Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER).

OBJECTIVES: To evaluate the impact of a mentoring program to encourage staff-delivered sleep-promoting strategies on sleep, function, depression, and anxiety among skilled nursing facility (SNF) residents. DESIGN: Modified stepped-wedge unit-level intervention. SETTING AND PARTICIPANTS: Seventy-two residents (mean age 75 ± 15 years; 61.5% female, 41% non-Hispanic white, 35% Black, 20% Hispanic, 3% Asian) of 2 New York City urban SNFs. METHODS: Expert mentors provided SNF staff webinars, in-person workshops, and weekly sleep pearls via text messaging. Resident data were collected at baseline, post-intervention (V1), and 3-month follow-up (V2), including wrist actigraphy, resident behavioral observations, Pittsburgh Sleep Quality Index (PSQI), Patient Health Questionnaire-9 (PHQ-9) depression scale, Brief Anxiety and Depression Scale (BADS), Brief Cognitive Assessment Tool (BCAT), and select Minimum Data Set 3.0 (MDS 3.0) measures. Linear mixed models were fit for continuous outcomes and mixed-effects logistic models for binary outcomes. Outcomes were modeled as a function of time. Planned contrasts compared baseline to V1 and V2. RESULTS: There was significant improvement in PSQI scores from baseline to V1 (P = .009), and from baseline to V2 (P = .008). Other significant changes between baseline and V1 included decreased depression (PHQ-9) (P = .028), increased daytime observed out of bed (P ≤ .001), and increased daytime observed being awake (P < .001). At V2 (vs baseline) being observed out of bed decreased (P < .001). Daytime sleeping by actigraphy increased from baseline to V1 (P = .004), but not V2. MDS 3.0 activities of daily living and pain showed improvements by the second quarter following implementation of SLUMBER (P's ≤ .034). There were no significant changes in BADS or BCAT between baseline and V1 or V2. CONCLUSIONS AND IMPLICATIONS: SNF residents had improvements in sleep quality and depression with intervention, but improvements were not sustained at 3-month follow-up. The COVID-19 pandemic led to premature study termination, so full impacts remain unknown.

Implementation Outcomes for the SLUMBER Sleep Improvement Program in Long-Term Care.

OBJECTIVES: To describe the implementation of a mentored staff-delivered sleep program in nursing facilities. DESIGN: Modified stepped-wedge unit-level intervention. SETTING AND PARTICIPANTS: This program was implemented in 2 New York City nursing facilities, with partial implementation (due to COVID-19) in a third facility. METHODS: Expert mentors provided staff webinars, in-person workshops, and weekly sleep pearls via text messaging. We used the integrated Promoting Action on Research Implementation in Health Services (i-PARiHS) framework as a post hoc approach to describe key elements of the SLUMBER implementation. We measured staff participation in unit-level procedures and noted their commentary during unit workshops. RESULTS: We completed SLUMBER within 5 units across 2 facilities and held 15 leadership meetings before and during program implementation. Sessions on each unit included 3 virtual webinar presentations and 4 in-person workshops for each nursing shift, held over a period of 3 to 4 months. Staff attendance averaged >3 sessions per individual staff member. Approximately 65% of staff present on each unit participated in any given session. Text messaging was useful for engagement, educational reinforcement, and encouraging attendance. We elevated staff as experts in the care of their residents as a strategy for staff engagement and behavior change and solicited challenging cases from staff during workshops to provide strategies to address resident behavior and encourage adoption when successful. CONCLUSIONS AND IMPLICATIONS: Engaging staff, leadership, residents, and family of nursing facilities in implementing a multicomponent sleep quality improvement program is feasible for improving nursing facilities' sleep environment. The program required gaining trust at multiple levels through presence and empathy, and reinforcement mechanisms (primarily text messages). To improve scalability, SLUMBER could evolve from an interdisciplinary investigator-based approach to internal coaches in a train-the-trainer model to effectively and sustainably implement this program to improve sleep quality for facility residents.

Improving sleep using mentored behavioral and environmental restructuring (SLUMBER): A randomized stepped-wedge design trial to evaluate a comprehensive sleep intervention in skilled nursing facilities.

