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Item 4012 Positive Deviants for Medication Therapy Management: A Mixed-Methods Comparative Case Study of Community Pharmacy Practices(Cambridge University Press, 2020-07-29) Adeoye-Olatunde, Omolola A.; Lake, Leslie M.; Hudmon, Karen S.; Zillich, Alan J.; Snyder, Margie E.; Medicine, School of MedicineOBJECTIVES/GOALS: To optimize medication use in older adults, Medication Therapy Management (MTM) was launched as part of Medicare Prescription Drug (Part D) policy. The objective of this study was to generate hypotheses for strategies that contribute to community pharmacies’ ability to achieve high performance on policy relevant MTM quality measures. METHODS/STUDY POPULATION: This mixed-methods comparative case study design incorporated two conceptual models; the Positive Deviance model and Chronic Care Model. The study population consisted of pharmacy staff employed by a Midwestern division of a national supermarket-community pharmacy chain. Data consisted of semi-structured interviews and demographics. Qualitative and quantitative data were analyzed abductively or using descriptive statistics, respectively. Case comparisons were synthesized using the Framework Method. MTM quality measures used to evaluate participant pharmacies’ MTM performance mirrored quality measures under Domain 4 (Drug Safety and Accuracy of Drug Pricing) of the 2017 Medicare Part D Plan’ Star Rating measures. RESULTS/ANTICIPATED RESULTS: Staff at 13 of the 18 selected pharmacies (72.2%) participated in interviews. Interviewees included 11 pharmacists, 11 technicians and three student interns. Strategies hypothesized as contributing to MTM performance included: 1. Strong pharmacist-provider relationships and trust, 2. Inability to meet patients’ cultural, linguistic, and socioeconomic needs (negatively contributing), 3. Technician involvement in MTM, 4. Providing comprehensive medication reviews in person vs. phone alone, 5. Placing high priority on MTM, 6. Using maximum number of clinical information systems (CISs) to identify eligible patients. 7. Technicians using CISs to collect information for pharmacists, 8. Faxing prescribers adherence medication therapy problems (MTPs) and calling on indication MTPs. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study resulted in eight strategies hypothesized to contribute to community pharmacy performance on MTM quality measures. To inform MTM policy recommendations, future research should engage stakeholders to assist with prioritizing hypotheses to be tested in a larger representative sample of pharmacies. CONFLICT OF INTEREST DESCRIPTION: This research was supported, in part, with support from the Indiana Clinical and Translational Sciences Institute funded, in part by grant number TL1TR001107 from the National Institutes of Health, National Center for Advancing Translational Sciences, Clinical and Translational Sciences Award. Dr. Adeoye-Olatunde is a part-time employee and Dr. Lake is a full-time employee at the Midwestern division, national supermarket-community pharmacy chain, where study procedures were conducted. Dr. Snyder reports personal fees from Westat, Inc., outside the submitted work.Item Applying human factors principles to alert design increases efficiency and reduces prescribing errors in a scenario-based simulation(Oxford University Press, 2014-10) Russ, Alissa L.; Zillich, Alan J.; Melton, Brittany L.; Russell, Scott A.; Chen, Siying; Spina, Jeffrey R.; Weiner, Michael; Johnson, Elizabette G.; Daggy, Joanne K.; McAnas, M. Sue; Hawsey, Jason M.; Puleo, Anthony G.; Doebbeling, Bradley N.; Saleem, Jason J.; Medicine Faculty Volunteers, IU School of MedicineOBJECTIVE: To apply human factors engineering principles to improve alert interface design. We hypothesized that incorporating human factors principles into alerts would improve usability, reduce workload for prescribers, and reduce prescribing errors. MATERIALS AND METHODS: We performed a scenario-based simulation study using a counterbalanced, crossover design with 20 Veterans Affairs prescribers to compare original versus redesigned alerts. We redesigned drug-allergy, drug-drug interaction, and drug-disease alerts based upon human factors principles. We assessed usability (learnability of redesign, efficiency, satisfaction, and usability errors), perceived workload, and prescribing