Center to Improve Veteran Involvement in Care (CIVIC)
Prescription Drug Monitoring Program to Evaluate Concurrent VA and non-VA Opioid Prescriptions
What is the purpose of this Study?
Controlled prescription medication overdose is the leading cause of fatal injury in the United States (US). Opioid analgesics (used to treat chronic pain) are associated with the majority of these overdoses, particularly when combined with benzodiazepines (sometimes used to treat post-traumatic stress disorder [PTSD], or other anxiety or sleep disorders). Veterans who use Veterans Affairs (VA) healthcare have twice the risk of medication overdose deaths than non-Veterans. Reasons for this increased risk are unknown, but theories include the unique health characteristics of Veterans (e.g., combat-related, comorbid physical and mental health disorders) and/or prescribing practices among VA clinicians. It is also possible that large numbers of Veterans who receive VA prescriptions simultaneously receive prescription medications from non-VA prescribers. State prescription drug monitoring programs (PDMPs) are available to help reduce prescription drug overdoses by providing data on dispensing of controlled medications across clinicians and systems.
We are linking together VA data and Oregon state data to study unsafe opioid use among Veterans and to determine what factors contribute to use of state PDMPs among VA clinicians. At the end of this three year study, we hope to have a greater understanding of Veterans' opioid-related fatal and nonfatal injury risk and clinicians' opioid prescribing practices. This research will be used to inform strategies to help save lives and prevent disability.
Who is participating in this Study?
Veterans: We will not be recruiting Veterans for this study. Instead, we will be studying national VA data and Oregon state data that are routinely collected by the VA and the state. We maintain a rigorous process to obtain these data and ensure that all information is kept secure and private. No individually-identifying information for Veterans will be reported; our research focuses on (and we only report) summary statistics for all Veterans combined.
Clinicians: We will be contacting VA clinicians who prescribe opioids to participate in an interview and internet survey. We expect to interview 24 clinicians from four specialties: primary care, pain medicine, psychiatry, and emergency medicine to learn first-hand what their experiences have been when prescribing potentially high-risk medications and/or using the state PDMP. We will then survey a sample of clinicians across VA facilities. The more responses we receive from clinicians, the more valid, and helpful, our research results will be. We will ensure the survey is short so that it will take the least amount of time possible.
If my information is used in this study, is it safe?
Veterans: The databases we are using in this study contain data that could identify Veterans. However, this identifying information is only being used to link across databases. Once databases are linked, personal identifiers will be removed. No data that could identify Veterans will ever be published or shared with non-study staff.
Clinicians: Clinicians' personal identifiers such as names and contact information will be collected and kept only for recruitment and scheduling purposes; these will be stored in locked filing cabinets or on secured, password-protected electronic files behind the VA firewall and separate from any study data. No personal or individual-level information from surveys will be reported. Survey results will be compiled and disseminated in aggregate form only.
To help us protect the privacy of Veterans and clinicians in this study, we have obtained a Certificate of Confidentiality from the National Institutes of Health. The researchers can use this Certificate to legally refuse to disclose information that may identify research participants in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings, for example, if there is a court subpoena. The researchers will use the Certificate to resist any demands for information that would identify research participants. (For more information on the Certificate of Confidentiality, please see below).
How will this study directly help Veterans?
The results of this research will contribute to knowledge on risks of unsafe prescription opioid use among Veterans, and will provide data for VA program offices to develop or expand services to improve use that can fit into routine clinical care and are Veteran-centered and effective. Also, it is possible that clinician participants will be motivated to increase their own use of states' PDMPs, or support PDMP use among others who treat patients with pain, thereby benefitting Veterans' health and safety.
Who is conducting this study?
This study is sponsored by the VA Office of Research and Development, Health Systems Research (HSR) Service. The research team is led by Kathleen Carlson, PhD, Principal Investigator. Dr. Carlson is based at the VA Portland Health Care System in Oregon and has been conducting research on Veterans' post-deployment health for 9 years. (You can read more here: http://www.portlandcoin.research.va.gov/people/index.asp.) Assisting her in Portland is Cody Goheen, Research Coordinator; Tess Gilbert, MHS, Senior Research Associate; and Kelly Reavis, MPH, Graduate Research Assistant.
Photo of Kelly Reavis, Cody Goheen, Kathleen Carlson, and Tess Gilbert
Other Study Team Members include:
Lawrence J. Cook, PhD, Statistician, University of Utah
Benjamin Morasco, PhD, Psychologist and Research Investigator, VA Portland Health Care System
Thomas Meath, MPH, Data Analyst, VA Portland Health Care System
J. Lucas Williams, MPH, Programmer, VA Portland Health Care System
Who can I contact for more information?
If you have any questions about this study, please contact:
Kathleen Carlson, PhD, Principal Investigator
(866) 949-1004, extension 52094
Kathleen.carlson@va.gov
Certificate of Confidentiality
The Certificate cannot be used to resist a demand for information from personnel of the United States federal or state government agency sponsoring the project and that will be used for auditing or program evaluation of agency funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA). Study participants should understand that a Certificate of Confidentiality does not prevent a study participant or a member of the study participant's family from voluntarily releasing information about him/herself or his/her involvement in this research. If an insurer, medical care provider, or other person obtains the study participant's written consent to receive research information, then the researchers will not use the Certificate to withhold that information.
The Certificate of Confidentiality will not be used to prevent disclosure to state or local authorities of child abuse and neglect or harm to self or others.
