Self-reported Usage Patterns of Opioid Analgesic Medications After Surgery



Status:Active, not recruiting
Healthy:No
Age Range:18 - 89
Updated:4/6/2019
Start Date:February 3, 2017
End Date:July 31, 2021

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Improving Opioid Prescription Safety After Surgery

The primary objective of this study is to better understand post-discharge utilization of
prescribed opioid analgesic medications following surgery. A secondary objective of this
study is to gain a better understanding of prevailing modes of storage for opioid
medications.

Hypothesis:

Prescription of medications for analgesia after surgery frequently occurs on an empiric
rather than individualized basis. The investigator will hypothesize that prescribed opioid
medications for analgesia after discharge from the hospital / surgery center are frequently
not taken.

Aims:

i) The descriptive first aim of this study is to define self-reported usage patterns of
opioid analgesic medications at home following surgery.

ii) The descriptive second aim of this study is to define prevailing modes of storage and/or
disposal for opioid medications prescribed to patients after hospital discharge following
surgery.

iii) The analytical second aim of this study is to characterize patients who do not take
significant amounts of their prescribed opioid medications.

Background & Exploratory Objective (s):

Accidents (unintentional injuries) were the 5th leading cause of death among the general
population in the United States in 2010. Among persons 1-44 years of age accidents
represented the leading cause of death. And, within this group, pharmaceuticals were the #1
course of death. Of the 22,134 medication associated deaths in 2010, 75.2% included opioid
analgesics. The trajectory of this development is alarming: Deaths from prescription opioid
overdoses have more than tripled in recent years. Of special concern is that children are
especially vulnerable to unintentional medication overdosing, accounting for 71,224 annual
emergency room visits for this reason from 2004-2005 alone. In addition to the individual
burden from morbidity and mortality, the costs of prescription opioid abuse to society are
immense: The average health care costs for patients abusing opioids are 8 times higher than
for non-abusers. In the United States alone, $55.7 billion were spent on sequelae in the
workplace and in healthcare costs. Accordingly, prescription drug overdosing has been coined
"An American Epidemic" and increasing resources to tackle this rapidly growing public health
problem have been made available on a national (National Institutes of Health, U.S. Food and
Drug Administration) and the state level as part of the Colorado Consortium for Prescription
Drug Abuse created through Governor Hickenlooper's efforts with the National Governors
Association.

Additionally, the prescription of opioids following surgery usually occurs using a "one size
fits all approach", leading potentially to many unused opioids that are then likely to be
utilized in a fashion unintended by prescribing clinician.

The goal of the proposed study is to assess self-reported intake relative to prescribed
amounts of analgesic medications after surgery. Better knowledge of this relationship will
permit the design of tools to individualize analgesic pharmacotherapy after hospital
discharge. The goal is to reduce the amount of opioid prescriptions that are not needed and
to improve non-opioid analgesia.

These data will inform future studies to design more patient-centered opioid prescribing
tools, which are based on anticipated need. This will likely decrease the amounts of
prescribed opioids that are available for non-medical use. Future studies will be aimed to
standardize their use to provide improved analgesia upon discharge following surgery.

Inclusion Criteria:

Adult patients undergoing:

- Cesarean section,

- Gastrointestinal surgery, or

- Thoracic surgery.

Exclusion Criteria:

- Patients under the age of 18 years of age,

- Patients known or suspected to be pregnant at the time of discharge,

- Patients that are prisoners,

- Patients that are decisionally challenged,

- Patients that are blind, and

- Patients that are illiterate.
We found this trial at
1
site
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Karsten Bartels, MD
Phone: 720-848-6752
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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