Identifying strategies that promote staff and resident influenza and COVID-19 vaccination in nursing homes: Perspectives from nursing home staff.

Resident and staff influenza and COVID-19 vaccination are critical components of infection prevention in nursing homes. Our study sought to characterize strategies that nursing home staff use to promote vaccination. Twenty-six telephone/videoconference interviews were conducted with administrators, directors of nursing, infection preventionists, and Minimum Data Set coordinators at 14 nursing homes across the US. Transcripts were analyzed using content analysis and a detailed audit trail was maintained. Staff described resident and staff influenza and COVID-19 vaccine hesitancy and confidence as well as varying approaches to promote vaccination. These included incentives, education efforts, and having a "vaccine champion" responsible for vaccine promotion. While many strategies had been in place prior to COVID-19 in support of improving influenza vaccination, participants reported implementing additional approaches to promote COVID-19 vaccination. Findings may inform future efforts to promote vaccination, which will be critical to mitigate the burden of influenza and COVID-19 in nursing homes.

Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach.

BACKGROUND: In pragmatic trials, on-site partners, rather than researchers, lead intervention delivery, which may result in implementation variation. There is a need to quantitatively measure this variation. Applying the Framework for Implementation Fidelity (FIF), we develop an approach for measuring variability in site-level implementation fidelity. This approach is then applied to measure site-level fidelity in a cluster-randomized pragmatic trial of Music & MemorySM (M&M), a personalized music intervention targeting agitated behaviors in residents living with dementia, in US nursing homes (NHs). METHODS: Intervention NHs (N = 27) implemented M&M using a standardized manual, utilizing provided staff trainings and iPods for participating residents. Quantitative implementation data, including iPod metadata (i.e., song title, duration, number of plays), were collected during baseline, 4-month, and 8-month site visits. Three researchers developed four FIF adherence dimension scores. For Details of Content, we independently reviewed the implementation manual and reached consensus on six core M&M components. Coverage was the total number of residents exposed to the music at each NH. Frequency was the percent of participating residents in each NH exposed to M&M at least weekly. Duration was the median minutes of music received per resident day exposed. Data elements were scaled and summed to generate dimension-level NH scores, which were then summed to create a Composite adherence score. NHs were grouped by tercile (low-, medium-, high-fidelity). RESULTS: The 27 NHs differed in size, resident composition, and publicly reported quality rating. The Composite score demonstrated significant variation across NHs, ranging from 4.0 to 12.0 [8.0, standard deviation (SD) 2.1]. Scaled dimension scores were significantly correlated with the Composite score. However, dimension scores were not highly correlated with each other; for example, the correlation of the Details of Content score with Coverage was τb = 0.11 (p = 0.59) and with Duration was τb = - 0.05 (p = 0.78). The Composite score correlated with CMS quality star rating and presence of an Alzheimer's unit, suggesting face validity. CONCLUSIONS: Guided by the FIF, we developed and used an approach to quantitatively measure overall site-level fidelity in a multi-site pragmatic trial. Future pragmatic trials, particularly in the long-term care environment, may benefit from this approach. TRIAL REGISTRATION: Clinicaltrials.gov NCT03821844. Registered on 30 January 2019, https://clinicaltrials.gov/ct2/show/NCT03821844 .

Pragmatic Trial of Personalized Music for Agitation and Antipsychotic Use in Nursing Home Residents With Dementia.