errors. RESULTS: Although prescribers received no training on the design changes, prescribers were able to resolve redesigned alerts more efficiently (median (IQR): 56 (47) s) compared to the original alerts (85 (71) s; p=0.015). In addition, prescribers rated redesigned alerts significantly higher than original alerts across several dimensions of satisfaction. Redesigned alerts led to a modest but significant reduction in workload (p=0.042) and significantly reduced the number of prescribing errors per prescriber (median (range): 2 (1-5) compared to original alerts: 4 (1-7); p=0.024). DISCUSSION: Aspects of the redesigned alerts that likely contributed to better prescribing include design modifications that reduced usability-related errors, providing clinical data closer to the point of decision, and displaying alert text in a tabular format. Displaying alert text in a tabular format may help prescribers extract information quickly and thereby increase responsiveness to alerts. CONCLUSIONS: This simulation study provides evidence that applying human factors design principles to medication alerts can improve usability and prescribing outcomes.Item Association of Intensive Care Unit Patient Load and Demand With Mortality Rates in US Department of Veterans Affairs Hospitals During the COVID-19 Pandemic(AMA, 2021) Bravata, Dawn M.; Perkins, Anthony J.; Myers, Laura J.; Arling, Greg; Zhang, Ying; Zillich, Alan J.; Reese, Lindsey; Dysangco, Andrew; Agarwal, Rajiv; Myers, Jennifer; Austin, Charles; Sexson, Ali; Leonard, Samuel J.; Dev, Sharmistha; Keyhani, Salomeh; Medicine, School of MedicineImportance Although strain on hospital capacity has been associated with increased mortality in nonpandemic settings, studies are needed to examine the association between coronavirus disease 2019 (COVID-19) critical care capacity and mortality. Objective To examine whether COVID-19 mortality was associated with COVID-19 intensive care unit (ICU) strain. Design, Setting, and Participants This cohort study was conducted among veterans with COVID-19, as confirmed by polymerase chain reaction or antigen testing in the laboratory from March through August 2020, cared for at any Department of Veterans Affairs (VA) hospital with 10 or more patients with COVID-19 in the ICU. The follow-up period was through November 2020. Data were analyzed from March to November 2020. Exposures Receiving treatment for COVID-19 in the ICU during a period of increased COVID-19 ICU load, with load defined as mean number of patients with COVID-19 in the ICU during the patient’s hospital stay divided by the number of ICU beds at that facility, or increased COVID-19 ICU demand, with demand defined as mean number of patients with COVID-19 in the ICU during the patient’s stay divided by the maximum number of patients with COVID-19 in the ICU. Main Outcomes and Measures All-cause mortality was recorded through 30 days after discharge from the hospital. Results Among 8516 patients with COVID-19 admitted to 88 VA hospitals, 8014 (94.1%) were men and mean (SD) age was 67.9 (14.2) years. Mortality varied over time, with 218 of 954 patients (22.9%) dying in March, 399 of 1594 patients (25.0%) dying in April, 143 of 920 patients (15.5%) dying in May, 179 of 1314 patients (13.6%) dying in June, 297 of 2373 patients (12.5%) dying in July, and 174 of 1361 (12.8%) patients dying in August (P < .001). Patients with COVID-19 who were treated in the ICU during periods of increased COVID-19 ICU demand had increased risk of mortality compared with patients treated during periods of low COVID-19 ICU demand (ie, demand of ≤25%); the adjusted hazard ratio for all-cause mortality was 0.99 (95% CI, 0.81-1.22; P = .93) for patients treated when COVID-19 ICU demand was more than 25% to 50%, 1.19 (95% CI, 0.95-1.48; P = .13) when COVID-19 ICU demand was more than 50% to 75%, and 1.94 (95% CI, 1.46-2.59; P < .001) when COVID-19 ICU demand was more than 75% to 100%. No association between COVID-19 ICU demand and mortality was observed for patients with COVID-19 not in the ICU. The association between COVID-19 ICU load and mortality was not consistent over time (ie, early vs late in the pandemic). Conclusions and Relevance This cohort study found that although facilities augmented ICU capacity during the pandemic, strains on critical care capacity were associated with increased COVID-19 ICU mortality. Tracking