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Principal Investigator: ERIC G. SMITH
Organization: EDITH NOURSE ROGERS MEMORIAL VETERANS HOSPITAL
Fiscal Year: 2024
Funding agency: Veterans Affairs
Background: VA use of prescribed stimulants (PS) has been skyrocketing. PS are beneficial for many
Veterans but can also cause serious risks ranging from cardiac problems, psychosis, mania, substance
abuse, and overdose. These risks have not been well-quantified inside or outside of the VA, and because of
Veterans’ high rates of physical and mental health conditions, these risks may be particularly high in
Veterans. PS will be the focus of VA’s next Psychotropic Drug Safety Initiative (PDSI) starting January 2022.
Significance: PS are potent and useful medications, but are not equally safe for all patients. This study will
use the VA’s very large nationwide databases to comprehensively quantify the risks from PS and identify
those patient groups at greatest risk of adverse effects. Thus, this study will help providers decide who to
start on stimulants, and how to manage patients once started. Because of the upcoming initiative, our study
will be useful to the VA as it seeks to improve PS safety and may have rapid impacts on improving care.
Innovation and Impact: This study will provide: 1) the first comprehensive look at the magnitude and
frequency of many PS risks; 2) a unique resource to support VA’s program offices as they set quality
improvement targets and seek to improve PS prescribing practices during and after the PDSI; 3) an
opportunity to confirm or refute the reported association between PS and mortality risks in patients receiving
PS “off label”; 4) the first systematic investigation about events during PS treatment, including tox screens and
the detection of duplicate prescriptions,that may signal increased risks for adverse effects; 5) a chart review
examining whether undiagnosed substance use may contribute to PS risks; 6) development of a risk score to
communicate our findings to providers, and help facilitate their discussions of PS risks with patients.
Specific Aims: Aim 1: Identify Patients at Particular Risk from PS; Aim 2: Identify Other Prescribing
Practices at or after PS Initiation Associated with Increased PS Risks; Aim 3: Develop Risk Scores (RS) to
Facilitate Risk Perception & Collaborative Decision-Making re: PS.
Methodology: This study primarily uses the VA’s large and detailed clinical databases, analyzed by high-
dimensional propensity scores and marginal structural models. These methods help address confounding,
which can sometimes lead to inaccurate conclusions from database information. Some of these methods also
can be implemented rapidly to provide a broad survey of risks, allowing the VA to use Veteran-specific data to
prioritize their safety efforts as the PDSI proceeds. Automated chart extraction concerning duplicate
prescriptions and a manual chart review concerning substance use will add detail to these PS risk
assessments. Risk scores for several different outcomes will be constructed by assessing risk factors identified
in Aim 1 & 2 plus those identified by random forest methods by iterative mixed effects logistic regression
models. The single most useful risk score, or risk score for a composite of several outcomes, will be chosen
with program office input, and this automatically-generated risk score will be formatted similar to VA’s existing
opioid risk score to facilitate similar use of the risk score using the program office’s clinical dashboard.
Next Steps: Given the ongoing PDSI initiative, this study’s findings have the potential to immediately help
Veterans through the team’s close relationship with program offices, who have well-established pathways for
communicating with providers. Since a similar opioid tool is already familiar, follow-up work may include VA
implementation of the risk score through a hybrid trial or, since a similar opioid tool is already in used,
through widespread adoption at VA’s with pre/post data gathering concerning patient safety events. Other
follow-up research may examine areas in which the PDSI did not change practices as much as expected, or
develop new approaches to communicate with providers, or new tools to assist them. This study will
contribute to improving care for thousands of Veterans receiving prescribed stimulants each year.
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