Ron I. Shorr, MD, MS – Grants and Contracts
Systolic Blood Pressure Intervention Trial (SPRINT)
Y1HC9100 (August 01, 2009 – July 30, 2018)
VA Site PI: Shorr
The Systolic Blood Pressure Intervention Trial (SPRINT) is a 2-arm, multicenter, randomized clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure (SBP) to a lower goal than currently recommended will reduce cardiovascular disease (CVD) risk. About 9250 participants with SBP ≥ 130 mm Hg and at least one additional CVD risk factor will be recruited at approximately 90 clinics within 5 clinical center networks (CCNs) over a 2-year period, and will be followed for 4-6 years. Approximately 4300 participants will have chronic kidney disease (CKD), and 3250 will be aged 75 or older. The primary outcome is the first occurrence of a myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure (HF), or CVD death. Secondary outcomes include all-cause mortality, decline in renal function or development of end stage renal disease (ESRD), dementia, decline in cognitive function, and small vessel cerebral ischemic disease.
Women’s Health Initiative Extension Study
N01WH04354 (October 1, 2010 – September 30, 2015)
Senior Consultant, SE Regional WHI Center: Shorr
The second WHI Extension Study from 2010 to 2015 enrolled 93,500 consenting participants from the first WHI Extension Study for an additional five years of follow-up Annual updates will continue to be collected and will focus on cardiovascular events and aging, much of which will complement the existing WHI resource. Only health events occurring in African-American or Hispanic women or former HT trial participants will be documented and adjudicated. Thus the overall WHI study population is divided into two new subsamples, the Medical Records Cohort (MRC) and the Self-Report Cohort (SRC), distinguishing the quality and extent of the outcome information collected.
Clinical and Translational Science Award
U54RR025208 & Ul1RR029890 (July 14, 2009 – March 31, 2014)
PI: Nelson, Director, Advanced Postdoctoral Program in Clinical Investigation (APPCI): Shorr
The overall mission of the University of Florida Clinical and Translational Science Institute (UF CTSI) is to improve human health by accelerating the translation of scientific discoveries into practical applications and practices for the diagnosis, treatment, prevention and cure of human diseases. It is geared to attract individual and team investigators to amplify their capabilities, and to help them more effectively and more quickly carry out their clinical and translational research. UF CTSI improvements include awarding of funding for pilot projects, changing the IRB submission process, creating new informatics resources, and introducing a common reimbursement price list for clinical research charges.
The Advanced Postgraduate Program in Clinical Investigation (APPCI) provides a comprehensive didactic curriculum and training program in clinical and translational science for senior fellows and junior faculty in the health sciences. The APPCI was first developed by the University of Florida under the Clinical Research Curriculum Award (K30) funded by the NIH from 1999 – 2010 and is now funded through the University of Florida’s Clinical and Translational Science Institute. APPCI Scholars receive tuition for core coursework and for up to 30 credit hours total (including core courses) toward a Master of Science with a concentration in clinical/ translational science. The APPCI also provides oversight of course and research progress by the APPCI Advisory Committee, review of grant applications, and access to faculty biostatisticians for assistance with research design and analysis in the development of research proposals, and opportunities for collaboration with other APPCI Scholars.
