Protocol and Statistical Analysis Plan for the Mode of Ventilation During Critical Illness (MODE) Trial.

BACKGROUND: For every critically ill adult receiving invasive mechanical ventilation, clinicians must select a mode of ventilation. The mode of ventilation determines whether the ventilator directly controls the tidal volume or the inspiratory pressure. Newer hybrid modes allow clinicians to set a target tidal volume; the ventilator controls and adjusts the inspiratory pressure. A strategy of low tidal volumes and low plateau pressure improves outcomes, but the optimal mode to achieve these targets is not known. RESEARCH QUESTION: Can a cluster-randomized trial design be used to assess whether the mode of mandatory ventilation affects the number of days alive and free of invasive mechanical ventilation among critically ill adults? STUDY DESIGN AND METHODS: The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot trial being conducted in the medical ICU at an academic center. The MODE trial compares the use of volume control, pressure control, and adaptive pressure control. The study ICU is assigned to a single-ventilator mode (volume control vs pressure control vs adaptive pressure control) for continuous mandatory ventilation during each 1-month study block. The assigned mode switches every month in a randomly generated sequence. The primary outcome is ventilator-free days to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of mechanical ventilation to 28 days after enrollment. Enrollment began November 1, 2022, and will end on July 31, 2023. RESULTS: This manuscript describes the protocol and statistical analysis plan for the MODE trial of ventilator modes comparing volume control, pressure control, and adaptive pressure control. INTERPRETATION: Prespecifying the full statistical analysis plan prior to completion of enrollment increases rigor, reproducibility, and transparency of the trial results. CLINICAL TRIAL REGISTRATION: The trial was registered with clinicaltrials.gov on October 3, 2022, before initiation of patient enrollment on November 1, 2022 (ClinicalTrials.gov identifier: NCT05563779).

Emergency department visits and hospital readmissions after a deprescribing intervention among hospitalized older adults.

BACKGROUND: Deprescribing is the planned/supervised method of dose reduction or cessation of medications that might be harmful, or no longer be beneficial. Though benefits of deprescribing are debatable in improving clinical outcomes, it has been associated with decreased number of potentially inappropriate medications, which may potentially reduce the risk of adverse events among hospitalized older adults. With unclear evidence for deprescribing in this population, this study aimed to examine time-to-first unplanned healthcare utilization, which included 90-day emergency department (ED) visits or hospital readmission and associated predictors, during a deprescribing intervention. METHODS: A secondary data analysis of a clinical trial (Shed-MEDS NCT02979353) was performed. Cox regression was used to compare the time-to-first 90-day ED visit/readmission/death from hospital discharge for the intervention and control groups. Additionally, we performed exploratory analysis of predictors (comorbidities, functional health status, drug burden index (DBI), hospital length of stay, health literacy, food insecurity, and financial burden) associated with the time-to-first 90-day ED visit/readmission/death. RESULTS: The hazard of first 90-day ED visits/readmissions/death was 15% lower in the intervention versus the control group (95% CI: 0.61-1.19, p = 0.352, respectively); however, this difference was not statistically significant. For every additional number of comorbidities (Hazard ratio (HR): 1.12, 95% CI: 1.04-1.21) and each additional day of hospital length of stay (HR: 1.04, 95% CI: 1.01-1.07) were significantly associated with a higher hazard of 90-day ED visit/readmission/death in the intervention group; whereas for each unit of increase in pre-hospital DBI score (HR: 1.08 and HR 1.16, respectively) was significantly associated with a higher hazard of 90-day ED visit/readmission/death in the control group. CONCLUSIONS: The intervention and control groups had comparable time-to-first 90-day ED visit/readmission/death during a deprescribing intervention. This finding suggests that deprescribing did not result in a higher risk of ED visit/readmission/death during the 90-day period following hospital discharge.

Patient-reported predictors of postdischarge mortality after cardiac hospitalization.

BACKGROUND: Adults hospitalized for cardiovascular events are at high risk for postdischarge mortality. Screening of psychosocial risk is prioritized by the Joint Commission. We tested whether key patient-reported psychosocial and behavioral measures could predict posthospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. METHODS: We conducted a prospective cohort study to test the prognostic utility of validated patient-reported measures, including health literacy, social support, health behaviors and disease management, and socioeconomic status. Cox survival analyses of mortality were conducted over a median of 3.5 years. RESULTS: Among 2977 adults hospitalized for either acute coronary syndrome or acute decompensated heart failure, the mean age was 53 years, and 60% were male. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unemployed (hazard ratio [HR]: 1.99, 95% confidence interval [CI]): 1.30-3.06), retired (HR: 2.14, 95% CI: 1.60-2.87), or unable to work due to disability (HR: 2.36, 95% CI: 1.73-3.21), as compared to those who were employed. Patient-reported perceived health competence (PHCS-2) and exercise frequency were also associated with mortality risk after adjusting for all other variables (HR: 0.86, 95% CI: 0.73-1.00 per four-point increase in PHCS-2; HR: 0.86, 95% CI: 0.77-0.96 per 3-day increase in exercise frequency, respectively). CONCLUSIONS: Patient-reported measures of employment status, perceived health competence, and exercise frequency independently predict mortality after a cardiac hospitalization. Incorporating these brief, valid measures into hospital-based screening may help with prognostication and targeting patients for resources during post-discharge transitions of care.

