Evaluation of Tricyclic Antidepressant Deprescribing in the Treatment of Diabetic Peripheral Neuropathy within Federally Qualified Health Centers.

BACKGROUND: Tricyclic antidepressants (TCAs) are a treatment option for diabetic peripheral neuropathy (DPN). Existing evidence demonstrates the prolonged use of TCA therapy increases the risk of cognitive decline and dementia, likely due to the anticholinergic effects of these medications. The anticholinergic activity is thought to contribute significantly to the observed increase in cognitive decline and dementia risks associated with long-term TCA use. There is little information available to describe the usage patterns of TCAs in DPN, particularly within underserved populations who receive care at Federally Qualified Health Centers (FQHCs). OBJECTIVES: The objective of this study was to characterize: 1) prescribing patterns of TCAs as a treatment for DPN and 2) evidence of deprescribing attempts in a FQHC population. METHODS: A retrospective chart review of electronic medical record (EMR) data for patients at two different FQHCs was performed. A convenience sample of 100 adults ≥ 18 years of age was stratified into two age groups, 18-55 years, and 55+ years. All patients had a diagnosis of Type 1 or Type 2 diabetes mellitus and had been prescribed TCAs in the previous four years and had a visit with a primary care provider (PCP) in the past 12 months. RESULTS: The study population was comprised of 100 individuals. Seventy-four of 100 were persistent users of TCAs at the time of data collection, and the mean duration of utilization was 54.8 months. In total, 104 TCAs were prescribed across 100 individual patients. Of all 104 prescribed TCAs, 66 (63%) were prescribed at a rate that exceeded thresholds associated with a higher risk of dementia. Black older adults prescribed TCAs were more likely to exceed this dose threshold. CONCLUSION: 65% of patients used TCAs with a strength, frequency, and duration that exceeded risk thresholds for dementia in an older adult population. Interventions preventing use of or deprescribing TCAs in patients with DPN should be conducted for the potential benefits of preventing or delaying cognitive impairment and promoting equitable care.

Home medication inventory method to assess over-the-counter (OTC) medication possession and use: A pilot study on the feasibility of in-person and remote modalities with older adults.

BACKGROUND: There is a need for reproducible methods to measure over-the-counter (OTC) medication possession and use. This is because OTC medications are self-managed, variably monitored by healthcare professionals, and in certain populations such as older adults some OTC medications may introduce risk and cause more harm than benefit. OBJECTIVE: (s): To develop and assess the feasibility of the Home Medication Inventory Method (HMIM), a novel method to measure possession and use of OTC medications. METHODS: We benchmarked, adapted, and standardized prior approaches to medication inventory to develop a method capable of addressing the limitations of existing methods. We then conducted a pilot study of the HMIM among older adults. Eligible participants were aged ≥60 years, reported purchasing or considering purchasing OTC medication, and screened for normal cognition. Interviews were conducted both in person and remotely. When possible, photographs of all OTC medications were obtained with participant consent and completion times were recorded for both in-person and remote modalities. RESULTS: In total 51 participants completed the pilot study. Home medication inventories were conducted in-person (n = 15) and remotely (n = 36). Inventories were completed in a mean (SD) of 20.2 min (12.7), and 96 % of inventories completed within 45 min. A total of 390 OTC medications were possessed by participants, for a mean (SD) of 7.6 (6.3) per participant. No differences in duration of interviews or number of medications reported were identified between in-person and remote modalities. Anticholinergic medications, a class targeted in the pilot as potentially harmful to older adults, were possessed by 31 % of participants, and 14 % of all participants reported use of such a medication within the previous 2 weeks. CONCLUSIONS: Implementing the HMIM using in-person and remote modalities is a feasible and ostensibly reproducible method for collecting OTC medication possession and use information. Larger studies are necessary to further generalize HMIM feasibility and reliability in diverse populations.

An Improved Statistical Modeling Approach to Individual Anticholinergic Drug Use Trend Analysis.