Hospital Responses to Medicare’s Nonpayment for Preventable Complication
R01HS020627 (September 1, 2011 – July 31, 2013)
PI: Waters, Co-I: Shorr
On October 1, 2008, Medicare implemented a policy that denies incremental payment for eight preventable complications of medical care. Even though this CMS policy is limited in terms of involved conditions, hospital reaction may be substantial because this policy change is viewed by many as the first in a series of CMS payment reforms intended to increase its emphasis on value-based purchasing, using both positive incentives and negative penalties. Hospital responses are likely to be more significant than they would be if the rule change was an isolated event rather than a precursor of future change. In addition, the negative ‘stick’ of non-reimbursement may be a more powerful motivator than an equal positive reward, in part because of revenue loss but also because of the negative stigma that results for an organization. We propose to examine the impact of Medicare’s new nonpayment rule on hospital behavior related to four of the eight conditions identified by CMS as preventable: catheter-associated urinary tract infection rates, central line- associated blood stream infection rates, falls, and hospital-acquired pressure ulcers. We will also assess how hospital responses may vary depending on particular circumstances, such as financial health and market conditions. Specifically, we propose to address the following research questions: (1) What is the impact of the CMS payment rule change on the incidence of these four conditions? (2) How will hospital circumstances influence responses to the CMS payment rule changes? And (3) How have hospitals altered their quality improvement activities (QI) in response to the CMS payment rule changes? National Database of Nursing Quality Indicators (NDNQI) data merged with American Hospital Association Annual Survey of Hospitals data, Medicare Cost Reports, and Area Resource File data will be used to examine hospital responses to the CMS payment change using multi-level, interrupted time series models in which unit, hospital and market characteristics influence patient outcomes. Six hospitals with varying levels of outcomes improvement will be also be selected for in-depth site visits, focusing on the changes in quality improvement activities that have occurred as a result of the CMS payment policy, as well as the barriers and facilitators to change. Because of the relative novelty of negative incentives, as well as the signal that the rule change sends to hospitals about future Medicare payment changes, our study will provide vital information to policymakers and payers across the country about the extent to which such policies achieve intended results. We will also provide important information on how responses may vary depending on particular hospital circumstances, such as financial health and market conditions. Hospitals in poor financial health may lose more under the new payment rules, adding to their problems in supporting quality improvement activities. In these turbulent financial times, it is critical that payment incentives designed to improve quality of care do not have unintended effects that compromise quality due to the financial pressure they create.
CMS Nonpayment for Iatrogenic Injury and the Risk of Falls in Hospitals
R01AG033005 (September 1, 2009 – October 30, 2013) (no cost extension)
Accidental falls are among the most common reported adverse events which occur during hospitalization. About 30% result in injury and of these, about a third cause serious injury. Beginning October 1, 2008, the Centers for Medicare & Medicaid Services (CMS) no longer reimbursed hospitals for treatment of injuries resulting from falls which occur during hospitalization.1-4 Although the intent of this rule change is to simultaneously reduce cost and improve the quality of health care in hospitalized patients, it is unknown what the effect of this reimbursement change will have on falls and fall prevention strategies in hospitals. The primary aim of this study is to determine whether this “legislative intervention” is associated with changes in: 1. Total and injurious patient falls. The secondary aim of this study is to determine whether CMS nonpayment for nosocomial injury results in changes in: 2. Use of physical restraints. There is considerable controversy surrounding the use of physical restraints in hospital settings.7,11,12 The adverse effects of physical restraints have been well described; however, it is not clear whether use of physical restraints prevents falls in acute care settings. The tertiary aims of this study are to determine: 3. The relationship between physical restraint use and the risk of patient falls at the level of the: 3a. nursing unit, and 3b. patient, and 4. Whether the relationship between physical restraint use and falls is altered by CMS payment changes at the level of the nursing unit. These aims will be accomplished using two approaches: 1) unit level aims will be addressed using a 54 month quasi-experimental study and physical restraint use 27 months before through 27 months after the CMS payment changes, and 2) patient-level hypotheses will be tested using a matched case-control approach. Two data sources will be utilized. Unit-level aims will be addressed using data from the National Database of Nursing Quality Indicators (NDNQI). Relevant to this application, data on falls, injurious falls, physical restraint use, as well as staffing information have been collected at the level of nursing unit in a systematic manner from nearly 1000 acute-care hospitals from every region of the country. Patient-level aims will be accomplished using data from 24 adult medical and/or surgical nursing units at the four adult hospitals in the Methodist Healthcare System (MHC). These hospitals share a unified electronic medical record system which will allow us to apply many of the approaches to data collection we developed for an NIH-funded trial of proximity alarm monitoring to prevent falls conducted at MHUH. In addition to informing future legislation on patient safety, information from this study will contribute to the long-term goals supporting the development of effective organizational and patient-specific strategies to reduce falls in hospitals. PUBLIC HEALTH RELEVANCE: The primary aim of this study is to determine whether elimination of Medicare payment for injuries sustained in hospitals is associated with changes in the frequency of falls and changes in fall prevention strategies, particularly the use of physical restraints.
