The design and conduct of a pragmatic cluster randomized trial of an advance care planning program for nursing home residents with dementia.

BACKGROUND/AIMS: A significant number of people with Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Advance care planning (ACP), the process of eliciting and documenting patient-centered preferences for care, is considered essential to providing high quality care for this population. Nursing homes are currently required by regulations to offer ACP to residents and families, but no training requirements exist for nursing home staff, and approaches to fulfilling this regulatory and ethical responsibility vary. As a result, residents may receive care inconsistent with their goals, such as unwanted hospitalizations. Pragmatic trials offer a way to develop and test ACP in real-world settings to increase the likelihood of adoption of sustainable best practices. METHODS: The "Aligning Patient Preferences-a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support (APPROACHES)" project is designed to pragmatically test and evaluate a staff-led program in 137 nursing homes (68 = intervention, 69 = control) owned by two nursing home corporations. Existing nursing home staff receive standardized training and implement the ACP Specialist program under the supervision of a corporate lead. The primary trial outcome is the annual rate of hospital transfers (admissions and emergency department visits). Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical, or billing purposes. Configurational analysis will also be performed to identify conditions associated with implementation. RESULTS: Partnerships with large corporate companies enable the APPROACHES trial to rely on corporate infrastructure to roll out the intervention, with support for a corporate implementation lead who is charged with the initial introduction and ongoing support for nursing home-based ACP Specialists. These internal champions connect the project with other company priorities and use strategies familiar to nursing home leaders for the initiation of other programs. Standardized data collection across nursing homes also supports the conduct of pragmatic trials in this setting. DISCUSSION: Many interventions to improve care in nursing homes have failed to demonstrate an impact or, if successful, maintain an impact over time. Pragmatic trials, designed to test interventions in real-world contexts that are evaluated through existing data sources collected routinely as part of clinical care, are well suited for the nursing home environment. A robust program that increases access to ACP for nursing home residents has the potential to increase goal-concordant care and is expected to reduce hospital transfers. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve the quality of care for residents with dementia.

Methodological challenges in pragmatic trials in Alzheimer's disease and related dementias: Opportunities for improvement.

BACKGROUND AND AIMS: We need more pragmatic trials of interventions to improve care and outcomes for people living with Alzheimer's disease and related dementias. However, these trials present unique methodological challenges in their design, analysis, and reporting-often, due to the presence of one or more sources of clustering. Failure to account for clustering in the design and analysis can lead to increased risks of Type I and Type II errors. We conducted a review to describe key methodological characteristics and obtain a "baseline assessment" of methodological quality of pragmatic trials in dementia research, with a view to developing new methods and practical guidance to support investigators and methodologists conducting pragmatic trials in this field. METHODS: We used a published search filter in MEDLINE to identify trials more likely to be pragmatic and identified a subset that focused on people living with Alzheimer's disease or other dementias or included them as a defined subgroup. Pairs of reviewers extracted descriptive information and key methodological quality indicators from each trial. RESULTS: We identified N = 62 eligible primary trial reports published across 36 different journals. There were 15 (24%) individually randomized, 38 (61%) cluster randomized, and 9 (15%) individually randomized group treatment designs; 54 (87%) trials used repeated measures on the same individual and/or cluster over time and 17 (27%) had a multivariate primary outcome (e.g. due to measuring an outcome on both the patient and their caregiver). Of the 38 cluster randomized trials, 16 (42%) did not report sample size calculations accounting for the intracluster correlation and 13 (34%) did not account for intracluster correlation in the analysis. Of the 9 individually randomized group treatment trials, 6 (67%) did not report sample size calculations accounting for intracluster correlation and 8 (89%) did not account for it in the analysis. Of the 54 trials with repeated measurements, 45 (83%) did not report sample size calculations accounting for repeated measurements and 19 (35%) did not utilize at least some of the repeated measures in the analysis. No trials accounted for the multivariate nature of their primary outcomes in sample size calculation; only one did so in the analysis. CONCLUSION: There is a need and opportunity to improve the design, analysis, and reporting of pragmatic trials in dementia research. Investigators should pay attention to the potential presence of one or more sources of clustering. While methods for longitudinal and cluster randomized trials are well developed, accessible resources and new methods for dealing with multiple sources of clustering are required. Involvement of a statistician with expertise in longitudinal and clustered designs is recommended.

