Browsing by Author "Oakes, Megan M"
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Item Open Access Assessing a Digital Medicine System in Veterans with Severe Mental Illness: A provider-randomized clinical trial (Preprint)(2021-12-09) Gonzales, Sarah; Okusaga, Olaoluwa O; Reuteman-Fowler, J Corey; Oakes, Megan M; Brown, Jamie N; Moore, Scott; Lewinski, Allison A; Rodriguez, Cristin; Moncayo, Norma; Smith, Valerie A; Malone, Shauna; List, Justine; Cho, Raymond Y; Jeffreys, Amy S; Bosworth, Hayden BBACKGROUNDSuboptimal medication adherence is a significant problem for patients with serious mental illness (SMI). Measuring medication adherence through subjective and objective measures can be challenging, time consuming and inaccurate.
OBJECTIVEWe evaluated a digital medicine system (DMS) compared to treatment as usual (TAU) on adherence to oral aripiprazole and patient and provider perspectives on the feasibility and acceptability of a DMS.
METHODSThis open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semi-structured interviews with patients and providers were used to examine feasibility and acceptability of using the DMS.
RESULTSWe enrolled 46 patients across 2 Veterans Affairs (VA) sites: (21 in DMS and 25 in TAU). There was no difference in medication refill over 3 and 6 months, respectively (82% and 75% DMS vs. 86% and 82% TAU). The DMS arm had 85% days covered during the period they were engaged with the DMS (144 days on average). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient themes included: pre-enrollment adherence strategies and interest in the DMS, positive impact on medication adherence, system usability challenges, support needs, and suggested design/functionality improvements. Provider themes included: concerns for patient medication adherence and interest in the DMS, concerns with the DMS, DMS dashboard usability, challenges of the DMS, and suggestions to increase provider use.
CONCLUSIONSThere was no observed difference in refill rates. Among those who engaged in the DMS arm, refill rates were relatively high (85%). The qualitative analyses highlighted areas for further refinement of the DMS.
CLINICALTRIALNCT03881449
Item Open Access Digital Medicine System in Veterans With Severe Mental Illness: Feasibility and Acceptability Study.(JMIR formative research, 2022-12) Gonzales, Sarah; Okusaga, Olaoluwa O; Reuteman-Fowler, J Corey; Oakes, Megan M; Brown, Jamie N; Moore, Scott; Lewinski, Allison A; Rodriguez, Cristin; Moncayo, Norma; Smith, Valerie A; Malone, Shauna; List, Justine; Cho, Raymond Y; Jeffreys, Amy S; Bosworth, Hayden BBackground
Suboptimal medication adherence is a significant problem for patients with serious mental illness. Measuring medication adherence through subjective and objective measures can be challenging, time-consuming, and inaccurate.Objective
The primary purpose of this feasibility and acceptability study was to evaluate the impact of a digital medicine system (DMS) among Veterans (patients) with serious mental illness as compared with treatment as usual (TAU) on medication adherence.Methods
This open-label, 2-site, provider-randomized trial assessed aripiprazole refill adherence in Veterans with schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder. We randomized 26 providers such that their patients either received TAU or DMS for a period of 90 days. Semistructured interviews with patients and providers were used to examine the feasibility and acceptability of using the DMS.Results
We enrolled 46 patients across 2 Veterans Health Administration sites: 21 (46%) in DMS and 25 (54%) in TAU. There was no difference in the proportion of days covered by medication refill over 3 and 6 months (0.82, SD 0.24 and 0.75, SD 0.26 in DMS vs 0.86, SD 0.19 and 0.82, SD 0.21 in TAU, respectively). The DMS arm had 0.85 (SD 0.20) proportion of days covered during the period they were engaged with the DMS (mean 144, SD 100 days). Interviews with patients (n=14) and providers (n=5) elicited themes salient to using the DMS. Patient findings described the positive impact of the DMS on medication adherence, challenges with the DMS patch connectivity and skin irritation, and challenges with the DMS app that affected overall use. Providers described an overall interest in using a DMS as an objective measure to support medication adherence in their patients. However, providers described challenges with the DMS dashboard and integrating DMS data into their workflow, which decreased the usability of the DMS for providers.Conclusions
There was no observed difference in refill rates. Among those who engaged in the DMS arm, the proportion of days covered by refills were relatively high (mean 0.85, SD 0.20). The qualitative analyses highlighted areas for further refinement of the DMS.Trial registration
