Modifications of the readiness assessment for pragmatic trials tool for appropriate use with Indigenous populations.

BACKGROUND: Inequities in health access and outcomes exist between Indigenous and non-Indigenous populations. Embedded pragmatic randomized, controlled trials (ePCTs) can test the real-world effectiveness of health care interventions. Assessing readiness for ePCT, with tools such as the Readiness Assessment for Pragmatic Trials (RAPT) model, is an important component. Although equity must be explicitly incorporated in the design, testing, and widespread implementation of any health care intervention to achieve equity, RAPT does not explicitly consider equity. This study aimed to identify adaptions necessary for the application of the 'Readiness Assessment for Pragmatic Trials' (RAPT) tool in embedded pragmatic randomized, controlled trials (ePCTs) with Indigenous communities. METHODS: We surveyed and interviewed participants (researchers with experience in research involving Indigenous communities) over three phases (July-December 2022) in this mixed-methods study to explore the appropriateness and recommended adaptions of current RAPT domains and to identify new domains that would be appropriate to include. We thematically analyzed responses and used an iterative process to modify RAPT. RESULTS: The 21 participants identified that RAPT needed to be modified to strengthen readiness assessment in Indigenous research. In addition, five new domains were proposed to support Indigenous communities' power within the research processes: Indigenous Data Sovereignty; Acceptability - Indigenous Communities; Risk of Research; Research Team Experience; Established Partnership). We propose a modified tool, RAPT-Indigenous (RAPT-I) for use in research with Indigenous communities to increase the robustness and cultural appropriateness of readiness assessment for ePCT. In addition to producing a tool for use, it outlines a methodological approach to adopting research tools for use in and with Indigenous communities by drawing on the experience of researchers who are part of, and/or working with, Indigenous communities to undertake interventional research, as well as those with expertise in health equity, implementation science, and public health. CONCLUSION: RAPT-I has the potential to provide a useful framework for readiness assessment prior to ePCT in Indigenous communities. RAPT-I also has potential use by bodies charged with critically reviewing proposed pragmatic research including funding and ethics review boards.

Evaluating the Implementation Fidelity of a Pilot Pragmatic Randomized Clinical Trial Comparing Daily-Delivered Meals to Mailed Frozen Meals.

In pragmatic clinical trials (PCTs), the intervention is carried out by participating sites instead of research staff. In this paper, we evaluate study sites' implementation adherence during a pilot PCT of home-delivered meals for older adults with dementia. Participants at three home-delivered meal programs were randomized to receive either (1) meals delivered daily or (2) frozen meals mailed every two weeks; participants' outcomes were tracked for six months. Using the adherence domains from the Framework for Implementation Fidelity, we identified six metrics to assess adherence, with a total possible adherence score ranging from 6 (low adherence) to 18 (high adherence); all three sites scored within the top quartile of adherence. Despite challenges to meal delivery during the COVID-19 pandemic, sites successfully implemented the intervention, justifying a follow-on PCT to test the comparative effectiveness of models of meal delivery on the time to nursing home placement for people living with dementia.

What We Know About Homeless Veterans With Other-than-honorable and Punitive Discharges: Data From the Grant and Per Diem (GPD) Program.

INTRODUCTION: The U.S. DVA Grant and Per Diem (GPD) program funds community agencies to provide housing and case management services to Veterans experiencing homelessness. GPD is one of the few VA programs that can enroll Veterans with Other-than-Honorable (OTH) military discharges. The characteristics of OTH Veterans and their outcomes in GPD are unknown. MATERIALS AND METHODS: We linked the Homeless Operations and Management Evaluation System database and VA Corporate Data Warehouse to identify Veterans with complete GPD enrollment and discharge data between 2018 and 2020. We categorized Veterans into three military discharge groups: Honorable, OTH, or Punitive. We evaluated key GPD process and outcomes measures: days enrolled in GPD, use of VA-funded emergency department care while in GPD, and whether a Veteran was successfully discharged from GPD, their housing status at program exit, employment status at program exit, and connection to mental health and substance abuse treatment at discharge. We conducted multivariable regressions to determine the adjusted association (controlling for demographics and comorbidities) between military discharge status and process and outcome measures. RESULTS: Among 21,646 Veterans in the GPD program, 20,517 (95%) were honorably discharged; 811 (4%) had an OTH discharge; and 318 (1%) had a Punitive discharge. There was no difference in GPD length of enrollment by discharge status. Compared to honorably discharged veterans, OTH and Punitive discharged Veterans were less likely to successfully exit GPD, more likely to be homeless and employed at program exit, and were less likely to have a VA-funded emergency department visit while in GPD and less likely to be connected to mental health care or substance use treatment at program exit. CONCLUSIONS: The GPD program serves hundreds of homeless Veterans with OTH and Punitive discharges every year, but they seem to be at greater risk for negative health and psychosocial outcomes and do not have the same access to VA services as other Veterans. These findings may inform policy considerations about expanding VA care and opportunities for community providers to serve Veterans with OTH and Punitive discharges.