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 .

Guilt as an Influencer in End-of-Life Care Decisions for Nursing Home Residents With Advanced Dementia.

The concept of guilt has been studied in the context of caregivers of older adults with advanced dementia, usually describing the feelings a person has of placing a loved one in a long-term care facility; however, little research has been done to understand how nursing home staff and proxies for older adults with dementia describe guilt as a decision-influencer in end-of-life care. For the current study, private, semi-structured interviews were conducted with 158 nursing home staff and 44 proxies in 13 nursing homes across four demographic regions in the United States. Interviews were reviewed and analyzed for how the concept of guilt was perceived as a decision-influencer. Nursing home staff described guilt as an important influencer in why proxies make decisions about end-of-life care. Staff noted that proxies who felt guilty about their relationship with their loved one or lack of time spent at end-of-life tended to be more aggressive in care decisions, whereas no proxies mentioned guilt as an influencer in care decisions. Rather, proxies used language of obligation and commitment to describe why they make decisions. Findings highlight the disconnect between nursing home staff and proxies in what motivates proxies to make end-of-life decisions for loved ones. Nursing home staff should be aware of misconceptions about proxies and work to understand proxies' true rationale and motivations for making care decisions. [Journal of Gerontological Nursing, 48(1), 22-27.].

Advancing clinical trials in nursing homes: A proposed roadmap to success.

An effective clinical research effort in nursing homes to address prevention and treatment of COVID-19 faced overwhelming challenges. Under the Health Care Systems Research Network-Older Americans Independence Centers AGING Initiative, a multidisciplinary Stakeholder Advisory Panel was convened to develop recommendations to improve the capability of the clinical research enterprise in US nursing homes. The Panel considered the nursing home as a setting for clinical trials, reviewed the current state of clinical trials in nursing homes, and ultimately developed recommendations for the establishment of a nursing home clinical trials research network that would be centrally supported and administered. This report summarizes the Panel's recommendations, which were developed in alignment with the following core principles: build on available research infrastructure where appropriate; leverage existing productive partnerships of researchers with groups of nursing homes and nursing home corporations; encompass both efficacy and effectiveness clinical trials; be responsive to a broad range of stakeholders including nursing home residents and their care partners; be relevant to an expansive range of clinical and health care delivery research questions; be able to pivot as necessary to changing research priorities and circumstances; create a pathway for industry-sponsored research as appropriate; invest in strategies to increase diversity in study populations and the research workforce; and foster the development of the next generation of nursing home researchers.

Advanced cognitive impairment among older nursing home residents.

BACKGROUND: Though work has been done studying nursing home (NH) residents with either advanced Alzheimer's disease (AD) or Alzheimer's disease related dementia (ADRD), none have distinguished between them; even though their clinical features affecting survival are different. In this study, we compared mortality risk factors and survival between NH residents with advanced AD and those with advanced ADRD. METHODS: This is a retrospective observational study, in which we examined a sample of 34,493 U.S. NH residents aged 65 and over in the Minimum Data Set (2011-2013). Incident assessment of advanced disease was defined as the first MDS assessment with severe cognitive impairment (Cognitive Functional Score equals to 4) and diagnoses of AD or ADRD. Demographics, functional limitations, and comorbidities were evaluated as mortality risk factors using Cox models. Survival was characterized with Kaplan-Maier functions. RESULTS: Of those with advanced cognitive impairment, 35 % had AD and 65 % ADRD. At the incident assessment of advanced disease, those with AD had better health compared to those with ADRD. Mortality risk factors were similar between groups (shortness of breath, difficulties eating, substantial weight-loss, diabetes mellitus, heart failure, chronic obstructive pulmonary disease, and pneumonia; all p < 0.01). However, stroke and difficulty with transfer (for women) were significant mortality risk factors only for those with advanced AD. Urinary tract infection, and hypertension (for women) only were mortality risk factors for those with advanced ADRD. Median survival was significantly shorter for the advanced ADRD group (194 days) compared to the advanced AD group (300 days). CONCLUSIONS: There were distinct mortality and survival patterns of NH residents with advanced AD and ADRD. This may help with care planning decisions regarding therapeutic and palliative care.

