Patient Care Initiatives and Studies

Clinical Care Initiatives and Clinical Trials

Prospective (forward looking, patient following) trials are the gold standard approach to seeking answers to research questions. Retrospective (looking at history) studies are an excellent approach to initially test a hypothesis. In the Malhotra lab we initially seek to test therapies to enhance patient care with retrospective research. Where our research indicates high value of a therapy, we seek to initiate prospective observational trials, or more ideally, prospective randomized trials, to more definitively assess potential to improve patient care.

Our retrospective clinical research and bench initiatives serve as the initial proving ground for potential therapies to improve care. In the clinical trials division, members of all divisions of the lab as well as external collaborators, seek to design ultra low cost clinical studies to test successful initiatives from the other divisions of the laboratory.

Our continued work to understand how disease progresses allows us to enhance care today while providing a better understanding of how our therapeutic approaches might work in the future. We consistently target holes in the common knowledge. Ongoing, and future, work focuses on randomized trials to study specific issues that will enhance quality of life while reducing cost and thereby providing maximal value. Our experience with clinical trials with novel therapeutic approaches will continue to drive our bench to bedside approach.

Initiatives include:


Project SOaR: Spinal surgery, Oncology and Radiation oncology

Patients with spinal cancers benefit from coordinated care from Spinal surgery, Oncology and Radiation oncology (SOaR). SOaR initiatives seek to improve access, reduce time to definitive care, and maximize patient outcomes. We partner with colleagues from medical oncology and radiation oncology to bring this work to fruition. We believe patients can only soar through their complex spinal oncology treatments when all significant care needs are addressed in a compassionate and efficient manner. Co-Leader: J. Jones, J. Schuster.


EVEN Studies: Eliminate Variation in End results for Neoplastic processes

EVEN studies seek to uncover inexplicable differences in outcomes for patients subsequent to treatment for spinal cancer. Where disparities are exposed new clinical approaches are designed with a focus on eliminating said disparity. We partner with colleagues from medical oncology and radiation oncology to bring this work to fruition. The Equity States Lab was established to mimic EVEN studies in broader populations.


VOICE: A Patients Voice

A Patients Voice was established to make sure that all patients feel they have a voice in their care and their opinions are respected as shared goals are established. As opposed to other mechanism that seek patient input, VOICE acts in real time. Today, 98% of the last 24,000 patients would recommend their neurosurgeon to family. With A Patients Voice (built into the PIPSI-Penn Interventional Patient Satisfaction Index) we believe we have moved the needle on patient care. When scores intermittently decline we nip the issue in real time, immediately addressing patient concerns.

Please see:  “A Patients Voice”:  Patient Satisfaction Survey – Penn Medicine 


ERAS: Enhanced Recovery After Surgery

We performed one of the first ever prospective randomized trials in the history of Penn Neurosurgery and the first ERAS randomized trial in the specialty of Neurosurgery. The randomized trial demonstrated the strengths and weakness of ERAS care and led to key modifications of the practice in our health system. Co-Leaders include E. Maloney and Z. Ali.


HAHHAH initiative: Happier at Home, Healthier at Home

HAHHAH focuses on providing patients with a safe and comfortable recovery at home after surgical intervention. Data has demonstrated that patients are happiest, and most comfortable, when recovering at home. We have demonstrated effective predictive models for determining for which patients, and subsequent to which procedures, a home recovery is safe. We have partnered with social work, IT, APP leadership, nursing leadership, physical therapy, occupational therapy and administration to facilitate this work. We seek to improve value for the patient, reduce cost, and increase the number of safe discharges to home while reducing the need for post-acute care rehab and nursing homes. Co-Leaders include M. Breen, D. Gardiner, U. Tambe, B. Gravina, A. Merolli, and J. Thurlow.


Project lessER:

Subsequent to surgical intervention patients may have side effects and symptoms that necessitate urgent clinical evaluation. Brain tumor patients visit the ER at a rate of nearly 20% in the first thirty days after surgery, whereas 15-25% of spinal cancer patients attend the ER in the first 30 days. Patients that have been thorough an ER evaluation indicate they would prefer an alternative option if possible. Project lessER seeks to provide patients access to alternatives that might dramatically curtail ER utilization. Co-Leaders include members of the Emergency Department, AMSAT team, and billing and finance.


ReST: Restorative Spinal Therapy Clinical Trials (NIH Funded)

These trials seek to take our spinal disc therapy, with a proven track record in bench research, and move toward translation models in order to prepare for eventual human testing.


AWESOME care: Access to Workup Enhances Surgical Oncology Measurements of Engagement in Care.

Patients with new spinal cancer diagnosis often require rapid evaluation, not only for clinical reasons but additionally for peace of mind. This clinical initiative seeks to enhance the process from a patient perspective. Success with AWESOME inspired some of the goals for AMSAT. AMSAT (Ambulatory Management team for Surgeon Accessibility and Throughput) has focused on improving patient access, optimizing patient care pathways, and optimizing the EHR such that a surgeons attention is on the patient and not the computer. AMSAT members work to enhance the patient experience for more than 30,000 patient visits per calendar year. Co-leaders: Administration, Physician extenders, surgeons, and clinical coordinators and navigators.


SOS Trial: Sleep in the OR Safe & Sound (NIH Funded)

Older adults sometimes report that they think less clearly for weeks to months after anesthesia and surgery. We wish to understand and eventually eliminate this feeling that some patients have. We believe “foggy” thinking may be related to a protein called tau. The purpose of our study is to measure the tau protein in patients before and after surgery using a common radiology study, a PET scan. Cognition will be studied before and after surgery. Co-Leader: R. Eckenhoff.


AATIC: Appropriate Antibiotic Timing Improves Surgical Care

We have previously demonstrated that certain peri-operative antibiotics are at risk for inappropriately timed delivery. Inappropriate timing results in an increased risk of peri-operative surgical site infection. This prospective work seeks to right-time antibiotic delivery through workflow improvement with the end goal of reduced surgical site infection.