Web-Based Informational Materials for Caregivers of Veterans Post Stroke (Uphold)
VA/HSR&D QUERI, Service Directed Project. #SDP 06-327 (May 2008 – February 2013)
PI: Uphold, Co-I: Shorr
Stroke survivors and their caregivers often do not have the information necessary to manage the recovery process at home. Presence of a competent and knowledgeable caregiver is a critical determinant of whether a stroke survivor’s mental and physical health improves and whether the survivor is institutionalized or remains at home or in the community. Unfortunately, many stroke caregivers lack basic information about strokes, strategies to care for stroke survivors, and ways to prevent complications and future strokes. In addition, caregivers often have no understanding of coping mechanisms to avoid caregiver burden. This implementation project addresses the VA/DoD Clinical Practice Guidelines for the Management of Stroke Rehabilitation recommendations for the need to increase guideline compliance in the area of family education. We will be using Step 4 of the Classic Six-Step QUERI Process which involves the development and implementation of programs to promote best practices.
Objective 1: Evaluate stroke and caregiver related information for web-based adaptation. Objective 2: Develop stroke caregiver materials based on identified gaps in currently available information; and prepare materials for pilot testing. Objective 3: Conduct formative evaluation of stroke caregiver materials; revise materials based on evaluation findings and implement promotion campaign. Objective 4: Post materials on the MHV website, conduct summative evaluation, and implement final revisions
Racial Disparities in Older Adults: Impact of Medicare Part D
R01AG034056 (September 15, 2009 – August 31, 2011)
PI: Hanlon, Co-I: Shorr
Both hypertension and ischemic heart disease (IHD which includes those with a history of myocardial infarction [MI] or it’s risk equivalent diabetes) are more common and more likely to be inadequately controlled in older African Americans when compared to older Caucasians. One key pathway to these racial disparities is greater cost related medication non adherence in older African Americans when compared to Caucasians. Medicare Part D which began January 2006 provides a drug benefit for those enrolled. The impact of this health policy intervention on racial disparities in medication use and control of chronic diseases such as hypertension and ischemic heart disease is unknown. The long-term objective of our proposed study is to reduce racial disparities in health outcomes by examining the impact of this policy intervention of increasing prescription drug coverage among the elderly. Using a longitudinal design we will examine two objectives. Objective 1 is to determine the impact of the Medicare Part D drug benefit intervention on racial differences in the use of antihypertensive medications in those with hypertension and the use of lipid lowering medications in those with IHD (i.e., those with a history of MI and/or diabetes. One specific hypothesis to be tested is that after the Medicare Part D implementation, older Africans Americans in this high risk group will receive more intense antihypertensive regimens than older Caucasians. A second specific hypothesis to be tested is that the disparity in any lipid lowering medication use between Caucasian and African American older adults in these high risk groups will be reduced after Medicare Part D implementation. Objective 2 is to determine the impact of the Medicare Part D drug benefit intervention on racial disparities in the control of hypertension and IHD. One specific hypothesis to be tested is that the disparity in uncontrolled blood pressure between Caucasian and African American older adults with hypertension will be reduced after Medicare Part D implementation. A second specific hypothesis to be tested is that the disparity in uncontrolled lipid levels between Caucasian and African American older adults with IHD will be reduced after Medicare Part D implementation. This study capitalizes on longitudinal data from the ongoing 11 year Medicare population based National Institute on Aging (NIA) funded Health Aging and Body Composition Study. Our multidisciplinary research team has extensive experience conducting health policy analyses, pharmaco-epidemiological studies with geriatric populations, health disparities and cardiovascular disease research and is uniquely positioned to shed light on this critical policy issue. Moreover, our proposed research is responsive to one of the three research action areas (public policy) outlined in PAR 07-379 entitled “Behavioral and Social Science Research on Understanding and Reducing Health Disparities” and will shed light upon the effectiveness of the Medicare Part D intervention to reduce health disparities. This study is also consistent with the interests of the National Institute on Aging’s Behavioral and Social Research Program’s Health Disparities Initiatives. PUBLIC HEALTH RELEVANCE: Both access to drug therapy treatment and chronic disease guideline adherence are included as part of the recently released list by Centers for Medicare and Medicaid Services (CMS) entitled “Evidentiary Priorities for the Elderly Population”. This list provides clinical research topics for which there are significant knowledge gaps. If Medicare Part D reduces racial disparities by increasing access to medication use which leads to better control of hypertension and IHD, then our study will inform other initiatives to expand insurance coverage to other vulnerable populations.
