studies

Effects of Medical Products on Suicidal Ideation and Behavior in Serious Mental Illness

Reducing risk of suicidal behavior is an urgent public health priority. Suicide accounted for approximately 45,000 deaths in the United States in 2016. While most major causes of death have steadily declined, suicide mortality in the US has increased by over 25% in the past 15 years, with greater increases in young people. Increasing rates of suicidal behavior are intertwined with prescription opioid use and opioid overdose. Traditional clinical trials will not be able to enroll large enough nor generalizable enough samples of patients to adequately inform regulation regarding these issues. We propose a comprehensive program of infrastructure development and methods development to support future generation of real-world evidence addressing these critical gaps. The project team will include health systems and embedded research organizations with deep expertise in stakeholder engagement, medical informatics, data science, clinical epidemiology, biostatistics, pragmatic clinical trial methods, implementation science, and innovations in care delivery. This program will be embedded in 4 integrated health systems serving a combined population of approximately 10 million members. This work will be conducted in collaboration with health system and patient/family stakeholders, to assure that methods and evidence developed will actually address real-world questions.

Site Principal Investigator:

Karen J. Coleman, PhD, MS

Funding Source:

Food and Drug Administration (FDA)

Funding Years:

09/30/2018 - 09/30/2021

Population-based diabetes in youth registry: SEARCH for Diabetes in Youth, Phase 4, California Site

The aims of this study are (1) to ascertain prevalent diabetes cases in calendar year 2017 among youth age <20 years at diagnosis, using cost-efficient approaches that maximize use of information in the electronic health records (EHRs) and administrative databases, (2) to continue to ascertain newly diagnosed (incident 2015-2020) diabetes cases in youth age <20 years, using cost-efficient approaches that maximize use of EHRs and administrative databases, (3) to determine agreement between the etiological classification of diabetes type using biochemical markers and provider assessment; to describe selected clinical characteristics at diagnosis, and to establish an infrastructure that facilitates the development of more detailed ancillary studies by storing biological samples and preserving contact with potential study participants, and (4) To optimize efficiency of SEARCH surveillance activities through targeted Development and Validation (D&V) Projects designed to utilize electronic health data to operationalize each of the three tiers of surveillance to the extent possible. (1U18 DP006133)

Principal Investigator:

Jean M. Lawrence, ScD, MPH, MSSA

Funding Source:

Centers for Disease Control and Prevention (CDC)

Funding Years:

2015 - 2020