Anticholinergic (AC) drugs are commonly prescribed to older adults for treating diseases and chronic conditions, such as chronic obstructive pulmonary disease, urinary incontinence, gastrointestinal disorder, or simply pain and allergy. The high prevalence of AC drug use can have a detrimental effect on the mental health of older adults. We aim to improve the prediction of future trends of AC drug use at the individual level, with pharmacy refill data. The individual drug use data presents challenges in the modeling, such as data being discrete-valued with excess zeros and having significant unobserved heterogeneity in the trend pattern. To address these challenges, we propose a statistical model of hierarchical structure and an EM scheme for the model parameter estimation. We evaluate the proposed modeling approach through a numerical study with synthetic data and a case study with real-world pharmacy refill data. The simulation study show that our analysis method outperforms the existing ones (e.g., reducing MSE significantly), particularly in terms of accurately predicting the trend pattern. The real-world case study further verifies the out-performance and demonstrate the advantageous features of our method. We expect the prediction tool developed based on our study can assist pharmacists' decision on initiating or strengthening behavioral interventions with the hope of discontinuing AC drug misuse.

Association between Change in the peripheral biomarkers of inflammation, astrocyte activation, and neuroprotection at one week of critical illness and hospital mortality in patients with delirium: A prospective cohort study.

OBJECTIVE: In critically ill adults with delirium, biomarkers of systemic inflammation, astrocyte activation, neuroprotection, and systemic inflammation measured at one week of critical illness may be associated with mortality. DESIGN: Prospective observational study. SETTING: Intensive care unit (ICU). PATIENTS: 178 ICU patients with delirium, alive and remaining in ICU at one week. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Blood samples collected for a pair of previously published, negative, clinical trials were utilized. Samples were collected at study enrollment/ICU admission (Day 1 sample) and one week later (Day 8 sample), and analyzed for interleukins (IL)-6, 8, 10, Insulin-like Growth Factor (IGF), S100 Binding Protein (S100B), Tumor Necrosis Factor Alpha (TNF-A) and C-Reactive Protein (CRP). Delirium, delirium severity, and coma were assessed twice daily using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), CAM-ICU-7, and Richmond Agitation-Sedation Scale (RASS), respectively. Mortality was assessed until discharge using the electronic medical record. Logistic regression models adjusting for age, sex, severity of illness, comorbidities, sepsis, and randomization status, were used to assess the relationship among biomarkers and mortality. Higher IL-10 quartiles at day 8 were associated with increased odds of hospital mortality (IL-10: OR 2.00 95%CI: 1.1-3.65, p = 0.023). There was a significant interaction between day 1 and day 8 biomarker quartiles only for IL-6. Patients with IL-6 values in the first three quartiles on admission to the ICU that transitioned to higher IL-6 quartiles at day 8 had increased probability of hospital mortality. CONCLUSION: In this hypothesis-generating study, higher IL-6 and IL-10 quartiles at one week, and increase in IL-6 from day 1 to day 8 were associated with increased hospital mortality. Studies with larger sample sizes are needed to confirm the mechanisms for these observations.

Lessons Learned from a Shared Curriculum on Tobacco Cessation Using a Mixed-Methods Approach.

Although the sharing of curricular content between health professional schools can reduce faculty burden, the literature provides little guidance to support these efforts. The objective of this investigation was to synthesize data from two prior studies to delineate recommendations guiding the future development of shared curricula in health professional education. Applying Rogers' Diffusion of Innovations Theory as a guiding framework, relevant data were extracted from a two-phase mixed-methods study evaluating the long-term impact of the shared Rx for Change: Clinician-Assisted Tobacco Cessation program. Phase 1, a qualitative study, involved telephone interviews with faculty participants of train-the-trainer workshops conducted between 2003 and 2005. These results informed the development of a phase 2 national survey, administered electronically as a long-term follow-up (13 to 15 years later) with train-the-trainer workshop participants. Results from the two studies were synthesized and summarized, producing seven key recommendations to guide development of shared curricula: (1) appeal to attendees, (2) relate content to clinical practice, (3) deliver live, in-person training, (4) develop high-quality materials, delivered by experts, (5) provide support, (6) meet accreditation standards, and (7) demonstrate effectiveness. Future program developers should consider these recommendations to enhance dissemination, adoption, and long-term sustainability of shared curricular content.

Racial disparities in the pharmacological treatment of insomnia: A time-to-event analysis using real-world data.