COVID-19 ICU demand may be useful to hospital administrators and health officials as they coordinate COVID-19 admissions across hospitals to optimize outcomes for patients with this illness.Item Care Coordination Strategies and Barriers during Medication Safety Incidents: a Qualitative, Cognitive Task Analysis(Springer, 2021) Russ-Jara, Alissa L.; Luckhurst, Cherie L.; Dismore, Rachel A.; Arthur, Karen J.; Ifeachor, Amanda P.; Militello, Laura G.; Glassman, Peter A.; Zillich, Alan J.; Weiner, Michael; Medicine, School of MedicineBackground: Medication errors are prevalent in healthcare institutions worldwide, often arising from difficulties in care coordination among primary care providers, specialists, and pharmacists. Greater knowledge about care coordination surrounding medication safety incidents can inform efforts to improve patient safety. Objectives: To identify strategies that hospital and outpatient healthcare professionals (HCPs) use, and barriers encountered, when they coordinate care during a medication safety incident involving an adverse drug reaction, drug-drug interaction, or drug-renal concern. Design: We asked HCPs to complete a form whenever they encountered these incidents and intervened to prevent or mitigate patient harm. We stratified incidents across HCP roles and incident categories to conduct follow-up cognitive task analysis interviews with HCPs. Participants: We invited all physicians and pharmacists working in inpatient or outpatient care at a tertiary Veterans Affairs Medical Center. We examined 24 incidents: 12 from physicians and 12 from pharmacists, with a total of 8 incidents per category. Approach: Interviews were transcribed and analyzed via a two-stage inductive, qualitative analysis. In stage 1, we analyzed each incident to identify decision requirements. In stage 2, we analyzed results across incidents to identify emergent themes. Key results: Most incidents (19, 79%) were from outpatient care. HCPs relied on four main strategies to coordinate care: cognitive decentering; collaborative decision-making; back-up behaviors; and contingency planning. HCPs encountered four main barriers: role ambiguity and constraints, breakdowns (e.g., delays) in care, challenges related to the electronic health record, and factors that increased coordination complexity. Each strategy and barrier occurred across all incident categories and HCP groups. Pharmacists went to extra effort to ensure safety plans were implemented. Conclusions: Similar strategies and barriers were evident across HCP groups and incident types. Strategies for enhancing patient safety may be strengthened by deliberate organizational support. Some barriers could be addressed by improving work systems.Item Effect of Medication Optimization vs Cognitive Behavioral Therapy Among US Veterans With Chronic Low Back Pain Receiving Long-term Opioid Therapy: A Randomized Clinical Trial(American Medical Association, 2022-11-01) Bushey, Michael A.; Slaven, James E.; Outcalt, Samantha D.; Kroenke, Kurt; Kempf, Carol; Froman, Amanda; Sargent, Christy; Baecher, Brad; Zillich, Alan J.; Damush, Teresa M.; Saha, Chandan; French, Dustin D.; Bair, Matthew J.; Psychiatry, School of MedicineImportance: Medication management and cognitive behavioral therapy (CBT) are commonly used treatments for chronic low back pain (CLBP). However, little evidence is available comparing the effectiveness of these approaches. Objective: To compare collaborative care medication optimization vs CBT on pain intensity, interference, and other pain-related outcomes. Design, setting, and participants: The Care Management for the Effective Use of Opioids (CAMEO) trial was a 12-month, comparative effectiveness randomized clinical trial with blinded outcome assessment. Recruitment of veterans with CLBP prescribed long-term opioids occurred at 7 Veterans Affairs primary care clinics from September 1, 2011, to December 31, 2014, and follow-up was completed December 31, 2015. Analyses were based on intention to treat in all randomized participants and were performed from March 22, 2015, to November 1, 2021. Interventions: Patients were randomized to receive either collaborative care with nurse care manager-delivered medication optimization (MED group) (n = 131) or psychologist-delivered CBT (CBT group) (n = 130) for 6 months, with check-in visits at 9 months and final outcome assessment