Research Projects

Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE)

Co-Chair of the Steering Committee: Rothman, Russell, Site-PI: Kripalani, Sunil, Site Co-PI: Daniel Munoz
Supported by PCORI Award (ASP-1502-27079)

ADAPTABLE is the first pragmatic clinical trial to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is a PCORI-funded initiative designed to improve the nation's capacity to conduct comparative clinical effectiveness research. PCORI announced a three-year, $14 million clinical trial comparing the benefits and risk for side effects of two commonly used doses of aspirin – low-dose 81 mg (“baby aspirin”) and regular strength 325 mg – in preventing heart attacks and strokes in people with heart disease.

The study, called ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness), aims to enroll and follow as many as 20,000 patients with heart disease quickly and efficiently using PCORnet’s resources. This study will compare the effectiveness of two daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. What we learn from the ADAPTABLE study will improve care and outcomes for patients with heart disease and could prevent as many as 88,800 deaths per year around the world.

Enhancing Inter-Facility Transfer for Patients with Acute Myocardial Infarction

PI: Ward, Michael, Mentor: Kripalani, Sunil
Supported by NHLBI K23 Award

In the U.S., nearly 500,000 patients suffer an ST-elevation myocardial infarction (STEMI) each year. Most emergency departments (EDs) lack the local capabilities to perform the definitive treatment, primary percutaneous coronary intervention (PCI). Thus, patients must be transferred to capable facilities, but inefficiencies in this process cause delays in timely reperfusion of coronary vessels and worsen patient outcomes. The time to reperfusion for transferred STEMI patients greatly lags behind those patients who present directly to PCI centers and fails to meet national benchmark standards in 90% of cases. Inadequate measurement and understanding of the timing and processes of care at referring EDs have hindered improvement in the timeliness of STEMI patient transfer. The study of coordination, communication, and organizational design, collectively known as "organizational behavior," is an accepted approach to study performance and variation in complex health systems. It has not yet been applied to the transfer of STEMI patients, but would likely reveal important targets for intervention.

This study aims to a) Examine referring ED operational data for candidate measures of timeliness and factors associated with reduced time to coronary reperfusion; b) Conduct a detailed qualitative assessment of the organizational behavior at referring EDs that transfer patients for primary PCI; and c) Examine the association between organizational behavior and time spent at referring EDs.

Mid-South Practice Transformation Network - Transforming Clinical Practice Initiative

PI: Rothman, Russell, Co-Investigators: Kripalani, Sunil; Spain, Thomas
Supported by $28 million CMS grant

Vanderbilt University has received a contract from the Centers for Medicare and Medicaid Services (CMS) for up to $28 million over four years to help more than 4,000 clinicians in the Southeast transform their clinical practices in ways that improve quality of patient care and hold down costs.“This project will provide an outstanding opportunity for us to continue to improve the quality of health care based on evidence-based best practices,” said Robert Dittus, M.D., MPH, Executive Vice President of Public Health and Health Care. “It will greatly contribute to our ability to help patients achieve their best possible health.”

The Vanderbilt contract supports a partnership between Vanderbilt, the Vanderbilt Health Affiliated Network (VHAN) and the Safety Net Consortium of Middle Tennessee. The Mid-South PTN is one of 39 health care networks and supporting organizations selected to participate in the $685 million Transforming Clinical Practice Initiative.

Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS)

Site Lead: Mixon, Amanda
Supported by AHRQ R18HS019598-01 to the Society of Hospital Medicine (SHM) with Dr. Schnipper as principal investigator.

Unresolved medication discrepancies during hospitalization can contribute to adverse drug events, resulting in patient harm. Discrepancies can be reduced by performing medication reconciliation; however, effective implementation of medication reconciliation has proven to be challenging. The goals of the Multi-Center Medication Reconciliation Quality Improvement Study (MARQUIS) are to operationalize best practices for inpatient medication reconciliation, test their effect on potentially harmful unintentional medication discrepancies, and understand barriers and facilitators of successful implementation.

