The grant simultaneously supports a groundbreaking comparative effectiveness research study using data from the INPC to compare the benefits and harms of three drugs commonly used to treat Alzheimer’s disease.
Both the infrastructure expansion, already underway, and the research study, Comparative Effectiveness Research Trial of Alzheimer’s Disease Drugs (COMET-AD), which officially commences enrollment this month, will serve as national models.
The INPC enhancement will provide unique insights to regional health information exchanges and a potential national network. Results of the COMET-AD study will offer critical guidance to clinicians, patients and caretakers nationwide.
The grant is one of only 10 Prospective Outcome Systems Using Patient-specific Electronic Data to Compare Tests and Therapies (PROSPECT) awards and advances the highly regarded strengths of the Regenstrief Institute in medical informatics and aging research and the clinical pharmacology expertise of the Indiana University School of Medicine.
Patients participating in the COMET-AD study, will be randomized for treatment with donepezil (Aricept), rivastigmine (Exelon), or galantamine (Reminyl), all Food and Drug Administration- approved treatments for Alzheimer’s disease. No patients will receive a placebo. The approximately 300 study participants will be patients at five memory care practices located within four central Indiana health care systems.
“The INPCcontains more than 3.5 billion medical observations such as laboratory, radiology and other test results and 60 million text documents including operative notes and discharge summaries for more than 11 million patients. It’s a robust resource for patient care and is already used for clinical outcomes and effectiveness research,” said grant principal investigator Paul Dexter, M.D.
“With this support from AHRQ, we are designing and building innovative tools to capture and securely store additional critical information about patient functional status, implanted medical devices like artificial joints, and a wide range of biological data,” said Dr. Dexter, who is a Regenstrief Institute investigator and associate professor of clinical medicine and of knowledge informatics and translation at the IU School of Medicine. “All this will provide insight to researchers and will help clinicians make more informed decisions for their patients and their families.”
Regenstrief Institute investigator Malaz Boustani, M.D., M.P.H., associate professor of medicine at the IU School of Medicine and IU Center for Aging Research center scientist, is the principal investigator of the COMET-AD study.
“COMET-AD focuses on a very vulnerable population – older adults with cognitive problems. Designing and building a health information technology infrastructure to help answer questions for this group with its many co-occurring diseases for which they take a variety of drugs, who have functional symptoms, and who often present with other issues, means we will be able to answer questions that will be relevant for all populations,” said Dr. Boustani, who also is scientific director of the Indianapolis Discovery Network for Dementia.
“And the results of our study will help physicians determine which drug is better for which patient. With the vast amount of information that INPC will provide, we may determine that one drug is best for all patients or we may find that certain patients do better with one drug than another,” said Dr. Boustani.