Potentially burdensome end-of-life transitions among nursing home residents with poor-prognosis cancer.

BACKGROUND: This study examined factors associated with potentially burdensome end-of-life (EOL) transitions between care settings among older adults with advanced cancer in nursing homes (NHs). METHODS: A retrospective analysis of deceased older NH residents with poor-prognosis solid tumors was conducted with Medicare claims and the Minimum Data Set. A potentially burdensome transition was defined as 2 or more hospitalizations or an intensive care unit admission in the last 90 days of life. RESULTS: Among 34,670 subjects, many had moderate to severe cognitive impairment (53.8%), full dependence in activities of daily living (ADLs; 66.5%), and comorbidities such as congestive heart failure (CHF; 29.3%) and chronic obstructive pulmonary disease (34.1%). Only 56.3% of the patients used hospice at any time in the 90 days before death; 36.0% of the patients experienced a potentially burdensome EOL transition, and this was higher among patients who did not receive hospice (45.4% vs 28.7%; P < .01). In multivariable analyses, full dependence in ADLs (odds ratio [OR], 1.70; P < .01), CHF (OR, 1.48; P < .01), and chronic obstructive pulmonary disease (OR, 1.28; P < .01) were associated with a higher risk of burdensome EOL transitions. Those with do-not-resuscitate directives (OR, 0.60; P < .01) and impaired cognition (OR, 0.89; P < .01) had lower odds of burdensome EOL transitions. CONCLUSIONS: NH residents with advanced cancer have substantial comorbidities and functional impairment, yet more than a third experience potentially burdensome EOL transitions. These findings help to identify a population at risk for poor EOL outcomes in order to target interventions, and they point to the importance of advanced care planning in this population.

Predicting Mortality and Adverse Outcomes: Comparing the Frailty Index to General Prognostic Indices.

BACKGROUND: Mortality prediction models are useful to guide clinical decision-making based on prognosis. The frailty index, which allows prognostication and personalized care planning, has not been directly compared with validated prognostic models. OBJECTIVE: To compare the discrimination of mortality, disability, falls, and hospitalization between a frailty index and validated prognostic indices. DESIGN: Secondary Analysis of the National Health and Aging Trends Study. PARTICIPANTS: Seven thousand thirty-three Medicare beneficiaries 65 years or older. MEASUREMENTS: We measured a deficit-accumulation frailty index, Schonberg index, and Lee index at the 2011 baseline assessment. Primary outcome was mortality at 5 years. Secondary outcomes were decline in activities of daily living (ADL), decline in instrumental activities of daily living (IADL), fall, and hospitalization at 1 year. We used C-statistics to compare discrimination between indices, adjusting for age and sex. RESULTS: The study population included 4146 (44.8%) with age ≥ 75 years, with a median frailty index of 0.15 (interquartile range 0.09-0.25). A total of 1385 participants died (14.7%) and 2386 (35.2%) were lost to follow-up. Frailty, Schonberg, and Lee indices predicted mortality similarly: C-statistics (95% confidence interval) were 0.78 (0.77-0.80) for frailty index; 0.79 (0.78-0.81) for Schonberg index; and 0.78 (0.77-0.80) for Lee index. The frailty index had higher C-statistics for decline in ADL function (frailty index, 0.80 [0.78-0.83]; Schonberg, 0.74 [0.72-0.76]; Lee, 0.74 [0.71-0.77]) and falls (frailty index, 0.66 [0.65-0.68]; Schonberg, 0.61 [0.58-0.63]; Lee, 0.61 [0.59-0.63]). C-statistics were similar for decline in IADL function (frailty index, 0.61 [0.59-0.63]; Schonberg, 0.60 [0.59-0.62]; Lee, 0.60 [0.58-0.62]) and hospitalizations (frailty index, 0.68 [0.66-0.70]; Schonberg, 0.68 [0.66-0.69]; Lee, 0.65 [0.63-0.67]). CONCLUSIONS: A deficit-accumulation frailty index performs as well as prognostic indices for mortality prediction, and better predicts ADL disability and falls in community-dwelling older adults. Frailty assessment offers a unifying approach to risk stratification for key health outcomes relevant to older adults.

