Browsing by Author "Gonzales, Sarah"
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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 Bridging the integration gap between patient-generated blood glucose data and electronic health records.(Journal of the American Medical Informatics Association : JAMIA, 2019-07) Lewinski, Allison A; Drake, Connor; Shaw, Ryan J; Jackson, George L; Bosworth, Hayden B; Oakes, Megan; Gonzales, Sarah; Jelesoff, Nicole E; Crowley, Matthew JTelemedicine can facilitate population health management by extending the reach of providers to efficiently care for high-risk, high-utilization populations. However, for telemedicine to be maximally useful, data collected using telemedicine technologies must be reliable and readily available to healthcare providers. To address current gaps in integration of patient-generated health data into the electronic health record (EHR), we examined 2 patient-facing platforms, Epic MyChart and Apple HealthKit, both of which facilitated the uploading of blood glucose data into the EHR as part of a diabetes telemedicine intervention. All patients were offered use of the MyChart platform; we subsequently invited a purposive sample of patients who used the MyChart platform effectively (n = 5) to also use the Apple HealthKit platform. Patients reported both platforms helped with diabetes self-management, and providers appreciated the convenience of the processes for obtaining patient data. Providers stated that the EHR data presentation format for Apple HealthKit was challenging to interpret; however, they also valued the greater perceived accuracy the Apple HealthKit data. Our findings indicate that patient-facing platforms can feasibly facilitate transmission of patient-generated health data into the EHR and support telemedicine-based care.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 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.Item Open Access Rationale and design of a nurse-led intervention to extend the HIV treatment cascade for cardiovascular disease prevention trial (EXTRA-CVD).(American heart journal, 2019-10) Okeke, Nwora Lance; Webel, Allison R; Bosworth, Hayden B; Aifah, Angela; Bloomfield, Gerald S; Choi, Emily W; Gonzales, Sarah; Hale, Sarah; Hileman, Corrilynn O; Lopez-Kidwell, Virginie; Muiruri, Charles; Oakes, Megan; Schexnayder, Julie; Smith, Valerie; Vedanthan, Rajesh; Longenecker, Chris TPersons living with human immunodeficiency virus (PLHIV) are at increased risk of atherosclerotic cardiovascular disease (ASCVD). In spite of this, uptake of evidence-based clinical interventions for ASCVD risk reduction in the HIV clinic setting is sub-optimal. METHODS: EXTRA-CVD is a 12-month randomized clinical effectiveness trial that will assess the efficacy of a multi-component nurse-led intervention in reducing ASCVD risk among PLHIV. Three hundred high ASCVD risk PLHIV across three sites will be randomized 1:1 to usual care with generic prevention education or the study intervention. The study intervention will consist of four evidence-based components: (1) nurse-led care coordination, (2) nurse-managed medication protocols and adherence support (3) home BP monitoring, and (4) electronic health records support tools. The primary outcome will be change in systolic blood pressure and secondary outcome will be change in non-HDL cholesterol over the course of the intervention. Tertiary outcomes will include change in the proportion of participants in the following extended cascade categories: (1) appropriately diagnosed with hypertension and hyperlipidemia (2) appropriately managed; (3) at treatment goal (systolic blood pressure <130 mm Hg and non-HDL cholesterol < National Lipid Association targets). CONCLUSIONS: The EXTRA-CVD trial will provide evidence appraising the potential impact of nurse-led interventions in reducing ASCVD risk among PLHIV, an essential extension of the HIV care continuum beyond HIV viral suppression.