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Abstract Background Clinical interventions often need to be adapted from their original design when they are applied to new settings. There is a growing literature describing frameworks and approaches to deploying and documenting adaptations of evidence-based practices in healthcare. Still, intervention modifications are often limited in detail and justification, which may prevent rigorous evaluation of interventions and intervention adaptation effectiveness in new contexts. We describe our approach in a case study, combining two complementary intervention adaptation frameworks to modify CONNECT for Quality, a provider-facing team building and communication intervention designed to facilitate implementation of a new clinical program. Methods This process of intervention adaptation involved the use of the Planned Adaptation Framework and the Framework for Reporting Adaptations and Modifications, for systematically identifying key drivers, core and non-core components of interventions for documenting planned and unplanned changes to intervention design. Results The CONNECT intervention’s original context and setting is first described and then compared with its new application. This lays the groundwork for the intentional modifications to intervention design, which are developed before intervention delivery to participating providers. The unpredictable nature of implementation in real-world practice required unplanned adaptations, which were also considered and documented. Attendance and participation rates were examined and qualitative assessment of reported participant experience supported the feasibility and acceptability of adaptations of the original CONNECT intervention in a new clinical context. Conclusion This approach may serve as a useful guide for intervention implementation efforts applied in diverse clinical contexts and subsequent evaluations of intervention effectiveness. Trial registration The study was registered at ClinicalTrials.gov ( NCT03300336 ) on September 28, 2017.

BackgroundPhysical resilience, or the ability to recover after a physical stressor, declines with aging. Efforts to preserve physical resilience in the older dialysis population are critically needed; however, validated, patient-centered measures that are sensitive to change are also needed. Our objective was to assess accelerometer-derived step count variability, or a measure of intra-individual variation in physical activity, as a potential measure of physical resilience among older adults receiving hemodialysis.MethodsCommunity-dwelling ambulatory older adults receiving in-center hemodialysis were prospectively enrolled. Participants wore wrist accelerometers during daytime hours on both dialysis and non-dialysis days up to 14 days, and the feasibility of accelerometer use was assessed from wear time. We used accelerometer data to compute step counts in 4-hour blocks and step count variability. Physical function was assessed with the Short Physical Performance Battery (SPPB which includes gait speed test), grip strength, activities of daily living (ADLs) instruments, and life space mobility. We assessed interval fatigue (subjective rating from 0 to 10) on dialysis and non-dialysis days and self-reported recovery time. We assessed the correlations of step count variability with measures of physical function and step count and interval fatigue.ResultsOf 37 enrolled participants, 29 had sufficient accelerometer data for analyses. Among the 29 participants, mean (SD) age was 70.6(4.8) years, and 55% (n=16) were male and 72% (n=21) were Black race. Participants were largely sedentary with median (Q1-Q3) self-reported total kilocalories per week of 200 (36–552). Step count variability was positively correlated with measures of physical function: SPPB (r=0.50, p

Abstract Background Quality improvement (QI) is used in nursing homes (NH) to implement and sustain improvements in patient outcomes. Little is known about how QI strategies are used in NHs. This lack of information is a barrier to replicating successful strategies. Guided by the Framework for Implementation Research, the purpose of this study was to map-out the use, evaluation, and reporting of QI strategies in NHs. Methods This scoping review was completed to identify reports published between July 2003 through February 2019. Two reviewers screened articles and included those with (1) the term “quality improvement” to describe their methods, or reported use of a QI model (e.g., Six Sigma) or strategy (e.g., process mapping) (2), findings related to impact on service and/or resident outcomes, and (3) two or more NHs included. Reviewers extracted data on study design, setting, population, problem, solution to address problem, QI strategies, and outcomes (implementation, service, and resident). Vote counting and narrative synthesis were used to describe the use of QI strategies, implementation outcomes, and service and/or resident outcomes. Results Of 2302 articles identified, the full text of 77 articles reporting on 59 studies were included. Studies focused on 23 clinical problems, most commonly pressure ulcers, falls, and pain. Studies used an average of 6 to 7 QI strategies. The rate that strategies were used varied substantially, e.g., the rate of in-person training (55%) was more than twice the rate of plan-do-study-act cycles (20%). On average, studies assessed two implementation outcomes; the rate these outcomes were used varied widely, with 37% reporting on staff perceptions (e.g., feasibility) of solutions or QI strategies vs. 8% reporting on fidelity and sustainment. Most studies (n = 49) reported service outcomes and over half (n = 34) reported resident outcomes. In studies with statistical tests of improvement, service outcomes improved more often than resident outcomes. Conclusions This study maps-out the scope of published, peer-reviewed studies of QI in NHs. The findings suggest preliminary guidance for future studies designed to promote the replication and synthesis of promising solutions. The findings also suggest strategies to refine procedures for more effective improvement work in NHs.