at 12 months. Main outcomes and measures: The primary outcome was change in Brief Pain Inventory (BPI) total score, a composite of the pain intensity and interference subscales at 6 (treatment completion) and 12 (follow-up completion) months. Scores on the BPI range from 0 to 10, with higher scores representing greater pain impact and a 30% improvement considered a clinically meaningful treatment response. Secondary outcomes included pain-related disability, pain catastrophizing, self-reported substance misuse, health-related quality of life, depression, and anxiety. Results: A total of 261 patients (241 [92.3%] men; mean [SD] age, 57.9 [9.5] years) were randomized and included in the analysis. Baseline mean (SD) BPI scores in the MED and CBT groups were 6.45 (1.79) and 6.49 (1.67), respectively. Improvements in BPI scores were significantly greater in the MED group at 12 months (between-group difference, -0.54 [95% CI, -1.18 to -0.31]; P = .04) but not at 6 months (between-group difference, -0.46 [95% CI, -0.94 to 0.11]; P = .07). Secondary outcomes did not differ significantly between treatment groups. Conclusions and relevance: In this randomized clinical trial among US veterans with CLBP who were prescribed long-term opioid therapy, collaborative care medication optimization was modestly more effective than CBT in reducing pain impact during the 12-month study. However, this difference may not be clinically meaningful or generalize to nonveteran populations.Item Evaluation of a “Meds-to-Beds” program on 30-day hospital readmissions(ACCP, 2020-05) Zillich, Alan J.; Jaynes, Heather A.; Davis, Hannah B.; Lantaff, Wendy M.; Myers, Jaclyn; Perkins, Susan M.; Shan, Mu; Snyder, Margie E.; Biostatistics, School of Public HealthBackground Effective programs for transitional care from hospital to home are needed to improve patient outcomes. Purpose To evaluate readmissions among patients who received a medication discharge program compared with control patients who did not receive the program. Methods This was a retrospective, observational cohort study during a 1-year period in a medium-sized Midwestern health system. The “meds-to-beds” program consisted of a pharmacist and/or technician delivering patient's medications to bedside prior to discharge. When indicated, the pharmacist provided medication counseling, reviewed discharge medications, and provided an updated medication list to patients. The intervention cohort was defined as all hospitalized patients eligible for and opting into the “meds-to-beds” program. The control cohort was defined as hospitalized patients eligible for the program who did not opt-in to receive it. Data were collected through both a retrospective chart review and an administrative claims data warehouse. The primary outcome was defined as any 30-day readmissions. Secondary outcomes were defined as any preventable 30-day readmissions using the Agency for Healthcare Research and Quality's potentially avoidable hospitalization for ambulatory care sensitive conditions classification. Multivariable logistic regression models examined the odds of 30-day readmissions between the intervention and control groups. Results Data were collected for 500 intervention and 1591 control patients. Both groups were similar with respect to age, gender, race, co-morbid conditions, and previous health care utilization. In the multivariable model, all-cause readmissions within 30 days were not significantly different between the intervention and control groups (odds ratio [OR] = 0.67; 95% confidence interval [CI]: 0.42-1.07, P = .09). The most common preventable readmissions were for pneumonia (43.2%), heart failure (18.9%), and dehydration (16.2%). In the multivariable model, patients in the intervention group were less likely to be readmitted for a preventable cause within 30-days than patients in the control group (OR = 0.49; 95% CI: 0.28-0.89, P = .02). Conclusion This “meds-to-beds” program was not associated with a significant reduction in 30-day all-cause readmissions but was associated with a reduction in 30-day preventable hospital readmissions.Item Heterogeneity in COVID-19 patient volume, characteristics and outcomes across US Department of Veterans Affairs facilities: an observational cohort study(BMJ, 2021) Bravata, Dawn M.; Myers, Laura J.; Perkins, Anthony J.; Keyhani, Salomeh; Zhang, Ying; Zillich, Alan