Insomnia Symptoms and Environmental Disruptors: A Preliminary Evaluation of Veterans in a Subacute Rehabilitation.

OBJECTIVES: Evaluate insomnia symptoms and environmental disruptors at admission and discharge in a subacute rehabilitation care setting. METHODS: Veterans (age ≥50) admitted to a Veterans Health Administration (VA) Hospital subacute rehabilitation between March and August 2022 completed baseline (N = 46) and follow up (N = 33) assessments with the Insomnia Severity Index (ISI), Sleep Need Questionnaire (SNQ), Epworth Sleepiness Scale (ESS), and an assessment of environmental sleep disruptors. Veterans were offered sleep resources after admission evaluations and outpatient referrals after discharge evaluations. Pearson correlation determined associations between length of stay (LOS), ISI, SNQ, and ESS scores at admission and discharge; chi-square and Wilcoxon Signed Rank Tests compared insomnia at admission and discharge. RESULTS: One-half of participants reported clinically meaningful insomnia symptoms and sleep needs at baseline with no significant change at discharge. Almost all (89.1%) Veterans reported sleep was disturbed by environmental factors, primarily staff awakenings. LOS was correlated with ESS scores at discharge (r = .52, p = .002). CONCLUSIONS: Environmental sleep disruption was common during a subacute rehabilitation admission and were not adequately addressed through sleep resources and treatment due to low uptake. CLINICAL IMPLICATIONS: Providers should assess sleep at admission and lessen environmental sleep disruptors by reducing noise, light, and non-essential awakenings at night.

Coordinated-Transitional Care (C-TraC) for Veterans from Subacute Rehabilitation to Home.

OBJECTIVES: To adapt a successful acute care transitional model to meet the needs of veterans transitioning from post-acute care to home. DESIGN: Quality improvement intervention. SETTING AND PARTICIPANTS: Veterans discharged from a subacute care unit in the VA Boston Healthcare System's skilled nursing facility. METHODS: We used the Replicating Effective Programs framework and Plan-Do-Study-Act cycles to adapt the Coordinated-Transitional Care (C-TraC) program to the context of transitions from a VA subacute care unit to home. The major adaptation of this registered nurse-driven, telephone-based intervention was combining the roles of discharge coordinator and transitional care case manager. We report the details of the implementation, its feasibility, and results of process measures, and describe its preliminary impact. RESULTS: Between October 2021 and April 2022, all 35 veterans who met eligibility criteria in the VA Boston Community Living Center (CLC) participated; none were lost to follow-up. The nurse case manager delivered core components of the calls with high fidelity-review of red flags, detailed medication reconciliation, follow-up with primary care physician, and discharge services were discussed and documented in 97.9%, 95.9%, 86.8%, and 95.9%, respectively. CLC C-TraC interventions included care coordination, patient and caregiver education, connecting patients to resources, and addressing medication discrepancies. Nine medication discrepancies were discovered in 8 patients (22.9%; average of 1.1 discrepancies per patient). Compared with a historical cohort of 84 veterans, more CLC C-TraC patients received a post-discharge call within 7 days (82.9% vs 61.9%; P = .03). There was no difference between rates of attendance to appointments and acute care admissions post-discharge. CONCLUSIONS AND IMPLICATIONS: We successfully adapted the C-TraC transitional care protocol to the VA subacute care setting. CLC C-TraC resulted in increased post-discharge follow-up and intensive case management. Evaluation of a larger cohort to determine its impact on clinical outcomes such as readmissions is warranted.

An innovative rehabilitation program for the veterans affairs post-acute skilled nursing setting: Preliminary results.