ClinicalTrials.gov NCT03881449; https://clinicaltrials.gov/ct2/show/NCT03881449.Item Open Access Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence.(JMIR medical informatics, 2016-03) Bosworth, Hayden B; Zullig, Leah L; Mendys, Phil; Ho, Michael; Trygstad, Troy; Granger, Christopher; Oakes, Megan M; Granger, Bradi BBackground
The use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain.Objective
The aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT.Methods
We describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence.Results
The four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed.Conclusion
To make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.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 Lessons learned from two randomized controlled trials: CITIES and STOP-DKD.(Contemporary clinical trials communications, 2020-09) Zullig, Leah L; Oakes, Megan M; McCant, Felicia; Bosworth, Hayden BBackground
Even well-designed, theoretically driven clinical trials can fall short of achieving the desired clinical outcomes. Our research team had an opportunity to conduct two randomized controlled trials that were enrolling patients in parallel. While both studies were targeting chronic disease management among patients with multiple comorbid conditions, the patient population and settings varied. The studies were the Cardiovascular Intervention Improvement Telemedicine Study (CITIES) and Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) studies. Both studies had null findings.Objectives
Our goal is to discuss common design considerations across CITIES and STOP-DKD and potential implications for the design of future randomized controlled trials.Methods
These were two 1:1 randomized controlled trials with attention control groups that recruited patients from various clinical practices in the Research Triangle area of North Carolina.Conclusions
We make three recommendations for future studies. First, we assert that it is important to allow for piloting the enrollment process to ensure that it is possible to identify and recruit a patient population that is well aligned with the clinical outcomes of the intervention. Second, analysis plans should be more targeted in their approach and should consider heterogeneity of treatment effects. Third, in order to support the transition of evidence generated from randomized controlled trials into clinical practice, it is important to consider even early stage randomized controlled trials through an implementation science lens.Trial registration
Simultaneous Risk Factor Control Using Telehealth to slow Progression of Diabetic Kidney Disease (STOP-DKD) NCT01829256; Cardiovascular Intervention Improvement Telemedicine Study NCT01142908.Item Open Access Medication rebates and health disparities: Mind the gap.(Research in social & administrative pharmacy : RSAP, 2020-03) Zullig, Leah L; Granger, Bradi B; Vilme, Helene; Oakes, Megan M; Bosworth, Hayden BCompared to white patients in the United States, people of racial and ethnic minority groups face higher rates of chronic disease including diabetes, obesity, stroke, cardiovascular disease and cancer. Minority groups are also less likely to receive medication therapy to manage complications of chronic disease as well as be adherent to these therapies. A recently announced proposed rule by the Department of Health and Human Services Office of the Inspector General (HHS OIG), which would discourage rebates between manufacturers and payers in favor of discounts directly provided to patients, has received significant attention for its anticipated impact on prescription drug pricing and reimbursement in Medicare. This commentary describes the proposed rule and how it may impact adherence among patients of racial minority groups through an illustrative case study and discussion.Item Open Access Potential impact of pharmaceutical industry rebates on medication adherence.(The American journal of managed care, 2019-05) Zullig, Leah L; Granger, Bradi B; Vilme, Helene; Oakes, Megan M; Bosworth, Hayden BMany patients struggle to take their prescription medications as prescribed. Multiple interacting factors influence medication nonadherence. The cost of medications, particularly a patient's out-of-pocket cost, spans several of these domains. One proposed option for reducing a patient's out-of-pocket cost involves directly sharing manufacturer rebates with patients to lower their out-of-pocket costs at the pharmacy counter. Rebates are widely used across industries (eg, pharmaceutical manufacturers, tourism taxes, automobile manufacturers) in negotiations between sellers and buyers for a particular product. Medication rebates play an important role in the current US pharmaceutical marketplace. However, rebate contract terms are not publicly reported, so it is difficult for patients to determine if, and how, a rebate is reflected in their out-of-pocket costs. This commentary addresses the role of rebates in the current US healthcare landscape and their relationship with medication adherence.Item Open Access Primary Care Providers' Acceptance of Pharmacists' Recommendations to Support Optimal Medication Management for Patients with Diabetic Kidney Disease.(Journal of general internal medicine, 2020-01) Zullig, Leah L; Jazowski, Shelley A; Davenport, Clemontina A; Diamantidis, Clarissa J; Oakes, Megan M; Patel, Sejal; Moaddeb, Jivan; Bosworth, Hayden BBackground