Impact of Medicare Part D on Racial Disparities in Diabetes Treatment and Outcome
R01HS017695 (September 30, 2009 – August 1, 2011)
PI: Hanlon, Co-I: Shorr
Many older adults respond to high out-of-pocket drug costs by skipping, reducing dosages of or not filling prescriptions for their medications. A primary goal of the new Medicare drug benefit (Part D) was to increase the availability of drug coverage and thereby improve medication use among older adults. Medicare Part D may have a disproportionate impact on medication use among beneficiaries in minority groups. For instance, African American beneficiaries have enrolled in Part D in greater numbers (62% vs. 48%) than Caucasian beneficiaries. Moreover, African American beneficiaries are more likely than Caucasian beneficiaries to qualify for generous Part D low-income subsidies. As a result, Part D may help to alleviate racial/ethnic disparities in clinical processes of care and health outcomes that have been documented for a range of chronic conditions among older adults. We will assess the impact of Part D on racial disparities in medication use and health outcomes for older adults with diabetes, a chronic condition with increasing prevalence. Given the worse glycemic control and higher diabetes-related mortality among African Americans compared to Caucasians, our proposed investigations have critical implications for health disparities. The long-term objective of our proposed study is to reduce racial/ethnic disparities in health by examining the impact of changes in insurance coverage among the elderly. This proposal has two primary objectives. First, we will assess racial differences in antidiabetic medication use, glycemic control, and diabetes-related hospitalizations and mortality for an elderly cohort with diabetes before the implementation of Part D. We hypothesize that older African American beneficiaries with diabetes will have lower levels of antidiabetic medication use, worse glycemic control, and higher diabetes-related hospitalization and mortality rates compared to Caucasian beneficiaries. Second, we will examine whether Part D mitigates racial disparities in medication use, glycemic control, and diabetes-related hospitalizations and mortality in the elderly. We hypothesize that older African Americans compared to Caucasians will experience a larger improvement in medication use, glycemic control, and diabetes-related hospitalizations and mortality. Our study will use longitudinal data from an 11-year, Medicare population-based prospective cohort study. We will adjust our estimates of the effect of race and Part D for socioeconomic status, comorbidities, health, functional and cognitive status, access to care, and other factors. Our research has important policy implications. Medicare Part D — the most substantial expansion of insurance benefits to older adults since the program’s inception over 40 years ago — is projected to cost just under $1 trillion between 2007 and 2017. If Medicare Part D reduces racial disparities in medication access, our study will inform other efforts to expand insurance coverage to vulnerable populations. Our multidisciplinary research team has extensive experience conducting health policy analyses, pharmacoepidemiologic studies with geriatric populations, health disparities and diabetes research, and is uniquely positioned to shed light on this critical policy issue.