BACKGROUND: Skilled nursing rehabilitative care plays a critical role in older adults' functional recovery impacting post-discharge outcomes. Variations across post-acute rehabilitative care services and patient outcomes indicate a need to improve rehabilitative care in this setting. We adapted a successful outpatient care program (Live Long Walk Strong-LLWS) to address this need in post-acute care settings within the Veterans Health Administration. LLWS differs from standard PT care by treating impairments linked to functional decline that are not traditionally targeted by standard care, providing formalized coaching to optimize behavior change, and providing post-discharge case management to optimize long-term outcomes. The purpose was to adapt, refine and implement the LLWS program for the Community Living Center (CLC), determine its acceptability and feasibility, and evaluate its preliminary effectiveness among older adults. METHODS: The design of the program was adapted from the original outpatient LLWS program to the CLC setting through quality improvement methods and the Replicating Effective Programs (REP) framework. Primary outcomes included measures of feasibility and acceptability of >80% enrollment and completion of sessions as well as preliminary effectiveness using performance-based and patient-reported measures of function including the Short Physical Performance Battery (SPPB), AM-PAC, a Global Rating of Change questionnaire, and a satisfaction survey. RESULTS: After 18 months, 51 Veterans had enrolled in the LLWS program, with 94.1% maintaining enrollment. We observed >80% completion of the inpatient and home follow-up sessions. Most patients were highly satisfied with care. Improvements in the SPPB (2.3 (SD 2.2) points), gait speed (0.17 (0.14) m/s) and the AM-PAC (6.5 (SD 5.7)) surpassed clinically meaningful thresholds. CONCLUSIONS: This novel care program is feasible and acceptable to Veterans, demonstrating preliminary effectiveness with improving functional outcomes. Future research is needed to further examine the program's impact on other important outcomes relative to standard modes of care.

My life, my story: Teaching patient centered care competencies for older adults through life story work.

We implemented "My Life, My Story" as an educational activity for enhancing patient-centered care (PCC) competencies across health professions trainees. Four hundred and eighty-two stories were completed for patients (M age = 72.5, SD = 12.7) primarily in inpatient medical settings, by trainees from seven disciplines. Trainees spent approximately 2 hours on the assignment; 84% felt this was a good use of their time. A mixed method survey evaluated the effectiveness of the activity on enhancing PCC competencies using open ended questions and ratings on the Consultation and Relational Empathy (CARE) Measure adapted for this project. The assignment most influenced trainees' ability to understand the patient as a "whole person" along with other PCC competencies such as showing empathy, really listening, building knowledge of values and goals, and building relationships. In addition, trainees perceived the activity enhanced patient care and was a positive contrast to usual care.

Improving Medication Reconciliation with Comprehensive Evaluation at a Veterans Affairs Skilled Nursing Facility.

BACKGROUND: Unintentional medication discrepancies due to inadequate medication reconciliation pose a threat to patient safety. Skilled nursing facilities (SNFs) are an important care setting where patients are vulnerable to unintentional medication discrepancies due to increased medical complexity and care transitions. This study describes a quality improvement (QI) approach to improve medication reconciliation in an SNF setting as part of the Multi-Center Medication Reconciliation Quality Improvement Study 2 (MARQUIS2). METHODS: This study was conducted at a 112-bed US Department of Veterans Affairs SNF. The researchers used several QI methods, including data benchmarking, stakeholder surveys, process mapping, and a Healthcare Failure Mode and Effect Analysis (HFMEA) to complete comprehensive baseline assessments. RESULTS: Baseline assessments revealed that medication reconciliation processes were error-prone, with high rates of medication discrepancies. Provider surveys and process mapping revealed extremely labor-intensive and highly complex processes lacking standardization. Factors contributing were polypharmacy, limited resources, electronic health record limitations, and patient exposure to multiple care transitions. HFMEA enabled a methodical approach to identify and address challenges. The team validated the best possible medication history (BPMH) process for hospital settings as outlined by MARQUIS2 for the SNF setting and found it necessary to use additional medication lists to account for multiple care transitions. CONCLUSION: SNFs represent a critical setting for medication reconciliation efforts due to challenges completing the reconciliation process and the concomitant high risk of adverse drug events in this population. Initial baseline assessments effectively identified existing problems and can be used to guide targeted interventions.

Addressing the Shortage of Physician Assistants in Medicine Clerkship Sites.

Addressing the shortage of clerkship sites, the VA Boston Healthcare System developed a physician assistant training program in a postacute health care setting.

Improving Access to Care by Admission Process Redesign in a Veterans Affairs Skilled Nursing Facility.

