A protocol for stakeholder engagement in deliver-EE: A pragmatic randomized comparative effectiveness trial evaluating effects of meal delivery on the ability of homebound older adults to remain in the community.

BACKGROUND: Few clinical trials include a detailed protocol for stakeholder engagement in the design and execution of the clinical trial. Deliver-EE is a pragmatic clinical trial to assess how different types of home-delivered meals can affect older adults' health and well-being. We present the protocol for stakeholder engagement in this national, multi-site trial and initial findings from our efforts. METHODS: Twenty-nine participants were recruited to two stakeholder advisory panels. The "Lived Experience Perspectives" panel is defined as the clients, caregivers, and meal delivery drivers with first-hand knowledge and lived experiences with meal delivery. The "System Perspectives" panel is defined as representatives from the larger financial, clinical, regulatory, and operational environments in which meal delivery to homebound older adults operate. Together, these two groups holistically represent interested parties that coordinate the interdependent elements of meal delivery to homebound older adults in order to: 1) inform our understanding of what matters most to older adults, their families, and the larger health and social care systems; 2) provide strategies to overcome challenges conducting the study; 3) enhance dissemination and uptake of study findings; and 4) identify opportunities for future research. RESULTS: Although stakeholder partners share a common goal of using home-delivered meals as a method to improve outcomes for homebound older adults, individuals have different goals for participating as advisors in this research. CONCLUSIONS: Understanding what individual stakeholders hope to gain from their participation is critical in designing an effective engagement protocol and critical for meaningful and rigorous stakeholder engagement in clinical trials.

A National Typology of Health Service Regulation in Assisted Living.

BACKGROUND AND OBJECTIVES: State-regulating agencies use 350 different licenses and certifications to govern assisted living (AL), resulting in significant variation in regulations governing health services, the scope of practice, and capacity. This lack of standardization makes it difficult to compare and contrast AL operations and residents' outcomes across similarly regulated communities. RESEARCH DESIGN AND METHODS: We used qualitative and quantitative methods to empirically develop and describe a typology of state AL regulations that captures inter- and intrastate variation. Based on the rules governing health services, we created regulatory specificity scores for 5 thematic dimensions: medication administration, third-party care, skilled nursing, medication review, and licensed nurse staffing. With these scores, we conducted a K-means cluster analysis to identify groups of AL license types. To differentiate the regulatory types, we calculated standardized mean differences across structure, process, outcome, and resident characteristics of the AL communities licensed under each type. RESULTS: We identified 6 types of AL differentiated by the regulatory provisions governing health services: Housing, Holistic, Hybrid, Hospitality, Healthcare, and Health Support. The types align with previous work and reflect tangible differences in resident characteristics, health service structures, processes, and outcomes. DISCUSSION AND IMPLICATIONS: This typology effectively captures differences across regulated dimensions and can inform and support quality of care. Researchers, policy-makers, and consumers may benefit from using this typology and acknowledging these differences in AL licensure when designing research studies, developing policies, and selecting an AL community.

Measuring the effects of a personalized music intervention on agitated behaviors among nursing home residents with dementia: design features for cluster-randomized adaptive trial.

BACKGROUND: Agitated and aggressive behaviors (behaviors) are common in nursing home (NH) residents with dementia. Medications commonly used to manage behaviors have dangerous side effects. NHs are adopting non-pharmacological interventions to manage behaviors, despite a lack of effectiveness evidence and an understanding of optimal implementation strategies. We are conducting an adaptive trial to evaluate the effects of personalized music on behaviors. Adaptive trials may increase efficiency and reduce costs associated with traditional RCTs by learning and making modifications to the trial while it is ongoing. METHODS: We are conducting two consecutive parallel cluster-randomized trials with 54 NHs in each trial (27 treatment, 27 control). Participating NHs were recruited from 4 corporations which differ in size, ownership structure, geography, and residents' racial composition. After randomization, there were no significant differences between the NHs randomized to each trial with respect to baseline behaviors, number of eligible residents, degree of cognitive impairment, or antipsychotic use. Agitated behavior frequency is assessed via staff interviews (primary outcome), required nursing staff conducted resident assessments (secondary outcome), and direct observations of residents (secondary outcome). Between the two parallel trials, the adaptive design will be used to test alternative implementation strategies, increasingly enroll residents who are likely to benefit from the intervention, and seamlessly conduct a stage III/IV trial. DISCUSSION: This adaptive trial allows investigators to estimate the impact of a popular non-pharmaceutical intervention (personalized music) on residents' behaviors, under pragmatic, real-world conditions testing two implementation strategies. This design has the potential to reduce the research timeline by improving the likelihood of powered results, increasingly enrolling residents most likely to benefit from intervention, sequentially assessing the effectiveness of implementation strategies in the same trial, and creating a statistical model to reduce the future need for onsite data collection. The design may also increase research equity by enrolling and tailoring the intervention to populations otherwise excluded from research. Our design will inform pragmatic testing of other interventions with limited efficacy evidence but widespread stakeholder adoption because of the real-world need for non-pharmaceutical approaches. {2A} TRIAL REGISTRATION: ClinicalTrials.gov NCT03821844 . Registered on January 30, 2019. This trial registration meets the World Health Organization (WHO) minimum standard.

