Browsing by Author "Miller, Julie"
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Item Open Access Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.(Medical care, 2024-07) Bosworth, Hayden B; Patel, Uptal D; Lewinski, Allison A; Davenport, Clemontina A; Pendergast, Jane; Oakes, Megan; Crowley, Matthew J; Zullig, Leah L; Patel, Sejal; Moaddeb, Jivan; Miller, Julie; Malone, Shauna; Barnhart, Huiman; Diamantidis, Clarissa JBackground/objective
Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression.Methods
We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control.Results
We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m2, 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m2 for the control and intervention groups, respectively, with no significant between-group difference (P=0.75).Conclusions
We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.Item Open Access eConsults' Impact on Care Access and Wait Times in Rheumatology.(Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases, 2022-04) Malcolm, Elizabeth J; Brandon, Zachary; Wilson, Lauren E; Shoup, John Paul; King, Heather A; Lewinski, Allison; Greiner, Melissa A; Malone, Shauna; Miller, Julie; Keenan, Robert T; Tarrant, Teresa K; Phinney, Donna; Cho, Alex; Bosworth, Hayden B; Shah, KevinBackground/objective
A growing number of health systems have implemented eConsults to improve access to specialty advice, but few studies have described their use in rheumatology or impact on visit wait times. We evaluated the uptake of an eConsult program and its impact on wait times for in-person rheumatology visits.Methods
In this quality improvement project, we analyzed electronic health record data from 4 intervention clinics and 4 comparison clinics, 12 months before and after implementation of an eConsult program. We compared median wait time for rheumatology appointments using a pre-post difference-in-differences analysis and quantile regression, adjusting for patient age, race, sex, clinic pair, and primary insurance payer. We also interviewed 11 primary care providers from the intervention clinics and conducted a rheumatology provider focus group (n = 4) to elucidate experiences with the program.Results
Rheumatologists recommended management in primary care or referral to another specialty for 41% of eConsults, reducing initial demand for in-person visits. The median wait times dropped in the intervention and the comparison clinics (42 and 25 days, respectively). Intervention clinic median wait time dropped 17 days more than comparison clinics, and this was nonstatistically significant (p = 0.089). eConsults fit provider care tasks best for triage or initial workup for diagnosis, and less well when tests required interpretation, or when back and forth communication was needed to manage the patient's condition.Conclusions
Implementation of eConsults for rheumatology was associated with reduced wait times for rheumatology appointments and supported primary care providers in the triage and workup for a substantial portion of patients.Item Open Access Factors influencing support for the implementation of community-based out-of-hospital cardiac arrest interventions in high- and low-performing counties.(Resuscitation plus, 2024-03) Ezem, Natalie; Lewinski, Allison A; Miller, Julie; King, Heather A; Oakes, Megan; Monk, Lisa; Starks, Monique A; Granger, Christopher B; Bosworth, Hayden B; Blewer, Audrey LAim of the study
Survival to hospital discharge from out-of-hospital cardiac arrest (OHCA) after receiving treatment from emergency medical services (EMS) is less than 10% in the United States. Community-focused interventions improve survival rates, but there is limited information on how to gain support for new interventions or program activities within these populations. Using data from the RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial, we aimed to identify the factors influencing emergency response agencies' support in implementing an OHCA intervention.Methods
North Carolina counties were stratified into high-performing or low-performing counties based on the county's cardiac arrest volume, percent of bystander-cardiopulmonary resuscitation (CPR) performed, patient survival to hospital discharge, cerebral performance in patients after cardiac arrest, and perceived engagement in the RACE-CARS project. We randomly selected 4 high-performing and 3 low-performing counties and conducted semi-structured qualitative interviews with emergency response stakeholders in each county.Results