OBJECTIVE: Examine the association between race and time to pharmacologic treatment of insomnia in a large multi-institutional cohort. METHODS: Retrospective analysis of electronic medical records from a regional health information exchange. Eligible patients included adults with at least one healthcare visit per year from 2010 to 2019, a new insomnia diagnosis code during the study period, and no prior insomnia diagnosis codes or medications. A Cox frailty model was used to examine the association between race and time to an insomnia medication after diagnosis. RESULTS: In total, 9557 patients were analyzed, 7773 (81.3%) of whom where White, 1294 (13.5%) Black, 238 (2.5%) Other, and 252 (2.6%) unknown race. About 6.2% of Black and 8% of Other race patients received an order for a Food and Drug Administration-approved insomnia medication after diagnosis compared with 13.5% of White patients. Black patients were significantly less likely to have an order for a Food and Drug Administration-approved insomnia medication at all time points (adjusted hazard ratio [aHR] range: 0.37-0.73), and patients reporting Other race were less likely to have received an order at 2 (aHR 0.51, 95% confidence interval [CI] 0.28-0.94), 3 (aHR 0.33, 95% CI 0.13-0.79), and 4 years (aHR 0.21, 95% CI 0.06-0.71) of follow-up. Similar results were observed in a sensitivity analysis including off-label medications. CONCLUSIONS: Patients belonging to racial minority groups are less likely to be prescribed an insomnia medication than White patients after accounting for sociodemographic and clinical factors. Further research is needed to determine the extent to which patient preferences and physician perceptions affect these prescribing patterns and investigate potential disparities in nonpharmacologic treatment.

A patient-centered nurse-supported primary care-based collaborative care program to treat opioid use disorder and depression: Design and protocol for the MI-CARE randomized controlled trial.

BACKGROUND: Opioid use disorder (OUD) contributes to rising morbidity and mortality. Life-saving OUD treatments can be provided in primary care but most patients with OUD don't receive treatment. Comorbid depression and other conditions complicate OUD management, especially in primary care. The MI-CARE trial is a pragmatic randomized encouragement (Zelen) trial testing whether offering collaborative care (CC) to patients with OUD and clinically-significant depressive symptoms increases OUD medication treatment with buprenorphine and improves depression outcomes compared to usual care. METHODS: Adult primary care patients with OUD and depressive symptoms (n ≥ 800) from two statewide health systems: Kaiser Permanente Washington and Indiana University Health are identified with computer algorithms from electronic Health record (EHR) data and automatically enrolled. A random sub-sample (50%) of eligible patients is offered the MI-CARE intervention: a 12-month nurse-driven CC intervention that includes motivational interviewing and behavioral activation. The remaining 50% of the study cohort comprise the usual care comparison group and is never contacted. The primary outcome is days of buprenorphine treatment provided during the intervention period. The powered secondary outcome is change in Patient Health Questionnaire (PHQ)-9 depression scores. Both outcomes are obtained from secondary electronic healthcare sources and compared in "intent-to-treat" analyses. CONCLUSION: MI-CARE addresses the need for rigorous encouragement trials to evaluate benefits of offering CC to generalizable samples of patients with OUD and mental health conditions identified from EHRs, as they would be in practice, and comparing outcomes to usual primary care. We describe the design and implementation of the trial, currently underway. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05122676. Clinical trial registration date: November 17, 2021.

Building Demand for Deprescribing Expertise: Pharmacists as Deprescribing Care Coordinators.

A number of barriers to deprescribing exist, with knowledge, skills, and self-efficacy often highlighted by prescribers within an interrupted, siloed nature of the existing health care system. Thus, deprescribing is not likely to occur without a change in the system. Pharmacists are extremely well positioned to positively impact the deprescribing process, and particularly senior care pharmacists given familiarity with population-specific pharmacodynamic and pharmacokinetic characteristics of medications. Similarly, our health care partners have endorsed pharmacists to not only collaborate but to drive the deprescribing trials. Therefore, no other profession is better positioned to advocate for the value of deprescribing as a core component of the pharmaceutical care process.