Health Literacy-Informed Communication to Reduce Discharge Medication Errors in Hospitalized Children: A Randomized Clinical Trial.

Importance: Inadequate communication between caregivers and clinicians at hospital discharge contributes to medication dosing errors in children. Health literacy-informed communication strategies during medication counseling can reduce dosing errors but have not been tested in the pediatric hospital setting. Objective: To test a health literacy-informed communication intervention to decrease liquid medication dosing errors compared with standard counseling in hospitalized children. Design, Setting, and Participants: This parallel, randomized clinical trial was performed from June 22, 2021, to August 20, 2022, at a tertiary care, US children's hospital. English- and Spanish-speaking caregivers of hospitalized children 6 years or younger prescribed a new, scheduled liquid medication at discharge were included in the analysis. Interventions: Permuted block (n = 4) randomization (1:1) to a health literacy-informed discharge medication communication bundle (n = 99) compared with standard counseling (n = 99). A study team member delivered the intervention consisting of a written, pictogram-based medication instruction sheet, teach back (caregivers state information taught), and demonstration of dosing with show back (caregivers show how they would draw the liquid medication in the syringe). Main Outcome and Measures: Observed dosing errors, assessed using a caregiver-submitted photograph of their child's medication-filled syringe and expressed as the percentage difference from the prescribed dose. Secondary outcomes included caregiver-reported medication knowledge. Outcome measurements were blinded to participant group assignment. Results: Among 198 caregivers randomized (mean [SD] age, 31.4 [6.5] years; 186 women [93.9%]; 36 [18.2%] Hispanic or Latino and 158 [79.8%] White), the primary outcome was available for 151 (76.3%). The observed mean (SD) percentage dosing error was 1.0% (2.2 percentage points) among the intervention group and 3.3% (5.1 percentage points) among the standard counseling group (absolute difference, 2.3 [95% CI, 1.0-3.6] percentage points; P < .001). Twenty-four of 79 caregivers in the intervention group (30.4%) measured an incorrect dose compared with 39 of 72 (54.2%) in the standard counseling group (P = .003). The intervention enhanced caregiver-reported medication knowledge compared with the standard counseling group for medication dose (71 of 76 [93.4%] vs 55 of 69 [79.7%]; P = .03), duration of administration (65 of 76 [85.5%] vs 49 of 69 [71.0%]; P = .04), and correct reporting of 2 or more medication adverse effects (60 of 76 [78.9%] vs 13 of 69 [18.8%]; P < .001). There were no differences in knowledge of medication name, indication, frequency, or storage. Conclusions and Relevance: A health literacy-informed discharge medication communication bundle reduced home liquid medication administration errors and enhanced caregiver medication knowledge compared with standard counseling. Routine use of these standardized strategies can promote patient safety following hospital discharge. Trial Registration: ClinicalTrials.gov Identifier: NCT05143047.

Deprescribing medications among patients with multiple prescribers: A socioecological model.

Deprescribing is the intentional dose reduction or discontinuation of a medication. The development of deprescribing interventions should take into consideration important organizational, interprofessional, and patient-specific barriers that can be further complicated by the presence of multiple prescribers involved in a patient's care. Patients who receive care from an increasing number of prescribers may experience disruptions in the timely transfer of relevant healthcare information, increasing the risk of exposure to drug-drug interactions and other medication-related problems. Furthermore, the fragmentation of healthcare information across health systems can contribute to the refilling of discontinued medications, reducing the effectiveness of deprescribing interventions. Thus, deprescribing interventions must carefully consider the unique characteristics of patients and their prescribers to ensure interventions are successfully implemented. In this special article, an international working group of physicians, pharmacists, nurses, epidemiologists, and researchers from the United States Deprescribing Research Network (USDeN) developed a socioecological model to understand how multiple prescribers may influence the implementation of a deprescribing intervention at the individual, interpersonal, organizational, and societal level. This manuscript also includes a description of the concept of multiple prescribers and outlines a research agenda for future investigations to consider. The information contained in this manuscript should be used as a framework for future deprescribing interventions to carefully consider how multiple prescribers can influence the successful implementation of the service and ensure the intervention is as effective as possible.