Bereaved Respondent Perceptions of Quality of Care by Inpatient Palliative Care Utilization in the Last Month of Life.

BACKGROUND: Under traditional Medicare, accountability measures are specific to each healthcare setting. With the growth of alternative payment models such as Medicare Advantage, the focus of accountability measures can be on the longitudinal episode of care. OBJECTIVE: Using the last month of life as the episode of care, examine bereaved family member perceptions of the quality of care by site of death and inpatient palliative/hospice care. DESIGN: Retrospective cohort study using the National Health Aging Trends Study waves 3-11. SUBJECTS: US decedents age 65 and older with family member or close friend survey response. MAIN MEASURES: Overall rating of the quality of care, perceptions of symptom management, being treated with respect, emotional/spiritual support, communication, and receipt of care that the decedent did not want. KEY RESULTS: Among 2796 interviews (weighted N = 12.6 million), 25.7% died at home with hospice, 10.9% at home without hospice, 10.0% in the ICU, 6.4% at a palliative care unit (PCU), 6.4% at a hospice IPU, 9.1% at hospital without inpatient palliative care, 13.2% at a nursing home without hospice, 9.8% in a nursing home with hospice, 4.1% at a hospice residence, and 4.4% at other locations without hospice. Dying at home with hospice received the highest rating of quality of care (60.2% stated excellent care) while the adjusted marginal differences in sites of death with inpatient palliative care services were rated lower: hospice residence 25.6% points lower (95% CI (-13.7%, -37.5%)) and a freestanding IPU was 16.9% points lower (95% CI (- 4.9%, -29.0%)). CONCLUSION: Examining the episode of care as the last month of life, hospice at home is associated with higher rating of the quality of care while inpatient palliative care services in hospital, hospice residence, or hospice IPU settings are rated lower.

Agreement of Antipsychotic Use between Nursing Home Electronic Records and Minimum Data Set.

OBJECTIVES: Nursing home (NH) Minimum Data Set (MDS) have frequently been used to measure medication use in epidemiologic studies, but there is little evidence on the accuracy of MDS-based medication records. We compared antipsychotic use estimated using 2 data sources-MDS and NH electronic medication administration records (eMAR). DESIGN: Cross-sectional comparison. SETTING AND PARTICIPANTS: This analysis was based on MDS and linked eMAR data of 604 NH residents with dementia at 54 NHs in 10 states, participating in a cluster-randomized pragmatic trial (METRIcAL), from June 2019 to February 2020. METHODS: One admission, quarterly, or annual MDS assessment was chosen for each participant. The MDS assessment recorded the number of antipsychotic treatment days during a 7-day window. We then identified antipsychotic administrations during the corresponding window in the eMAR. We used Cohen kappa to assess agreement in the proportion of participants on antipsychotics during the week and used intraclass correlation coefficient (ICC) to assess the agreement of treatment days. We further used the eMAR data as a reference to calculate validity parameters. RESULTS: A total of 29.5% of study participants were identified as antipsychotic users based on the MDS vs 28.3% based on the eMAR data (kappa value: 0.96). MDS-based average treatment duration was estimated to be 2.0, consistent with eMAR-based estimate (1.8 days, ICC: 0.96). The sensitivity was 98.8% (95% CI 95.8%-99.9%), the specificity was 97.9% (95% CI 96.1%-99.1%), the positive predictive value was 94.9% (95% CI 90.8%-97.3%), and the negative predictive value was 99.5% (95% CI 98.2%-99.9%). CONCLUSIONS AND IMPLICATIONS: Agreement between the MDS and eMAR in antipsychotic use is high, suggesting that the MDS is a valid tool to measure antipsychotic use in epidemiologic studies. Further studies with large and diverse populations are warranted to confirm our findings.

Using Structured Observations to Evaluate the Effects of a Personalized Music Intervention on Agitated Behaviors and Mood in Nursing Home Residents With Dementia: Results From an Embedded, Pragmatic Randomized Controlled Trial.