Measuring Effects of Nondrug Interventions on Behaviors: Music & Memory Pilot Study.

BACKGROUND/OBJECTIVES: Most people with Alzheimer disease and related dementias will experience agitated and/or aggressive behaviors during the later stages of the disease. These behaviors cause significant stress for people living with dementia and their caregivers, including nursing home (NH) staff. Addressing these behaviors without the use of chemical restraints is a growing focus of policy makers and professional organizations. Unfortunately, evidence for nonpharmacological strategies for addressing dementia-related behaviors is lacking. DESIGN: Six-month, preintervention-postintervention pilot study. SETTING: US NHs (n = 4). PARTICIPANTS: Residents with advanced dementia (n = 45). INTERVENTION: Music & Memory, an individualized music program in which the music a resident preferred when she/he was young is delivered at early signs of agitation, using a personal music player. MEASUREMENTS: Dementia-related behaviors for the same residents were measured three ways: (1) observationally using the Agitation Behavior Mapping Instrument (ABMI); (2) staff report using the Cohen-Mansfield Agitation Inventory (CMAI); and (3) administratively using the Minimum Data Set-Aggressive Behavior Scale (MDS-ABS). RESULTS: ABMI score was 4.1 (SD = 3.0) preintervention while not listening to the music, 4.4 (SD = 2.3) postintervention while not listening to the music, and 1.6 (SD = 1.5) postintervention while listening to music (P < .01). CMAI score was 61.2 (SD = 16.3) preintervention and 51.2 (SD = 16.1) postintervention (P < .01). MDS-ABS score was 0.8 (SD = 1.6) preintervention and 0.7 (SD = 1.4) postintervention (P = .59). CONCLUSION: Direct observations were most likely to capture behavioral responses, followed by staff interviews. Nursing-home based, pragmatic trials that rely solely on available administrative data may fail to detect effects of nonpharmaceutical interventions on behaviors. Findings are relevant to evaluations of nonpharmaceutical strategies for addressing behaviors in NHs, and will inform a large, National Institute on Aging-funded pragmatic trial beginning spring 2019. J Am Geriatr Soc 67:2134-2138, 2019.

Individualized Music Program is Associated with Improved Outcomes for U.S. Nursing Home Residents with Dementia.

OBJECTIVES: The objective of this study was to compare resident outcomes before and after implementation of an individualized music program, MUSIC & MEMORY (M&M), designed to address the behavioral and psychological symptoms associated with dementia (BPSD). SETTING: 98 nursing homes trained in the M&M program during 2013 and 98 matched-pair comparisons. PARTICIPANTS: Long-stay residents with Alzheimer's disease and related dementias (ADRD) residing in M&M participating facilities (N = 12,905) and comparison facilities (N = 12,811) during 2012-2013. INTERVENTION: M&M is a facility-level quality improvement program that provides residents with music specific to their personal histories and preferences. MEASUREMENTS: Discontinuation of anxiolytic and antipsychotic medications, and reductions in behavioral problems and depressed mood in 2012 (pre-intervention) and 2013 (intervention), calculated using Minimum Data Set (MDS) assessments. RESULTS: The proportion of residents who discontinued antipsychotic medication use over a 6-month period increased from 17.6% to 20.1% among M&M facilities, while remaining stable among comparison facilities (15.9% to 15.2%). The same trend was observed for anxiolytic medications: Discontinuation of anxiolytics increased in M&M facilities (23.5% to 24.4%), while decreasing among comparison facilities (24.8% to 20.0%). M&M facilities also demonstrated increased rates of reduction in behavioral problems (50.9% to 56.5%) versus comparison facilities (55.8% to 55.9%). No differences were observed for depressed mood. CONCLUSIONS: These results offer the first evidence that the M&M individualized music program is associated with reductions in antipsychotic medication use, anxiolytic medication use, and BPSD symptoms among long-stay nursing home residents with ADRD.