OBJECTIVE: To test the effect of a personalized music intervention on agitated behaviors and medication use among long-stay nursing home residents with dementia. DESIGN: Pragmatic, cluster-randomized controlled trial of a personalized music intervention. Staff in intervention facilities identified residents' early music preferences and offered music at early signs of agitation or when disruptive behaviors typically occur. Usual care in control facilities may include ambient or group music. SETTING AND PARTICIPANTS: The study was conducted between June 2019 and February 2020 at 54 nursing homes (27 intervention and 27 control) in 10 states owned by 4 corporations. METHODS: Four-month outcomes were measured for each resident. The primary outcome was frequency of agitated behaviors using the Cohen-Mansfield Agitation Inventory. Secondary outcomes included frequency of agitated behaviors reported in the Minimum Data Set and the proportion of residents using antipsychotic, antidepressant, or antianxiety medications. RESULTS: The study included 976 residents with dementia [483 treatment and 493 control; mean age = 80.3 years (SD 12.3), 69% female, 25% African American]. CMAI scores were not significantly different (treatment: 50.67, SE 1.94; control: 49.34, SE 1.68) [average marginal effect (AME) 1.33, SE 1.38, 95% CI -1.37 to 4.03]. Minimum Data Set-based behavior scores were also not significantly different (treatment: 0.35, SE 0.13; control: 0.46, SE 0.11) (AME -0.11, SE 0.10, 95% CI -0.30 to 0.08). Fewer residents in intervention facilities used antipsychotics in the past week compared with controls (treatment: 26.2, SE 1.4; control: 29.6, SE 1.3) (AME -3.61, SE 1.85, 95% CI -7.22 to 0.00), but neither this nor other measures of psychotropic drug use were statistically significant. CONCLUSIONS AND IMPLICATIONS: Personalized music was not significantly effective in reducing agitated behaviors or psychotropic drug use among long-stay residents with dementia. Barriers to full implementation included engaging frontline nursing staff and identifying resident's preferred music.

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.

Nursing home leaders' perceptions of a research partnership.

BACKGROUND/OBJECTIVE: Partnerships between healthcare providers and researchers may accelerate the translation of interventions into widespread practice by testing them under real-world conditions, but depend on provider's willingness to engage with researchers and ability to fully implement an intervention. AIM: To understand nursing home leader's motivations for participating in a research study and perceptions of the process and value. METHODS: After a feasibility study of tuned lighting in a nursing home, we conducted semi-structured telephone interviews with six facility leaders. Interviews were audio-recorded, transcribed, and independently coded by four investigators. RESULTS: Three themes emerged: (1) The importance of the nursing home's culture and context: the facility had stable leadership, clear processes for prioritizing and implementing new initiatives, and an established interest in the study's topic. (2) The importance of leader's belief in the value of the intervention: leaders perceived research generally and the intervention specifically as positively impacting their facility and residents. (3) The importance of ongoing collaboration and flexibility throughout the study period: leaders served as champions to catalyze the project and overcome implementation barriers. CONCLUSION: Nursing home leader's perspectives about their participation in a feasibility study underscore the importance of establishing strong researcher-provider partnerships, understanding the environment in which the intervention will be implemented, and employing pragmatic methods that allow for flexibility in response to real-world implementation barriers. We recommend eliciting qualitative information to understand the environment in which an intervention will be implemented and to engage opinion leaders who can inform the protocol and champion its success.

Cognitive behavioral treatment for suicidal alcohol abusing adolescents: development and pilot testing.

The purpose of this study was to pilot a cognitive behavioral treatment protocol for adolescents with co-occurring alcohol use disorder and suicidality, examine its association with symptomatic improvement, and determine its feasibility and acceptability. Treatment consisted of a 6 month acute treatment phase, 3 month maintenance phase, and a 3 month booster phase, as well as case management services. Participants were also permitted to receive concurrent pharmacotherapy. Five of six families completed the protocol. Measures of alcohol use and suicidality were collected at intake, end of acute treatment, and post-treatment. Decreases in alcohol use and suicidal ideation were reported for all participants. Two of the five participants, both with a prior history of suicide attempts, re-attempted during the course of the protocol. Both were maintained in the study and improved over the subsequent portion of the treatment. A high retention rate, strong therapeutic alliance ratings, and low perceived treatment obstacles provide support for the feasibility and acceptability of this intervention. Preliminary results suggest that integrated outpatient cognitive behavioral treatment for alcohol abusing suicidal adolescents is feasible, acceptable, and associated with symptomatic improvement.