Confusion assessment method accurately screens for hepatic encephalopathy and predicts short-term mortality in hospitalized patients with cirrhosis.

Hepatic encephalopathy (HE), a subtype of delirium, is common in cirrhosis and associated with poor outcomes. Yet, objective bedside screening tools for HE are lacking. We examined the relationship between an established screening tool for delirium, Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and short-term outcomes while comparing its performance with previously established measures of cognitive function such as West Haven criteria (WHC). Prospectively enrolled adults with cirrhosis who completed the CAM-ICU from 6/2014-6/2018 were followed for 90 days. Blinded provider-assigned West Haven Criteria (WHC) and other measures of cognitive function were collected. Logistic regression was used to test associations between CAM-ICU status and outcomes. Mortality prediction by CAM-ICU status was assessed using Area under the Receiver Operating Characteristics curves (AUROC). Of 469 participants, 11% were CAM-ICU( +), 55% were male and 94% were White. Most patients were Childs-Pugh class C (59%). CAM-ICU had excellent agreement with WHC (Kappa = 0.79). CAM-ICU( +) participants had similar demographic features to those CAM-ICU(-), but had higher MELD (25 vs. 19, p < 0.0001), were more often admitted to the ICU (28% vs. 7%, p < 0.0001), and were more likely to be admitted for HE and infection. CAM-ICU( +) participants had higher mortality (inpatient:37% vs. 3%, 30-day:51% vs. 11%, 90-day:63% vs. 23%, p < 0.001). CAM-ICU status predicted mortality with AUROC of 0.85, 0.82 and 0.77 for inpatient, 30-day and 90-day mortality, respectively. CAM-ICU easily screens for delirium/HE, has excellent agreement with WHC, and identifies a hospitalized cirrhosis cohort with high short-term mortality.

Recommendations for outcome measurement for deprescribing intervention studies.

Interpreting results from deprescribing interventions to generate actionable evidence is challenging owing to inconsistent and heterogeneous outcome definitions between studies. We sought to characterize deprescribing intervention outcomes and recommend approaches to measure outcomes for future studies. A scoping literature review focused on deprescribing interventions for polypharmacy and informed a series of expert panel discussions and recommendations. Twelve experts in deprescribing research, policy, and clinical practice interventions participating in the Measures Workgroup of the US Deprescribing Research Network sought to characterize deprescribing outcomes and recommend approaches to measure outcomes for future studies. The scoping review identified 125 papers reflecting 107 deprescribing studies. Common outcomes included medication discontinuation, medication appropriateness, and a broad range of clinical outcomes potentially resulting from medication reduction. Panel recommendations included clearly defining clinically meaningful medication outcomes (e.g., number of chronic medications, dose reductions), ensuring adequate sample size and follow-up time to capture clinical outcomes resulting from medication discontinuation (e.g., quality of life [QOL]), and selecting appropriate and feasible data sources. A new conceptual model illustrates how downstream clinical outcomes (e.g., reduction in falls) should be interpreted in the context of initial changes in medication measures (e.g., reduction in mean total medications). Areas needing further development include implementation outcomes specific to deprescribing interventions and measures of adverse drug withdrawal events. Generating evidence to guide deprescribing is essential to address patient, caregiver, and clinician concerns about the benefits and harms of medication discontinuation. This article provides recommendations and an initial conceptual framework for selecting and applying appropriate intervention outcomes to support deprescribing research.

Helping the Helpers - A research protocol for user-centered technology to aid caregiver management of medications for people with Alzheimer's disease and related dementias.

BACKGROUND AND OBJECTIVE: Systematically supporting caregiver-assisted medication management through IT interventions is a critical area of need toward improving outcomes for people living with ADRD and their caregivers, but a significant gap exists in the evidence base from which IT interventions to support caregivers' medication tasks can be built. User-centered design can address the user needs evidence gap and provide a scientific mechanism for developing IT interventions that meet caregivers' needs. The present study employs the three phases of user-centered design to address the first two stages of the NIH Stage Model for Behavioral Intervention Development. METHODS: We will conduct a three-phase study employing user-centered design techniques across three aims: Aim 1) assess the needs of ADRD caregivers who manage medications for people with ADRD (Stage 0); Aim 2) co-design a prototype IT intervention to support caregiver-assisted medication management collaboratively with ADRD caregivers (Stage IA); and Aim 3) feasibility test the prototype IT intervention with ADRD caregivers (Stage IB). DISCUSSION: Our user-centered design protocol provides a template for integrating the three phases of user-centered design to address the first two stages of the NIH Stage Model that can be used broadly by researchers who are developing IT interventions for ADRD caregivers.

