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PPO 20-121 – HSR Study

PPO 20-121
Identifying Risk Factors for New Persistent Opioid Use Among Veterans Following Treatment for Early Stage Cancer
Marilyn M. Schapira, MD MPH
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, PA
Funding Period: October 2020 - March 2022


Background: Veterans are at higher risk of cancer than the general population due to older age, higher chronic tobacco use, alcohol use, environmental exposures, and other behavioral risk factors. Veterans who are diagnosed and treated for early stage cancer may expect long-term survival but face adverse effects of treatment including the risk of new persistent opioid use and related adverse outcomes including opioid use disorder. Veterans may be at higher risk for these outcomes given their high prevalence of mental health conditions including post-traumatic stress disorder (PTSD) and substance use disorder (SUD). Significance/Impact: The prevalence of cancer survivors in the Veteran population is increasing. It is essential that Veterans receive adequate pain management during cancer treatment but also that the long- term risks associated with chronic or unsafe prescription opioid use be minimized. The Centers for Disease Control (CDC) and the Veterans Health Administration/Department of Defense (VHA-DoD) have developed guidelines for safe use of prescription opioids but those guidelines exclude patients with cancer. It is essential to elucidate the pattern of and risks associated with prescription opioid use in this population and understand the risk factors associated with adverse outcomes. These findings can inform future guidelines and practice. Innovation: This study is innovate in seeking to describe the trajectory of opioid prescribing practices and the associated outcomes in a Veteran population treated for early stage cancer. Veterans have a distinct risk profile including a higher prevalence of mental health conditions including substance abuse that will inform the design of this study. The study is also innovative in examining these outcomes among Veterans dual enrolled in VA and Medicare Part D pharmacy benefits. Finally, the study is innovative in examining these outcomes across a range of cancer types that are common in the VA population. Specific Aims: The specific aims of this study are 1) to determine the incidence and patterns of new persistent opioid use, unsafe opioid prescribing practice, and associated adverse outcomes among Veterans in the 13 months following the treatment of early stage cancer, and 2) to identify factors associated with higher rates of new persistent opioid use and unsafe opioid prescribing patterns in this population. Methodology: This is a retrospective cohort study of Veterans who were diagnosed with cancer in the period 1/1/2015 to 12/31/2016. Eligibility criteria will include age 21 years and older, a new diagnosis of early stage cancer of the prostate, bladder, lung, oropharynx, colon, rectum, esophagus, stomach, liver, pancreas, or soft tissue (sarcoma), receipt of a definitive surgical procedure, and opioid naïve in the 12 months to 31 days prior to the index surgery. Outcomes will include new persistent opioid use, unsafe opioid prescribing practices, opioid use disorder, opioid overdose, and non-overdose opioid adverse events. Exclusion criteria will include enrollment in hospice prior to the index surgical procedure. Data sources will include the Corporate Data Warehouse (CDW) inpatient, outpatient, pharmacy, and Oncology raw files, Veterans Affairs/Centers for Medicare and Medicaid Services (VA-CMS) Data, and the VA Suicide Data Repository. A sub-analysis will be conducted among subjects who are dual enrolled in VA and Medicare Part D pharmacy benefits. Next Steps/ Implementation: The results of this study will inform the design and implementation of decision support tools for pain management for Veterans with early stage cancer. Results may also inform clinical post- surgery clinical guidelines for patients with cancer. However, we first need to better quantify and understand the extent of the problem, who is at greatest risk, and how best to ameliorate the risk. To ensure that our work is informed by the needs of the VA, we will collaborate with the VHA National Program for Addictive Disorders in Mental Health Services and consult with VA leaders in opioid stewardship for surgical procedures. The overarching goal of our program is to improve the quality of life among Veterans who are cancer survivors.

External Links for this Project

NIH Reporter

Grant Number: I21HX003273-01

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None at this time.

DRA: Substance Use Disorders, Cancer
DRE: TRL - Applied/Translational, Treatment - Implementation
Keywords: Cancer, Pain, Pharmacology
MeSH Terms: None at this time.

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