Readiness assessment for pragmatic trials (RAPT): a model to assess the readiness of an intervention for testing in a pragmatic trial.

BACKGROUND: Pragmatic randomized, controlled trials (PCTs) test the effectiveness of interventions implemented in routine clinical practice. Because PCT findings are generalizable, this approach is gaining momentum among interventionists and funding agencies seeking to accelerate the testing and adoption of evidence-based strategies to improve care and outcomes. Particular attention is being paid to non-pharmacological interventions, which are often complex and may be difficult to uniformly implement across multiple sites. While many such non-pharmacological interventions have proven efficacious in small trials, most have not been widely adopted. PCTs could accelerate effectiveness testing and adoption, yet there are no established criteria to identify interventions ready for testing in a PCT. METHODS: We convened 30 interventionists and healthcare leaders to identify criteria to assess the readiness of non-pharmacological interventions for PCTs. Based on this discussion, we created a model with multiple domains, qualitative scoring guidelines for each domain, and a graphical summary of readiness assessments. All workshop participants had an opportunity to review and comment on the resulting model; three piloted it with their own interventions. Several other experts also provided input. RESULTS: The Readiness Assessment for Pragmatic Trials (RAPT) model enables interventionists to assess an intervention's readiness for PCTs. RAPT includes nine domains: implementation protocol, evidence, risk, feasibility, measurement, cost, acceptability, alignment, and impact. Domains reflect a range of considerations regarding the feasibility of successfully employing PCT methods and the prospect of an intervention's widespread adoption, if proven effective. Individuals evaluating an intervention are asked to qualitatively assess each domain from low to high readiness. In this report, we provide assessment guidelines and examples of scored interventions. CONCLUSIONS: RAPT is the first model to help interventionists and funders assess the extent to which interventions are ready for PCTs. Scoring efficacious interventions using RAPT can inform research team discussions regarding whether or not to advance an intervention to effectiveness testing using a PCT and how do design that PCTs.

Fact Box decision support tools reduce decisional conflict about antibiotics for pneumonia and artificial hydration in advanced dementia: a randomized controlled trail.

Background: fact Boxes are decision support tools that can inform about treatment effects. Objectives: to test whether Fact Box decision support tools impacted decisional conflict, knowledge and preferences about the use of antibiotics and artificial hydration in advanced dementia. Design: randomized controlled trial. Setting: Swiss-German region of Switzerland. Subjects: two hundred thirty-two participants (64 physicians, 100 relatives of dementia patients, 68 professional guardians) randomly allocated to intervention (N = 114) or control (N = 118). Intervention: two-page Fact Box decision support tools on antibiotics for pneumonia and artificial hydration in advanced dementia (at 1-month). Methods: participants were mailed questionnaires at baseline and one month later that asked questions about treatments based on hypothetical scenarios. The primary outcome was change in decisional conflict (DCS-D; range 0 < 100) about treatment decisions. Secondary outcomes included knowledge about treatments (range 0 < 7) and preferences to forego treatments. Results: participants were: mean age, 55.6 years; female, 62.8%. Relative to control participants, intervention participants experienced less decisional conflict about using antibiotics (unstandardized beta (b) = -8.35, 95% Confidence Interval (CI), -12.43, -4.28) and artificial hydration (b = -6.02, 95% CI, -9.84, -2.20) at 1-month compared to baseline. Intervention participants displayed greater knowledge about the use of antibiotics (b = 2.24, 95% CI, 1.79, 2.68) and artificial hydration (b = 3.01, 95% CI, 2.53, 3.49), and were significantly more likely to prefer to forego antibiotics (odds ratio, 2.29, 95% CI, 1.08, 4.84) but not artificial hydration. Conclusions: fact Box decision support tools reduced decisional conflict, increased knowledge and promoted preferences to forego antibiotics in advanced dementia among various decision-makers. Trial registration: FORSbase (12091).

Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting.

BACKGROUND: The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. METHODS: In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). RESULTS: Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). CONCLUSIONS: Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.

Physician and Surrogate Agreement with Assisted Dying and Continuous Deep Sedation in Advanced Dementia in Switzerland.

BACKGROUND: Assisted dying and continuous deep sedation (CDS) are controversial practices. Little is known about the perceptions of physicians and surrogates about these practices for patients with advanced dementia. OBJECTIVES: To describe and compare physician and surrogate agreement with the use of assisted dying and CDS in advanced dementia. DESIGN, SETTING, SUBJECTS: Physicians (n = 64) and surrogates (n = 168) of persons with advanced dementia were recruited as part of a randomized controlled trial in Switzerland that tested decision support tools in this population. METHODS: At baseline, the participants were asked about their agreement with assisted dying and CDS in advanced dementia using the following response options: "completely agree," "somewhat agree," "somewhat disagree," "completely disagree," and "do not know." Multivariable logistic regressions compared the likelihood that surrogates versus physicians would completely or somewhat agree (vs. completely or somewhat disagree) with these practices. RESULTS: The physicians and surrogates, respectively, had a mean age (SD) of 50.6 years (9.9) and 57.4 years (14.6); 46.9% (n = 30/64) and 68.9% (n = 115/167) were women. A total of 20.3% (n = 13/64) of the physicians and 47.0% (n = 79/168) of the surrogates agreed with assisted dying in advanced dementia. Surrogates were significantly more likely to agree with this practice than physicians (adjusted odds ratio, 3.87; 95% CI: 1.94, 7.69). With regard to CDS, 51.6% (n = 33/64) of the physicians and 41.9% (n = 70/169) of the surrogates agreed with this practice, which did not differ significantly between the groups. CONCLUSIONS: The surrogates were more agreeable to considering assisted dying in the setting of advanced dementia than the physicians, and about half of the participants in both groups reported CDS to be an appropriate option for this population.

Hospice Use Following Implantable Cardioverter-Defibrillator Implantation in Older Patients: Results From the National Cardiovascular Data Registry.

BACKGROUND: Older recipients of implantable cardioverter-defibrillators (ICDs) are at increased risk for short-term mortality in comparison with younger patients. Although hospice use is common among decedents aged >65, its use among older ICD recipients is unknown. METHODS AND RESULTS: Medicare patients aged >65 matched to data in the National Cardiovascular Data Registry - ICD Registry from January 1, 2006 to March 31, 2010 were eligible for analysis (N=194 969). The proportion of ICD recipients enrolled in hospice, cumulative incidence of hospice admission, and factors associated with time to hospice enrollment were evaluated. Five years after device implantation, 50.9% of patients were either deceased or in hospice. Among decedents, 36.8% received hospice services. The cumulative incidence of hospice enrollment, accounting for the competing risk of death, was 4.7% (95% confidence interval [CI], 4.6%-4.8%) within 1 year and 21.3% (95% CI, 20.7%-21.8%) at 5 years. Factors most strongly associated with shorter time to hospice enrollment were older age (adjusted hazard ratio, 1.77; 95% CI, 1.73-1.81), class IV heart failure (versus class I; adjusted hazard ratio, 1.79; 95% CI, 1.66-1.94); ejection fraction <20 (adjusted hazard ratio, 1.57; 95% CI, 1.48-1.67), and greater hospice use among decedents in the patients' health referral region. CONCLUSIONS: More than one-third of older patients dying with ICDs receive hospice care. Five years after implantation, half of older ICD recipients are either dead or in hospice. Hospice providers should be prepared for ICD patients, whose clinical trajectories and broader palliative care needs require greater focus.

