Past Projects
EMERGE: Emergency Medicine Education and Research by Global Experts
Principal Investigator: Prashant Mahajan, MD, MPH, MBA
EMERGE is a pilot project to develop an international network of experts in emergency
room departments to collaborate in research and share emergency medicine-related education.
SABER is assisting this project by developing a combined dataset derived from electronic
medical records from 10 countries (and counting) to describe the departments in each
country, to answer research questions, and to create a platform for prospective research
initiatives. As the project evolves from pilot stage, SABER will provide project management,
software development, and statistical analysis support for its clinical research initiatives.
MANAGE HF: A Multifaceted Adaptive Mobile Application to Promote Self-Management and
Improve Outcomes in Heart Failure
Principal Investigator: Michael Dorsch, PharmD, MS
Sponsor: National Institute on Aging (NIA)
Manage HF is a phase 3, multicenter, 12 week, randomized, and double-blind clinical
trial. This study will investigate the effectiveness of two contextual just-in-time
adaptive interventions (JITAIs) delivered via a mobile app for patients with heart
failure. The clinical worsening intervention targets self-management of behaviors
to prevent worsening of a patient’s heart failure symptoms. The dietary sodium intervention
promotes lower sodium intake. Eligible participants will be randomized to the dietary
sodium intervention, the clinical worsening intervention, both interventions, or no
intervention in a 1:1:1:1 manner, stratified by site, gender, and heart failure type
(HFpEF versus HFrEF).
MOIDS: Missed Opportunities for Improving Diagnosis in Pediatric Emergency Care
Principal Investigator: Prashant Mahajan, MD MPH MBA
Sponsor: Agency for Healthcare Research and Quality (AHRQ)
MOIDS is an observational study to test an electronic health record (EHR) algorithm
for identifying missed opportunities for diagnosis. The EHR-based algorithm and non-EHR
measures will be reviewed across 5 pediatric emergency departments retrospectively
and iteratively to refine the algorithms. Then the refined and tested algorithms will
be applied to all pediatric ED visits at the sites prospectively. Expert reviewers
will then assess all identified cases for judgment on whether the cases are missed
opportunities, reviewing patient-related factors, patient-provider interactions, diagnostic
tests, follow-up and tracking of diagnostic information, and referrals. Inter-rater
reliability will be assessed. Frequency of MOIDS and characteristics associated with
MOIDS will be assessed, along with the performance characteristics of the algorithm.
SABER provides data management and statistical support for this study.
SLSIII: Scleroderma Lung Study
Principal Investigator: Dinesh Khanna, MD, MSC
Sponsor: Bristol Myers Squibb (BMS)
SLS III is an investigator-initiated clinical research study focused on examining
the combined anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for
treating sclerodera-related interstitial lung disease. This research tests whether
combining pirfenidone and mycophenolate will result in a more rapid and possibly greater
improvement in lung function than when mycophenolate is used alone. While both of
these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat
other medical conditions, neither drug has been FDA-approved for the treatment of
scleroderma-related lung disease. SABER provides project management, clinical monitoring,
data management, software programming, and statistical analysis for this study.Content