INTRODUCTION: Poor sleep is ubiquitous in skilled nursing facilities (SNFs) and is associated with a myriad of negative symptoms. Non-pharmacological interventions can improve sleep, yet sustainability has not been demonstrated. The Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER) trial will test whether a staff mentoring approach to address resident sleep issues positively impacts sleep quality and whether improved sleep benefits mood, cognitive performance, and activity engagement for residents living in SNFs. INTERVENTION: This is a four-year hybrid type I effectiveness/implementation randomized stepped-wedge trial using a comprehensive sleep improvement program conducted in three urban SNFs. METHODS: We will provide SNF staff with sleep promotion strategies over a four-month intervention. Staff will have access to in-person workshops, webinars, weekly sleep pearls via text messaging, environmental data, and expert program mentors. We will consent residents for data collection (at baseline, end of intervention, and three- and six-months post-intervention) including resident observations, questionnaires, and wrist actigraphy (to objectively measure sleep). We will also use selected Minimum Data Set 3.0 (MDS) measures. CONCLUSION: SLUMBER uses a unique strategy to iteratively improve sleep interventions through SNF staff buy-in, expert mentoring, and technological supports within a quality improvement framework. As a stepped-wedge trial, the initial SNF units provide opportunities for program improvement in subsequent units, accounting for variation across resident populations at different sites. Protocol limitations include strategies which may require substantial customization for greater spread. A comprehensive staff training program that addresses both sleep quality and related symptoms has the opportunity for considerable dissemination. TRIAL REGISTRATION: USGOV Clinical Trials ID: NCT03327324.

Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients: Protocol for a Multisite Randomized Controlled Trial.

BACKGROUND: Older adults with cognitive impairment have more emergency department visits and 30-day readmissions and are more likely to die after visiting the emergency department than people without cognitive impairment. Emergency department providers frequently do not identify cognitive impairment. Use of cognitive screening tools, along with better understanding of root causes for emergency department visits, could equip health care teams with the knowledge needed to develop individually tailored care management strategies for post-emergency department care. By identifying and directly addressing patients' and informal caregivers' (or care partners') psychosocial and health care needs, such strategies could reduce the need for repeat acute care. We have used the terms "caregiver" and "care partner" interchangeably. OBJECTIVE: We aimed to describe the protocol for a randomized controlled trial of a new care management intervention, the Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED) trial, compared with usual care. We described the research design, intervention, outcome measures, data collection techniques, and analysis plans. METHODS: Emergency department patients who were aged ≥75 years and screened positive for cognitive impairment via either the Mini-Cog or the proxy-reported Short Informant Questionnaire on Cognitive Decline in the Elderly, with a planned discharge to home, were recruited to participate with their identified informal (family or friend) caregiver in the 2-site POISED randomized controlled trial at New York University Langone Health and Indiana University. The intervention group received 6 months of care management from the POISED Care Team of registered nurses and specialty-trained paraprofessionals, who perform root cause analyses, administer standardized assessments, provide advice, recommend appropriate referrals, and, when applicable, implement dementia-specific comorbid condition protocols. The control group received care as recommended at emergency department discharge (usual care) and were given information about resources for further cognitive assessment. The primary outcome is repeat emergency department use; secondary outcomes include caregiver activation for patient health care management, caregiver depression, anxiety, and experience of social support as important predisposing and time-varying enabling and need characteristics. Data were collected from questionnaires and patients' electronic health records. RESULTS: Recruitment was conducted between March 2018 and May 2021. Study findings will be published in peer-reviewed journals and presented to peer audiences, decision makers, stakeholders, and other interested persons. CONCLUSIONS: The POISED intervention is a promising approach to tailoring care management based on root causes for emergency department admission of patients with cognitive impairment with the aim of reducing readmissions. This trial will provide insights for caregivers and emergency department and primary care providers on appropriate, personalized, and proactive treatment plans for older adults with cognitive impairment. The findings will be relevant to audiences concerned with quality of life for individuals with cognitive impairment and their caregivers. TRIAL REGISTRATION: ClinicalTrials.gov NCT03325608; https://clinicaltrials.gov/ct2/show/NCT03325608. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36607.

A difference-in-difference approach to examining the impact of cannabis legalization on disparities in the use of cigarettes and cannabis in the United States, 2004-17.

