IMPH Research in Patient Safety and Clinical Quality

Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis 
Cost-Effectiveness of Nutrition Intervention in Long Term Care 
Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial 
Creating Simulation-Based Performance Assessment Tools for Practicing Physicians 
Health Literacy, Hospital Discharge, and Cardiovascular Outcomes 
Prevention of Weight Loss in Long Term Care Veterans 
Reducing Hospitalizations in Medicare Beneficiaries: A Collaboration Between Acute and Post-Acute Care

Altering Sedation Paradigms to Improve Brain Injury and Survival in Severe Sepsis

The need for mechanical ventilation (MV) secondary to sepsis is the leading cause of admission to the intensive care unit, often necessitating sedation for patient safety and comfort. Recently, we have learned that these sedative medications contribute to iatrogenic injury, such as prolonging ventilator time and ICU length of stay and exacerbating acute brain dysfunction. This acute brain dysfunction, manifested as delirium and coma, occurs in 50%-70% of MV septic patients and is a significant contributor not only to death but also to functional and cognitive decline, which can persist for years after recovery of lung and other organ function, levying significant costs to patients and society. Despite advances in the management of acute respiratory failure and sepsis, few clinical trials have examined the effects that supportive therapies, like sedation, may have on both short- and long-term outcomes in this vulnerable population. The gamma-aminobutyric acid (GABA)-ergic benzodiazepines, in particular, have been shown to increase brain dysfunction, promote infection, and prolong MV. Therefore, the short-acting GABA-ergic sedative propofol and the alpha2 agonist dexmedetomidine are becoming widely used to sedate septic MV patients. There are only a few randomized trials, however, to guide clinicians when selecting between these and other sedatives, and none have explored the mechanisms underlying the differences in outcomes, though some data indicate that GABA-ergic and alpha2 agonist agents have very different effects on innate immunity, apoptosis, arousability, and respiratory drive. In early animal and human studies, dexmedetomidine had more anti-inflammatory effects than the GABA-ergic agents; dexmedetomidine improved bacterial clearance, whereas propofol impaired it. In addition, sedation with dexmedetomidine instead of benzodiazepines reduces delirium by 20%-30% and improves arousability, cognition, and attentiveness in ventilated patients. Alpha2 agonists induce unconsciousness at the brainstem- more akin to natural sleep-which may improve autonomic function and immunity. All these factors converge to suggest that sedation with an alpha2 agonist rather than a GABAergic agent may improve outcomes, including brain function, MV, and survival, for septic MV patients. We therefore propose the MENDS II (Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure) study, in which we will test the hypotheses that sedation of MV severely septic patients with an alpha2 agonist (dexmedetomidine) rather than a GABAergic agent (propofol) will (Aim 1A) increase days alive without delirium or coma, (Aim 1B) increase ventilator-free days, (Aim 2A) improve 90-day survival, (Aim 2B) decrease long-term cognitive impairment, and (Aim 3) reduce the pro-inflammatory cytokine cascade following sepsis. We will randomize 530 ventilated, severely septic patients requiring goal-directed sedation with dexmedetomidine or propofol, giving the study 90% power to detect a difference of 1.5 delirium/coma-free days and an absolute difference in mortality of 10% between the two groups. Read more.

Funding Source: NIH/NHBLI
PI: Pratik Pandharipande

Cost-Effectiveness of Nutrition Intervention in Long Term Care

This funded translational study utilizes the federal regulation to train non-nursing staff for nutritional care delivery.  Specifically, this study uses a controlled, intervention design to determine the cost-effectiveness of a between-meal snack intervention relative to a usual care control group in a group of 200 residents in 4 community nursing homes. Non-nursing staff trained as “feeding assistants” will offer residents in the intervention group a choice between supplements and other snack foods and fluids twice daily, five days per week, for 24 weeks while also providing a standardized prompting protocol to enhance intake and independence in eating.  The impact of the training program on residents’ nutritional status is monitored by research staff during this time period. Read more.

Funding Source: NIH/NIA
PI: Sandra F. Simmons, PhD

Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

This funded study uses a controlled, intervention design to determine the cost-effectiveness of oral liquid nutritional supplements with an alternative nutrition intervention that offers residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 200 residents in four community nursing homes.  Each intervention is being implemented for 24 weeks while research staff monitor nutritional intake, body weight and other health outcomes. Read more.

Funding Source: Agency for Healthcare Research and Quality
PI:Sandra F. Simmons, PhD