From 10/2021 to 02/2022, we completed 29 interviews across the 7 counties (EMS (n = 9), telecommunications (n = 7), fire/first responders (n = 7), and hospital representatives (n = 6)). We identified three themes salient to community support for OHCA intervention: (1) initiating support at emergency response agencies; (2) obtaining support from emergency response agency staff (senior leadership and emergency response teams); and (3) and maintaining support. For each theme, we described similarities and differences by high- and low-performing county.Conclusions
We identified techniques for supporting effective engagement of emergency response agencies in community-based interventions for OHCA improving survival rates. This work may inform future programs and initiatives around implementation of community-based interventions for OHCA.Item Open Access Impact of financial medication assistance on medication adherence: a systematic review.(Journal of managed care & specialty pharmacy, 2021-07) Hung, Anna; Blalock, Dan V; Miller, Julie; McDermott, Jaime; Wessler, Hannah; Oakes, Megan M; Reed, Shelby D; Bosworth, Hayden B; Zullig, Leah LBACKGROUND: The prevalence of financial medication assistance (FMA), including patient assistance programs, coupons/copayment cards, vouchers, discount cards, and programs/pharmacy services that help patients apply for such programs, has increased. The impact of FMA on medication adherence and persistence has not been synthesized. OBJECTIVE: The primary objective of this study was to review published studies evaluating the impact of FMA on the three phases of medication adherence (initiation [or primary adherence], implementation [or secondary adherence], and discontinuation) and persistence. Among these studies, the secondary objective was to report the impact of FMA on patient out-of-pocket costs and clinical outcomes. METHODS: A systematic review was performed using MEDLINE and Web of Science. RESULTS: Of 656 articles identified, eight studies met all inclusion criteria. Seven studies examined FMA for medications treating cardiovascular diseases, while one study assessed FMA for cancer medications. Among included studies, FMA had a positive impact on medication adherence or persistence, and most measured this impact over one year or less. Of the three phases of medication adherence, implementation (5 of 8) was most commonly reported, followed by discontinuation (3 of 8), and then initiation (1 of 8). Regarding implementation, users of FMA had a higher mean medication possession ratio (MPR) than nonusers, ranging from 7 to 18 percentage points higher. The percentage of patients who discontinued medication was 7 percentage points lower in users of FMA versus nonusers for cardiovascular disease states. In one cancer study, FMA had a larger impact on initiation than discontinuation, ie, compared to nonusers, users of FMA were less likely to abandon an initial prescription (risk ratio= 0.12, 95% confidence interval [CI]: 0.08-0.18), and this effect was larger than the decreased likelihood of discontinuing the medication (hazard ratio = 0.76, 95% CI: 0.66-0.88). In 3 of 8 studies reporting on medication persistence, FMA increased the odds of medication persistence for one year ranged from 11% to 47%, depending on the study. In addition to adherence, half of the studies reported on FMA impacts on patient out-of-pocket costs and 3 of 8 studies reported on clinical outcomes. Impacts on patient out-of-pocket costs were mixed; two studies reported that out-of-pocket costs were higher for users of a coupon or a voucher versus nonusers, one study reported the opposite, and one study reported null effects. Impacts on clinical outcomes were either positive or null. CONCLUSIONS: We found that FMA has positive impacts on all phases of medication adherence as well as medication persistence over one year. Future studies should assess whether FMA has differential impacts based on phase of medication adherence and report on its longer-term (ie, beyond one year) impacts on medication adherence. DISCLOSURES: This work was sponsored by a grant from Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Hung reports past employment by Blue Cross Blue Shield Association and CVS Health and a grant from PhRMA outside of the submitted work. Zullig reports research funding from Proteus Digital Health and the PhRMA Foundation. consulting fees from Novartis. Reed reports receiving research support from Abbott Vascular, AstraZeneca, Janssen Research & Development, Monteris, PhRMA Foundation, and TESARO and consulting fees from Sanofi/Regeneron, NovoNordisk, SVC Systems, and Minomic International, Inc. Bosworth reports research grants from the PhRMA Foundation, Proteus Digital Health, Otsuka, Novo Nordisk, Sanofi, Improved Patient Outcomes, Boehinger Ingelheim, NIH, and VA, as well as consulting fees from Sanofi, Novartis, Otsuka, Abbott, Xcenda, Preventric Diagnostics, and the Medicines Company. The other authors have nothing to report. This work was presented as a poster presentation at the ESPACOMP Annual Meeting in November 2020.Item Open Access Patients' Experiences With Staphylococcus aureus and Gram-Negative Bacterial Bloodstream Infections: Results From Cognitive Interviews to Inform Assessment of Health-Related Quality of Life.(Open forum infectious diseases, 2022-02) King, Heather A; Doernberg, Sarah B; Grover, Kiran; Miller, Julie; Oakes, Megan; Wang, Tsai-Wei; McFatrich, Molly; Ruffin, Felicia; Staman, Karen; Lane, Hannah G; Rader, Abigail; Sund, Zoë; Bosworth, Hayden B; Reeve, Bryce B; Fowler, Vance G; Holland, Thomas LBackground