Using Knowledge Discovery Strategies to Identify Fall Related Injuries
VA/HSR&D Service IIR-05-120 (July 2008 – June 2011)
PI: Luther, Co-I: Shorr
Knowledge discovery in databases (KDD) techniques were applied to text data from the electronic health record (EHR). We compared KDD techniques, regular expression-based pattern matching and statistical text mining (STM) on their ability to identify and characterize circumstances of falls treated in the ambulatory care setting. Falls are an important health care issue among aging Veterans. A history of a previous fall is the single most important clinical indicator of risk for additional falls and targets Veterans for fall prevention programs.
The goal of this study was to explore the usefulness of KDD strategies to identify Veterans who seek care for injurious falls in VHA ambulatory care. Objectives: 1) Create a benchmark dataset on which KDD analyses will be conducted; 2) Compare the ability of KDD techniques to identify fall-related ambulatory events (FRAE) with three types of data (text-based notes alone, text-based notes plus information from administrative data, and text-based notes plus information from chart review) using area under the receiver operating characteristic (AUROC) curve analyses; 3) Test the generalizability of the results from VISN8 in data from other VAMCs; 4) Apply the KDD method found to be most highly predictive in Objective 2 to identify mechanism and place of injury associated with FRAE; and, 5) Investigate the effects of embedded semi-structured text passages such as templates on statistical text mining algorithms.
Trial of Proximity Alarms to Reduce Patient Falls
R01AG025285 (May 01, 2005 – April 30, 2009)
Proximity alarm systems are promoted as an approach to reduce falls and decrease use of physical restraints in hospitals, but they have not been tested rigorously. The goal of the proposed study is to test an intervention to introduce and implement proximity alarms on the risk of falls in hospitalized patients at Methodist-University Hospital (M-UH), a 652-bed urban community hospital in Memphis, Tennessee. The hospital provides primary to tertiary care to a diverse adult patient population. We propose to test the intervention using a group randomized trial conducted on 16 25-bed general medical-surgical nursing units at M-UH. Nursing units will be randomized within blocks of 2 based on rates of falls that occur during an initial 3-month observation period. Over a 15-month intervention, 8 nursing units will be randomized to receive the alarm-based intervention, and 8 will utilize existing nursing care methods to minimize falls. Intervention units will receive an adequate supply of proximity alarm monitoring systems to apply to all patients considered by nursing staff to be at high risk for falls. An implementation team, consisting of a nurse-champion, geriatrician and biomedical instrumentation specialist, will train and conduct regular follow-up on intervention units to address technical issues related to use of the alarms. The primary outcome measure, patient falls, will be ascertained prospectively by a nurse-manager using a method we have developed to collect patient (e.g., orientation and postural blood pressure) and environmental data collected in a standardized manner. The primary aim of the study is to determine whether proximity alarm monitoring reduces falls. We have designed the study to test the hypothesis that patient falls will be 25% lower on intervention units compared to control units. The secondary aims are to determine whether proximity alarm monitoring reduces the use of physical restraints, or decreases patient care costs. This will be the first methodologically sound study to evaluate this promising approach to reducing falls in hospitals. Whether or not alarms successfully reduce falls, findings from this proposed study have the potential to widely impact purchasing decisions and clinical practice related to fall prevention in acute-care settings.
Intervention Development for Shared Decision Making in Stroke Prevention
VA/HSR&D QUERI, Service Directed Project. #RRP 07-305 (October 2007 – August 2008)
PI: Uphold, Co-PI: Shorr
This project addresses recent clinical practice guidelines that recommend “administration of antithrombotic therapy to all patients with atrial fibrillation (AF), except those with lone AF, to prevent thromboembolism.” AF is the most common risk factor for stroke. Despite strong evidence that use of anticoagulation in AF reduces the risk of strokes, only about half of AF out-patients receive anti-thrombotics. Reasons for the low rates of guideline adherence include patient, provider, and system barriers. Despite barriers, research shows that veterans have a strong desire for information and want to share in decisions with providers. Further, the VHA “promotes system-wide implementation of shared decision making” and it is well-known that sharing decisions is effective. Thus, this project will be the first step in developing a video on shared decision-making and anti-thrombotic choices that nurses can disseminate to veterans in the hospital, in outpatient clinics, and in their homes.