OBJECTIVE: The objective of this research was to determine if a personalized music intervention reduced the frequency of agitated behaviors as measured by structured observations of nursing home (NH) residents with dementia. DESIGN: The design was a parallel, cluster-randomized, controlled trial. SETTING: The setting was 54 NH (27 intervention, 27 control) from four geographically-diverse, multifacility NH corporations. PARTICIPANTS: The participants were 976 NH residents (483 intervention, 493 control) with Alzheimer's disease or related dementias (66% with moderate to severe symptoms); average age 80.3 years (SD: 12.3) and 25.1% were Black. INTERVENTION: The intervention was individuals' preferred music delivered via a personalized music device. MEASUREMENT: The measurement tool was the Agitated Behavior Mapping Instrument, which captures the frequency of 13 agitated behaviors and five mood states during 3-minute observations. RESULTS: The results show that no verbally agitated behaviors were reported in a higher proportion of observations among residents in NHs randomized to receive the intervention compared to similar residents in NHs randomized to usual care (marginal interaction effect (MIE): 0.061, 95% CI: 0.028-0.061). Residents in NHs randomized to receive the intervention were also more likely to be observed experiencing pleasure compared to residents in usual care NHs (MIE: 0.038; 95% CI: 0.008-0.073)). There was no significant effect of the intervention on physically agitated behaviors, anger, fear, alertness, or sadness. CONCLUSIONS: The conclusions are that personalized music may be effective at reducing verbally-agitated behaviors. Using structured observations to measure behaviors may avoid biases of staff-reported measures.

Pragmatic Implementation of a Music Intervention in Nursing Homes Before and During COVID-19.

OBJECTIVES: We conducted 2 trials of a music intervention for managing behaviors in nursing home (NH) residents with dementia, before (2019) and during (2021) the pandemic. In this report, we compare adherence fidelity across the trials using the Framework for Implementation Fidelity (FIF). DESIGN: Cross-sectional, descriptive implementation comparison. SETTING AND PARTICIPANTS: Fifty-four NHs randomized to receive the intervention (27 pre-COVID, 27 during COVID) METHODS: We compare the trials on the following FIF criteria: coverage (number of residents receiving the intervention); duration (minutes of music received per exposed day); frequency (percentage of residents with nursing staff use of music in the past week); and details of content (adherence to core components of the intervention). We report NH-level performance in each domain and compare characteristics of NHs in the bottom (low) and top (high) terciles of adherence. RESULTS: Across FIF domains, adherence fidelity was lower during COVID compared with pre-COVID: coverage, residents exposed (COVID: 7.5, SD 5.6; pre-COVID: 12.7, SD 3.6); duration, music minutes per exposed day (COVID: 2.5, SD 5.1; pre-COVID: 27.1, SD 23.9); frequency, percentage of residents with nursing use of intervention in the past week (COVID: 15.0, SD 31.5; pre-COVID 40.4, SD 25.6); and details of content, compliance with core components of the intervention (COVID: 8.3, SD 1.9; pre-COVID 9.6, SD 2.0). In both trials, high-adherence fidelity NHs had better nursing staff ratios, greater percentages of Medicare residents, and lower percentages of Black residents, compared with low-fidelity NHs. CONCLUSIONS AND IMPLICATIONS: Adherence fidelity was worse in the COVID vs pre-COVID trial, despite adaptations between trials intended to reduce staff burden and increase clinical targeting of the intervention. Results may point to the long-term effects of COVID on quality improvement capacity in NHs and/or a lack of available resources in most NHs to implement complex behavioral interventions without direct research support.

Home-Delivered Meals and Nursing Home Placement Among People With Self-Reported Dementia: A Pilot Pragmatic Clinical Trial.