Patients with diabetic kidney disease (DKD) often struggle with blood pressure control. In team-based models of care, pharmacists and primary care providers (PCPs) play important roles in supporting patients' blood pressure management.Objective
To describe whether PCPs' acceptance of pharmacists' recommendations impacts systolic blood pressure (SBP) at 36 months.Design
An observational analysis of a subset of participants randomized to the intervention arm of the Simultaneous risk factor control using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study.Participants
STOP-DKD participants for whom (1) the pharmacist made at least one recommendation to the PCP; (2) there were available data regarding the PCP's corresponding action; and (3) there were SBP measurements at baseline and 36 months.Intervention
Participants received monthly telephone calls with a pharmacist addressing health behaviors and medication management. Pharmacists made medication-related recommendations to PCPs.Main measures
We fit an unadjusted generalized linear mixed model to assess the association between the number of pharmacists' recommendations for DKD and blood pressure management and PCPs' acceptance of such recommendations. We used a linear regression model to evaluate the association between PCP acceptance and SBP at 36 months, adjusted for baseline SBP.Key results
Pharmacists made 176 treatment recommendations (among 59 participants), of which 107 (61%) were accepted by PCPs. SBP significantly declined by an average of 10.5 mmHg (p < 0.01) among 47 of 59 participants who had valid measurements at baseline and 36 months. There was a significant association between the number of pharmacist recommendations and the odds of PCP acceptance (OR 1.19; 95%CI 1.00, 1.42; p < 0.05), but no association between the number of accepted recommendations and SBP.Conclusions
Pharmacists provided actionable medication-related recommendations. We identified a significant decline in SBP at 36 months, but this reduction was not associated with recommendation acceptance.Trial registration
NCT01829256.Item Open Access Racial differences in nocturnal dipping status in diabetic kidney disease: Results from the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) study.(Journal of clinical hypertension (Greenwich, Conn.), 2017-12) Zullig, Leah L; Diamantidis, Clarissa J; Bosworth, Hayden B; Bhapkar, Manjushri V; Barnhart, Huiman; Oakes, Megan M; Pendergast, Jane F; Miller, Julie J; Patel, Uptal DWhile racial variation in ambulatory blood pressure (BP) is known, patterns of diurnal dipping in the context of diabetic kidney disease have not been well defined. The authors sought to determine the association of race with nocturnal dipping status among participants with diabetic kidney disease enrolled in the STOP-DKD (Simultaneous Risk Factor Control Using Telehealth to Slow Progression of Diabetic Kidney Disease) trial. The primary outcome was nocturnal dipping-percent decrease in average systolic BP from wake to sleep-with categories defined as reverse dippers (decrease <0%), nondippers (0%-<10%), and dippers (≥10%). Twenty-four-hour ambulatory BP monitoring was completed by 108 participants (54% were nondippers, 24% were dippers, and 22% were reverse dippers). In adjusted models, the common odds of reverse dippers vs nondippers/dippers and reverse dippers/nondippers vs dippers was 2.6 (95% confidence interval, 1.2-5.8) times higher in blacks than in whites. Without ambulatory BP monitoring data, interventions that target BP in black patients may be unable to improve outcomes in this high-risk group.Item Open Access Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study: Protocol and baseline characteristics of a randomized controlled trial.