AIMS: To estimate the impact of recreational and medical cannabis laws (RCL, MCL) on the use of cannabis and cigarettes in the United States. DESIGN: A difference-in-difference approach was applied to data from the 2004-17 National Survey on Drug Use and Health (NSDUH). SETTING: United States. PARTICIPANTS: Nationally representative cross-sectional survey of Americans aged 12 years and older (combined analytical sample for 2004-17, n = 783 663). MEASUREMENTS: Data on past-month use of (1) cigarettes and (2) cannabis were used to classify respondents into four groups: cigarette and cannabis co-use, cigarette-only use, cannabis-only use or no cigarette or cannabis use. State of residence was measured by self-report. MCL/RCL status came from state government websites. FINDINGS: Difference-in-difference analyses suggest that MCL was associated with an increase in cigarette-cannabis co-use overall [adjusted odds ratio (aOR) = 1.09; 95% confidence interval (CI) = 1.02-1.16], with the greatest increases among those aged 50 years and above (aOR = 1.60; CI = 1.39-1.84), married (aOR = 1.19; CI = 1.07-1.31), non-Hispanic (NH) black (aOR = 1.14; CI = 1.02-1.07) and with a college degree or above (aOR = 1.15; CI = 1.06-1.24). MCL was associated with increases in cigarette-only use among those aged 50 years and above (aOR = 1.07; CI = 1.01-1.14) and NH black (aOR = 1.16; CI = 1.06-1.27) and increases in cannabis-only use among those aged 50 years and above (aOR = 1.24; CI = 1.07-1.44) and widowed/divorced/separated (aOR = 1.18; CI = 1.01-1.37). RCL was associated with an increase in cannabis-only use overall (aOR = 1.21; 95% CI = 1.09-1.34), a decline in cigarette-only use overall (aOR = 0.89; 95% CI = 0.81-0.97) and increases in co-use among those who were married (aOR = 1.24; CI = 1.02-1.50) and aged 50 years and above (aOR = 1.37; CI = 1.03-1.84). CONCLUSIONS: Recreational and medical cannabis legalization have had a varying impact on the use, and co-use, of cannabis and cigarettes in the United States.

Implementing an interprofessional narrative medicine program in academic clinics: Feasibility and program evaluation.

Interprofessional education (IPE) is a critical component of medical education and is affected by the characteristics of the clinical teams in which students and residents train. However, clinical teams are often shaped by professional silos and hierarchies which may hinder interprofessional collaborative practice (IPCP). Narrative medicine, a branch of health humanities that focuses on close reading, reflective writing, and sharing in groups, could be an innovative approach for improving IPE and IPCP. In this report, we describe the structure, feasibility, and a process-oriented program evaluation of a narrative medicine program implemented in interprofessional team meetings in three academic primary care clinics. Program evaluation revealed that a year-long narrative medicine program with modest monthly exposure was feasible in academic clinical settings. Staff members expressed engagement and acceptability as well as support for ongoing implementation. Program success required administrative buy-in and sustainability may require staff training in narrative medicine.

Towards Design of Self-Organizing Biomimetic Systems.

The ability of designing biosynthetic systems with well-defined functional biomodules from scratch is an ambitious and revolutionary goal to deliver innovative, engineered solutions to future challenges in biotechnology and process systems engineering. In this work, several key challenges including modularization, functional biomodule identification, and assembly are discussed. In addition, an in silico protocell modeling approach is presented as a foundation for a computational model-based toolkit for rational analysis and modular design of biomimetic systems.

Modular assembling process of an in-silico protocell.

The bottom-up approach of synthetic biology is driven by the need for a deepened understanding of the interaction of functional modules in living or artificial systems. The hope is that the gained knowledge will help to optimize existing systems, or, as one long-term goal of synthetic biology, to build up artificial cell-like entities from single building blocks. This article focuses on a system theoretic approach to synthetic biology, and in particular on the construction of a protocell model by the modular assembling process. Different models for an in-silico protocell are described that combines experimentally validated biological subsystems with theoretical assumptions. The in-silico protocell that is characterized consists of three different functional modules: the membrane proliferating module, the membrane contraction module, and a positioning module. Additional theoretical hypotheses are tested in order to merge the module models to one protocell model with synchronously working parts. The different approaches used here for developing a protocell model could be helpful for assembling the different modules to one system in reality. Depending on the objective one wants to achieve a more or less detailed modeling approach is appropriate.

SAR and biological evaluation of novel trans-3,4-dimethyl-4-arylpiperidine derivatives as opioid antagonists.

The phenolic hydroxy group of opiate-derived ligands is of known importance for biological activity. We have developed a SAR study around LY255582 by comparing the effect of the hydroxy group in the 2- and 4-position of the phenyl ring. Also, we have proved that the 3-position of the phenyl ring is optimal for opioid activity. Furthermore, we have successfully replaced the hydroxy group in LY255582 by carbamate and carboxamide groups. The new analogs have high affinity for the opioid receptors comparable to the corresponding phenol. Carboxamide analog 12 has an improved metabolism profile and proved to be efficacious in in vivo studies.