We previously conducted a concept elicitation study on the impact of Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) on health-related quality of life (HRQoL) from the patient's perspective and found significant impacts on HRQoL, particularly in the physical and functional domains. Using this information and following guidance on the development of patient-reported outcome (PRO) measures, we determined which combination of measures and items (ie, specific questions) would be most appropriate in a survey assessing HRQoL in bloodstream infections.Methods
We selected a variety of measures/items from the Patient-Reported Outcomes Measurement Information System (PROMIS) representing different domains. We purposefully sampled patients ~6-12 weeks post-SAB/GNB and conducted 2 rounds of cognitive interviews to refine the survey by exploring patients' understanding of items and answer selection as well as relevance for capturing HRQoL.Results
We interviewed 17 SAB/GNB patients. Based on the first round of cognitive interviews (n = 10), we revised the survey. After round 2 of cognitive interviewing (n = 7), we finalized the survey to include 10 different PROMIS short forms/measures of the most salient HRQoL domains and 2 adapted questions (41 items total) that were found to adequately capture HRQoL.Conclusions
We developed a survey from well-established PRO measures that captures what matters most to SAB/GNB patients as they recover. This survey, uniquely tailored to bloodstream infections, can be used to assess these meaningful, important HRQoL outcomes in clinical trials and in patient care. Engaging patients is crucial to developing treatments for bloodstream infections.Item Open Access Patients' Experiences With Staphylococcus aureus and Gram-negative Bacterial Bloodstream Infections: A Qualitative Descriptive Study and Concept Elicitation Phase To Inform Measurement of Patient-reported Quality of Life.(Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021-07) King, Heather A; Doernberg, Sarah B; Miller, Julie; Grover, Kiran; Oakes, Megan; Ruffin, Felicia; Gonzales, Sarah; Rader, Abigail; Neuss, Michael J; Bosworth, Hayden B; Sund, Zoë; Drennan, Caitlin; Hill-Rorie, Jonathan M; Shah, Pratik; Winn, Laura; Fowler, Vance G; Holland, Thomas LBackground
Although Staphylococcus aureus and gram-negative bacterial bloodstream infections (SAB/GNB) cause substantial morbidity, little is known regarding patient perceptions' of their impact on quality of life (QOL). Guidance for assessing QOL and disease-specific measures are lacking. We conducted a descriptive qualitative study to gain an in-depth understanding of patients' experiences with SAB/GNB and concept elicitation phase to inform a patient-reported QOL outcome measure.Methods
We conducted prospective one-time, in-depth, semi-structured, individual, qualitative telephone interviews 6- 8 weeks following bloodstream infection with either SAB or GNB. Patients were enrolled in an institutional registry (tertiary academic medical center) for SAB or GNB. Interviews were audio-recorded, transcribed, and coded. Directed content analysis identified a priori and emergent themes. Theme matrix techniques were used to facilitate analysis and presentation.Results
Interviews were completed with 30 patients with SAB and 31 patients with GNB. Most patients were at or near the end of intravenous antibiotic treatment when interviewed. We identified 3 primary high-level concepts: impact on QOL domains, time as a critical index, and sources of variability across patients. Across both types of bloodstream infection, the QOL domains most impacted were physical and functional, which was particularly evident among patients with SAB.Conclusions
SAB/GNB impact QOL among survivors. In particular, SAB had major impacts on multiple QOL domains. A combination of existing, generic measures that are purposefully selected and disease-specific items, if necessary, could best capture these impacts. Engaging patients as stakeholders and obtaining their feedback is crucial to conducting patient-centered clinical trials and providing patient-centered care.