Importance: Home-delivered meals promote food security and independence among homebound older adults. However, it is unclear which of the 2 predominant modes of meal delivery, daily-delivered vs mailed (or drop-shipped) frozen meals, promotes community living for homebound older adults with dementia. Objective: To assess the risk of nursing home admission within 6 months between homebound individuals receiving daily-delivered vs drop-shipped frozen meals. Design, Setting, and Participants: This pilot, multisite, 2-arm, pragmatic clinical trial included older adults with self-reported dementia on waiting lists for meals at 3 Meals on Wheels (MOW) programs in Texas and Florida between April 7 and October 8, 2021, to assess time to nursing home placement. Interventions: Participants were randomized to receive either meals delivered by an MOW driver or frozen meals that were mailed to participants' homes every 2 weeks. Participants received their assigned intervention for up to 6 months. Main Outcomes and Measures: The primary study outcome was days from randomization to a Minimum Data Set nursing home admission assessment within 6 months. Feasibility of conducting this type of study was examined by tracking enrollment, examining baseline characteristics, monitoring participants' intervention fidelity, measuring the proportion of participants linked with Centers for Medicare & Medicaid Services (CMS) data, and analyzing the primary study outcome. Results: Among 325 eligible participants who were randomized, 243 enrolled in the study (mean [SD] age, 81 [8.0] years; 152 (62.6%) were female): 128 to the daily-delivered meals group and 115 to the drop-shipped frozen meals group; 119 participants (49.0%) lived alone. Among the total participants enrolled, 227 (93.4%) were linked deterministically to their CMS data; probabilistic methods were used to link the remaining 16 participants (6.6%). At 6 months from randomization, 160 participants (65.8%) were still receiving meals, and 25 (10.1%; 95% CI, 6.3%-14.0%) were admitted to a nursing home. After adjusting for sex, race and ethnicity, age, program, and living arrangement and the use of death as a censoring event, the adjusted log hazard ratio of nursing home placement between daily-delivered and drop-shipped frozen meals was -0.67 (95% CI, -1.52 to 0.19). Conclusions and Relevance: This pilot randomized clinical trial demonstrated the feasibility of enrolling participants with self-reported dementia on waiting lists at MOW programs, linking their data, and evaluating outcomes. While this pilot study was not powered to detect meaningful, statistically significant differences in nursing home placement, its feasibility and initial results warrant exploration in a follow-on, adequately powered trial. Trial Registration: ClinicalTrials.gov Identifier: NCT04850781.

Assessing the representativeness of cluster randomized trials: Evidence from two large pragmatic trials in United States nursing homes.

BACKGROUND/AIMS: When the randomized clusters in a cluster randomized trial are selected based on characteristics that influence treatment effectiveness, results from the trial may not be directly applicable to the target population. We used data from two large nursing home-based pragmatic cluster randomized trials to compare nursing home and resident characteristics in randomized facilities to eligible non-randomized and ineligible facilities. METHODS: We linked data from the high-dose influenza vaccine trial and the Music & Memory Pragmatic TRIal for Nursing Home Residents with ALzheimer's Disease (METRICaL) to nursing home assessments and Medicare fee-for-service claims. The target population for the high-dose trial comprised Medicare-certified nursing homes; the target population for the METRICaL trial comprised nursing homes in one of four US-based nursing home chains. We used standardized mean differences to compare facility and individual characteristics across the three groups and logistic regression to model the probability of nursing home trial participation. RESULTS: In the high-dose trial, 4476 (29%) of the 15,502 nursing homes in the target population were eligible for the trial, of which 818 (18%) were randomized. Of the 1,361,122 residents, 91,179 (6.7%) were residents of randomized facilities, 463,703 (34.0%) of eligible non-randomized facilities, and 806,205 (59.3%) of ineligible facilities. In the METRICaL trial, 160 (59%) of the 270 nursing homes in the target population were eligible for the trial, of which 80 (50%) were randomized. Of the 20,262 residents, 973 (34.4%) were residents of randomized facilities, 7431 (36.7%) of eligible non-randomized facilities, and 5858 (28.9%) of ineligible facilities. In the high-dose trial, randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (132.5 vs 145.9 and 91.9, respectively), for-profit status (91.8% vs 66.8% and 68.8%), belonging to a nursing home chain (85.8% vs 49.9% and 54.7%), and presence of a special care unit (19.8% vs 25.9% and 14.4%). In the METRICaL trial randomized facilities differed from eligible non-randomized and ineligible facilities by the number of beds (103.7 vs 110.5 and 67.0), resource-poor status (4.6% vs 10.0% and 18.8%), and presence of a special care unit (26.3% vs 33.8% and 10.9%). In both trials, the characteristics of residents in randomized facilities were similar across the three groups. CONCLUSION: In both trials, facility-level characteristics of randomized nursing homes differed considerably from those of eligible non-randomized and ineligible facilities, while there was little difference in resident-level characteristics across the three groups. Investigators should assess the characteristics of clusters that participate in cluster randomized trials, not just the individuals within the clusters, when examining the applicability of trial results beyond participating clusters.