Patterns of physical activity and survival following cardiac resynchronization therapy implantation: the ALTITUDE activity study.

AIMS: Cardiac resynchronization therapy with implantable defibrillator backup (CRT-D) improves outcomes, but predictors and markers of response remain limited. Physical activity information collected by CRT devices may provide insights to CRT response and the relationship between activity changes and survival. METHODS AND RESULTS: Patients entered into the LATITUDE remote monitoring system from 2008 to 2012 after receipt of a new CRT-D were eligible. Mean daily activity was calculated from LATITUDE uploads at baseline (first 3-10 days following implant) and 6 months (180-210 days). Pairwise differences for baseline-6-month activity were calculated, and survival according to quintiles of 6-month activity change was assessed. Cox regression was used to examine the adjusted association between survival and baseline-6-month activity change. A total of 26 509 patients were followed for a median of 2.3 years (mean age 70.2 ± 11.0 years, 70.7% male). Mean baseline activity was 66.2 ± 47.7 min/day, with mean paired increase at 6 months of 37.1 ± 48.2 min/day [95% CI (confidence interval), 36.5-37.6, P < 0.0001], though 15.5% of patients did not improve or worsened at 6 months. Survival at 3 years was significantly higher in the largest baseline-6-month activity change quintile vs. the lowest quintile (88.9% vs. 62.1%, log-rank P-value < 0.001). Adjusted for age and gender, higher 6-month activity change was associated with a lower risk of death (adjusted hazard ratios 0.65 per 30 min increase in activity, 95% CI, 0.63-0.67). CONCLUSIONS: Change in physical activity between baseline and 6 months following CRT implantation is strongly associated with survival.

PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization prior to recruitment feasible with 100% participation of facilities randomized to the intervention arm. Critical regulatory issues included minimal risk determination, waiver of informed consent, and determination that nursing home providers were not engaged in human subjects research. Intervention training and implementation were initiated on 5 January 2016 using corporate infrastructures for new program roll-out guided by standardized training elements designed by the research team. Video Status Reports in facilities' electronic medical records permitted "real-time" adherence monitoring and corrective actions. The Centers for Medicare and Medicaid Services Virtual Research Data Center allowed for rapid outcomes ascertainment. Conclusion We must rigorously evaluate interventions to deliver more patient-focused care to an increasingly frail nursing home population. Video decision support is a practical approach to improve advance care planning. PRagmatic trial Of Video Education in Nursing homes has the potential to promote goal-directed care among millions of older Americans in nursing homes and establish a methodology for future pragmatic randomized controlled trials in this complex healthcare setting.

A Randomized Controlled Trial of a CPR and Intubation Video Decision Support Tool for Hospitalized Patients.