J.; Dysangco, Andrew; Lindsey, Reese; Sharmitha, Dev; Myers, Jennifer; Austin, Charles; Sexson, Ali; Arling, Greg; Medicine, School of MedicineObjective Studies describe COVID-19 patient characteristics and outcomes across populations, but reports of variation across healthcare facilities are lacking. The objectives were to examine differences in COVID-19 patient volume and mortality across facilities, and understand whether facility variation in mortality was due primarily to differences in patient versus facility characteristics. Design Observational cohort study with multilevel mixed effects logistic regression modelling. Setting The Veterans Health Administration (VA) is the largest healthcare system in the USA. Participants Patients with COVID-19. Main outcome All-cause mortality within 45 days after COVID-19 testing (March–May, follow-up through 16 July 2020). Results Among 13 510 patients with COVID-19, 3942 (29.2%) were admitted (2266/3942 (57.5%) ward; 1676/3942 (42.5%) intensive care unit (ICU)) and 679/3942 (17.2%) received mechanical ventilation. Marked heterogeneity was observed across facilities in median age (range: 34.3–83.9 years; facility mean: 64.7, SD 7.2 years); patient volume (range: 1–737 at 160 facilities; facility median: 48.5, IQR 14–105.5); hospital admissions (range: 1–286 at 133 facilities; facility median: 11, IQR 1–26.5); ICU caseload (range: 1–85 at 115 facilities; facility median: 4, IQR 0–12); and mechanical ventilation (range: 1–53 at 90 facilities; facility median: 1, IQR 0–5). Heterogeneity was also observed in facility mortality for all patients with COVID-19 (range: 0%–29.7%; facility median: 8.9%, IQR 2.4%–13.7%); inpatients (range: 0%–100%; facility median: 18.0%, IQR 5.6%–28.6%); ICU patients (range: 0%–100%; facility median: 28.6%, IQR 14.3%–50.0%); and mechanical ventilator patients (range: 0%–100%; facility median: 52.7%, IQR 33.3%–80.6%). The majority of variation in facility mortality was attributable to differences in patient characteristics (eg, age). Conclusions Marked heterogeneity in COVID-19 patient volume, characteristics and mortality were observed across VA facilities nationwide. Differences in patient characteristics accounted for the majority of explained variation in mortality across sites. Variation in unadjusted COVID-19 mortality across facilities or nations should be considered with caution.Item Hypertension treatment intensification among stroke survivors with uncontrolled blood pressure(Elsevier, 2015-05) Roumie, Christianne L.; Zillich, Alan J.; Bravata, Dawn M.; Jaynes, Heather A.; Myers, Laura J.; Yoder, Joseph; Cheng, Eric M.; Department of Medicine, IU School of MedicineObjective The study objective was to evaluate a pharmacist hypertension care management program within the patient-centered medical home. Methods This was a retrospective case-control study. Cases included all patients with hypertension who were referred to the care management program, and controls included patients with hypertension who were not referred to the program during the same 1-year period. Each case was matched to a maximum of 3 controls on the basis of primary care physician, age ±5 years, gender, diagnoses of diabetes and kidney disease, baseline systolic blood pressure ±10 mm Hg, and number of unique antihypertensive medications. Pharmacists provided a hypertension care management program under an approved scope of practice that allowed pharmacists to meet individually with patients, adjust medications, and provide patient education. Primary outcomes were systolic blood pressure and diastolic blood pressure at 6 and 12 months. Multivariate regression models compared each blood pressure end point between cases and controls adjusting for age, comorbidities, baseline blood pressure, and baseline number of blood pressure medications. Results A total of 573 patients were referred to the hypertension program; 86% (465/543) had at least 1 matched control and were included as cases in the analyses; 3:1 matching was achieved in 90% (418/465) of cases. At baseline, cases and controls did not differ with respect to age, gender, race, or comorbidity; baseline blood pressure was higher (139.9/80.0 mm Hg vs 136.7/78.2 mm Hg, P ≤ .0002) in the cases compared with controls. Multivariate regression modeling identified significantly lower systolic blood pressure for the cases compared with controls at