BACKGROUND: Inefficient and inadequate nursing home screening processes can delay care transitions from hospitals to post-acute care facilities and result in inappropriate and delayed transfers. The increased volume of admission requests and need for efficient and effective transfers between care settings converged to make the Community Living Center (CLC; skilled nursing facility in the Department of Veterans Affairs) admission screening process an organizational priority for improvement. A quality improvement (QI) project was conducted to develop a new process for a 112-bed CLC and improve efficiency and access to care. METHODS: The Model for Improvement was used to complete a 13-month continuous QI project. The multidisciplinary QI Workgroup developed aims and measures, analyzed work flow processes, and identified problem areas. Interventions were rapidly tested using Plan-Do-Study-Act cycles. Successful interventions were sustained by developing standard operating procedures and local policy. RESULTS: Several interventions were implemented that focused on standardization, automation, and streamlining. The final result was a new hybrid model that included an Admissions Team consisting of a unit nurse manager, a social worker, and administrative staff. The time from bed request to patient transfer improved from a median of 3.3 days in the baseline period to 2.3 days in the final month of the project. CONCLUSION: A highly structured and team-based QI approach enabled rapid redesign of an admission screening process that improved efficiency and decreased the time from request to admission. This redesign strategy provides instruction for other facilities interested in improving screening processes and access to care.

Clostridium perfringens empyema in a patient with metastatic squamous cell carcinoma of the lung.

We report a rare case of Clostridium perfringens (CP) empyema in a patient with metastatic squamous cell cancer of the lung. Clostridial empyemas are rare and clinically variable with some reports noting consequent necrotizing infections and septic shock and others noting quick resolution with source control and antibiotic treatment. This is the first case report to our knowledge to report a CP empyema in a patient with lung malignancy. Given the comorbid lung malignancy, the patient's presenting symptoms were mild with only mild shortness of breath, fevers, and generalized weakness despite the large CP empyema. Early antibiotics and source control with daily drainage of the pleural fluid allowed for successful management, circumventing a complex critical care course and successful management without ambulatory oxygen therapy on discharge.

Improved Transitional Care Through an Innovative Hospitalist Model: Expanding Clinician Practice From Acute to Subacute Care.

Hospitalist physician rotations between acute inpatient hospitals and subacute care facilities with dedicated time in each environment may foster quality improvement and educational opportunities.

Respiratory Tract Infection Clinical Trials from 2007 to 2012. A Systematic Review of ClinicalTrials.gov.

RATIONALE: Respiratory tract infections are highly prevalent and variable, and confer considerable morbidity and mortality. There is a growing need for new treatments for such infections, particularly in the setting of worsening antibacterial resistance. OBJECTIVES: We analyzed data from ClinicalTrials.gov to summarize activity in respiratory infection trials, identify gaps in research activity, and inform efforts to address disparities between antimicrobial resistance and development of new antibacterial drugs. METHODS: We examined 69,779 interventional trials registered with ClinicalTrials.gov from 2007 to 2012, focusing on study conditions and interventions to identify respiratory infection-related trials. Programmatic identification with manual confirmation yielded 6,253 infectious disease trials, 1,377 respiratory infection trials, and 270 lower respiratory tract infection trials for analysis. MEASUREMENTS AND MAIN RESULTS: The 1,377 respiratory infection trials accounted for 2% of all trials and 22% of infectious diseases trials. Such trials (54.8%) were more likely than either nonrespiratory infectious diseases trials (48.1%) or noninfectious disease trials (42.8%) to receive industry funding. Stratification of respiratory infection trials by registration year demonstrated declining industry funding: 181 (64.9%) in 2007-2008 to 110 (46.0%) in 2011-2012. Respiratory infection trials more frequently evaluated vaccines (52.7 vs. 15.5% of nonrespiratory tract infection trials). Lower respiratory tract infection trials (excluding tuberculosis) focused primarily on bacterial pathogens (78.5%) followed by viral (12.6%), fungal (5.6%), and nontuberculous mycobacterial (3.0%) pathogens. Approximately 40% of 120 lower respiratory tract infection trials that were completed or terminated published results in the literature. On multivariable logistic regression analysis, a treatment focus was associated with decreased odds of publishing results (odds ratio, 0.28; 95% confidence interval, 0.10-0.82; P = 0.02). There were also generally low numbers of studies evaluating novel antimicrobial agents (community-acquired pneumonia, 15.9%; hospital-acquired pneumonia, 16.7%; ventilator-associated pneumonia, 5.3%). CONCLUSIONS: From 2007 to 2012, respiratory infection trials did not occur in numbers commensurate with global impact. The number of trials registered per year did not increase throughout the study period, partly due to declining industry support. There was a concerning reduction in prevention-oriented lower respiratory infection trials and an overall low number of such trials involving novel antimicrobials.