Design Considerations for Embedded Pragmatic Clinical Trials of Advance Care Planning Interventions for Persons Living With Dementia.

Advance care planning (ACP) is an important part of comprehensive care for persons living with dementia (PLWD). While many trials have established the efficacy of ACP in improving end-of-life communication and documentation of care preferences, there remains a gap in clinical usage. Embedded pragmatic clinical trials (ePCTs) may facilitate the uptake of evidence-based care into existing healthcare by deploying efficacious ACP interventions into real-world settings. However rigorous conduct of ePCTs of ACP for PLWD presents several unique methodological considerations. Here we describe a framework for the construction of these research studies, with a focus on distinguishing between the target of study: the PLWD, their care partners, or both. We outline specific considerations at each step of the research study process including 1) participant identification/eligibility, 2) participant recruitment/enrollment, 3) intervention implementation, and 4) outcome selection/ascertainment. These considerations are weighed in further detail by describing the approaches from three published trials. Specifically, we consider how potential challenges were overcome by tradeoffs in study design. Finally, we offer directions for future growth to advance ePCTs for ACP among PLWD and catalyze future research.

Behavioral symptoms, depression symptoms, and medication use in Michigan nursing home residents with dementia during COVID-19.

BACKGROUND: The COVID-19 pandemic significantly disrupted nursing home (NH) care, including visitation restrictions, reduced staffing levels, and changes in routine care. These challenges may have led to increased behavioral symptoms, depression symptoms, and central nervous system (CNS)-active medication use among long-stay NH residents with dementia. METHODS: We conducted a retrospective, cross-sectional study including Michigan long-stay (≥100 days) NH residents aged ≥65 with dementia based on Minimum Data Set (MDS) assessments from January 1, 2018 to June 30, 2021. Residents with schizophrenia, Tourette syndrome, or Huntington's disease were excluded. Outcomes were the monthly prevalence of behavioral symptoms (i.e., Agitated Reactive Behavior Scale ≥ 1), depression symptoms (i.e., Patient Health Questionnaire [PHQ]-9 ≥ 10, reflecting at least moderate depression), and CNS-active medication use (e.g., antipsychotics). Demographic, clinical, and facility characteristics were included. Using an interrupted time series design, we compared outcomes over two periods: Period 1: January 1, 2018-February 28, 2020 (pre-COVID-19) and Period 2: March 1, 2020-June 30, 2021 (during COVID-19). RESULTS: We included 37,427 Michigan long-stay NH residents with dementia. The majority were female, 80 years or older, White, and resided in a for-profit NH facility. The percent of NH residents with moderate depression symptoms increased during COVID-19 compared to pre-COVID-19 (4.0% vs 2.9%, slope change [SC] = 0.03, p < 0.05). Antidepressant, antianxiety, antipsychotic and opioid use increased during COVID-19 compared to pre-COVID-19 (SC = 0.41, p < 0.001, SC = 0.17, p < 0.001, SC = 0.07, p < 0.05, and SC = 0.24, p < 0.001, respectively). No significant changes in hypnotic use or behavioral symptoms were observed. CONCLUSIONS: Michigan long-stay NH residents with dementia had a higher prevalence of depression symptoms and CNS active-medication use during the COVID-19 pandemic than before. During periods of increased isolation, facility-level policies to regularly assess depression symptoms and appropriate CNS-active medication use are warranted.

Home-delivered meals for people with dementia: Which model delays nursing home placement? - Protocol for a feasibility pilot.

BACKGROUND: Home-delivered meals promote food security, socialization, and independence among homebound older adults. However, it is unclear which of the two predominant modes of meal delivery, daily-delivered vs. drop-shipped, frozen meals, promotes community living for homebound older adults with dementia. Our objective is to present the protocol for a pilot multisite, two-arm, pragmatic feasibility trial comparing the effect of two modes of meal delivery on nursing home placement among people with dementia. We include justifications for individual randomization with different consent processes and waivers for specific elements of the trial. METHODS: 236 individuals with dementia on waiting lists at three Meals on Wheels programs' in Florida and Texas will be randomized to receive either: 1) meals delivered multiple times per week by a Meals on Wheels volunteer or paid driver who may socialize with and provide an informal wellness check or 2) frozen meals that are mailed to participants' homes every two weeks. We will evaluate and refine processes for recruitment and randomization; assess adherence to the intervention; identify common themes in participant experience; and test processes for linking participant data with Medicare records and nursing home assessment data. We will conduct exploratory analyses examining time to nursing home placement, the primary outcome for the larger trial. CONCLUSION: This pilot will inform the follow-on large-scale, definitive pragmatic trial. In addition, the justifications for individual randomization with differing consent procedures for elements of a pragmatic trial provide a model for future trialists looking to develop ethical and feasible pragmatic studies enrolling people with dementia.