Challenges in Deprescribing among Older Adults in Post-Acute Care Transitions to Home.

OBJECTIVES: Medications with a higher risk of harm or that are unlikely to be beneficial are used by nearly all older patients in home health care (HHC). The objective of this study was to understand stakeholders' perspectives on challenges in deprescribing these medications for post-acute HHC patients. DESIGN: Qualitative individual interviews were conducted with stakeholders involved with post-acute deprescribing. SETTING AND PARTICIPANT: Older HHC patients, HHC nurses, pharmacists, and primary/acute care/post-acute prescribers from 9 US states participated in individual qualitative interviews. MEASURES: Interview questions were focused on the experience, processes, roles, training, workflow, and challenges of deprescribing in hospital-to-home transitions. We used the constant comparison approach to identify and compare findings among patient, prescriber, and pharmacist and HHC nurse stakeholders. RESULTS: We interviewed 9 older patients, 11 HHC nurses, 5 primary care physicians (PCP), 3 pharmacists, 1 hospitalist, and 1 post-acute nurse practitioner. Four challenges were described in post-acute deprescribing for HHC patients. First, PCPs' time constraints, the timing of patient encounters after hospital discharge, and the lack of prioritization of deprescribing make it difficult for PCPs to initiate post-acute deprescribing. Second, patients are often confused about their medications, despite the care team's efforts in educating the patients. Third, communication is challenging between HHC nurses, PCPs, specialists, and hospitalists. Fourth, the roles of HHC nurses and pharmacists are limited in care team collaboration and discussion about post-acute deprescribing. CONCLUSIONS AND IMPLICATIONS: Post-acute deprescribing relies on multiple parties in the care team yet it has challenges. Interventions to align the timing of deprescribing and that of post-acute care visits, prioritize deprescribing and allow clinicians more time to complete related tasks, improve medication education for patients, and ensure effective communication in the care team with synchronized electronic health record systems are needed to advance deprescribing during the transition from hospital to home.

Using intervention mapping to design and implement a multicomponent intervention to improve antibiotic and NSAID prescribing.

Successfully changing prescribing behavior to reduce inappropriate antibiotic and nonsteroidal anti-inflammatory drug (NSAID) prescriptions often requires combining components into a multicomponent intervention. However, multicomponent interventions often fail because of development and implementation complexity. To increase the likelihood of successfully changing prescribing behavior, we applied a systematic process to design and implement a multicomponent intervention. We used Intervention Mapping to create a roadmap for a multicomponent intervention in unscheduled outpatient care settings in the Veterans Health Administration. Intervention Mapping is a systematic process consisting of six steps that we grouped into three phases: (i) understand behavioral determinants and barriers to implementation, (ii) develop the intervention, and (iii) define evaluation plan and implementation strategies. A targeted literature review, combined with 25 prescriber and 25 stakeholder interviews, helped identify key behavioral determinants to inappropriate prescribing (e.g. perceived social pressure from patients to prescribe). We targeted three desired prescriber behaviors: (i) review guideline-concordant prescribing and patient outcomes, (ii) manage diagnostic and treatment uncertainty, and (iii) educate patients and caregivers. The intervention consisted of components for academic detailing, prescribing feedback, and alternative prescription order sets. Implementation strategies consisted of preparing clinical champions, conducting readiness assessments, and incentivizing use of the intervention. We chose a mixed-method study design with a commonly used evaluation framework to assess effectiveness and implementation outcomes in a subsequent trial. This study furthers knowledge about causes of inappropriate antibiotic and NSAID prescribing and demonstrates how theoretical, empirical, and practical information can be systematically applied to develop a multicomponent intervention to help address these causes.

Reducing adverse drug events from antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs) is a patient safety priority. Successfully changing prescribing behavior to reduce inappropriate prescriptions can require combining intervention components, each with different mechanisms for behavior change, into a multicomponent intervention. However, multicomponent interventions often fail because of development and implementation complexity. To increase the chance of successfully changing antibiotic and NSAID prescribing, the objective this study was to apply a systematic process to design and implement a multicomponent intervention. Three desired prescriber behaviors were targeted: (i) review guideline-concordant prescribing and patient outcomes, (ii) manage diagnostic and treatment uncertainty, and (iii) educate patients and caregivers. The designed intervention consisted of components for prescribing feedback, academic detailing, and alternative prescription order sets. Strategies to improve use of the intervention consisted of preparing clinical champions, conducting readiness assessments prior to study onset, and incentivizing use of the intervention. We chose a mixed-method study design with a commonly used evaluation framework to assess effectiveness and implementation outcomes of the multicomponent intervention in a subsequent trial.