Deprescribing anticholinergics in primary care older adults: Experience from two models and impact on a continuous measure of exposure.

Background: Deprescribing interventions delivered through the electronic medical record have not significantly reduced the use of high-risk anticholinergics in prior trials. Pharmacists have been identified as ideal practitioners to conduct deprescribing; however, little experience beyond collaborative consult models has been published. Objective: To evaluate the impact of two pilot pharmacist-based advanced practice models nested within primary care. Methods: Pilot studies of a collaborative clinic-based pharmacist deprescribing intervention and a telephone-based pharmacist deprescribing intervention were conducted. Patients receiving the clinic-based pharmacy model were aged 55 years and older and referred for deprescribing at a specialty clinic. Patients receiving the telephone-based pharmacy model were aged 65 years and older and called by a clinical pharmacist for deprescribing without referral. Deprescribing was defined as a discontinuation or dose reduction reported either in clinical records or through self-reporting. Results: The 18 patients receiving clinic-based deprescribing had a mean age of 68 years and 78% were female. Among 24 medications deemed eligible for deprescribing, 23 (96%) were deprescribed. The clinic-based deprescribing model resulted in a 93% reduction in median annualized total standardized dose (TSD), 56% lowered their annualized exposure below a cognitive risk threshold, and 4 (17%) of medications were represcribed within 6 months. The 24 patients receiving telephone-based deprescribing had a mean age of 73 years and 92% were female. Among 24 medications deemed eligible for deprescribing, 12 (50%) were deprescribed. There was no change in the median annualized TSD, the annualized TSD was lowered below a cognitive risk threshold in 46%, and no medications were represcribed within 6 months. Few withdrawal symptoms or adverse events were reported in both groups. Conclusions: Pharmacist-based deprescribing successfully reduced exposure to high-risk anticholinergics in primary care older adults, yet further work is needed to understand the impact on clinical outcomes.

A 12-Year Retrospective Study of the Prevalence of Anticholinergic Polypharmacy and Associated Outcomes Among Medicare Patients with Overactive Bladder in the USA.

BACKGROUND AND OBJECTIVE: Antimuscarinics, drugs with anticholinergic properties, are frequently prescribed for overactive bladder, and anticholinergic burden is associated with adverse events. The "Polypharmacy: Use of Multiple Anticholinergic Medications in Older Adults" (Poly-ACH) measure was developed by the Pharmacy Quality Alliance and is used by the Centers for Medicare and Medicaid Services. Using the Poly-ACH measure, we assessed the prevalence of anticholinergic polypharmacy among Medicare patients in the USA with overactive bladder and determined associations between polypharmacy and medical conditions, care, and spending. METHODS: This was a retrospective cohort study of Medicare beneficiaries with overactive bladder (coverage period: 2006-2017). Anticholinergic polypharmacy, measured by the Poly-ACH, was defined as concurrent use of two or more anticholinergics, each with two or more prescription claims on different dates of service for ≥ 30 cumulative days. Change in annual frequency of anticholinergic polypharmacy was assessed using logistic regression. Associations between anticholinergic polypharmacy over 3 years and falls, fractures, mental status, and medical care spending were assessed with longitudinal regression models. RESULTS: In total, 226,712 patients contributed 940,201 person-years of follow-up after overactive bladder diagnosis. The share of patients meeting the Poly-ACH definition was 3.3% in 2006 and 1.7% in 2017. Women and nursing home residents had higher risks of anticholinergic polypharmacy. Having 1 year or more of positive Poly-ACH status in the 3 years prior was associated with higher rates of all outcomes. CONCLUSIONS: Anticholinergic polypharmacy was uncommon among older adults with overactive bladder. Prevalence was higher among women and nursing home residents, and it was associated with negative outcomes, highlighting potential longitudinal implications of anticholinergic burden.