Abstract Background and objectives After dialysis initiation, older adults may experience orthostatic or post-dialysis hypotension. Some orthostasis-causing antihypertensives (i.e., central alpha agonists and alpha blockers), are considered potentially inappropriate medications (PIMs) for older adults because they carry more risk than benefit. We sought to (1) describe antihypertensive PIM prescribing patterns before and after dialysis initiation and (2) ascertain the potential risk of adverse outcomes when these medications are continued after dialysis initiation. Design, setting, participants, and measurements Using United States Renal Data System data, we evaluated monthly prevalence of antihypertensive PIM claims in the period before and after dialysis initiation among older adults aged ≥66 years initiating in-center hemodialysis in the US between 2013 and 2014. Patients with an antihypertensive PIM prescription at hemodialysis initiation and who survived for 120 days were classified as ‘continuers’ or ‘discontinuers’ based on presence or absence of a refill within the 120 days after initiation. We compared rates of hospitalization and risk of death across these groups from day 121 through 24 months after dialysis initiation. Results Our study included 30,760 total patients, of whom 5981 (19%) patients had an antihypertensive PIM claim at dialysis initiation and survived ≥120 days. Most [65% (n = 3920)] were continuers. Those who continued (versus discontinued) were more likely to be black race (26% versus 21%), have dual Medicare-Medicaid coverage (31% versus 27%), have more medications on average (12 versus 9) and have no functional limitations (84% versus 80%). Continuers experienced fewer all-cause hospitalizations and deaths, but neither were statistically significant after adjustment (Hospitalization: RR 0.93, 95% CI 0.86, 1.00; Death: HR 0.89, 95% CI: 0.78–1.02). Conclusions Nearly one in five older adults had an antihypertensive PIM at dialysis initiation. Among those who survived ≥120 days, continuation of an antihypertensive PIM was not associated with increased risk of all-cause hospitalization or mortality.

Rationale & Objective: Physical function is not routinely measured in older adults receiving dialysis. We evaluated the appropriateness of repeated measurements of physical function, including Short Physical Performance Battery (SPPB), handgrip strength, and activities of daily living (ADLs), in older adults receiving dialysis. Study Design: Prospective study. Setting & Participants: 37 community-dwelling adults 65 years and older receiving in-center hemodialysis at 5 dialysis units located in North Carolina. Exposures: SPPB (an assessment of standing balance, chair stands, and gait speed), handgrip strength, and Katz and Lawton ADLs at baseline and subsequent 3-month intervals up to 6 months. Outcomes: Completion rate, presence of floor or ceiling effects, and presence of clinically meaningful change in physical function measurements. Results: Of 55 potential participants, we enrolled 37 (67%) older adults receiving hemodialysis. Among 35 enrolled participants who completed baseline assessment in a dialysis unit, mean age was 70.1 (SD, 5) years, 46% (n = 16) were women, 77% (n = 27) were African American, and median time receiving dialysis was 2.7 (IQR, 0.6-5.0) years. There were 3 deaths within the observation period, and study retention at 3 and 6 months was 83% (n = 29) and 74% (n = 26), respectively. Participants tolerated measurements; only 2 participants did not attempt 1 of the performance-based tests at a study visit. Baseline median SPPB score, grip strength, and gait speed were 6 (IQR, 4-9), 55 (IQR, 42-70) kg, and 0.76 (IQR, 0.46-0.86) m/s, respectively. Baseline median for Katz and Lawton ADLs were 6 (IQR, 6-6) and 7 (IQR, 4-8), respectively; ceiling effects were observed for both measures. For some participants, clinically meaningful changes (improvement or decline) in SPPB score, grip strength, and gait speed occurred at each 3-month interval. Limitations: Limited geographic and ethnic variation. Conclusions: SPPB, handgrip strength, and gait speed alone are appropriate measures for interval physical function assessment in community-dwelling older adults receiving in-center hemodialysis.