Patient-reported predictors of post-discharge mortality after cardiac hospitalization.

Background: Adults hospitalized for cardiovascular events are at high risk for post-discharge mortality. Hospital-based screening of health-related psychosocial risk factors is now prioritized by the Joint Commission and the National Quality Forum to achieve equitable, high-quality care. We tested our hypothesis that key patient-reported psychosocial and behavioral measures could predict post-hospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. Methods: This was a prospective cohort of adults hospitalized at Vanderbilt University Medical Center. Validated patient-reported measures of health literacy, social support, disease self-management, and socioeconomic status were used as predictors of interest. Cox survival analyses of mortality were conducted over a median 3.5-year follow-up (range: 1.25 - 5.5 years). Results: Among 2,977 adults, 1,874 (63%) were hospitalized for acute coronary syndrome and 1,103 (37%) were hospitalized for acute decompensated heart failure; 60% were male; and the mean age was 53 years. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unable to work due to disability (Hazard Ratio (HR) 2.36, 95% Confidence Interval (CI): 1.73-3.21), who were retired (HR 2.14, 95% CI 1.60-2.87), and who reported unemployment (HR 1.99, 95% CI 1.30-3.06) as compared to those who were employed. Patient-reported measures of disease self-management, perceived health competence and exercise frequency, were also associated with mortality risk after full covariate adjustment (HR 0.86, 95% CI 0.73-1.00 per four-point increase), (HR 0.86, 95% CI 0.77-0.96 per three-day change), respectively. Conclusions: Patient-reported measures of employment status independently predict post-discharge mortality after a cardiac hospitalization. Measure of disease self-management also have prognostic modest utility. Hospital-based screening of psychosocial risk is increasingly prioritized in legislative policy. Incorporating brief, valid measures of employment status and disease self-management factors may help target patients for psychosocial, financial, and rehabilitative resources during post-discharge transitions of care.

Model-Guided Decision-Making for Thromboprophylaxis and Hospital-Acquired Thromboembolic Events Among Hospitalized Children and Adolescents: The CLOT Randomized Clinical Trial.

Importance: Rates of hospital-acquired venous thromboembolism (HA-VTE) are increasing among pediatric patients. Identifying at-risk patients for whom prophylactic interventions should be considered remains challenging. Objective: To determine whether use of a previously validated HA-VTE prognostic model, together with pediatric hematologist review, could reduce pediatric inpatient rates of HA-VTE. Design, Setting, and Participants: This pragmatic randomized clinical trial was performed from November 2, 2020, through January 31, 2022, at a single-center academic children's hospital (Monroe Carell Jr Children's Hospital at Vanderbilt). All pediatric hospital admissions (aged <22 years) under inpatient status were included and randomized. Intervention: All patients had an HA-VTE probability automatically calculated daily, which was visible to the hematology research team for patients in the intervention group. Patients with an elevated risk (predicted probability ≥2.5%) underwent additional medical record review by the research team to determine eligibility for thromboprophylaxis. Main Outcomes and Measures: The primary outcome was rate of HA-VTE. Secondary outcomes included rates of prophylactic anticoagulation and anticoagulation-associated bleeding events. Results: A total of 17 427 hospitalizations met eligibility criteria, were randomized, and were included in the primary analysis: patients had a median (IQR) age of 1.7 (0 to 11.1) years; there were 9143 (52.5%) female patients and 8284 (47.5%) male patients, and there were 445 (2.6%) Asian patients, 2739 (15.9%) Black patients, and 11 752 (67.4%) White patients. The 2 groups were evenly balanced in number (8717 in the intervention group and 8710 in the control group) and patient characteristics. A total of 58 patients (0.7%) in the control group and 77 (0.9%) in the intervention group developed HA-VTE (risk difference: 2.2 per 1000 patients; 95% CI, -0.4 to 4.8 per 1000 patients; P = .10). Recommendations to initiate thromboprophylaxis were accepted by primary clinical teams 25.8% of the time (74 of 287 hospitalizations). Minor bleeding events were rare among patients who received anticoagulation (3 of 74 [4.1%]), and no major bleeding events were observed during the study period. Among patients randomized to the control group, the model exhibited high discrimination accuracy (C statistic, 0.799, 95% CI, 0.725 to 0.856). Conclusions and Relevance: In this randomized clinical trial of the use of a HA-VTE prognostic model to reduce pediatric inpatient rates of HA-VTE, despite the use of an accurate and validated prognostic model for HA-VTE, there was substantial reluctance by primary clinical teams to initiate thromboprophylaxis as recommended. In this context, rates of HA-VTE between the control and intervention groups were not different. Future research is needed to identify improved strategies for prevention of HA-VTE and to overcome clinician concerns regarding thromboprophylaxis. Trial Registration: ClinicalTrials.gov Identifier: NCT04574895.