Monitoring quality control: can we get better data?

Quality control is important in many fields, especially industrial production. Major research has been developed with regard to industrial quality control to ensure reliable and consistent products. We adapt and develop methodology in quality control to monitor data collection in epidemiologic studies. There are no procedures currently used by epidemiologists to evaluate quality control during the actual process of data collection; methods are implemented only after the data have been collected. We focus on procedures that can be used during data collection: instrument calibration and population sampling. For the first, we propose methods utilizing Shewhart control charts and Westgard stopping rules. For evaluating population sampling, we present methods utilizing regression analysis. We provide a motivating example to highlight the utility of these methods. The proposed methodology may help investigators to identify data quality problems that can be corrected while data are still being collected, and also to identify biases in data collection that might be adjusted later.

Youden Index and optimal cut-point estimated from observations affected by a lower limit of detection.

The receiver operating characteristic (ROC) curve is used to evaluate a biomarker's ability for classifying disease status. The Youden Index (J), the maximum potential effectiveness of a biomarker, is a common summary measure of the ROC curve. In biomarker development, levels may be unquantifiable below a limit of detection (LOD) and missing from the overall dataset. Disregarding these observations may negatively bias the ROC curve and thus J. Several correction methods have been suggested for mean estimation and testing; however, little has been written about the ROC curve or its summary measures. We adapt non-parametric (empirical) and semi-parametric (ROC-GLM [generalized linear model]) methods and propose parametric methods (maximum likelihood (ML)) to estimate J and the optimal cut-point (c *) for a biomarker affected by a LOD. We develop unbiased estimators of J and c * via ML for normally and gamma distributed biomarkers. Alpha level confidence intervals are proposed using delta and bootstrap methods for the ML, semi-parametric, and non-parametric approaches respectively. Simulation studies are conducted over a range of distributional scenarios and sample sizes evaluating estimators' bias, root-mean square error, and coverage probability; the average bias was less than one percent for ML and GLM methods across scenarios and decreases with increased sample size. An example using polychlorinated biphenyl levels to classify women with and without endometriosis illustrates the potential benefits of these methods. We address the limitations and usefulness of each method in order to give researchers guidance in constructing appropriate estimates of biomarkers' true discriminating capabilities.

Evidence of absence or absence of evidence? A reanalysis of the effects of low-dose aspirin in in vitro fertilization.

OBJECTIVE: To assess the conflicting evidence whether low-dose aspirin is beneficial in IVF and to evaluate the meta-analysis performed by Gelbaya et al. and reported in March 2007 in Human Reproduction Update, in which they found no effects of low-dose aspirin and recommended discontinuing its use in IVF. We present a reanalysis of the effects of low-dose aspirin in IVF and raise methodological questions regarding the analysis by Gelbaya et al. DESIGN: A meta-analysis of prospective randomized trials evaluating the effects of low-dose aspirin in IVF. PATIENT(S): Women undergoing IVF/intracytoplasmic sperm injection. INTERVENTION(S): Low-dose acetylsalicylic acid (aspirin). MAIN OUTCOME MEASURE(S): Pregnancy rates, implantation rates, miscarriage rates. RESULT(S): Ten randomized clinical trials were included in the analysis. Clinical pregnancy rate per ET was significant when low-dose aspirin was compared with no treatment (risk ratio 1.15, 95% confidence interval 1.03-1.27). Nonsignificant estimates comparing low-dose aspirin with no treatment were found for implantation and miscarriage rates. CONCLUSION(S): Our results suggest that aspirin may increase clinical pregnancy rates and that more data are needed to resolve the issue. At this point, there is no reason to change clinical management and discontinue the use of aspirin.