Usability-In-Place-Remote Usability Testing Methods for Homebound Older Adults: Rapid Literature Review.

BACKGROUND: Technology can benefit older adults in many ways, including by facilitating remote access to services, communication, and socialization for convenience or out of necessity when individuals are homebound. As people, especially older adults, self-quarantined and sheltered in place during the COVID-19 pandemic, the importance of usability-in-place became clear. To understand the remote use of technology in an ecologically valid manner, researchers and others must be able to test usability remotely. OBJECTIVE: Our objective was to review practical approaches for and findings about remote usability testing, particularly remote usability testing with older adults. METHODS: We performed a rapid review of the literature and reported on available methods, their advantages and disadvantages, and practical recommendations. This review also reported recommendations for usability testing with older adults from the literature. RESULTS: Critically, we identified a gap in the literature-a lack of remote usability testing methods, tools, and strategies for older adults, despite this population's increased remote technology use and needs (eg, due to disability or technology experience). We summarized existing remote usability methods that were found in the literature as well as guidelines that are available for conducting in-person usability testing with older adults. CONCLUSIONS: We call on the human factors research and practice community to address this gap to better support older adults and other homebound or mobility-restricted individuals.

A core outcome set for studies evaluating interventions to prevent and/or treat delirium for adults requiring an acute care hospital admission: an international key stakeholder informed consensus study.

BACKGROUND: Trials of interventions to prevent or treat delirium in adults in an acute hospital setting report heterogeneous outcomes. Our objective was to develop international consensus among key stakeholders for a core outcome set (COS) for future trials of interventions to prevent and/or treat delirium in adults with an acute care hospital admission and not admitted to an intensive care unit. METHODS: A rigorous COS development process was used including a systematic review, qualitative interviews, modified Delphi consensus process, and in-person consensus using nominal group technique (registration http://www.comet - initiative.org/studies/details/796 ). Participants in qualitative interviews were delirium survivors or family members. Participants in consensus methods comprised international representatives from three stakeholder groups: researchers, clinicians, and delirium survivors and family members. RESULTS: Item generation identified 8 delirium-specific outcomes and 71 other outcomes from 183 studies, and 30 outcomes from 18 qualitative interviews, including 2 that were not extracted from the systematic review. De-duplication of outcomes and formal consensus processes involving 110 experts including researchers (N = 32), clinicians (N = 63), and delirium survivors and family members (N = 15) resulted in a COS comprising 6 outcomes: delirium occurrence and reoccurrence, delirium severity, delirium duration, cognition, emotional distress, and health-related quality of life. Study limitations included exclusion of non-English studies and stakeholders and small representation of delirium survivors/family at the in-person consensus meeting. CONCLUSIONS: This COS, endorsed by the American and Australian Delirium Societies and European Delirium Association, is recommended for future clinical trials evaluating delirium prevention or treatment interventions in adults presenting to an acute care hospital and not admitted to an intensive care unit.

A Core Outcome Set for Research Evaluating Interventions to Prevent and/or Treat Delirium in Critically Ill Adults: An International Consensus Study (Del-COrS).

OBJECTIVES: Delirium in critically ill adults is highly prevalent and has multiple negative consequences. To-date, trials of interventions to prevent or treat delirium report heterogenous outcomes. To develop international consensus among key stakeholders for a core outcome set for future trials of interventions to prevent and/or treat delirium in critically ill adults. DESIGN: Core outcome set development, as recommended by the Core Outcome Measures in Effectiveness Trials Handbook. Methods of generating items for the core outcome set included a systematic review and qualitative interviews with ICU survivors and family members. Consensus methods include a two-round web-based Delphi process and a face-to-face meeting using nominal group technique methods. SUBJECTS: International representatives from three stakeholder groups: 1) clinical researchers, 2) ICU interprofessional clinicians, and 3) ICU survivors and family members. SETTING: Telephone interviews, web-based surveys, and a face-to-face consensus meeting held at the 2019 European Delirium Association's annual meeting in Edinburgh, Scotland. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Qualitative interviews with 24 ICU survivors and family members identified 36 potential outcomes; six were additional to the 97 identified from the systematic review. After item reduction, 32 outcomes were presented in Delphi Round 1; 179 experts participated, 38 ICU survivors/family members (21%), 100 clinicians (56%), 41 researchers (23%). Three additional outcomes were added to Round 2; 134 Round 1 participants (75%) completed it. Upon conclusion of the consensus building processes, the final core outcome set comprised seven outcomes: delirium occurrence (including prevalence or incidence); delirium severity; time to delirium resolution; health-related quality of life; emotional distress (i.e., anxiety, depression, acute and posttraumatic stress); cognition (including memory); and mortality. CONCLUSIONS: This core outcome set, endorsed by the American and Australian Delirium Societies and European Delirium Association, is recommended for future clinical trials evaluating delirium prevention or treatment interventions in critically ill adults.

Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial.

INTRODUCTION: A growing body of scientific evidence points to the potentially harmful cognitive effects of anticholinergic medications among older adults. Most interventions designed to promote deprescribing of anticholinergics have directly targeted healthcare professionals and have had mixed results. Consumer-facing technologies may provide a unique benefit by empowering patients and can complement existing healthcare professional-centric efforts. METHODS: We initiated a randomized clinical trial to evaluate the effectiveness of a patient-facing mobile application (Brain Safe app) compared to an attention control medication list app in reducing anticholinergic exposure among community-dwelling older adults. Study participants are adults aged 60 years and above, currently using at least one prescribed strong anticholinergic, and receiving primary care. The trial plans to enroll a total of 700 participants, randomly allocated in 1:1 proportion to the two study arms. Participants will have the Brain Safe app (intervention arm) or attention control medication list app (control arm) loaded onto a smartphone (study provided or personal device). All participants will be followed for 12 months and will have data collected at baseline, at 6 months, and 12 months by blinded outcome assessors. The primary outcome of the study is anticholinergic exposure measured as total standard daily dose (TSDD) computed from medication prescription electronic records. Secondary outcomes of the study are cognitive function and health-related quality of life. DISCUSSION: A consumer-facing intervention to promote deprescribing of potentially high-risk medications can be part of a multi-pronged approach to reduce inappropriate medication use among older adult patients. Delivering a deprescribing intervention via a mobile app is a novel approach and may hold great promise to accelerate deployment of medication safety initiatives across diverse patient populations. CLINICAL TRIAL REGISTRATION: Registered at ClinicalTrials.gov on October 10, 2019. Identifier number: NCT04121858.

Multicomponent behavioral intervention to reduce exposure to anticholinergics in primary care older adults.

OBJECTIVE: To test the impact of a multicomponent behavioral intervention to reduce the use of high-risk anticholinergic medications in primary care older adults. DESIGN: Cluster-randomized controlled trial. SETTING AND PARTICIPANTS: Ten primary care clinics within Eskenazi Health in Indianapolis. INTERVENTION: The multicomponent intervention included provider- and patient-focused components. The provider-focused component was computerized decision support alerting of the presence of a high-risk anticholinergic and offering dose- and indication-specific alternatives. The patient-focused component was a story-based video providing education and modeling an interaction with a healthcare provider resulting in a medication change. Alerts within the medical record triggered staff to play the video for a patient. Our design intended for parallel, independent priming of both providers and patients immediately before an outpatient face-to-face interaction. MEASUREMENT: Medication orders were extracted from the electronic medical record system to evaluate the prescribing behavior and population prevalence of anticholinergic users. The intervention was introduced April 1, 2019, through March 31, 2020, and a preintervention observational period of April 1, 2018, through March 31, 2019, facilitated difference in difference comparisons. RESULTS: A total of 552 older adults had visits at primary care sites during the study period, with mean age of 72.1 (SD 6.4) years and 45.3% African American. Of the 259 provider-focused alerts, only three (1.2%) led to a medication change. Of the 276 staff alerts, 4.7% were confirmed to activate the patient-focused intervention. The intervention resulted in no significant differences in either the number of discontinue orders for anticholinergics (intervention: two additional orders; control: five fewer orders, p = 0.7334) or proportion of the population using anticholinergics following the intervention (preintervention: 6.2% and postintervention: 5.1%, p = 0.6326). CONCLUSION: This multicomponent intervention did not reduce the use of high-risk anticholinergics in older adults receiving primary care. Improving nudges or a policy-focused component may be necessary to reduce use of high-risk medications.