Six U.S. hospitals are participating in this quality improvement mentored implementation study. Each hospital has collected baseline data on the primary outcome: the number of potentially harmful unintentional medication discrepancies per patient, as determined by a trained on-site pharmacist taking a “gold standard” medication history. With the guidance of their mentors, each site has also begun to implement one or more of 11 best practices to improve medication reconciliation. To understand the effect of the implemented interventions on hospital staff and culture, we are performing mixed methods program evaluation including surveys, interviews, and focus groups of front line staff and hospital leaders.

Traditional Healers as Adherence Partners for PLHIV in Rural Mozambique

PI: Audet, Carolyn
Supported by National Institute of Mental Health K01 Award

HIV-positive people living in rural Mozambique often consult a traditional healer prior to seeking help from a clinic, thereby, delaying diagnosis and treatment. Traditional healers are a preferred and trusted source within the community. Deeply rooted in cultural customs, they are ideally positioned to improve health outcomes of this population by linking them to clinical care and treatment. Healers can maintain confidentiality, explain the disease in local cultural context and support lifelong antiretroviral therapies. This research focuses on developing a novel strategy for engaging traditional healers as treatment advocates, educators, and adherence coaches for patients newly diagnosed with HIV in Zambézia Province, Mozambique.

PCORnet: Clinical Data Research Network (CDRN) - Phase II

PI: Rothman, Russell
Supported by PCORI Award

The Mid-South Clinical Data Research Network (CDRN) was founded in 2014 under PCORI Phase I funding. Our CDRN encompasses three large networks with multiple health systems, ambulatory practices and hospital across the country. In Phase II, our CDRN will include additional health systems in that expand our reach across the South, and increase access to research and informatics expertise. Our expanded CDRN includes a diverse array of academic and community hospitals, primary care and specialty practices, and community health centers in rural and urban areas, reaching over 9 million patients in the South, plus 14 million patients nationally.

Population Mobility and Retention in HIV Care Among Postpartum Women in South Africa

PI: Clouse, Kate
Supported by K01 Award

This work aims to 1) Determine the frequency of clinic shopping and identify factors associated with clinic switching using existing databases. 2) To characterize mobility and health care utilization among pregnant and postpartum HIV-positive women. 3) To determine the effect of mobility on retention in HIV care and adherence to ART.

Moderate Dose Hydroxyurea for Stroke Prevention in Children with Sickle Cell Disease in Sub-Saharan Africa

Co-PI: Aliyu, Muktar
Supported by Thrasher Research Foundation

The aims of this randomized controlled trial are to assess the efficacy of moderate dose Hydroxyurea therapy for secondary stroke prevention when compared to low dose Hydroxyurea therapy among children with Sickle Cell Anemia, and to determine whether moderate Hydroxyurea therapy decreases the rate of all-cause hospitalizations when compared to low dose Hydroxyurea therapy.

Optimizing Integrated PMTCT Services in Rural North-Central Nigeria

PI: Aliyu, Muktar
Supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development R01 Award

This parallel, cluster randomized trial evaluates the impact of a family-focused Prevention of Mother-to-Child Transmission package that includes: 1) task-shifting to lower-care providers at Prevention of Mother-to-Child Transmission sites; 2) Point of care CD4+ testing; (3) Integrated mother-infant care; and (4) a prominent role for influential family members, working with community health workers.

Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health

PI: Wilkins, Consuelo
Supported by U54 Award

The Vanderbilt-Miami-Meharry Center of Excellence in Precision Medicine and Population Health will bring together institutions and faculty with substantial expertise in precision medicine and health disparities research among African Americans and Latinos/Hispanics. The Center will leverage unique assets and resources to develop novel methods and approaches to advance population health.

A Randomized Controlled Trial to Deprescribe for Older Patients with Polypharmacy Transferred from the Hospital to Skilled Nursing Facilities

PI: Simmons, Sandra, Vasilevskis, Ed
Supported by the NIH National Institute of Aging R01 Award

The goal of this randomized, controlled intervention trial is to implement a deprescribing protocol prior to hospital discharge for patients being transferred to skilled nursing facilities and evaluate the effects of the intervention on polypharmacy, geriatric syndromes, medication adherence and other health outcomes.