Protocol and statistical analysis plan for the Mode of Ventilation During Critical IllnEss (MODE) trial.

Introduction: For every critically ill adult receiving invasive mechanical ventilation, clinicians must select a mode of ventilation. The mode of ventilation determines whether the ventilator directly controls the tidal volume or the inspiratory pressure. Newer hybrid modes allow clinicians to set a target tidal volume, for which the ventilator controls and adjusts the inspiratory pressure. A strategy of low tidal volumes and low plateau pressure improves outcomes, but the optimal mode to achieve these targets is not known. Methods and analysis: The Mode of Ventilation During Critical Illness (MODE) trial is a cluster-randomized, multiple-crossover pilot trial being conducted in the medical intensive care unit (ICU) at an academic center. The MODE trial compares the use of volume control, pressure control, and adaptive pressure control. The study ICU is assigned to a single ventilator mode (volume control versus pressure control versus adaptive pressure control) for continuous mandatory ventilation during each 1-month study block. The assigned mode switches every month in a randomly generated sequence. The primary outcome is ventilator-free days (VFDs) to study day 28, defined as the number of days alive and free of invasive mechanical ventilation from the final receipt of mechanical ventilation to 28 days after enrollment. Enrollment began November 1, 2022 and will end on July 31, 2023. Ethics and dissemination: The trial was approved by the Vanderbilt University Medical Center institutional review board (IRB# 220446). Results of this study will be submitted to a peer-reviewed journal and presented at scientific conferences. Trial registration number: The trial was registered with clinicaltrials.gov on October 3, 2022, prior to initiation of patient enrollment on November 1, 2022 (ClinicalTrials.gov identifier: NCT05563779).

How to Deprescribe Potentially Inappropriate Medications During the Hospital-to-Home Transition: Stakeholder Perspectives on Essential Tasks.

PURPOSE: Nearly all older patients receiving postacute home health care (HHC) use potentially inappropriate medications (PIMs) that carry a risk of harm. Deprescribing can reduce and optimize the use of PIMs, yet it is often not conducted among HHC patients. The objective of this study was to gather perspectives from patient, practitioner, and HHC clinician stakeholders on tasks that are essential to postacute deprescribing in HHC. METHODS: A total of 44 stakeholders, including 14 HHC patients, 15 practitioners (including 9 primary care physicians, 4 pharmacists, 1 hospitalist, and 1 nurse practitioner), and 15 HHC nurses, participated. The stakeholders were from 12 US states, including New York (n = 29), Colorado (n = 2), Connecticut (n = 1), Illinois (n = 2), Kansas (n = 2), Massachusetts (n = 1), Minnesota (n = 1), Mississippi (n = 1), Nebraska (n = 1), Ohio (n = 1), Tennessee (n = 1), and Texas (n = 2). First, individual interviews were conducted by experienced research staff via video conference or telephone. Second, the study team reviewed all interview transcripts and selected interview statements regarding stakeholders' suggestions for important tasks needed for postacute deprescribing in HHC. Third, concept mapping was conducted in which stakeholders sorted and rated selected interview statements regarding importance and feasibility. A content analysis was conducted of data collected in the individual interviews, and a mixed-method analysis was conducted of data collected in the concept mapping. FINDINGS: Four essential tasks were identified for postacute deprescribing in HHC: (1) ongoing review and assessment of medication use, (2) patent-centered and individualized plan of deprescribing, (3) timely and efficient communication among members of the care team, and (4) continuous and tailored medication education to meet patient needs. Among these tasks, developing patient-centered deprescribing considerations was considered the most important and feasible, followed by medication education, review and assessment of medication use, and communication. IMPLICATIONS: Deprescribing during the transition of care from hospital to home requires the following: continuous medication education for patients, families, and caregivers; ongoing review and assessment of medication use; patient-centered deprescribing considerations; and effective communication and collaboration among the primary care physician, HHC nurse, and pharmacist.

Why do older adults decline participation in research? Results from two deprescribing clinical trials.