ABSTRACT Risk factors for nonadherence to osteoporosis medication have been well described for cohorts of women with osteoporosis, but little is known about predictors or mediators of nonadherence in men. We conducted a secondary analysis of a national cohort of male veterans to explore factors associated with nonadherence to osteoporosis medications. We included veterans with a prescription for an oral bisphosphonate or calcitonin between 2000 and 2010. We identified demographic, comorbid, and fracture‐related risk factors by their International Classification of Diseases‐9 (ICD‐9) and Current Procedural Terminology (CPT) codes and used multivariable logistic regression to evaluate their association with adherence. Adherence was measured by medication possession ratio (MPR) over 5 years, starting at the time of their first prescription during the study period and censoring at death or end of study period. Of 135,306 men identified with at least one prescription for an osteoporosis medication during the study period, 90,406 (67%) were nonadherent (MPR

Abstract Background There is limited evidence on the relationship between social support and renal outcomes in African Americans. We sought to determine the association of social support with prevalent chronic kidney disease (CKD) and kidney function decline in an African American cohort. We also examined whether age modifies the association between social support and kidney function decline. Methods We identified Jackson Heart Study (JHS) participants with baseline (Exam in 2000–2004) functional and structural social support data via the Interpersonal Support Evaluation List (ISEL) and social network size questions, respectively. With ISEL as our primary exposure variable, we performed multivariable regression models to evaluate the association between social support and prevalent CKD [estimated glomerular filtration rate (eGFR) 30% decrease in eGFR over approximately 10 years). All models were adjusted for baseline sociodemographics, diabetes, hypertension, smoking status, and body mass index; models for eGFR decline and RRFD were additionally adjusted for eGFR and ACR. In models for eGFR decline, we assessed for interaction between age and social support. For secondary analyses, we replaced ISEL with its individual domains (appraisal, belonging, self-esteem, and tangible) and social network size in separate models as exposure variables. Results Of 5301 JHS participants, 4015 (76%) completed the ISEL at baseline. 843 (21%) had low functional social support (ISEL score

Rationale & Objective: Attention to geriatric impairments is not routinely provided to older adults receiving dialysis. Our objective was to identify patient and personnel perspectives on experiences with geriatric problems, unmet needs that may affect a patient’s ability to maintain his or her functional status, and preferences for design of a geriatric model of care tailored to address the unmet needs. Study Design: Qualitative study using semi-structured interviews and focus groups. Setting & Participants: 14 hemodialysis patients 55 years and older and 24 dialysis unit personnel (eg, nephrologists, nurses, patient care technicians, and social workers) representing 5 dialysis units. Analytical Approach: Content analysis to identify themes reflecting unmet needs and design considerations for a geriatric model of care for older adults receiving dialysis. Results: 4 themes (or unmet needs) identified from both patient and personnel transcripts were: (1) mobility, which referred to the insufficient mobility assessment and transportation services; (2) medications, which referred to insufficient attention to appropriate prescribing and medication self-management; (3) social support, which referred to insufficient support for activities of daily living and emotional problems; and (4) communication, which referred to insufficient patient-provider and interprofessional communication, including data transfer across separate health systems. Although participants generally acknowledged that an integrated model of care could result in benefits across all 4 areas of unmet need, they noted that the program design would need to minimize disruption of current workflow and practices in dialysis units. Limitations: The findings may not be broadly representative of all older adults receiving dialysis and dialysis unit personnel. Conclusions: There is insufficient attention to mobility, medication management, social support, and communication needs for older adults receiving in-center hemodialysis. Addressing these unmet needs in a geriatric model of care and measuring its effectiveness are areas of future research.

Abstract Background Successful implementation of new clinical programs depends on effectively establishing, reorganizing, or enhancing team structures and processes to coordinate the work of individuals who are interdependent in their tasks, manage relationships, and share responsibility for outcomes. However, a one-size-fits-all approach is rarely effective. In partnership with VA national clinical leaders and local clinical champions, the Optimizing Function and Independence VA Quality Enhancement Research Initiative program (Function QUERI) will evaluate efforts to implement team-based clinical programs for Veterans at risk for functional decline and disability. Methods Function QUERI will implement and evaluate three innovative, evidence-based clinical programs in VA medical centers: (1) a group physical therapy program for knee osteoarthritis (Group PT); (2) assisted early mobility for hospitalized older veterans (STRIDE), a supervised walking program for hospitalized older veterans; and (3) implementation of helping invested family members improve veteran experiences study (iHI-FIVES), a skills training program for caregivers of disabled Veterans. A common reason for clinical care gaps in these populations is poor communication and coordination among the many interdisciplinary providers involved in their care. To facilitate the implementation of the clinical programs, Function QUERI will evaluate the impact of complexity science-based implementation intervention to promote team readiness (CONNECT), an implementation intervention designed as a bundle of interaction-oriented activities to promote team function and readiness for change, on the implementation of clinical programs across multiple sites. The evaluation will use a mixed methods design. Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects. For STRIDE and iHI-FIVES projects, we will randomize participating sites to implement the clinical program, with the CONNECT intervention or not, and will use a stepped-wedge cluster randomized trial design. Discussion Function QUERI will translate its findings across its projects to identify the contextual factors and components from CONNECT that improve team processes and function to optimize effective implementation for future rollout of VA clinical programs. Synthesizing findings within and across projects, we will specify dimensions of team characteristics and function that enhance capacity for clinical innovation and uptake of evidence-based programs. Trial registration NCT03300336 Registered September 28, 2017, NCT03474380 Registered March 15, 2018.