Long-term evaluation of a train-the-trainer workshop for pharmacy faculty using the RE-AIM framework.

BACKGROUND: Although two thirds of tobacco users express interest in quitting, few pharmacists address tobacco use as part of routine practice. Historically, pharmacy schools provided inadequate tobacco cessation training for students. To address this educational gap, train-the-trainer workshops were conducted between 2003 and 2005 to train pharmacy faculty (n = 191) to teach a shared, national tobacco cessation curriculum at their academic institutions. OBJECTIVE: To characterize faculty perceptions of the train-the-trainer workshops and estimate the long-term reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) of the shared curriculum at pharmacy schools. METHODS: This study is the second phase of a sequential mixed methods study. Results from Phase 1, a qualitative study, informed the development of survey items for Phase 2. Applying the RE-AIM framework, a web-based survey was developed and administered to train-the-trainer participants. RESULTS: Of 191 trainees, 137 were locatable; of these, 111 completed a survey (81.0%). Most (n = 87; 78.4%) reported current employment in academia. The most highly rated reason for attending a workshop was to improve teaching of tobacco cessation content, and 98.1% reported moderate or high confidence for teaching tobacco cessation. Among those who practice in a clinical setting, 70.6% reported asking their patients about tobacco use all or almost all the time. Just over three fourths of faculty respondents who work in academia believe that shared curricula should be more broadly considered for use in pharmacy schools, and 79.0% agreed that shared curricula are a cost-effective approach to teaching. CONCLUSION: Evidence is provided for long-term reach, effectiveness, adoption, implementation, and maintenance of the Rx for Change shared tobacco cessation training program. Participants perceived that the workshop resulted in long-term, positive effects on their careers as well as their teaching and clinical practice.

Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study.

BACKGROUND: The COVID-19 pandemic necessitated "going remote" with the delivery, support, and assessment of a study intervention targeting older adults enrolled in a clinical trial. While remotely delivering and assessing technology is not new, there are few methods available in the literature that are proven to be effective with diverse populations, and none for older adults specifically. Older adults comprise a diverse population, including in terms of their experience with and access to technology, making this a challenging endeavor. OBJECTIVE: Our objective was to remotely deliver and conduct usability testing for a mobile health (mHealth) technology intervention for older adult participants enrolled in a clinical trial of the technology. This paper describes the methodology used, its successes, and its limitations. METHODS: We developed a conceptual model for remote operations, called the Framework for Agile and Remote Operations (FAR Ops), that combined the general requirements for spaceflight operations with Agile project management processes to quickly respond to this challenge. Using this framework, we iteratively created care packages that differed in their contents based on participant needs and were sent to study participants to deliver the study intervention-a medication management app-and assess its usability. Usability data were collected using the System Usability Scale (SUS) and a novel usability questionnaire developed to collect more in-depth data. RESULTS: In the first 6 months of the project, we successfully delivered 21 care packages. We successfully designed and deployed a minimum viable product in less than 6 weeks, generally maintained a 2-week sprint cycle, and achieved a 40% to 50% return rate for both usability assessment instruments. We hypothesize that lack of engagement due to the pandemic and our use of asynchronous communication channels contributed to the return rate of usability assessments being lower than desired. We also provide general recommendations for performing remote usability testing with diverse populations based on the results of our work, including implementing screen sharing capabilities when possible, and determining participant preference for phone or email communications. CONCLUSIONS: The FAR Ops model allowed our team to adopt remote operations for our mHealth trial in response to interruptions from the COVID-19 pandemic. This approach can be useful for other research or practice-based projects under similar circumstances or to improve efficiency, cost, effectiveness, and participant diversity in general. In addition to offering a replicable approach, this paper tells the often-untold story of practical challenges faced by mHealth projects and practical strategies used to address them. TRIAL REGISTRATION: ClinicalTrials.gov NCT04121858; https://clinicaltrials.gov/ct2/show/NCT04121858.