BACKGROUND: Heterogenous older adult populations are underrepresented in clinical trials, and their participation is necessary for interventions that directly target them. The purpose of this study was to evaluate reasons why hospitalized older adults declined participation in two deprescribing clinical trials. METHODS: We report enrollment data from two deprescribing trials, Shed-MEDS (non-Veterans) and VA DROP (Veterans). For both trials, inclusion criteria required participants to be hospitalized, age 50 or older, English-speaking, and taking five or more home medications. Eligible patients were approached for enrollment while hospitalized. When an eligible patient or surrogate declined participation, the reason(s) were recorded and subsequently analyzed inductively to develop themes, and a chi-square test was used for comparison (of themes between Veterans and non-Veterans). RESULTS: Across both trials, 1226 patients (545 non-Veterans and 681 Veterans) declined enrollment and provided reasons, which were condensed into three themes: (1) feeling overwhelmed by their current health status, (2) lack of interest or mistrust of research, and (3) hesitancy to participate in a deprescribing study. A greater proportion of Veterans expressed a lack of interest or mistrust in research (42% vs 26%, chi-square value = 36.72, p < .001), whereas a greater proportion of non-Veterans expressed feeling overwhelmed by their current health status (54% vs 35%, chi-square value = 42.8 p < 0.001). Across both trials, similar proportion of patients expressed hesitancy to participate in a deprescribing study, with no significant difference between Veterans and non-Veterans (23% and 21%). CONCLUSIONS: Understanding the reasons older adults decline participation can inform future strategies to engage this multimorbid population.

Pragmatic evaluation of events and benefits of lipid lowering in older adults (PREVENTABLE): Trial design and rationale.

Whether initiation of statins could increase survival free of dementia and disability in adults aged ≥75 years is unknown. PREVENTABLE, a double-blind, placebo-controlled randomized pragmatic clinical trial, will compare high-intensity statin therapy (atorvastatin 40 mg) with placebo in 20,000 community-dwelling adults aged ≥75 years without cardiovascular disease, disability, or dementia at baseline. Exclusion criteria include statin use in the prior year or for >5 years and inability to take a statin. Potential participants are identified using computable phenotypes derived from the electronic health record and local referrals from the community. Participants will undergo baseline cognitive testing, with physical testing and a blinded lipid panel if feasible. Cognitive testing and disability screening will be conducted annually. Multiple data sources will be queried for cardiovascular events, dementia, and disability; survival is site-reported and supplemented by a National Death Index search. The primary outcome is survival free of new dementia or persisting disability. Co-secondary outcomes are a composite of cardiovascular death, hospitalization for unstable angina or myocardial infarction, heart failure, stroke, or coronary revascularization; and a composite of mild cognitive impairment or dementia. Ancillary studies will offer mechanistic insights into the effects of statins on key outcomes. Biorepository samples are obtained and stored for future study. These results will inform the benefit of statins for increasing survival free of dementia and disability among older adults. This is a pioneering pragmatic study testing important questions with low participant burden to align with the needs of the growing population of older adults.

Screening Health-Related Social Needs in Hospitals: A Systematic Review of Health Care Professional and Patient Perspectives.

Health outcomes are markedly influenced by health-related social needs (HRSN) such as food insecurity and housing instability. Under new Joint Commission requirements, hospitals have recently increased attention to HRSN to reduce health disparities. To evaluate prevailing attitudes and guide hospital efforts, the authors conducted a systematic review to describe patients' and health care providers' perceptions related to screening for and addressing patients' HRSN in US hospitals. Articles were identified through PubMed and by expert recommendations, and synthesized by relevance of findings and basic study characteristics. The review included 22 articles, which showed that most health care providers believed that unmet social needs impact health and that screening for HRSN should be a standard part of hospital care. Notable differences existed between perceived importance of HRSN and actual screening rates, however. Patients reported high receptiveness to screening in hospital encounters, but cautioned to avoid stigmatization and protect privacy when screening. Limited knowledge of resources available, lack of time, and lack of actual resources were the most frequently reported barriers to screening for HRSN. Hospital efforts to screen and address HRSN will likely be facilitated by stakeholders' positive perceptions, but common barriers to screening and referral will need to be addressed to effectively scale up efforts and impact health disparities.

Caregiver and Clinician Perspectives on Discharge Medication Counseling: A Qualitative Study.