Physiologic signals such as the electroencephalogram (EEG) demonstrate irregular behaviors due to the interaction of multiple control processes operating over different time scales. The complexity of this behavior can be quantified using multi-scale entropy (MSE). High physiologic complexity denotes health, and a loss of complexity can predict adverse outcomes. Since postoperative delirium is particularly hard to predict, we investigated whether the complexity of preoperative and intraoperative frontal EEG signals could predict postoperative delirium and its endophenotype, inattention. To calculate MSE, the sample entropy of EEG recordings was computed at different time scales, then plotted against scale; complexity is the total area under the curve. MSE of frontal EEG recordings was computed in 50 patients ≥ age 60 before and during surgery. Average MSE was higher intra-operatively than pre-operatively (p = 0.0003). However, intraoperative EEG MSE was lower than preoperative MSE at smaller scales, but higher at larger scales (interaction p < 0.001), creating a crossover point where, by definition, preoperative, and intraoperative MSE curves met. Overall, EEG complexity was not associated with delirium or attention. In 42/50 patients with single crossover points, the scale at which the intraoperative and preoperative entropy curves crossed showed an inverse relationship with delirium-severity score change (Spearman ρ = −0.31, p = 0.054). Thus, average EEG complexity increases intra-operatively in older adults, but is scale dependent. The scale at which preoperative and intraoperative complexity is equal (i.e., the crossover point) may predict delirium. Future studies should assess whether the crossover point represents changes in neural control mechanisms that predispose patients to postoperative delirium.

Abstract Background Pressure ulcers/injuries (PrUs), a critical concern for nursing homes (NH), are responsible for chronic wounds, amputations, septic infections, and premature deaths. PrUs occur most commonly in older adults and NH residence is a risk factor for their development, with at least one of every nine U.S. NH residents experiencing a PrU and many NHs having high incidence and prevalence rates, in some instances well over 20%. PrU direct treatment costs are greater than prevention costs, making prevention-focused protocols critical. Current PrU prevention protocols recommend repositioning residents at moderate, high, and severe risk every 2 h. The advent of visco-elastic (VE) high-density foam support-surfaces over the past decade may now make it possible to extend the repositioning interval to every 3 or 4 h without increasing PrU development. The TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study aims to determine: 1) whether repositioning interval can be extended for NH residents without compromising PrU incidence and 2) how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. Methods In this proposed cluster randomized study, 9 NHs will be randomly assigned to one of three repositioning intervals (2, 3, or 4 h) for a 4-week period. Each enrolled site will use a single NH-wide repositioning interval as the standard of care for residents at low, moderate, and high risk of PrU development (N = 951) meeting the following criteria: minimum 3-day stay, without PrUs, no adhesive allergy, and using VE support surfaces (mattresses). An FDA-cleared patient monitoring system that records position/movement of these residents via individual wireless sensors will be used to visually cue staff when residents need repositioning and document compliance with repositioning protocols. Discussion This study will advance knowledge about repositioning frequency and clinically assessed PrU risk level in relation to PrU incidence and medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines. Trial registration Clinical Trial Registration: NCT02996331.

Background: The contribution of hip fracture to the risk of subsequent fractures is unclear. Methods: Data from the Baltimore Hip Studies and the Established Populations for Epidemiologic Studies of the Elderly (EPESE) were used. Baltimore subjects enrolled at the time of hip fracture ( n=549) and EPESE subjects without previous fractures at baseline ( n=10,680) were followed for 2?10 years. Self-reported nonhip skeletal fracture was the outcome, and hip fracture was a time-varying covariate in a survival analysis stratified by study site. The model was adjusted for race, sex, age, BMI, stroke, cancer, difficulty walking across a room, dependence in grooming, dependence in transferring, and cognitive impairment. Results: The rate of all subsequent self-reported fractures after hip fracture was 10.4 fractures/100 person-years. The unadjusted hazard of nonhip skeletal fracture was 2.52 (95% confidence interval 2.05 to 3.12) for subjects with hip fracture compared with subjects without; when adjusted for other known fracture risk factors the hazard ratio was 1.62 (1.30 to 2.02). Men and women had a similar relative risk increase. The increased risk of secondary fracture after hip fracture persisted over time. Conclusions: A hip fracture is associated with a 2.5-fold increased risk of subsequent fracture, which is not entirely explained by prefracture risk factors. Careful attention to secondary prevention is warranted in these patients. [ABSTRACT FROM AUTHOR]