(Contemporary clinical trials, 2018-06) Diamantidis, Clarissa J; Bosworth, Hayden B; Oakes, Megan M; Davenport, Clemontina A; Pendergast, Jane F; Patel, Sejal; Moaddeb, Jivan; Barnhart, Huiman X; Merrill, Peter D; Baloch, Khaula; Crowley, Matthew J; Patel, Uptal DDiabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) in the United States. Multiple risk factors contribute to DKD development, yet few interventions target more than a single DKD risk factor at a time. This manuscript describes the study protocol, recruitment, and baseline participant characteristics for the Simultaneous Risk Factor Control Using Telehealth to slOw Progression of Diabetic Kidney Disease (STOP-DKD) study. The STOP-DKD study is a randomized controlled trial designed to evaluate the effectiveness of a multifactorial behavioral and medication management intervention to mitigate kidney function decline at 3 years compared to usual care. The intervention consists of up to 36 monthly educational modules delivered via telephone by a study pharmacist, home blood pressure monitoring, and medication management recommendations delivered electronically to primary care physicians. Patients seen at seven primary care clinics in North Carolina, with diabetes and [1] uncontrolled hypertension and [2] evidence of kidney dysfunction (albuminuria or reduced estimated glomerular filtration rate [eGFR]) were eligible to participate. Study recruitment completed in December 2014. Of the 281 participants randomized, mean age at baseline was 61.9; 52% were male, 56% were Black, and most were high school graduates (89%). Baseline co-morbidity was high- mean blood pressure was 134/76 mmHg, mean body mass index was 35.7 kg/m2, mean eGFR was 80.7 ml/min/1.73 m2, and mean glycated hemoglobin was 8.0%. Experiences of recruiting and implementing a comprehensive DKD program to individuals at high risk seen in the primary care setting are provided.Trial registration
NCT01829256.Item Open Access The new landscape of medication adherence improvement: where population health science meets precision medicine.(Patient preference and adherence, 2018-01) Zullig, Leah L; Blalock, Dan V; Dougherty, Samantha; Henderson, Rochelle; Ha, Carolyn C; Oakes, Megan M; Bosworth, Hayden BDespite the known health and economic benefits of medications, nonadherence remains a significant, yet entirely preventable public health burden. Over decades, there have been numerous research studies evaluating health interventions and policy efforts aimed at improving adherence, yet no universal or consistently high impact solutions have been identified. At present, new challenges and opportunities in policy and the movement toward value-based care should foster an environment that appreciates adherence as a mechanism to improve health outcomes and control costs (eg, fewer hospitalizations, reduced health care utilization). Our objective was to provide a commentary on recent changes in the landscape of research and health policy directed toward improving adherence and an actionable agenda to achieve system level savings and improved health by harnessing the benefits of medications. Specifically, we address the complementary perspectives of precision medicine and population health management; integrating data sources to develop innovative measurement of adherence and target adherence interventions; and behavioral economics to determine appropriate incentives.Item Open Access The relationship between Pittsburgh Sleep Quality Index subscales and diabetes control.(Chronic illness, 2019-09) Telford, Onala; Diamantidis, Clarissa J; Bosworth, Hayden B; Patel, Uptal D; Davenport, Clemontina A; Oakes, Megan M; Crowley, Matthew JOBJECTIVES:: Data suggest that poor sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) contributes to suboptimal diabetes control. How the subscales comprising the PSQI individually relate to diabetes control is poorly understood. METHODS:: In order to explore how PSQI subscales relate to diabetes control, we analyzed baseline data from a trial of a telemedicine intervention for diabetes. We used multivariable modeling to examine: (1) the relationship between the global PSQI and hemoglobin A1c (HbA1c); (2) the relationships between the 7 PSQI subscales and HbA1c; and (3) medication nonadherence as a possible mediating factor. RESULTS:: Global PSQI was not associated with HbA1c (n = 279). Only one PSQI subscale, sleep disturbances, was associated with HbA1c after covariate adjustment; HbA1c increased by 0.4 points for each additional sleep disturbances subscale point (95%CI 0.1 to 0.8). Although the sleep disturbances subscale was associated with medication nonadherence (OR 2.04, 95%CI 1.27 to 3.30), a mediation analysis indicated nonadherence does not mediate the sleep disturbances-HbA1c relationship. DISCUSSION:: The sleep disturbances subscale may drive the previously observed relationship between PSQI and HbA1c. The mechanism for the relationship between sleep disturbances and HbA1c remains unclear, as does the impact on HbA1c of addressing sleep disturbances.