Creating Simulation-Based Performance Assessment Tools for Practicing Physicians

Creating simulation-based performance assessment tools for practicing physicians A team of leading simulation researchers and educators propose a 10-center study of the applicability of mannequin-based simulation to high-stakes assessment of practicing clinicians who are seeking board recertification. This unique study will address important issues for performance evaluation of practicing clinicians, which include the development of standardized scenarios with associated reliable scoring instruments, distributed delivery and assessment of clinicians' performance using those scenarios across multiple testing sites, and a description of the distribution of medical/technical and behavioral performance of 200 practicing board- certified anesthesiologists (BCA). The results will inform competency assessment of physicians in other specialties as well as physicians-in-training. Using a network of experienced simulation instructors and programs already offering all-day simulation courses that are mandatory for BCA desiring Maintenance of Certification in Anesthesia (MOCA) provides a singular opportunity to address some of the challenges of measuring clinical competency using high-fidelity simulation. The Specific Aims are to: 1) Develop standardized, generalizable simulation scenarios with associated valid, reliable performance assessment tools to conduct simulation-based assessment of BCA; 2) Demonstrate that simulation-based clinical assessment can be reliably delivered across multiple national sites for the purpose of evaluating board-certified physicians seeking recertification; 3) Describe quantitatively and qualitatively the distribution of clinical performance during simulation from a large and diverse cross-section of board-certified physicians; and 4) Begin to address the remaining challenges and questions related to reliable and valid simulation-based assessment of practicing physicians' clinical competency. The products of Aim 1 will be 4 standardized scenarios, associated reliable performance rating instruments, and detailed methods for conducting clinical performance ratings. In Aim 2, we will conduct more than 100 MOCA(R) courses over a two-year period in 10 ASA-Endorsed centers; the clinical performance of 200 BCA will be assessed. We hypothesize that there will be a broad distribution of medical/technical and (especially) behavioral performance ratings from poor to excellent, reflecting a diverse cross-section of participants. Finally, we will hold a national stakeholders consensus conference to discuss the remaining challenges and questions related to reliable and valid simulation-based assessment of clinical competency. The results will delineate the requirements of future validation studies of clinical performance assessment and provide important guidance for simulation-based competency assessment across multiple specialties. PUBLIC HEALTH RELEVANCE: Assurance of physicians' ability to detect and manage uncommon but potentially lethal events is an area of particular societal concern and may be amenable to simulation-based performance assessment. This multicenter study will develop rigorous methods and measures for assessing the acute care competency of practicing physicians using mannequin-based high-fidelity simulation. Read more.

Funding Source: AHRQ
PI: Matthew Weinger

Health Literacy, Hospital Discharge, and Cardiovascular Outcomes

The period following hospital discharge is a vulnerable time for patients in which poorly coordinated care and medication mismanagement are common. Suboptimal care in the peri-discharge period contributes to preventable adverse events, hospital readmission, and higher mortality, particularly in high-risk conditions such as acute coronary syndromes (ACS). Low health literacy is a prevalent risk factor for poor processes and outcomes of care, but little research has been conducted on the role of health literacy in this high-risk setting. The goal of this research is to examine how health literacy and other patient characteristics affect the quality of hospital discharge and related outcomes after hospitalization. We will test a conceptual framework that includes patient-, provider-, and system-related factors as potential mediators and moderators of these relationships. The Specific Aims are to: 1) Determine the association of health literacy with the quality of hospital discharge, including the impact on communication, preparedness for discharge, and subsequent medication management. 2) Examine the effect of health literacy and hospital discharge quality on functional status, health- related quality of life, and unplanned health care utilization 30 and 90 days after hospital discharge. 3) Examine the effect of health literacy and hospital discharge quality on mortality after hospitalization. We will perform a prospective cohort study of 3,000 adults hospitalized for ACS and discharged to home. Data collection and analyses will be grounded in a conceptual framework that relates health literacy to processes and outcomes of care. During hospitalization, we will administer a robust set of validated sociodemographic, educational, cognitive, psychological, cultural, and behavioral measures. For Aim 1, we will interview patients by telephone 2-3 days after discharge to assess the quality of hospital discharge, including measures of patient-provider communication and preparedness for discharge. For Aim 2, we will review medical records and interview patients by telephone 30 and 90 days after discharge to assess changes in functional status, health-related quality of life, and unplanned health care utilization, including Emergency Department visits and rehospitalization. For Aim 3, we will ascertain mortality using the Social Security Administration Death Master File, following patients for up to 3.5 years after enrollment. We will use multivariable path analyses and survival analyses to model the direct and indirect relationships among health literacy, other measured factors, potential mediators or moderators, and each outcome of interest. This interdisciplinary research will greatly enhance our understanding of how health literacy affects hospital discharge processes and outcomes after hospitalization. Findings will enable us to better design interventions to improve services for patients with low health literacy, as well as other high-risk groups. Knowledge gained from this study may also help improve cardiovascular outcomes and reduce literacy-related health disparities. Read more.

Funding Source: NIH/NHLBI
PI: Sunil Kripalani

Prevention of Weight Loss in Long Term Care Veterans

This translational research study involves a staff training and management intervention in two VA facilities to improve daily nutritional care practices both during and between meals as provided by routine nursing home staff. Read more.

Funding Source: VA HSR&D Merit Award
PI: Sandra F. Simmons, PhD

Reducing Hospitalizations in Medicare Beneficiaries: A Collaboration Between Acute and Post-Acute Care

This funded study combines two innovative interventions to address the frequent and often unnecessary hospital readmissions of Medicare and Medicaid patients from post-acute care (PAC) in skilled nursing facilities (SNFs). The two interventions, INTERACT (Interventions to Reduce Acute Care Transfers), and IMPACT (Improved Post-Acute Care Transitions) are evidence-based and generalizable to the majority of hospital and PAC settings, consistent with the intent of the Affordable Care Act (ACA).  If effective, the combined intervention will result in substantial reductions in costs while also improving care quality and patient satisfaction.

Funding Source: Centers for Medicare and Medicaid Services (CMS)
PI: John F. Schnelle, PhD