OBJECTIVES: Children are at increased risk for medication errors and the transition from hospital-to-home is a vulnerable time for errors to occur. This study aimed to explore the perspectives of multidisciplinary clinicians and caregivers regarding discharge medication counseling and to develop a conceptual model to inform intervention efforts to reduce discharge medication dosing errors. METHODS: We conducted semistructured interviews with clinicians and caregivers of children <4 years old discharged from the hospital on a liquid medication. A hierarchical coding system was developed using the interview guide and several transcripts. Qualitative analysis employed an iterative inductive-deductive approach to identify domains and subthemes and inform a conceptual framework. RESULTS: We conducted focus groups and individual interviews with 17 caregivers and 16 clinicians. Using the Donabedian structure-process-outcomes model of quality evaluation, domains and subthemes included: (1) infrastructure of healthcare delivery, including supplies for counseling, content and organization of discharge instructions, clinician training and education, roles and responsibilities of team members, and hospital pharmacy delivery and counseling program; (2) processes of healthcare delivery, including medication reconciliation, counseling content, counseling techniques, and language barriers and health literacy; and (3) measurable outcomes, including medication dosing accuracy and caregiver understanding and adherence to discharge instructions. CONCLUSIONS: The conceptual model resulting from this analysis can be applied to the development and evaluation of interventions to reduce discharge medication dosing errors following a hospitalization. Interventions should use a health literacy universal precautions approach-written materials with plain language and pictures and verbal counseling with teach-back and show-back.

What works in medication reconciliation: an on-treatment and site analysis of the MARQUIS2 study.

BACKGROUND: The second Multicenter Medication Reconciliation Quality Improvement Study demonstrated a marked reduction in medication discrepancies per patient. The aim of the current analysis was to determine the association of patient exposure to each system-level intervention and receipt of each patient-level intervention on these results. METHODS: This study was conducted at 17 North American Hospitals, the study period was 18 months per site, and sites typically adopted interventions after 2-5 months of preintervention data collection. We conducted an on-treatment analysis (ie, an evaluation of outcomes based on patient exposure) of system-level interventions, both at the category level and at the individual component level, based on monthly surveys of implementation site leads at each site (response rate 65%). We then conducted a similar analysis of patient-level interventions, as determined by study pharmacist review of documented activities in the medical record. We analysed the association of each intervention on the adjusted number of medication discrepancies per patient in admission and discharge orders, based on a random sample of up to 22 patients per month per site, using mixed-effects Poisson regression with hospital site as a random effect. We then used a generalised linear mixed-effects model (GLMM) decision tree to determine which patient-level interventions explained the most variance in discrepancy rates. RESULTS: Among 4947 patients, patient exposure to seven of the eight system-level component categories was associated with modest but significant reductions in discrepancy rates (adjusted rate ratios (ARR) 0.75-0.97), as were 15 of the 17 individual system-level intervention components, including hiring, reallocating and training personnel to take a best possible medication history (BPMH) and training personnel to perform discharge medication reconciliation and patient counselling. Receipt of five of seven patient-level interventions was independently associated with large reductions in discrepancy rates, including receipt of a BPMH in the emergency department (ED) by a trained clinician (ARR 0.40, 95% CI 0.37 to 0.43), admission medication reconciliation by a trained clinician (ARR 0.57, 95% CI 0.50 to 0.64) and discharge medication reconciliation by a trained clinician (ARR 0.64, 95% CI 0.57 to 0.73). In GLMM decision tree analyses, patients who received both a BPMH in the ED and discharge medication reconciliation by a trained clinician experienced the lowest discrepancy rates (0.08 per medication per patient). CONCLUSION AND RELEVANCE: Patient-level interventions most associated with reductions in discrepancies were receipt of a BPMH of admitted patients in the ED and admission and discharge medication reconciliation by a trained clinician. System-level interventions were associated with modest reduction in discrepancies for the average patient but are likely important to support patient-level interventions and may reach more patients. These findings can be used to help hospitals and health systems prioritise interventions to improve medication safety during care transitions.

Deprescribing Medications Among Older Adults From End of Hospitalization Through Postacute Care: A Shed-MEDS Randomized Clinical Trial.