both 6 and 12 months (6-month risk ratio [RR], 9.7; 95% confidence interval [CI], 2.7-35.3; 12-month RR, 20.3; 95% CI, 4.1-99.2; P < .01 for both comparisons). Diastolic blood pressure was significantly lower at 12 months (RR, 2.9; 95% CI, 1.2-7.1; P < .01) but not at 6 months (RR, 1.0; 95% CI, 0.31-3.4; P = .9) for the cases compared with controls. Conclusions Patients who were referred to the pharmacist hypertension care management program had a significant improvement in most blood pressure outcomes. This program may be an effective method of improving blood pressure control among patients in a medical home model of primary care.Item Impact of Electronic Medication Reminder Caps on Patient Adherence and Blood Pressure(Sage, 2021) Mehas, Nicolette; Hudmon, Karen Suchanek; Jaynes, Heather; Klink, Steve; Downey, Laura; Zillich, Alan J.; Medicine, School of MedicineBackground: Medication adherence is widely recognized as an essential component of chronic disease management, yet only 50% of patients take their medication as prescribed. Newer technologies have the potential to improve medication adherence. Objective: To conduct a pilot study estimating the impact of a pharmacy-dispensed electronic reminder cap (SMARxT cap), which also records cap openings, on medication adherence and blood pressure (BP). Methods: After a 30-day run-in period, 28 individuals were randomized to receive a SMARxT or placebo cap on each BP medication. The primary outcome was adherence measured via (1) the medication possession ratio, (2) number of cap openings, and (3) self-report. The secondary outcome was the average of 2 BP readings at 6 months. Mean changes from baseline to 6 months were compared between the 2 groups. Results: The medication possession ratio increased 2.7% in the SMARxT cap group and decreased 1.1% in the control group (P = .13), and cap openings increased 11.9% in the SMARxT cap group and 9.9% in the control group (P = .83). Self-reported adherence increased 1.1 points in the SMARxT cap group and 0.8 points in the control group (P = .64). Systolic BP decreased 8.2 mm Hg in the SMARxT cap group and 2.8 mm Hg in the placebo cap group (P = .35), and diastolic BP decreased to 6.2 mm Hg in the SMARxT cap group and was unchanged in the placebo cap group (P = .06). Conclusions: Use of SMARxT cap showed nonsignificant improvement in medication adherence and BP lowering. This technology has potential to characterize and improve medication-taking behavior.Item Implementing Brief Tobacco Cessation Interventions in Community Pharmacies: An Application of Rogers’ Diffusion of Innovations Theory(MDPI, 2022-05-30) Hilts, Katy Ellis; Corelli, Robin L.; Prokhorov, Alexander V.; Zbikowski, Susan M.; Zillich, Alan J.; Hudmon, Karen Suchanek; Health Policy and Management, School of Public HealthPharmacists, as highly accessible members of the healthcare team, have considerable potential to address tobacco use among patients. However, while published data suggest that pharmacists are effective in helping patients quit, barriers exist to routine implementation of cessation services in community pharmacy settings. Within the context of a randomized trial (n = 64 pharmacies), surveys were administered over a period of 6 months to assess pharmacists' perceptions of factors associated with the implementation of "Ask-Advise-Refer", a brief intervention approach that facilitates patient referrals to the tobacco quitline. Study measures, grounded in Rogers' Diffusion of Innovations Theory, assessed pharmacists' perceptions of implementation facilitators and barriers, perceptions of intervention materials provided, and perceived efforts and personal success in implementing Ask-Advise-Refer at 6-months follow-up. Findings indicate that while the brief intervention approach was not difficult to understand or implement, integration into normal workflows presents greater challenges and is associated with overall confidence and implementation success. Lack of time was the most significant barrier to routine implementation. Most (90.6%) believed that community pharmacies should be active in promoting tobacco quitlines. Study results can inform future development of systems-based approaches that lead to broad-scale adoption of brief interventions, including but not limited to tobacco cessation, in pharmacy settings.
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