The objectives of this study are to: 1) describe patient’s knowledge, attitudes, and beliefs about anti-thrombotics, and 2) develop and evaluate a script & video design to improve shared decision-making for stroke prevention.
Clinical Research Curriculum Award
K30RR022963 (September 27, 2005 – July 31, 2007)
PI: Flynn, Co-Director: Shorr
The University of Tennessee Health Science Center (UTHSC) and St. Jude Children’s Research Hospital (SJCRH) have formed a consortium to improve and expand multidisciplinary didactic training of clinical research skills and mentorship for career development of new clinical investigators. We will build on the strengths of each institution, including the existing Master of Science in Epidemiology Program (MSE), the General Clinical Research Center, the 21st Century Scholars Program, and a rich environment of clinical research activities, including active Centers of Excellence and experienced senior research faculty, spanning both campuses. Close collaboration with UTHSC’s Colleges of Medicine, Nursing, Dentistry, and Pharmacy will strengthen our multidisciplinary efforts. Specifically, we plan to increase the relevance of the current MSE by establishing a Clinical Research Track. We also plan to improve accessibility to training by creating a Clinical Research Certificate program that offers web-based, self-paced learning, with 4 core courses in clinical research. These certificate courses will offer credit transferable to the MSE. Additionally, to improve accessibility to training, we hope to establish scholarships for qualified students. Finally, we plan to establish a supervised mentorship program that will facilitate linkages across institutions, colleges, departments, and disciplines. The consortium will sponsor formal workshops on successful mentoring. K30 MSE participants in the Clinical Research Track will be assigned a mentoring team consisting of 5 individuals, at least 2 who have completed formal mentor training, to assist in their career development. This proposed K30 grant initiative will allow the consortium to incorporate existing pockets of clinical research training and support into an integrated program through education (coursework), mentoring, and financially through the support of the 21st Century Scholars Program. By increasing the relevance of training, its accessibility for busy clinicians, and formal mentoring, we will provide a continuum of career-development support for the next generation of clinical researchers advancing prevention, diagnosis, and management of human disease.
Randomized Controlled Trial of Enhanced Pharmacy Care in Older Veteran Outpatients
VA/HSR&D #SAF 98-152 (October 2000 – March 2004)
PI: Rosenthal, Consultant: Shorr
Complications resulting from medications, or adverse drug events (ADEs), are prevalent and are a major source of excess morbidity and costs. ADEs are particularly problematic in older patients because of their higher burden of comorbidity and diminished physiologic reserve. In addition, older patients are more likely to be exposed to polypharmacy, a major risk factor for ADEs. While ADEs may be idiosyncratic, many result from medical errors and inadequate systems for ensuring the safe and effective use of medications.
The goal of the proposed study is to test the efficacy of a potentially potent intervention to improve the use of medications in older outpatients enrolled in VA primary care clinics. The intervention-Enhanced Pharmacy Care-involves a formal, multi-dimensional evaluation of patients’ medication regimens by a trained clinical pharmacist and board-certified geriatrician.
The study has the following six aims: 1) Compare changes in prescribing practices-as measured by medication appropriateness, number of medications, and cost of prescribed medications-between baseline and follow-up in patients randomized to Enhanced Pharmacy Care and patients randomized to usual care; 2) Compare other medication-based endpoints in the two groups, including the occurrence of potential ADEs, medication compliance, and patient knowledge of medications; 3) Compare changes in health-related-quality-of-life in the two groups; 4) Compare patient perceptions of the quality of VA outpatient care in the two groups; 5) Compare health care utilization during the one-year study period in the two groups; and 6) Examine attitudes of primary care providers (PCPs) about the intervention.