Effect of advance care planning video on do-not-hospitalize orders for nursing home residents with advanced illness.

BACKGROUND: The purpose of the study is to evaluate the effect of an Advance Care Planning (ACP) Video Program on documented Do-Not-Hospitalize (DNH) orders among nursing home (NH) residents with advanced illness. METHODS: Secondary analysis on a subset of NHs enrolled in a cluster-randomized controlled trial (41 NHs in treatment arm implemented the ACP Video Program: 69 NHs in control arm employed usual ACP practices). Participants included long (> 100 days) and short (≤ 100 days) stay residents with advanced illness (advanced dementia or cardiopulmonary disease (chronic obstructive pulmonary disease or congestive heart failure)) in NHs from March 1, 2016 to May 31, 2018 without a documented Do-Not-Hospitalize (DNH) order at baseline. Logistic regression with covariate adjustments was used to estimate the impact of the resident being in a treatment versus control NH on: the proportion of residents with new DNH orders during follow-up; and the proportion of residents with any hospitalization during follow-up. Clustering at the facility-level was addressed using hierarchical models. RESULTS: The cohort included 6,117 residents with advanced illness (mean age (SD) = 82.8 (8.4) years, 65% female). Among long-stay residents (n = 3,902), 9.3% (SE, 2.2; 95% CI 5.0-13.6) and 4.2% (SE, 1.1; 95% CI 2.1-6.3) acquired a new DNH order in the treatment and control arms, respectively (average marginal effect, (AME) 5.0; SE, 2.4; 95% CI, 0.3-9.8). Among short-stay residents with advanced illness (n = 2,215), 8.0% (SE, 1.6; 95% CI 4.6-11.3) and 3.5% (SE 1.0; 95% CI 1.5-5.5) acquired a new DNH order in the treatment and control arms, respectively (AME 4.4; SE, 2.0; 95% CI, 0.5-8.3). Proportion of residents with any hospitalizations did not differ between arms in either cohort. CONCLUSIONS: Compared to usual care, an ACP Video Program intervention increased documented DNH orders among NH residents with advanced disease but did not significantly reduce hospitalizations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688 .

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 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 .

Effect of a Video-Assisted Advance Care Planning Intervention on End-of-Life Health Care Transitions Among Long-Stay Nursing Home Residents.

OBJECTIVE: To determine the relationship between an advance care planning (ACP) video intervention, Pragmatic Trial of Video Education in Nursing Homes (PROVEN), and end-of-life health care transitions among long-stay nursing home residents with advanced illness. DESIGN: Pragmatic cluster randomized clinical trial. Five ACP videos were available on tablets or online at intervention facilities. PROVEN champions employed by nursing homes (usually social workers) were directed to offer residents (or their proxies) ≥1 video under certain circumstances. Control facilities employed usual ACP practices. SETTING AND PARTICIPANTS: PROVEN occurred from February 2016 to May 2019 in 360 nursing homes (119 intervention, 241 control) owned by 2 health care systems. This post hoc study of PROVEN data analyzed long-stay residents ≥65 years who died during the trial who had either advanced dementia or cardiopulmonary disease (advanced illness). We required an observation time ≥90 days before death. The analytic sample included 923 and 1925 advanced illness decedents in intervention and control arms; respectively. METHODS: Outcomes included the proportion of residents with 1 or more hospital transfer (ie, hospitalization, emergency department use, or observation stay), multiple (≥3) hospital transfers during the last 90 days of life, and late transitions (ie, hospital transfer during the last 3 days or hospice admission on the last day of life). RESULTS: Hospital transfers in the last 90 days of life among decedents with advanced illness were significantly lower in the intervention vs control arm (proportion difference = -1.7%, 95% CI -3.2%, -0.1%). The proportion of decedents with multiple hospital transfers and late transitions did not differ between the trial arms. CONCLUSIONS AND IMPLICATIONS: Video-assisted ACP was modestly associated with reduced hospital transfers in the last 90 days of life among nursing home residents with advanced illness. The intervention was not significantly associated with late health care transitions and multiple hospital transfers.

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.