BACKGROUND: Decisions about cardiopulmonary resuscitation (CPR) and intubation are a core part of advance care planning, particularly for seriously ill hospitalized patients. However, these discussions are often avoided. OBJECTIVES: We aimed to examine the impact of a video decision tool for CPR and intubation on patients' choices, knowledge, medical orders, and discussions with providers. DESIGN: This was a prospective randomized trial conducted between 9 March 2011 and 1 June 2013 on the internal medicine services at two hospitals in Boston. PARTICIPANTS: One hundred and fifty seriously ill hospitalized patients over the age of 60 with an advanced illness and a prognosis of 1 year or less were included. Mean age was 76 and 51% were women. INTERVENTION: Three-minute video describing CPR and intubation plus verbal communication of participants' preferences to their physicians (intervention) (N = 75) or control arm (usual care) (N = 75). MAIN MEASURES: The primary outcome was participants' preferences for CPR and intubation (immediately after viewing the video in the intervention arm). Secondary outcomes included: orders to withhold CPR/intubation, documented discussions with providers during hospitalization, and participants' knowledge of CPR/ intubation (five-item test, range 0-5, higher scores indicate greater knowledge). RESULTS: Intervention participants (vs. controls) were more likely not to want CPR (64% vs. 32%, p <0.0001) and intubation (72% vs. 43%, p < 0.0001). Intervention participants (vs. controls) were also more likely to have orders to withhold CPR (57% vs. 19%, p < 0.0001) and intubation (64% vs.19%, p < 0.0001) by hospital discharge, documented discussions about their preferences (81% vs. 43%, p < 0.0001), and higher mean knowledge scores (4.11 vs. 2.45; p < 0.0001). CONCLUSIONS: Seriously ill patients who viewed a video about CPR and intubation were more likely not to want these treatments, be better informed about their options, have orders to forgo CPR/ intubation, and discuss preferences with providers. TRIAL REGISTRATION: Clinicaltrials.gov NCT01325519 Registry Name: A prospective randomized trial using video images in advance care planning in seriously ill hospitalized patients.

Health Outcomes of Obtaining Housing Among Older Homeless Adults.

OBJECTIVES: We determined the impact of obtaining housing on geriatric conditions and acute care utilization among older homeless adults. METHODS: We conducted a 12-month prospective cohort study of 250 older homeless adults recruited from shelters in Boston, Massachusetts, between January and June 2010. We determined housing status at follow-up, determined number of emergency department visits and hospitalizations over 12 months, and examined 4 measures of geriatric conditions at baseline and 12 months. Using multivariable regression models, we evaluated the association between obtaining housing and our outcomes of interest. RESULTS: At 12-month follow-up, 41% of participants had obtained housing. Compared with participants who remained homeless, those with housing had fewer depressive symptoms. Other measures of health status did not differ by housing status. Participants who obtained housing had a lower rate of acute care use, with an adjusted annualized rate of acute care visits of 2.5 per year among participants who obtained housing and 5.3 per year among participants who remained homeless. CONCLUSIONS: Older homeless adults who obtained housing experienced improved depressive symptoms and reduced acute care utilization compared with those who remained homeless.

End-of-life transitions among nursing home residents with cognitive issues.

BACKGROUND: Health care transitions in the last months of life can be burdensome and potentially of limited clinical benefit for patients with advanced cognitive and functional impairment. METHODS: To examine health care transitions among Medicare decedents with advanced cognitive and functional impairment who were nursing home residents 120 days before death, we linked nationwide data from the Medicare Minimum Data Set and claims files from 2000 through 2007. We defined patterns of transition as burdensome if they occurred in the last 3 days of life, if there was a lack of continuity in nursing homes after hospitalization in the last 90 days of life, or if there were multiple hospitalizations in the last 90 days of life. We also considered various factors explaining variation in these rates of burdensome transition. We examined whether there was an association between regional rates of burdensome transition and the likelihood of feeding-tube insertion, hospitalization in an intensive care unit (ICU) in the last month of life, the presence of a stage IV decubitus ulcer, and hospice enrollment in the last 3 days of life. RESULTS: Among 474,829 nursing home decedents, 19.0% had at least one burdensome transition (range, 2.1% in Alaska to 37.5% in Louisiana). In adjusted analyses, blacks, Hispanics, and those without an advance directive were at increased risk. Nursing home residents in regions in the highest quintile of burdensome transitions (as compared with those in the lowest quintile) were significantly more likely to have a feeding tube (adjusted risk ratio, 3.38), have spent time in an ICU in the last month of life (adjusted risk ratio, 2.10), have a stage IV decubitus ulcer (adjusted risk ratio, 2.28), or have had a late enrollment in hospice (adjusted risk ratio, 1.17). CONCLUSIONS: Burdensome transitions are common, vary according to state, and are associated with markers of poor quality in end-of-life care.