Project Name:
Effects of Medical Products on Suicidal Ideation and Behavior

Principal Investigator:
Gregory Simon, MD, MPH

Principal Investigator Contact Information: 
gregory.e.simon@kp.org

Principal Investigator Institution:
KP Washington Health Research Institute

Funder:
Food and Drug Administration (FDA)

Funding Period:
9/30/2018 to 9/30/2021

Abstract:
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. 

Specific Tasks include:

  • Augment the existing FDA Sentinel Initiative data infrastructure to support study of severe mental illness, suicidal ideation, and suicidal behavior
  • Evaluate and improve generalizability of models predicting suicidal behavior for use in future observational research and pragmatic trials

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. 

This infrastructure and methods development will enable a robust program of research regarding the effects of medical products on suicidal ideation and behavior, including:

  • Scalable and re-usable methods to assess suicidal ideation and behavior as an adverse effect of existing products
  • Scalable and re-usable methods to assess therapeutic effects of existing products for reducing suicidal ideation and behavior
  • Scalable and re-usable methods to rapidly evaluate possible therapeutic and adverse effects of new medical products on suicidal ideation and behavior
  • Large pragmatic trials to evaluate therapeutic effects of promising new product(s) on suicidal behavior

                 

Grant Number:
N/A

Participating Sites:
Kaiser Permanente Washington
Harvard Pilgrim Healthcare
Kaiser Permanente Northern California
Kaiser Permanente Southern California
Henry Ford Health System                

Investigators:
Gregory Simon MD MPH
Susan Shortreed PhD
Yates Coley PhD
Richard Platt MD MS
Jeffrey Brown PhD
Darren Toh ScD
Jessica Young PhD
Stacy Sterling PhD
Karen Coleman PhD
Jean Lawrence ScD
Brian Ahmedani PhD

Major Goals

  • Augment the existing FDA Sentinel Initiative data infrastructure to support study of severe mental illness, suicidal ideation, and suicidal behavior
  • Evaluate and improve generalizability of models predicting suicidal behavior for use in future observational research and pragmatic trials.

Description of study sample:
Expected to include approximately 4.5 million members of participating health systems.

Current Status:
Initial year of work will focus on data infrastructure development.

Study Registration:
N/A

Publications:
N/A

Resources:
N/A

Lessons Learned:
N/A
What's next?
N/A