulating gene expression in response to the environment, is an important driver of normal cellular aging. Several DNAm epigenetic clocks have been developed to serve as a proxy for cellular aging. We calculated the epigenetic ages of 89 adults with SCD (mean age, 30.64 years; 60.64% female) using 5 published epigenetic clocks: Horvath, Hannum, PhenoAge, GrimAge, and DunedinPACE. We hypothesized that in chronic disease, such as SCD, individuals would demonstrate epigenetic age acceleration, but the results differed depending on the clock used. Recently developed clocks more consistently demonstrated acceleration (GrimAge, DunedinPACE). Additional demographic and clinical phenotypes were analyzed to explore their association with epigenetic age estimates. Chronological age was significantly correlated with epigenetic age in all clocks (Horvath, r = 0.88; Hannum, r = 0.89; PhenoAge, r = 0.85; GrimAge, r = 0.88; DunedinPACE, r = 0.34). The SCD genotype was associated with 2 clocks (PhenoAge, P = .02; DunedinPACE, P < .001). Genetic ancestry, biological sex, β-globin haplotypes, BCL11A rs11886868, and SCD severity were not associated. These findings, among the first to interrogate epigenetic aging in adults with SCD, demonstrate epigenetic age acceleration with recently developed epigenetic clocks but not older-generation clocks. Further development of epigenetic clocks may improve their predictive ability and utility for chronic diseases such as SCD.Item Open Access Dissemination of Evidence-Based Recommendations for Sickle Cell Disease to Primary Care and Emergency Department Providers in North Carolina: A Cost Benefit Analysis.(Journal of health economics and outcomes research, 2021-04) Tanabe, Paula; Blewer, Audrey L; Bonnabeau, Emily; Bosworth, Hayden B; Clayton, Denise H; Crego, Nancy; Earls, Marian F; Eason, Kern; Forlines, Grayson; Rains, Gary; Young, Matthew; Shah, NirmishBackground: Sickle cell disease (SCD) is a genetic condition affecting primarily individuals of African descent, who happen to be disproportionately impacted by poverty and who lack access to health care. Individuals with SCD are at high likelihood of high acute care utilization and chronic pain episodes. The multiple complications seen in SCD contribute to significant morbidity and premature mortality, as well as substantial costs to the healthcare system. Objectives: SCD is a complex chronic disease resulting in the need for primary, specialty and emergency care. Many providers do not feel prepared to care for individuals with SCD, despite the existence of evidence-based guidelines. We report the development of a SCD toolbox and the dissemination process to primary care and emergency department (ED) providers in North Carolina (NC). We report the effect of this dissemination on health-care utilization, cost of care, and overall cost-benefit. Methods: The SCD toolbox was adapted from the National Heart, Lung, and Blood Institute recommendations. Toolbox training was provided to quality improvement specialists who then disseminated the toolbox to primary care providers (PCPs) affiliated with the only NC managed care coordination system and ED providers. Tools were made available in paper, online, and in app formats to participating managed care network practices (n=1 800). Medicaid claims data were analyzed for total costs and benefits of the toolbox dissemination for a 24-month pre- and 18-month post-intervention period. Results: There was no statistically significant shift in the number of outpatient specialty visits, ED visits or hospitalizations. There was a small decrease in the number of PCP visits in the post-implementation period. The dissemination resulted in a net cost-savings of $361 414 ($14.03 per-enrollee per-month on average). However, the estimated financial benefit associated with the dissemination of the SCD toolbox was not statistically significant. Conclusions: Although we did not find the expected shift to increased PCP visits and decreased ED visits and hospitalizations, there were many lessons learned.Item Open Access Integration of Mobile Health Into Sickle Cell Disease Care to Increase Hydroxyurea Utilization: Protocol for an Efficacy and Implementation Study.(JMIR research protocols, 2020-07) Hankins, Jane S; Shah, Nirmish; DiMartino, Lisa; Brambilla, Donald; Fernandez, Maria E; Gibson, Robert W; Gordeuk, Victor R; Lottenberg, Richard; Kutlar, Abdullah; Melvin, Cathy; Simon, Jena; Wun, Ted; Treadwell, Marsha; Calhoun, Cecelia; Baumann, Ana; Potter, Michael B; Klesges, Lisa; Bosworth, Hayden; Sickle Cell Disease Implementation ConsortiumBACKGROUND:Hydroxyurea prevents disease complications among patients with sickle cell disease (SCD). Although its efficacy has been endorsed by the National Health Lung and Blood Institute evidence-based guidelines, its adoption is low, both by patients with SCD and providers. Mobile health (mHealth) apps provide benefits in improving medication adherence and self-efficacy among patients with chronic diseases and have facilitated prescription among medical providers. However, mHealth has not been systematically tested as a tool to increase hydroxyurea adherence nor has the combination of mHealth been assessed at both patient and provider levels to increase hydroxyurea utilization. OBJECTIVE:This study aims to increase hydroxyurea utilization through a combined two-level mHealth intervention for both patients with SCD and their providers with the goals of increasing adherence to hydroxyurea among patients and improve hydroxyurea prescribing behavior among providers. METHODS:We will test the efficacy of 2 mHealth interventions to increase both patient and provider utilization and knowledge of hydroxyurea in 8 clinical sites of the NHLBI-funded Sickle Cell Disease Implementation Consortium (SCDIC). The patient mHealth intervention, InCharge Health, includes multiple components that address memory, motivation, and knowledge barriers to hydroxyurea use. The provider mHealth intervention, Hydroxyurea Toolbox (HU Toolbox), addresses the clinical knowledge barriers in prescribing and monitoring hydroxyurea. The primary hypothesis is that among adolescents and adults with SCD, adherence to hydroxyurea, as measured by the proportion of days covered (the ratio of the number of days the patient is covered by the medication to the number of days in the treatment period), will increase by at least 20% after 24 weeks of receiving the InCharge Health app, compared with their adherence at baseline. As secondary objectives, we will (1) examine the change in health-related quality of life, acute disease complications, perceived health literacy, and perceived self-efficacy in taking hydroxyurea among patients who use InCharge Health and (2) examine potential increases in the awareness of hydroxyurea benefits and risks, appropriate prescribing, and perceived self-efficacy to correctly administer hydroxyurea therapy among SCD providers between baseline and 9 months of using the HU Toolbox app. We will measure the reach, adoption, implementation, and maintenance of both the InCharge Health and the HU Toolbox apps using the reach, effectiveness, adoption, implementation, and maintenance framework and qualitatively evaluate the implementation of both mHealth interventions. RESULTS:The study is currently enrolling study participants. Recruitment is anticipated to be completed by mid-2021. CONCLUSIONS:If this two-level intervention, that is, the combined use of InCharge Health and HU Toolbox apps, demonstrates efficacy in increasing adherence to hydroxyurea and prescribing behavior in patients with SCD and their providers, respectively, both apps will be offered to other institutions outside the SCDIC through a future large-scale implementation-effectiveness study. TRIAL REGISTRATION:ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16319.Item Open Access Sickle cell disease is a global prototype for integrative research and healthcare(Advanced Genetics, 2021-03) Royal, Charmaine DM; Babyak, Michael; Shah, Nirmish; Srivatsa, Shantanu; Stewart, Kearsley A; Tanabe, Paula; Wonkam, Ambroise; Asnani, Monika