Importance: Deprescribing is a promising approach to addressing the burden of polypharmacy. Few studies have initiated comprehensive deprescribing in the hospital setting among older patients requiring ongoing care in a postacute care (PAC) facility. Objective: To evaluate the efficacy of a patient-centered deprescribing intervention among hospitalized older adults transitioning or being discharged to a PAC facility. Design, Setting, and Participants: This randomized clinical trial of the Shed-MEDS (Best Possible Medication History, Evaluate, Deprescribing Recommendations, and Synthesis) deprescribing intervention was conducted between March 2016 and October 2020. Patients who were admitted to an academic medical center and discharged to 1 of 22 PAC facilities affiliated with the medical center were recruited. Patients who were 50 years or older and had 5 or more prehospital medications were enrolled and randomized 1:1 to the intervention group or control group. Patients who were non-English speaking, were unhoused, were long-stay residents of nursing homes, or had less than 6 months of life expectancy were excluded. An intention-to-treat approach was used. Interventions: The intervention group received the Shed-MEDS intervention, which consisted of a pharmacist- or nurse practitioner-led comprehensive medication review, patient or surrogate-approved deprescribing recommendations, and deprescribing actions that were initiated in the hospital and continued throughout the PAC facility stay. The control group received usual care at the hospital and PAC facility. Main Outcomes and Measures: The primary outcome was the total medication count at hospital discharge and PAC facility discharge, with follow-up assessments during the 90-day period after PAC facility discharge. Secondary outcomes included the total number of potentially inappropriate medications at each time point, the Drug Burden Index, and adverse events. Results: A total of 372 participants (mean [SD] age, 76.2 [10.7] years; 229 females [62%]) were randomized to the intervention or control groups. Of these participants, 284 were included in the intention-to-treat analysis (142 in the intervention group and 142 in the control group). Overall, there was a statistically significant treatment effect, with patients in the intervention group taking a mean of 14% fewer medications at PAC facility discharge (mean ratio, 0.86; 95% CI, 0.80-0.93; P < .001) and 15% fewer medications at the 90-day follow-up (mean ratio, 0.85; 95% CI, 0.78-0.92; P < .001) compared with the control group. The intervention additionally reduced patient exposure to potentially inappropriate medications and Drug Burden Index. Adverse drug event rates were similar between the intervention and control groups (hazard ratio, 0.83; 95% CI, 0.52-1.30). Conclusions and Relevance: Results of this trial showed that the Shed-MEDS patient-centered deprescribing intervention was safe and effective in reducing the total medication burden at PAC facility discharge and 90 days after discharge. Future studies are needed to examine the effect of this intervention on patient-reported and long-term clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02979353.

How "age-friendly" are deprescribing interventions? A scoping review of deprescribing trials.

OBJECTIVE: To assess how age-friendly deprescribing trials are regarding intervention design and outcome assessment. Reduced use of potentially inappropriate medications (PIMs) can be addressed by deprescribing-a systematic process of discontinuing and/or reducing the use of PIMs. The 4Ms-"Medication", "Mentation", "Mobility", and "What Matters Most" to the person-can be used to guide assessment of age-friendliness of deprescribing trials. DATA SOURCE: Published literature. STUDY DESIGN: Scoping review. DATA EXTRACTION METHODS: The literature was identified using keywords related to deprescribing and polypharmacy in PubMed, EMBASE, Web of Science, ProQuest, CINAHL, and Cochrane and snowballing. Study characteristics were extracted and evaluated for consideration of 4Ms. PRINCIPAL FINDINGS: Thirty-seven of the 564 trials identified met the review eligibility criteria. Intervention design: "Medication" was considered in the intervention design of all trials; "Mentation" was considered in eight trials; "Mobility" (n = 2) and "What Matters Most" (n = 6) were less often considered in the design of intervention. Most trials targeted providers without specifying how matters important to older adults and their families were aligned with deprescribing decisions. OUTCOME ASSESSMENT: "Medication" was the most commonly assessed outcome (n = 33), followed by "Mobility" (n = 13) and "Mentation" (n = 10) outcomes, with no study examining "What Matters Most" outcomes. CONCLUSIONS: "Mentation" and "Mobility", and "What Matters Most" have been considered to varying degrees in deprescribing trials, limiting the potential of deprescribing evidence to contribute to improved clinical practice in building an age-friendly health care system.

Implementation considerations of deprescribing interventions: A scoping review.

Over half of older adults experience polypharmacy, including medications that may be inappropriate or unnecessary. Deprescribing, which is the process of discontinuing or reducing inappropriate and/or unnecessary medications, is an effective way to reduce polypharmacy. This review summarizes (1) the process of deprescribing and conceptual models and tools that have been developed to facilitate deprescribing, (2) barriers, enablers, and factors associated with deprescribing, and (3) characteristics of deprescribing interventions in completed trials, as well as (4) implementation considerations for deprescribing in routine practice. In conceptual models of deprescribing, multilevel factors of the patient, clinician, and health-care system are all related to the efficacy of deprescribing. Numerous tools have been developed for clinicians to facilitate deprescribing, yet most require substantial time and, thus, may be difficult to implement during routine health-care encounters. Multiple deprescribing interventions have been evaluated, which mostly include one or more of the following components: patient education, medication review, identification of deprescribing targets, and patient and/or provider communication about high-risk medications. Yet, there has been limited consideration of implementation factors in prior deprescribing interventions, especially with regard to the personnel and resources in existing health-care systems and the feasibility of incorporating components of deprescribing interventions into the routine care processes of clinicians. Future trials require a more balanced consideration of both effectiveness and implementation when designing deprescribing interventions.