OBJECTIVES/SPECIFIC AIMS: The objective of this project is to determine whether HRV, collected peri-operatively, is predictive of cognitive decline among older adults who undergo elective surgery/anesthesia. METHODS/STUDY POPULATION: This project is a part of the ongoing INTUIT/PRIME study, which is collecting pre- and post-operative cognitive testing, fMRI imaging, CSF samples, and EEG recordings from 200 older adults (age ≥ 60) undergoing elective non-cardiac/non-neurologic surgery scheduled to last > 2 hours at Duke University Medical Center and Duke Regional Hospital. This project utilizes data from the first 60 INTUIT participants who contributed continuous heart rate data before and during surgery. Participants undergo cognitive testing prior to surgery (baseline) and at 6 weeks after surgery. Our primary dependent variable is the change in the composite score from baseline to 6-weeks. Delirium is assessed in the hospital with the twice daily 3D-CAM tool, so we will report the proportion of individuals with 6-week cognitive decline who exhibited delirium in the days following surgery. Participants’ echocardiogram (ECG) recordings are extracted pre- and intraoperatively from B650/B850 patient monitors with VSCapture software. HRV is defined as the variability between successive R-spikes or inter-beat-intervals on ECG. RESULTS/ANTICIPATED RESULTS: We anticipate that lower intraoperative HRV is associated with worse cognitive decline at 6 weeks after surgery. As secondary objectives, we will determine whether pre-operative HRV or change in HRV (from pre-operative to intra-operative measures) are predictive of cognitive decline after surgery. We expect that in-hospital delirium will be detected in a higher proportion of those with 6-week cognitive decline, compared to those with stable or improved cognition at 6 weeks. DISCUSSION/SIGNIFICANCE OF IMPACT: HRV may address the present need for pre- and intra-operative cognitive risk stratification in the elderly. Physiological indices like HRV have the potential to dramatically change our understanding of CI in older adults undergoing surgery, as they offer an accessible, cost-effective, and non-invasive means whereby clinicians, particularly those unfamiliar with the nuances of geriatric and CI/dementia-related care, can monitor patients and refer those at high-risk of CI after surgery for early intervention.

Although most care for people with serious illness is delivered by multiple providers and agencies, there is no gold standard for how to assemble, train, unify, and sustain strong teams. Using lessons from complexity science, a way of studying complex systems, we propose improving team connections; the quality, quantity, and timeliness of information flow; and the purposeful seeking of diverse perspectives to interpret information and make decisions as a means of driving effective self-organization of teams and leading to high-quality outcomes. We highlight an adaptable intervention that helped improve connections, information flow, and cognitive diversity and resulted in effective self-organization in the Department of Veterans Affairs health care system. Finally, we describe challenges to building teams across systems and sectors, and we present research priorities for spreading a complexity science-based approach to optimize teams that care for people with serious illness.

Purpose of the Study: The CONNECT intervention is designed to improve staff connections, communication, and use of multiple perspectives for problem solving. This analysis compared staff descriptions of the learning climate, use of social constructivist learning processes, and outcomes in nursing facilities receiving CONNECT with facilities receiving a falls education program alone., Design and Methods: Qualitative evaluation of a randomized controlled trial was done using a focus group design. Facilities (n = 8) were randomized to a falls education program alone (control) or CONNECT followed by FALLS (intervention). A total of 77 staff participated in 16 focus groups using a structured interview protocol. Transcripts were analyzed using framework analysis, and summaries for each domain were compared between intervention and control facilities., Results: Notable differences in descriptions of the learning climate included greater learner empowerment, appreciation of the role of all disciplines, and seeking diverse viewpoints in the intervention group. Greater use of social constructivist learning processes was evidenced by the intervention group as they described greater identification of communication weaknesses, improvement in communication frequency and quality, and use of sense-making by seeking out multiple perspectives to better understand and act on information. Intervention group participants reported outcomes including more creative fall prevention plans, a more respectful work environment, and improved relationships with coworkers. No substantial difference between groups was identified in safety culture, shared responsibility, and self-reported knowledge about falls., Implications: CONNECT appears to enhance the use of social constructivist learning processes among nursing home staff. The impact of CONNECT on clinical outcomes requires further study.